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Contacts and department numbers
About SIDC
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Scope of activities
Instructions
Contact
Medical Devices
Scope of activities
Instructions
List of registered / announced medical devices, codes and economic operators from 1.1.2018
Contact
Links
Pharmacopoeia
Pharmacopoeia department
Main menu
State Institute for Drug Control
Medicine
Medical devices
Clinical Trials
Legal basis (all)
Article 10a well-established use application
Samostatná úplná na experimentálnych údajoch do 2003
Odkazovaná žiadosť (liek rovnocenný s liekom registrovaným v EÚ)
Article 10(1) generic application
Odkazovaná žiadost s rozdielmi v porovnaní s referencným liekom (hybridná)
Nová kombinácia známych liečiv (fixná kombinácia)
Odkazovaná žiadost - liek podobný s biologickým referencným liekom (biosimilar)
Homeopatikum - samostatná úplná
Homeopatikum - zjednodušený postup
Samostatná úplná – nové liečivo
Originálny prípravok
Odkazovaná ž. s rozdielmi v porovaní s liekom registrovaným v SR - rovnaký
Žiadost so súhlasom držitela registrácie lieku (informovaný súhlas)
Tradičný rastlinný liek
Samostatná úplná – známe liečivo
zatiaľ nedefinované
Všetky typy registrácie
Decentralised
EU
EU Orphan
Mutual recognition procedure
National
?
All indication groups
ANAESTHETICA (LOKÁLNE)
AMINOACIDA
ANAESTHETICA (CELKOVÉ)
PSYCHOSTIMULANTIA (NOOTROPNE LIEČ., ANALEPTIKA)
ANALGETICA, ANTIPYRETICA
ANOREXICA
ANTACIDA (VRÁTANE ANTIULCEROSNYCH LIEČIV)
ANTHELMINTICA
ANTIANAEMICA
ANTIARRYTHMICA
BRONCHODILATANTIA, ANTIASTHMATICA
ANTIBIOTICA (PROTI MIKROB. A VÍRUSOVÝM INFEKCIAM)
ANTICOAGULANTIA (FIBRINOLYTICA, ANTIFIBRINOL.)
ANTICONCIPIENTIA
ANTIDIABETICA (VRÁTANE INZULÍNU)
ANTIDOTA, DETOXICANTIA
ANTIEMETICA, ANTIVERTIGINOSA
ANTIEPILEPTICA, ANTICONVULSIVA
ANTIHAEMORRHOIDALIA
ANTIHISTAMINICA, HISTAMIN
ANTIPARASITICA (ANTIPROTOZOICA, ANTIMALARICA)
ANTIMYCOTICA (LOKÁLNE A CELKOVÉ)
ANTIPARKINSONICA
ANTIRHEUMATICA, ANTIPHLOGISTICA, ANTIURATICA
ANTIDEPRESSIVA
HYPOLIPIDAEMICA
ANTISEPTICA, DESINFICIENTIA (LOKÁLNE)
ANTIMIGRAENICA,ANTISEROTONICA
ANTIHORMONA
ANTITUSSICA
SOLI A IONTY PRO P.O. A PARENT. APLIKÁCIU
CARDIACA
CHEMOTHERAPEUTICA (VRATANE TUBERKULOSTATIK)
CHOLERETICA, CHOLEKINETICA
CYTOSTATICA
DERMATOLOGICA
DIAETETICA
DIAGNOSTICA
DIGESTIVA, ADSORBENTIA, ACIDA
DIURETICA
EXPECTORANTIA, MUCOLYTICA
PARASYMPATHOLYTICA, GANGLIOPLEGICA
GYNAECOLOGICA
HORMONA (LIEČIVA S HORMONÁLNOU AKTIVITOU)
HYPNOTICA, SEDATIVA
HYPOTENSIVA
IMMUNOPRAEPARATA
LAXANTIA
MYORELAXANTIA
OPHTHALMOLOGICA
ANALGETICA - ANODYNA
PARASYMPATHOMIMETICA
ANTIPSYCHOTICA (NEUROLEPTICA)
OTORHINOLARYNGOLOGICA
ANXIOLYTICA
SPASMOLYTICA
SUBSTITUTIO SANGUINIS (A KRVNÉ DERIVÁTY)
INFUNDIBILIA
SYMPATHOLYTICA
SYMPATHOMIMETICA
HEPATICA
UTEROTONICA
VASODILATANTIA
VASOPRESSORICA
VENOPHARMACA, ANTIVARICOSA
VITAMINA, VITAGENA
VARIA I
RADIOPHARMACA
MULTIVITAMÍNY A STOPOVÉ PRVKY
TRADIČNÉ RASTLINNÉ LIEKY
HOMEOPATICA
FYTOPHARMACA
STOMATOLOGICA
Všetky
Yes
No
?
Všetky
Yes
No
?
Všetky druhy výdaja
Medicinal product not subject to medical prescription.
Medicinal product subject to medical prescription.
Medicinal product subject to restricted medical prescription.
Medicinal product subject to special medical prescription with skew blue stripe.
Unknown
Yes
No
?
All groups
?
A
B
D
F
G
H
I
J
K
L
N
O
P
Z
?
Všetky liečivá
(034 UNIMED)
(AAI101)
(AB1010)
(ABP 980)
(AFQ056)
(AllerT)
(ALX-0171)
(AMG 073)
(AMG 334)
(AZD4831)
(AZD5423)
(AZD8233 solution for injection)
(AZD8233)
(AZD9291)
(AZD9833 - 25 mg)
(BAY 2395840)
(BAY 2433334)
(BI 1358894)
(BI 425809)
(BI 456906)
(BI 695501)
(CJM112)
(CP-690
(CRN00808)
(CSJ117)
(DFV890)
(DP-b99)
(EMD 525797)
(Epanova)
(G321605)
(GED0507)
(GSK1605786A)
(GWP42003-P)
(Imunor)
(LASAG (composition of Aspirin iv 500mg))
(LCZ696)
(LIK066)
(LJN452)
(Lu AE58054)
(Lu AF41156/OPC-34712)
(LY2605541)
(LY3009104)
(LYS006)
(MEK162 15mg)
(MOD-4023)
(MPSK3169A (RO6801831))
(MSB0010841)
(NAI-Acne 3% gel)
(NIS793)
(nitisinone)
(Not applicable)
(NT 201)
(PF-00547659)
(PF-04937319 )
(PF-04937319)
(PF-04950615)
(PF-05208773)
(PF-05285401)
(PF-06651600)
(PH-797804)
(PR-171)
(PRCL-02)
(Prevenar 13)
(Propolis Cream 0
(QGE031)
(ramucirumab)
(RO4917838/F18)
(RO4995819/F04)
(RO6867461)
(RT001)
(RVT-101)
(S06593)
(S066913)
(S38844)
(S42909)
(S47445)
(SAR292833)
(SAR442168)
(SFC 50/100 mcg)
(SFC DISKUS 50/100 mcg)
(Sch 418131
(SLN360)
(SM-13496)
(Sublingual tablet of HDM Allergen Extracts)
(SYL1801 sodium)
(TAK-875)
(TD-1473)
(TH-302)
(TV-1106)
(V565)
(VTX002)
(VX-509)
(VX-661)
(Y010218)
80 mg)
ABT-267 (ABT-450/ritonavir/ABT-267)
AMISULPRIDE (SEP-4199 -100mg)
AMLODIPINE BESILATE (S05179)
AVIBACTAM (CAZ AVI)
avibactam (CAZ104)
Avibactam sodium
BISOPROLOL FUMARATE
Carbidopa
carbidopa (ND0612)
CEDAZURIDINE (ASTX727)
Cefepime Hydrochloride (cefepime-enmetazobactam)
Clofazimine (RHB-104)
DECITABINE (ASTX727)
Dermatophagoides farinae allergen extract (STG320)
DERMATOPHAGOIDES FARINAE EXTRACT (HDM SLIT-tablet)
Diclofenac (ProF-001)
diphtheriae anatoxinum
Ethinylestradiol (E)
ETHINYLESTRADIOL (LPRI-424)
Fluticasone Propionate (Fluticasone Propionate/Formoterol Fumarate Inhalation Suspension)
formerly KH902)
Formoterol
Formoterol (LAS40464)
FORMOTEROL FUMARATE
Formoterol Fumarate (PT010A)
FORMOTEROL FUMARATE DIHYDRATE
formoterol fumarate dihydrate (K-haler)
Galicaftor
Galicaftor (ABBV-2222)
Glycopyrronium bromide
GLYCOPYRRONIUM BROMIDE (CHF 5993 pMDI)
Glycopyrronium bromide (CHF 5993)
GLYCOPYRRONIUM BROMIDE (CHF5993 pMDI)
GLYCOPYRRONIUM BROMIDE (QVA149)
GLYCOPYRRONIUM BROMIDE (QVM149)
Golimumab (JNJ-78934804)
hard (BUX-PVII prototype))
inactivated) (QIV (Quadrivalent Influenza Vaccine))
INDACATEROL MALEATE (QVA149)
INDAPAMIDE
INSULIN GLARGINE (HOE901/AVE0010)
INSULIN GLARGINE (Insulin glargine/lixisenatide)
insuline glargine (Lantus/AVE0010)
inzulín lispro
Iptacopan (LNP023)
Ivacaftor (VX-445/TEZ/IVA)
Levodopa (Accordion Pill™ Carbidopa/Levodopa 50/400 mg)
Levodopa (Immediate Release carbidopa/levodopa 25/100 mg)
LIRAGLUTIDE
LIRAGLUTIDE (Insulin degludec liraglutide PDS290)
LIRAGLUTIDE (Insulin degludec liraglutide V2 PDS290)
Live attenuated mumps virus (RIT4385 strain)
Live attenuated rubella virus (Wistar RA 27/3 strain) (209762)
lumateperone tosylate (salt); lumateperone (free base) (ITI-007)
masitinib (AB1010)
masitinib mesylate (AB1010)
MK-0887A)
MOMETASONE FUROATE
MOMETASONE FUROATE (QMF149)
MVT-601 (previously TAK-385)
Naloxone hydrochloride dihydrate (OXN 10/5mg)
Not available (Meropenem/RPX7009)
NYSTATIN
Olodaterol (Ba 679/BI 1744)
olodaterol (Tiotropium 2.5μg/Olodaterol 2.5μg)
OPC-347112)
OPC-34712)
pGX3002 (VGX-3100)
PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 10A
PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 11A
PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 12F
PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 14
PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 15B
PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 18C
PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 19A
PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 19F
PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 22F
PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 23F
PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 3
PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 33F (PF-06482077)
PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 4
PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 5
PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 6A
PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 6B
PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 7F
PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 8
PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 9V
POLYMYXIN B SULFATE
potassium bicarbonate (ADV7103)
Quinidine sulfate (AVP-786)
Rifabutin
RITONAVIR
ROSUVASTATIN (EXT1036A)
RVT-901)
SALBUTAMOL SULFATE (PT027)
Samidorphan L-Malate (ALKS 3831)
SEMAGLUTIDE (IcoSema 700 U/ml + 2 mg/mL PDS290)
solution for injection)
T-1331285)
TAZOBACTAM (CXA-201)
Tazobactam Sodium (CXA-201)
tepotinib (MSC2156119J)
tetani anatoxinum
Tezacaftor
TIPIRACIL HYDROCHLORIDE (S95005)
Tramadol (DKP.TRIS + TRAM.HCl)
Tregalizumab
Tregalizumab (BT061)
Trospium chloride (KarXT)
Umeclidinium
VILANTEROL (GSK573719+GW642444)
Vilanterol Trifenatate (GSK2834425)
Zidebactam (WCK 5222 (FEP-ZID))
Zolmitriptan (JM-010)
- (LY2484595)
- (SENS-401)
(+)-α-dihydrotetrabenazine (ADE513)
2- a]pyridin-3- yl)methyl)morpholine-4-carboxylate (BLU-5937)
5%)
550-10 )
550-10)
550)
555)
6-difluoro-4-(methylcarbamoyl)phenyl)-7-methylimidazo[1
A modified house dust mite extract from Dermatophagoides pteronyssinus and Dermatophagoides farinae (PURETHAL® Mites)
AADvac1 (AADvac1)
ABBV-154 (ABBV-154)
ABIRATERONE ACETATE (JNJ 212082 )
Abrocitinib (Abrocitinib Tablets)
Abrocitinib (PF-04965842)
ABT 494 (ABT 494 3mg)
ABT-450
ABT-450 (ABT-450)
ABT-494 (ABT-494)
ABX464 (ABX464)
ACALABRUTINIB (ACP-196)
ACLIDINIUM BROMIDE
acotiamide (Z-338)
ADALIMUMAB (331731-18-1)
Adalimumab (adalimumab)
ADALIMUMAB (GP2017)
ADALIMUMAB (CHS-1420)
ADALIMUMAB (M923)
adrenomedullin pegol (BAY 1097761)
adriforant (ZPL389)
AF35700 (AF35700)
AF35700 (Lu AF35700)
AFLIBERCEPT (ABP 938)
Aflibercept (Aflibercept)
Aflibercept (ALT-L9)
Aflibercept (AVT06)
AFLIBERCEPT (BAY 86-5321)
AFLIBERCEPT (CT-P42)
AFLIBERCEPT (Eylea)
Aflibercept (SCD411)
AFLIBERCEPT (SOK583A1)
AGOMELATINE (S20098)
AKST4290 (AKST4290)
Albutropin (TV-1106)
ALE.F02 (ALE.F02)
Alectinib (RO5424802)
Alirocumab (REGN727/SAR236553)
Alirocumab (SAR236553 (REGN727))
ALISKIREN (SPP100)
Allergen extract of Betula verrucosa (SUBLIVAC FIX Birch)
ALPELISIB
ALPELISIB (BYL719)
Aluminium hydroxide (AD04)
Ambrisentan (N-003)
AMIFAMPRIDINE PHOSPHATE
amiselimod (MT-1303)
AMISULPRIDE
Anacetrapib (MK-0859)
Anti-MAdCAM antibody (PF-00547659)
apabetalone (RVX000222)
Apalutamide
Apalutamide (ARN-509)
Apalutamide (JNJ-56021927)
APIXABAN (BMS-562247)
Apolipoprotein A-I [human] (CSL112)
Apraglutide (TA799)
ARIPIPRAZOLE (OPC-14597)
ASCIMINIB (ABL001)
Asundexian (BAY 2433334)
ATEZOLIZUMAB
Atezolizumab (Ro 554-1267/F03-01)
ATEZOLIZUMAB (RO5541267)
ATEZOLIZUMAB (RO5541267/F03)
ATEZOLIZUMAB (TECENTRIQ)
Aticaprant (JNJ-67953964)
Atorvastatin calcium trihydrate (A)
Atrasentan (ABT-627)
ATROPINE SULFATE (OT_101)
Atropine Sulfate (SYD-101 0.01%)
Atuliflapon (AZD5718)
avacincaptad pegol (ARC1905)
AVELUMAB (MSB0010718C)
AZACITIDINE (Azacitidine Teva 25mg/ml Powder for Suspension for Injection)
AZD5069 (AZD5069)
AZD9977 (AZD9977)
Azoximer bromide
BALUGRASTIM (Balugrastim)
BARICITINIB
BARICITINIB (LY3009104)
Batoclimab (IMVT-1401)
Bazedoxifene (BAZE-X1)
BCX7353 (BCX7353)
BCX9930 (BCX9930)
BECLOMETASONE DIPROPIONATE
BELIMUMAB (L04AA26)
BEMPEDOIC ACID (ETC-1002)
benralizumab (MEDI-563)
berotralstat (BCX7353)
Betahistine dihydrochloride (AM-125)
Betrixaban Maleate (Betrixaban Maleate IR Capsules
BETULA VERRUCOSA (108) POLLEN EXTRACT
BEVACIZUMAB
BEVACIZUMAB (PF-06439535)
BEVACIZUMAB (RO4876646/F02)
Bevacizumab Biosimilar (HD204)
BEZAFIBRATE (B0)
BI 1015550 (BI 1015550)
BI 690517 (BI 690517)
BI 695500 (BI 695500)
BILASTINE (Bilastine 10 mg orodispersible tablets)
BILASTINE (Bilastine ophthalmic solution 0.6%)
BILASTINE (Bilastine)
BIMATOPROST (T4032)
Bimekizumab (UCB4940)
Binimetinib
binimetinib (MEK162)
Birch pollen allergen extract
BLINATUMOMAB
BMS986165 (BMS-986165)
Bosutinib
Botulinum-Toxin Type A (NT 201)
BRAZIKUMAB (MEDI2070)
Brensocatib (INS1007)
Brentuximab vedotin (SGN-35)
brepocitinib (PF-06700841 5mg)
BREXPIPRAZOLE (Brexpiprazole (OPC-34712))
Brexpiprazole (Lu AF41156
Brexpiprazole (Lu AF41156/ OPC-34712)
Brexpiprazole (OPC-34712)
BRIVARACETAM
brodalumab (AMG 827)
BROLUCIZUMAB
BT-11 (BT-11)
Budesonide
BUDESONIDE (Budenofalk® suppositories (BUS))
BUDESONIDE (Budesonide 9 mg prolonged-release capsules
BUDESONIDE (Symbicort HFA pMDI 80/4.5)
Bumetanide (S95008)
buparlisib (BKM120)
Buspirone hydrochloride
BUSULFAN
cabazitaxel (XRP6258)
Cabozantinib (XL184)
Cadazolid (ACT-179811)
Cagrilintide (Cagrilintide A 10 mg/mL catridge)
Calcifediol Monohydrate (Calcifediol monohydrate)
Camizestrant (AZD9833- 25 mg)
CANAGLIFLOZIN (JNJ-28431754-ZAE)
CANAGLIFLOZIN (JNJ-28431754)
CANAKINUMAB (ACZ885)
Cangrelor tetrasodium
capivasertib (AZD5363)
capsaicin (N/A)
Carbidopa
carfilzomib
Carfilzomib (PR-171)
Cariprazine (Cariprazine)
Cariprazine HCL (RGH-188)
CASPOFUNGIN ACETATE
cat-PAD (Not applicable)
Cebranopadol (GRT6005)
CEDAZURIDINE
CEFEPIME HYDROCHLORIDE
Ceftaroline fosamil (ceftaroline fosamil powder for concentrate for solution for infusion)
Ceftazidime pentahydrate
Ceftobiprole medocaril (Ceftobiprole medocaril)
Ceftolozane
cemiplimab (REGN2810)
CENOBAMATE (YKP3089)
CICLOSPORIN (PADciclo 0.06%)
CICLOSPORIN (T1580)
Cilgavimab (AZD1061)
Cinacalcet (AMG 073)
Ciprofloxacin (BAYQ3939)
CISPLATINA (cisplatina)
CLADRIBINE (Cladribine)
Clarithromycin
CLOSTRIDIUM BOTULINUM TOXIN TYPE A (BTX-A-HAC NG)
Clotrimazole
COBITOLIMOD (Cobitolimod)
COLISTIMETHATE SODIUM (Colistimethate sodium (CMS))
Conbercept (KH916
concentrate of proteolytic enzymes enriched in bromelain (NexoBrid)
concizumab (Concizumab C 100 mg/mL PDS290)
CONESTAT ALFA (Ruconest)
Copanlisib (BAY84-1236 )
Copanlisib (BAY84-1236)
cotadutide (MEDI0382)
Crizotinib (PF-02341066)
CXA-101
CYCLOPHOSPHAMIDE
dabigatran etexilate (BIBR 1048 MS )
DABIGATRAN ETEXILATE (BIBR 1048 MS)
dabrafenib (DRB436)
Dalcetrapib (Dalcetrapib)
DANICOPAN (ALXN2040)
Danoprevir (RO5190591/F24)
dapagliflozin (BMS-512148)
DAPAGLIFLOZIN PROPANEDIOL (Dapagliflozin)
DAROLUTAMIDE (BAY 1841788)
DCVAC/LuCa (DCVAC/LuCa)
DCVAC/PCa (DCVAC/PCa)
DECITABINE
DECITABINE (Decitabine)
DEFERASIROX (ICL670)
Degarelix
Delafloxacin meglumine (RX-3341-83)
Delgocitinib (Delgocitinib)
Denosumab (AMG 162)
Denosumab (TVB-009 (denosumab) solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS) (TVB-009P))
DEQUALINIUM CHLORIDE
Dermatophagoides pteronyssinus allergen extract
DERMATOPHAGOIDES PTERONYSSINUS EXTRACT
Deudextromethorphan Hydrobromide
Deuterium depleted water (DDW) (Depletin)
Deutetrabenazine (SD-809)
Dexketoprofen
Dextrose Monohydrate (APHD-012)
DIENOGEST
DIGAMOLENIC ACID and DIGAMOLENATE (DS107E DGLA Cream)
DIGOXIN IMMUNE FAB (OVINE) (AMAG-423 )
Dimethyl Fumarate (BG00012)
dinaciclib (MK-7965/SCH 727965)
DINUTUXIMAB (Dinutuximab)
DISULFIRAM
DISULFIRAMUM (disulfiramum)
do not established yet (QGE031)
DOXORUBICIN HYDROCHLORIDE (Doxorubicin)
Doxycycline Hyclate (NA)
Drospirenone
Drospirenone (LF111)
DROSPIRENONE (LPRI-CF113)
Dulaglutide
Dulaglutide (LY2189265)
Duloxetine hydrochloride (D)
Dupilumab (REGN668/SAR231893)
Dupilumab (SAR231893)
durvalumab (MEDI4736)
EDARAVONE (MCI-186)
Edoxaban
EDOXABAN (as anhydrous free form) (DU176b)
EDP-938 (EDP-938)
Efavaleukin alfa (AMG 592)
EFGARTIGIMOD ALFA (Efgartigimod PH20 SC)
Efpeglenatide (SAR439977)
Elenbecestat (E2609)
Elexacaftor
Eliapixant (BAY 1817080 25 mg tablets)
Elinzanetant (BAY 3427080 (formerly NT-814))
Elobixibat (Elobixibat)
ENCORAFENIB
Encorafenib (PF-07263896)
Enmetazobactam
Ensifentrine (RPL554)
ENTRECTINIB (RO7102122 - F04/F06/F10/F14/F24)
ENZALUTAMIDE
ENZALUTAMIDE (MDV3100)
Epcoritamab (ABBV-GMAB-3013)
EPOETIN ALFA (APO-EPO)
EPTINEZUMAB (ALD403)
EPTINEZUMAB (Eptinezumab)
ERAVACYCLINE (TP-434)
ERENUMAB (AMG334)
ertugliflozin (MK-8835)
Ertugliflozin (PF-04971729 / MK-8835)
Esketamine (for (S)-2-(o-chlorophenyl)-2-(methylamino)cyclohexanone) (Esketamine - Nasal Solution - eq 140mg/mL esketamine base (eq 161.4 mg/mL esketamine HCl))
ESKETAMINE Esketamine (for (S)-2-(o-chlorophenyl)-2-(methylamino)cyclohexanone) (Esketamine - Nasal Solution - eq 140mg/mL esketamine base (eq 161.4 mg/mL esketamine HCl))
ESLICARBAZEPINE ACETATE (BIA 2-093)
ESTETROL (E4)
Estetrol monohydrate (Estetrol (E4))
ETANERCEPT (Etanercept)
ETANERCEPT (GP2015)
etrasimod L-arginine (APD334)
Etrolizumab (Ro 549-0261/F04-02)
ETROLIZUMAB (Ro 549-0261/F04)
Everolimus (RAD001)
EVOBRUTINIB (M2951)
EVOLOCUMAB
EVOLOCUMAB (AMG 145)
EVP-6124 (EVP-6124)
EXENATIDE ( ITCA 650 20 mcg/day)
EXENATIDE (Exenatide)
EZETIMIBE
Faricimab (RO6867461)
FASIGLIFAM (TAK-875 25mg)
FASIGLIFAM (TAK-875 50mg)
FENEBRUTINIB (RO7010939)
Fesoterodine Fumarate
fevipiprant (QAW039)
FEZOLINETANT (ESN364)
FILGOTINIB (GS-6034)
FILGRASTIM (EP2006)
Finerenone (BAY 94-8862 coated tablet 10 mg)
FINERENONE (BAY 94-8862 IR tablet 10 mg)
fingolimod (FTY720)
Firibastat (QGC001)
FluBHPVE6E7 (FluBHPVE6E7)
FLUTICASONE FUROATE
fluticasone propionate
Formoterol Fumarate
Formoterol Fumarate dihydrate (FOR258)
FOSFOMYCIN
Fovista (E10030)
Fulranumab (JNJ-42160443)
FULVESTRANT (ZD9238)
G1T28 Di-HCl (G1T28)
G1T28 x 2HCl (G1T28)
Gadopiclenol (gadopiclenol(form.G03277.066 &G03277.100))
Galicaftor
GALICAFTOR (ABBV-2222)
gallium (68Ga) gozetotide (AAA517)
gallium (68Ga) NODAGA-RGD (IASON RGD 20 MBq/mL
GEMCITABINE (C79325)
GENTAMICIN SULFATE (Cogenzia)
Gepotidacin (GSK2140944)
GEVOKIZUMAB (S78989)
Giredestrant (Ro 719-7597/F18)
Glenzocimab (ACT017)
GLYCOPYRRONIUM BROMIDE
GLYCOPYRRONIUM BROMIDE (Glycopyrronium bromide 1mg/5ml)
GLYCOPYRRONIUM BROMIDE (NVA237)
GLYCOPYRRONIUM BROMIDE (NVA237B)
GOLIMUMAB (SCH 900259)
GS-5745 (GS-5745)
GSK1605786A (GSK1605786A)
GSK573719/vilanterol (GSK573719/vilanterol)
Guselkumab
Guselkumab (CNTO1959)
hexyl aminolevulinate hydrochloride (P-1206)
HTL0018318 (HTL0018318.HCl)
Human allogenic liver-derived progenitor cells (HALPC)
Human Immunoglobulin (KIg10)
Human normal immunoglobulin (HyQvia)
Human normal immunoglobulin (HyQvia)
Human normal immunoglobulin (KIOVIG)
Human Normal Immunoglobulin (Octanorm 16.5%)
CHLOROPROCAINE (Chloroprocaine 3%)
IANALUMAB (VAY736)
ibodutant (MEN15596)
ibrutinib
Ibrutinib (JNJ-54179060)
idarucizumab (BI 655075)
IFOSFAMIDE (ifosfamide)
IMATINIB MESILATE (Imatinib)
INCLISIRAN (KJX839)
indacaterol
INDACATEROL ACETATE
Indacaterol acetate (QAB149)
INDACATEROL MALEATE
INFLIXIMAB (CT-P13)
INFLIXIMAB (Remsima (CT-P13))
Influenza vaccine (surface antigen
INN not yet assigned (THR-149)
Inosine Acedoben Dimepranol (IAD) (Isoprinosine)
INOTUZUMAB OZOGAMICIN (Besponsa)
Insulin Aspart
INSULIN ASPART (FIAsp 3ml PDS290)
INSULIN DEGLUDEC
Insulin Efsitora Alfa (LY3209590)
INSULIN GLARGINE (HOE901 - U300)
INSULIN GLARGINE (HOE901-new formulation)
INSULIN GLARGINE (Mylan's Insulin glargine)
Insulin icodec
insulin icodec (insulin icodec 700 U/mL PDS290)
INSULIN LISPRO (LY900014)
Iptacopan
Iptacopan (LNP023)
IRAK 4 (PF-06650833)
isatuximab (SAR650984)
Iscalimab (CFZ533)
ISIS 449884 (ISIS 449884)
ISIS 678354 (ISIS 678354)
Itepekimab (SAR440340)
IVABRADINE (S16257)
Ivermectin (Ivermectin 9 mg tablets)
IXEKIZUMAB (LY2439821)
K0706 (K0706)
L-carnitine propyl hydrochloride (ST 261)
LACOSAMIDE (lacosamide)
LACOSAMIDE (SPM927)
Lampalizumab (Ro 549-0249/F03-01)
Lampalizumab (Ro5490249/F03- 01)
Lanicemine (AZD6765 )
LAQUINIMOD (TV-5600)
Larotrectinib (BAY 2757556)
LEBRIKIZUMAB (RO5490255/F01-01)
LEBRIKIZUMAB (RO5490255/F01-02)
Lenabasum (JBT-101)
Leuprolide Mesylate (LMIS 25 mg)
LEUPROLIDE MESYLATE (LMIS 50 mg)
LEUPRORELIN
Levodopa
LIGELIZUMAB (QGE031)
Lipefilgrastim (XM22)
LIPEGFILGRASTIM
litifilimab (BIIB059)
Live attenuated measles virus (Schwarz strain)
Lixisenatide
Lixivaptan (0C23)
Lonapegsomatropin (ACP-011)
Losmapimod (GW856553)
Lumacaftor (VX-809)
Lumicitabine (JNJ-64041575)
Lurasidone (SM-13496)
Lurasidone Hydrochloride (SM-13496)
LX4211 (LX4211)
LY2605541
LY3209590 (LY3209590)
LY3298176 (LY3298176)
LY3361237 (LY3361237)
LY3471851 (LY3471851)
LY3502970 (LY3502970)
M2951 (M2951)
macimorelin (AEZS-130)
MACITENTAN (JNJ-67896062 / ACT-064992)
Mannitol (Bronchitol)
masitinib
Masitinib mesilate (AB1010)
masitinib mesylate
masitinib mesylate (AB1010 )
masitinib mesylate (AB1010)
mavoglurant (AFQ056)
mavrilimumab (CAM-3001)
melphalan flufenamide hydrochloride (Melflufen)
Mepolizumab (SB-240563)
Mericitabine (RO5024048/F14)
Meropenem
MESALAZINE
MESALAZINE (SPD476)
MESALAZINE (TP05)
METFORMIN HYDROCHLORIDE
Methyl (S)-2-((2-(2
Metoprololi tartras (M)
Micronized purified flavonoic fraction (S05682)
Micronized purified flavonoid fraction (S05682)
MIDODRINE HYDROCHLORIDE (SPD426)
midostaurin (PKC412)
MIJ821 (MIJ821)
MIRABEGRON (Mirabegron)
mirabegron (YM178)
MIRIKIZUMAB (LY3074828)
Mirogabalin (DS-5565)
MOLGRAMOSTIM (Molgramostim 300 mcg nebuliser solution)
mometasone fuorate (MF)
Mongersen (GED-0301)
Monoclonal antibody TB-403 (THR-317)
MT-1303 (MT-1303)
MT-3995 (MT-3995)
N Acetyl L leucine (IB1001)
N-(3-MORPHOLIN-4-YLPROPYL)-4-SULFANOYLBENZAMIDE HYDROCHLORIDE (XUN 034)
N-Acetyl-L-Leucine (IB1001)
N/A (PF-06425090)
N/A (0114-0006B)
N/A (ATB200)
N/A (BAY 1817080 25mg tablets)
N/A (GX-H9)
N/A (LMTM/TRx0237)
N/A (NNC0148-0287 C 4200 nmol/mL)
N/A (NNC0194-0499 B 50 mg/mL)
N/A (NNC0365-3769 B 5 mg/mL)
N/A (RA101495)
N/A (RO7102122)
N/A (RO7223280)
N/A (RO7247669/F01-01)
N/A (VTX958)
N/A (Ziltivekimab B 15 mg/mL DV3430-C1)
Nacubactam (OP0595)
Naloxone Hydrochloride Prolonged Release (Naloxone Hydrochloride Prolonged Release Tablets)
Narsoplimab (OMS721)
NBI-1065845 (NBI-1065845)
Nelivaptan (BH-200)
Neomycin sulfate
NERIDRONATE SODIUM (GRT7013)
Newnorm (Newnorm)
NILOTINIB (AMN107)
nipocalimab (M281/JNJ-80202135)
Nitroglycerin (MED2005)
Non as of yet (LX1606)
None yet (BI 425809)
Not applicable (ABT 494 3mg)
Not applicable (AMG 334)
Not applicable (G1256067_168)
Not Assigned (GSK2831781)
Not available (BL-8040)
Not available (EDP-305)
Not available (EMA401)
Not available (Lu AG09222)
Not available (LY2835219)
Not available (LY3337641)
Not available (SAR442168)
Not available (TAK-954)
not yet assigned (TRV027)
Not yet available (QBW251)
Not yet available (Acetyl-GED-0507-34-LEVO 1%)
Not Yet defined (MPDL3280A-RO5541267-F-03)
Not Yet defined (RO5541267)
Obefazimod (ABX464)
OBICETRAPIB (TA-8995)
OBINUTUZUMAB (RO5072759)
OC000459 (OC000459)
Ocrelizumab
Ocrelizumab (RO4964913/F07-01)
Ocrelizumab (RO4964913/F07)
Octocog alfa.
OFATUMUMAB (OMB157)
OG1953 (KSI-301)
OLANZAPINE
olaparib (AZD2281)
Olezarsen (ISIS 678354)
Oliceridine (TRV130)
Olodanrigan (EMA401)
Omadacycline (PTK 0796)
Omalizumab (BP11)
OMALIZUMAB (TEV-45779)
Omarigliptin (MK-3102 )
Omarigliptin (MK-3102)
Omecamtiv Mecarbil (AMG 423)
ontamalimab (SHP647)
OPC-108459 (OPC-108459)
ORM-12741 (ORM-12741)
Oxycodone hydrochloride
Ozanimod (RPC1063 (equivalent to ozanimod HCl))
Ozanimod (RPC1063)
Ozanimod HCl (RPC1063)
Padsevonil (UCB0942)
Palbociclib (PD-0332991)
paliperidone palmitate (R092670)
paltusotine (CRN00808)
Pamiparib (BGB-290)
PANTOPRAZOLE ( PF-05208751)
PANTOPRAZOLE SODIUM
PAZOPANIB (GW786034)
PEGFILGRASTIM (Pegylated Apo-Filgrastim)
PEGINTERFERON BETA-1A (BIIB017)
pegnivacogin (REG 1)
pegpleranib sodium (E10030)
PEGylated Proline-interferon alpha-2b recombinant (AOP2014)
PEGylated Proline-interferone alpha-2b recombinant (AOP2014)
Pelacarsen (TQJ230)
Pemafibrate (K-877)
PEMBROLIZUMAB
Pending (MEDI9929)
PERINDOPRIL ARGININE
PF-04965842 (PF-04965842 Tablets)
PF-04965842 (PF-04965842)
PF-05221304 (PF-05221304-82)
PF-06480605 (PF-06480605)
PF-06650833 100 mg (PF-06650833)
PF-06651600 (PF-06651600 10 mg)
PF-06651600 (PF-06651600 50 mg)
PF-06730512 (PF-06730512)
PF-06826647 (PF-06826647)
PF-06835919 (PF-06835919)
PF-06865571 (PF-06865571 )
PF-06882961 (PF-06882961 )
PF-06940434 (PF-06940434)
PF-07220060 MONOHYDRATE (PF-07220060)
pGX3001
Phosphatidylcholine (LT-02)
Pimavanserin (ACP-103)
Pimivalimab (JTX-4014)
Pimodivir (JNJ-63623872-ZCD)
Pixantrone (base) (Pixantrone)
plozalizumab (MLN1202)
PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 1
Pomalidomide
ponatinib (AP24534)
Ponsegromab (PF-06946860)
potassium citrate
Prednisolone (prednisolone)
PREGABALIN (20648)
PREGABALIN (Pregabalin)
PROLGOLIMAB (BCD-100)
Rabeximod (Rabeximod)
Ralinepag (APD811)
Ranibizumab (BP05)
RANIBIZUMAB (LUBT010)
RANIBIZUMAB (Lucentis)
Ranibizumab (QL1205)
RANIBIZUMAB (RFB002)
RANIBIZUMAB (RFB002A)
RANIBIZUMAB (RFB002E)
Ranibizumab (Xlucane)
RANOLAZINE
RAPASTINEL (AGN-241659 (previously GLYX-13))
Raxatrigine (proposed) (BIIB074)
Recombinant Anti-VEGF Humanized Monoclonal Antibody Ophthalmic Injection (HLX04-O )
Recombinant Human Insulin (Technosphere® Insulin (TI) Inhalation Powder)
recombinant human lecithin-cholesterol acyltransferase (rhLCAT) (MEDI6012)
REGORAFENIB (BAY 73-4506)
Relugolix (RVT-601
REMDESIVIR (Remdesivir)
Remibrutinib (LOU064)
resiniferatoxin (MTX-071)
Reslizumab (CEP-38072)
RG7774 (RG7774/F08)
RhuDex choline salt (RhuDex 25 mg (31.75 mg RhuDex choline salt) granules)
RIBOCICLIB (LEE011)
Rifamycin Sodium (Rifamycin SV-MMX®)
rilematovir (JNJ-53718678)
Rilotumumab (AMG 102)
RISANKIZUMAB (ABBV-066)
Ritonavir (Ritonavir)
RITUXIMAB (CT- P10)
RIVAROXABAN
RIVAROXABAN (BAY 59-7939)
RIVAROXABAN (BAY59-7939)
RIVAROXABAN (JNJ-39039039/BAY 59-7939)
ROFLUMILAST (Roflumilast 250 μg)
ROGARATINIB (BAY 1163877 hydrochloride coated tablet 200 mg)
Rolapitant (SCH 619734 hydrochloride monohydrate)
Romosozumab (AMG785)
ROPINIROLE (SK&F101468)
ROTIGOTINE (Rotigotine)
roxadustat (AZD9941)
roxadustat (FG-4592/ASP1517 - 20 mg)
roxadustat (FG-4592/ASP1517 20mg)
RPC1063 (0.25 mg RPC1063)
RTH258 (RTH258 formerly ESBA1008)
RUCAPARIB (CO-338)
Runcaciguat (BAY 1101042)
Runcaciguat (BAY1101042)
ruxolitinib (INC424)
S38093 (S38093-2)
SACITUZUMAB GOVITECAN (IMMU-132)
sacubitril/valsartan (LCZ696 )
sacubitril/valsartan (LCZ696)
Sarilumab (SAR153191)
sebetralstat (KVD900 300 mg Film Coated Tablet)
Secukinumab
Secukinumab (AIN457)
SELATOGREL (ACT-246475)
SELEXIPAG
Selinexor (KPT-330)
SELONSERTIB (GS-4997)
Seltorexant (JNJ-42847922)
Semaglutide
semaglutide (Semaglutide 3 mg)
SEMAGLUTIDE (Semaglutide 5 mg)
semaglutide (Semaglutide B 1.34 mg/ml PDS290)
Semaglutide (Semaglutide B 1.34mg/ml PDS290)
Semaglutide (Semaglutide B 2.68 mg/ml PDS290)
SEMAGLUTIDE (Semaglutide D 0.5 mg/ml DV3396)
SEMAGLUTIDE (Semaglutide J 1.34 mg/mL)
semuloparin sodium (AVE5026)
SERELAXIN (RLX030)
simoctocog alfa (Human-cl rhFVIII)
Siponimod (BAF312A)
SIROLIMUS (Not applicable )
sitagliptin phosphate (MK-0431)
Sodium 2-(9-oxoacridin-10-yl)acetate (Not applicable)
SODIUM IODIDE (FDY-5301)
SODIUM OXYBATE (SMO.IR)
Sodium zirconium cyclosilicate (AZD7270)
solifenacin succinate (solifenacin succinate)
solithromycin (CEM-101)
Somapacitan (Somapacitan PDS290 10 mg/1.5 ml)
somatrogon (PF-06836922)
Sotagliflozin (LX4211)
SOTAGLIFLOZIN (SAR439954)
SULODEXIDE
SULOPENEM (Sulopenem)
Sunitinib malate
Sutent ( )
SYL1001 (SYL1001)
Tafasitamab (MOR00208)
tafluprost
Talazoparib (PF-06944076)
Tanezumab (PF-04383119)
Tanimilast (CHF6001 )
TAZEMETOSTAT (EPZ-6438 )
TEBIPENEM PIVOXIL HYDROBROMIDE (TBPM-PI-HBr)
tecemotide (EMD531444)
Tedizolid Phosphate (TR-701 FA)
TELISOTUZUMAB VEDOTIN (ABBV-399)
tenapanor (AZD1722)
tepotinib
TERBINAFINE HYDROCHLORIDE (P-3058 10%)
tetani et diphtheriae anatoxinum
tetrofosmin
TEV-48574 (TEV-48574)
Tezepelumab (MEDI9929 anti-TSLP mAb (AMG157))
TIANEPTINE (S01574)
Ticagrelor
ticagrelor (Ticagrelor 60 mg film-coated tablets)
ticagrelor (Ticagrelor 90mg film-coated tablets)
ticagrelor (Ticagrelor)
Tildrakizumab
Tildrakizumab (Tildrakizumab)
TIOTROPIUM
tiotropium bromide
Tirzepatide (LY3298176)
TIRZEPATIDE (Tirzepatide)
Tislelizumab (BGB-A317)
to be confirmed (ASP8302)
Tocilizumab (MSB11456)
Tofacitinib (CP-690
tofacitinib (CP 690
tofacitinib (CP-690
tozorakimab (MEDI3506)
Tralokinumab (CAT-354)
Tramadol hydrochloride Celecoxib (MR308 Tablet 100 mg)
TRASTUZUMAB (Hercules)
TRASTUZUMAB (PF-05280014)
Trastuzumab emtansine (RO530-4020/F02-01)
TRASTUZUMAB SC (Ro 045-2317/F07)
TRAZODONE HYDROCHLORIDE (039(C))
Tregalizumab
TREOSULFAN (Treosulfan)
TRIAMCINOLONE ACETONIDE (CLS-TA)
TRIFLURIDINE
TRIMETAZIDINE DIHYDROCHLORIDE (S06790)
TROPIFEXOR (LJN452)
Tucatinib (ONT-380)
UBLITUXIMAB (TG-1101)
UMECLIDINIUM BROMIDE
Umeclidinium/Vilanterol (GSK573719/GW642444)
Upadacitinib (ABT-494)
ustekinumab (CNTO1275)
vadadustat (AKB-6548)
Varenicline tartrate - No IMP is being administered to trial subjects (CP-526
VARENICLINE TARTRATE (CP-526
Vascular endothelial growth factor receptor-3 (VEGFR-3) derivative fused to a human immunoglobulin (IgG)1 Fc fragment (no proposed INN at this stage) (OPT-302)
Vedolizumab
Vedolizumab (MLN0002)
Vedolizumab (Vedolizumab)
Vedolizumab SC (MLN0002 SC)
Veliparib (ABT-888)
Veliparib (ABT-888)
Vemurafenib (RO5185426/F20)
Verinurad (RDEA3170)
veverimer (TRC101)
VIBEGRON (RVT-901)
Vibegron (URO-901
Vilanterol trifenatate (Vilanterol/GW642444 Inhalation Powder)
vilaprisan (BAY 1002670)
VILDAGLIPTIN (LAF237)
VILDAGLIPTIN (Vildagliptin)
VINFLUNINE (L0070)
vismodegib (GDC-0449 )
Vixotrigine (BIIB074)
Volasertib (BI 6727)
VORTIOXETINE
VORTIOXETINE (vortioxetine)
Will not be assigned (BT588)
Xanomeline Tartrate
XmAb®5871 (XENP5871)
XXB750 (XXB750)
Zamicastat (BIA 5-1058)
Zibotentan (Zibotentan)
Zimberelimab (AB122)
ziritaxestat (G451990)
Zolpidemi tartras (Z)
Všetky ochorenia
1. Acne
1. Acne vulgaris
1. Acute coronary syndrome
1. Acute myeloid leukaemia, 2. Myelodysplastic syndrome, 3. Solid tumor
1. Acute myeloid leukaemia, 2. Myelodysplastic syndrome, 3. Solid tumor, 4. Chronic myelomonocytic leukaemia
1. Acute myeloid leukemia, 2. Leukaemias acute myeloid, 3. Neoplasms benign, malignant and unspecified (incl cysts and polyps), 4. Leukaemias, 5. Acute myeloid leukaemia
1. Acute myocardial infarction
1. Acute pain
1. Acute pancreatitis
1. Acute schizophrenia
1. Acute ulcerative colitis
1. Adenocarcinoma of the gastroesophageal junction, 2. Gastric cancer recurrent, 3. Gastric cancer stage IV NOS, 4. Gastric cancer stage III
1. Advanced breast cancer
1. Advanced cancer, 2. Leukaemias
1. Akútna pyelonefritída; 2. Infekcie močových ciest
1. Alergická rinitída, 2. Alergická konjunktivitída
1. Alergická rinokonjunktivitída; 2. Urtikária
1. Alkaptonuria
1. Allergic conjunctivitis
1. Allergic rhinitis due to other allergen
1. Allergic rhinitis due to pollen
1. Allergic rhinoconjunctivitis, 2. Allergic rhinitis (excl hay fever)
1. Alveolar rhabdomyosarcoma, 2. Inflammatory myofibroblastic tumor, 3. Anaplastic large cell lymphoma T- and null-cell types, 4. Alveolar soft part sarcoma, 5. Renal cell carcinoma, 6. Clear cell sarcoma
1. Alzheimer's disease
1. Alzheimer's disease, 2. Nervous system disorders
1. Amyotrophic lateral sclerosis
1. Anemia
1. Angiofibromatóza, 2. Juvenilná angiofibromatóza
1. Ankylosing spondylitis
1. Arteriosclerotic cardiovascular disease, 2. Atherosclerotic cardiovascular disease
1. Asthma
1. Asthma NOS
1. Asthma-COPD overlap syndrome
1. Asthma, 2. Asthma bronchial, 3. Eosinophilic asthma
1. Aterosklerotické kardiovaskulárne ochorenie, 2. Zvýšený lipoproteín (a)
1. Atherosclerosis
1. Atopic dermatitis
1. Atrial fibrillation
1. Atrial fibrillation, 2. Acute coronary syndrome, 3. Percutaneous coronary intervention
1. Atrial fibrillation, 2. Percutaneous coronary intervention
1. Attack coronary, 2. Acute coronary syndrome, 3. Non ST segment elevation acute coronary syndrome, 4. ST segment elevation
1. Axial spondyloarthritis
1. Back pain, 2. Opioid induced constipation
1. Basal cell carcinoma
1. Bipolar depression
1. Birch pollen allergy
1. Bladder cancer stage I, with cancer in situ
1. Breast cancer
1. Breast cancer NOS stage I
1. Breast cancer stage unspecified
1. Bronchiectasis
1. Cancer pain
1. Cardiogenic shock, 2. Acute myocardial infarction
1. Cardiovascular disease, unspecified
1. Cardiovascular event prophylaxis
1. Central retinal vein occlusion, 2. Macular oedema, 3. Visual impairment
1. Cerebellar embolism, 2. Embolic stroke, 3. Embolic cerebral infarction, 4. Brain stem embolism
1. Cervical cancer stage IV, 2. Cervical cancer recurrent
1. Clostridium difficile infection
1. Colitis (excl infective)
1. Colitis ulcerative acute episode
1. Colon cancer stage IV, 2. Colon cancer metastatic, 3. Colorectal cancer stage IV, 4. Colorectal cancer metastatic
1. Colorectal cancer metastatic
1. Community acquired pneumonia
1. Complex regional pain syndrome Type I, 2. Complex regional pain syndrome Type II
1. COPD
1. COPD exacerbation
1. Coronary artery disease
1. Coronary heart disease
1. Crohn's disease
1. Crohnova choroba, 2. Ulcerózna kolitída
1. Cystic fibrosis
1. Cystic fibrosis NOS
1. Dedičný angioedém typu I 2. Dedičný angioedém typu II.
1. Dedičný angioedém typu I, 2. Dedičný angioedém typu II.
1. Dementia Alzheimer's type, 2. Alzheimer's disease, 3. Prodromal Alzheimer's disease
1. Dementia of the Alzheimer's type, with delusions, 2. Hallucinations
1. Dementia of the Alzheimer's type, with depressed mood
1. Depression, 2. Major depressive disorder NOS
1. Detrusor hyperreflexia, 2. Overactive bladder
1. Diabetes mellitus
1. Diabetes mellitus (incl subtypes)
1. Diabetes mellitus non-insulin-dependent
1. Diabetes, 2. Type II diabetes mellitus
1. Diabetic macular edema, 2. Eye disorders
1. Diabetic macular oedema, 2. Diabetic macular edema
1. Diabetic nephropathy
1. Diabetic peripheral neuropathic pain
1. Diarrhoea predominant irritable bowel syndrome, 2. Diarrhea predominant irritable bowel syndrome
1. Diastolic heart failure, 2. Heart failure
1. Diffuse large B-cell lymphoma NOS, 2. Follicular B-cell non-Hodgkin's lymphoma
1. Disease Crohns
1. Diverticulitis of colon (without mention of haemorrhage)
1. Dry eye
1. Dry eyes, 2. Dry eye syndrome
1. Dyskinesias and movement disorders NEC
1. Endometrial carcinoma, 2. Endometrial carcinoma recurrent, 3. Papillary serous endometrial carcinoma
1. Eosinophilic asthma
1. Epilepsy
1. Erectile dysfunction, 2. Erectile disturbance, 3. Male erectile disorder, 4. Erectile dysfunction NOS
1. Essential hypertension
1. Estrogen receptor positive breast cancer
1. Eye disorders
1. Eye disorders, 2. Neovascular age-related macular degeneration, 3. Wet macular degeneration
1. Familiárna hypertriglyceridémia; 2. Hyperchylomikronémia
1. Febrile neutropenia
1. Fibromyalgia
1. Focal epilepsy
1. Frontotemporal dementia, 2. Alzheimer's disease
1. Functional dyspepsia
1. Fungemia
1. Gastrointestinal disorders
1. Gastrointestinal stromal tumor
1. Gastrointestinal stromal tumor, 2. ALL, 3. CML, 4. Metastatic melanoma
1. Generalised anxiety disorder
1. Generalised tonic-clonic seizures
1. Generalized anxiety disorder
1. Geographic atrophy
1. Germ cell cancer
1. Glioblastoma multiforme
1. Growth hormone deficiency
1. Haemophilia A
1. Haemophilia A (Factor VIII)
1. Head and neck cancer
1. Heart failure
1. Heart failure with reduced ejection fraction
1. Heart failure, 2. Type 2 diabetes mellitus
1. Hemofília A (faktor VIII.), 2. Hemofília B (faktor IX.)
1. Hemorrhage
1. Hepatic fibrosis, 2. Hepatic fibrosis and cirrhosis, 3. Liver cirrhosis
1. Hepatic impairment
1. Hepatoblastomas, 2. Neuroblastoma, 3. Soft tissue sarcomas, 4. Osteosarcoma, 5. Rhabdomyosarcomas, 6. Ewing's sarcoma
1. Hepatocellular carcinoma recurrent, 2. Hepatocellular carcinoma non-resectable, 3. Hepatocellular carcinoma resectable
1. HER-2 positive breast cancer
1. HER-2 positive gastric cancer, 2. HER-2 positive breast cancer
1. Hereditary angioedema
1. Hot flashes
1. House dust mite allergy, 2. Allergic asthma
1. HPV 2. Cervikálna dysplázia vysokého stupňa (HSIL)
1. Human papilloma virus test positive, 2. Cervical high grade squamous intraepithelial lesion
1. Hyperglycemia
1. Hypercholesterolaemia
1. Hypercholesterolemia
1. Hypercholesterolemia, 2. Dyslipidemia
1. Hyperparathyroidism secondary
1. Hyperphosphatemia
1. Hypotension orthostatic symptomatic
1. Chemotherapy antiemetic prophylaxis, 2. Prophylaxis of nausea and vomiting
1. Choroidal neovascularization
1. Choroidal neovascularization, 2. Visual impairment
1. Chronic heart failure
1. Chronic hepatitis C
1. Chronic idiopathic constipation
1. Chronic inflammatory demyelinating polyradiculoneuropathy
1. Chronic kidney disease
1. Chronic kidney disease stage 3, 2. Chronic kidney disease stage 5, 3. Chronic kidney disease stage 4
1. Chronic kidney disease stage 4, 2. Chronic kidney disease stage 5, 3. Chronic kidney disease stage 3
1. Chronic lymphocytic leukemia
1. Chronic lymphocytic leukemia refractory
1. Chronic lymphocytic leukemia, 2. Chronic lymphocytic leukemia recurrent
1. Chronic lymphoid leukemia
1. Chronic obstructive pulmonary disease
1. Chronic phase chronic myeloid leukemia
1. Chronic venous insufficiency
1. chronické ochorenie obličiek, 2. diabetes II. typu
1. IBD, 2. Ulcerative colitis, 3. Ulcerative colitis, unspecified, 4. Gastrointestinal disorders
1. Idiopathic generalized epilepsy
1. Ileitis terminal
1. Impaired liver function
1. Incomplete bladder emptying, 2. Residual urine, 3. Bladder retention, 4. Detrusor muscle weakness, 5. Weakness detrusor muscle
1. Infected skin ulcer
1. Infection urinary tract
1. Infections and infestations
1. Infekčná hnačková choroba zapríčinená Clostridium difficile, 2. Hnačka, Clostridium difficile
1. Influenza
1. Influenza viral infections
1. Insulin-requiring type II diabetes mellitus
1. Intra-abdominal infection
1. Ischaemic coronary artery disorders
1. Ischemic stroke
1. Ischemická cievna mozgová príhoda
1. Juvenile idiopathic arthritis
1. Klasický Hodgkinov lymfóm 2. Hodgkinova choroba 3. Hodgkinova choroba NEC 4. Hodgkinov lymfóm 5. Choroby krvi a lymfatického systému 6. Zhubné a nezhubné nádory, nádory s neurčitým alebo neznámym správaním
1. Knee osteoarthritis, 2. Hips osteoarthritis
1. Kolorektálny karcinóm; 2. Metastatický kolorektálny karcinóm
1. Komplikované infekcie močových ciest 2. akútna nekomplikovaná pyelonefritída
1. Kutánny lupus erythematosus; 2. Subakútny kutánny lupus erythematosus; 3. Chronický kutánny lupus erythematosus
1. Leg ulcer
1. Lung cancer
1. Lung cancer non-small cell stage III
1. Lung carcinoma cell type unspecified stage IV
1. Lung squamous cell carcinoma metastatic, 2. Metastatic renal cell carcinoma, 3. Malignant neoplasm of oropharynx, 4. Malignant neoplasm of hypopharynx, 5. Larynx neoplasm malignant, 6. Ovarian cancer recurrent, 7. Metastatic gastric adenocarcinoma, 8. Esophageal adenocarcinoma site unspecified recurrent, 9. Esophageal adenosquamous carcinoma, 10. Pancreatic adenocarcinoma metastatic, 11. Cholangiocarcinoma recurrent, 12. Clear cell endometrial carcinoma, 13. Skin melanoma, 14. Urothelial carcinoma
1. Macular oedema, 2. Visual impairment
1. Macular oedema, 2. Visual impairment, 3. Retinal vein occlusion
1. Major depression
1. Major depressive disorder NOS
1. Major depressive disorder, recurrent episode
1. Major depressive disorder, recurrent episode, severe degree, without mention of psychotic behavior, 2. Major depressive disorder, recurrent episode, unspecified degree, 3. Major depressive disorder, recurrent episode, mild degree, 4. Major depressive disorder, recurrent episode, moderate degree
1. Major depressive disorder, recurrent episode, severe degree, without mention of psychotic behavior, 2. Major depressive disorder, single episode, 3. Major depressive disorder, single episode, severe degree, without mention of psychotic behavior, 4. Major depressive disorder, recurrent episode, unspecified degree, 5. Major depressive disorder, single episode, moderate degree, 6. Major depressive disorder, recurrent episode, mild degree, 7. Major depressive disorder, recurrent episode, moderate degree, 8. Major depressive disorder, single episode, unspecified degree
1. Major depressive disorder, single episode, 2. Major depressive disorder, recurrent episode
1. Makulárny edém 2. Diabetický makulárny edém 3. Oklúzia vetvy sietnicovej žily
1. Malignant glioma
1. Malignant solid tumor, 2. Neoplasm malignant
1. Malignant solid tumor, 2. Solid tumor, 3. Hematological malignancy, 4. Hepatic impairment
1. Melanoma
1. Metastatic breast cancer
1. Metastatic colorectal cancer
1. Metastatic gastric cancer
1. Metastatic melanoma
1. Metastatic renal cell carcinoma
1. Metastatic squamous cell carcinoma
1. Migraine
1. Multidrug resistant bacterial infection
1. Multiple myeloma
1. Multiple sclerosis relapse
1. Multiple sclerosis, 2. Multiple sclerosis relapse
1. Mumps immunization, 2. Rubella with unspecified complications, 3. Measles immunization, 4. Rubella with other specified complication, 5. Rubella immunization, 6. Mumps with other specified complication, 7. Measles without mention of complication, 8. Measles with unspecified complication, 9. Measles-like rash
1. Myelodysplastic syndrome
1. Myelodysplastic syndrome, 2. Acute myeloid leukaemia, 3. Solid tumor
1. NASH with fibrosis, 2. NASH
1. Nealkoholová steatohepatitída, 2. Hepatická fibróza
1. Neoplasm malignant
1. Neoplasms benign, malignant and unspecified (incl cysts and polyps)
1. Neovascular age-related macular degeneration, 2. Age-related macular degeneration, 3. Macular degeneration, 4. Wet macular degeneration
1. Neovascular age-related macular degeneration, 2. Eye disorders
1. Neovascular age-related macular degeneration, 2. Wet macular degeneration
1. Nervous system disorders, 2. Relapsing-remitting multiple sclerosis
1. Neurodevelopmental disorder, 2. Hypersalivation
1. Neuroendocrine tumour
1. Neurogenic bladder
1. Neuropathic pain
1. Neuropathic pain, 2. Lumbar radiculopathy
1. Neutropenia, 2. Febrile neutropenia
1. Nodular (follicular) lymphoma
1. Non-alcoholic steatohepatitis
1. Non-Hodgkin's lymphoma transformed recurrent
1. Non-insulin-dependent diabetes mellitus, 2. Diabetes mellitus non-insulin-dependent, 3. Type II diabetes mellitus inadequate control, 4. Type II diabetes mellitus
1. Non-small cell lung cancer
1. Non-small cell lung cancer metastatic
1. Non-small cell lung cancer NOS
1. Non-small cell lung cancer stage IV, 2. Non-small cell lung cancer metastatic, 3. Non-small cell lung cancer recurrent, 4. Non-small cell lung cancer
1. Non-small cell lung cancer stage IV, 2. Non-small cell lung cancer recurrent, 3. Non-small cell lung cancer
1. Non-small cell lung cancer stage IV, 2. Non-small cell lung cancer stage IIIB
1. Nosocomial pneumonia
1. Obesity
1. Obesity, 2. Overweight
1. Onychomycosis
1. Opioid induced constipation
1. Oral contraception
1. Osteoporosis postmenopausal
1. Other and unspecified alcohol dependence
1. Ovarian epithelial cancer metastatic
1. Overactive bladder
1. Pancreatic cancer non-resectable
1. Pancreatic carcinoma metastatic
1. Pancreatic neuroendocrine tumor metastatic
1. Parkinson's disease
1. Parkinson's disease and parkinsonism
1. Paroxysmal atrial fibrillation
1. Partial epilepsy
1. Partial seizures NOS
1. Perennial allergic rhinitis
1. Peripheral arterial disease
1. Peripheral arterial disease, 2. Acute coronary syndrome, 3. Coronary artery disease, 4. Atherosclerosis cerebral
1. Peripheral revascularization
1. Plaque psoriasis
1. Polycythemia vera
1. Post herpetic neuralgia
1. Post polycythemia vera myelofibrosis, 2. Post essential thrombocythemia myelofibrosis, 3. Post polycythaemia vera myelofibrosis, 4. Post essential thrombocythaemia myelofibrosis, 5. Polycythemia vera, 6. Thalassemia, 7. Acute graft versus host disease in intestine, 8. Acute graft versus host disease in skin, 9. Acute graft versus host disease in liver, 10. Acute graft versus host disease, 11. Chronic graft versus host disease, 12. Chronic graft versus host disease in liver, 13. Chronic graft versus host disease in intestine, 14. Chronic graft versus host disease in skin
1. Progression of prostate cancer, 2. Hormone-refractory prostate cancer
1. Progressive relapsing multiple sclerosis
1. Progressive supranuclear palsy
1. Prostate cancer
1. Prostate cancer metastatic
1. Prostate cancer metastatic, 2. Castration-resistant prostate cancer
1. Prostate cancer, 2. Hormone-refractory prostate cancer
1. Prostate carcinoma
1. Psoriasis
1. Psoriasis palm & soles
1. Psoriasis vulgaris
1. Psoriatic arthritis
1. Psoriatic arthritis, 2. Axial spondyloarthritis
1. Psychiatric disorders
1. Psychiatric disorders, 2. Depressed mood disorders and disturbances, 3. Depressive disorders
1. Pulmonary alveolar proteinosis
1. Pulmonary arterial hypertension
1. Pyelonephritis acute, 2. Urinary tract infections
1. Relapsing-remitting multiple sclerosis
1. Relapsujúca skleróza multiplex; 2. Primárna progresívna skleróza multiplex
1. Renal tubular acidosis
1. Respiratory syncytial virus infection
1. Respiratory, thoracic and mediastinal disorders
1. Respiratory, thoracic and mediastinal disorders, 2. Idiopathic pulmonary fibrosis
1. Retinal vein occlusion
1. Retinopathy of prematurity
1. Rheumatoid arthritis
1. Rheumatoid arthritis and associated conditions
1. Secondary progressive multiple sclerosis
1. Schizophrenia
1. Schizophrenia, 2. Alzheimer's disease
1. Skin bacterial infection
1. Small cell lung cancer
1. Small cell lung cancer extensive stage
1. Smoking cessation therapy
1. Solid tumor
1. Solid tumour, 2. Malignant solid tumour
1. Solid tumour, 2. Malignant solid tumour, 3. Malignant solid tumor, 4. Solid tumor
1. Spastic hemiparesis
1. Spastic paresis
1. Squamous cell carcinoma of head and neck
1. Srdcové zlyhávanie; 2. Chronické ochorenie obličiek
1. Stroke, 2. Myocardial infarction
1. Suicidal ideation, 2. Major depression, 3. Depression suicidal, 4. Suicidal behaviour
1. Systemic lupus erythematosus
1. Testicular germ cell cancer, 2. Seminoma, 3. Non-seminoma testicular cancer
1. Tetanus immunization, 2. Diphtheria immunisation
1. Thermal burns
1. Thromboembolism
1. Treatment-resistant schizophrenia
1. Trigeminal neuralgia
1. Triple negative breast cancer
1. Type 1 diabetes mellitus
1. Type 2 diabetes mellitus
1. Type 2 diabetes mellitus, 2. Hyperglycemia
1. Type II diabetes mellitus
1. Type II diabetes mellitus inadequate control
1. Type II diabetes mellitus inadequate control, 2. Type 2 diabetes mellitus, 3. Non-insulin-dependent diabetes mellitus, 4. Type II diabetes mellitus, 5. Diabetes mellitus non-insulin-dependent
1. Type II diabetes mellitus with renal manifestations
1. Ulcerative colitis
1. Ulcerative colitis, 2. Disease Crohns
1. Ulcerózna kolitída, 2. Crohnova choroba
1. Ulcerózna kolitída; 2. Crohnova choroba
1. Urinary tract infection
1. Urinary tract infection NOS
1. Uterine fibroids, 2. Fibroids, 3. Intramural leiomyoma of uterus
1. Vaginitis, 2. Vaginal infection, 3. Non-specific vaginitis, 4. Acute vaginitis, 5. Vaginitis bacterial
1. Venous thromboembolism
1. Venous thromboembolism prophylaxis
1. Vrodené genetické poruchy 2. Niemann-Pickova choroba
1. Vulvovaginitis
1. Wet macular degeneration, 2. Eye disorders, 3. Neovascular age-related macular degeneration
1.Komplikovaná infekcia močového traktu; 2. Akútna nekomplikovaná pyelonefritída; 3. V nemocnici získaná bakteriálna pneumónia; 4. Komplikovaná intraabdominálna infekcia; 5. Bakteriálna penumónia súvisiaca s umelou pľúcnou ventiláciou.
Acute heart failure
Acute Myeloid Leukemia
Agitácia u pacientov s demenciou Alzheimerovho typu
Akromegália
Akútna cystitída
Akútna infekcia dýchacích ciest spôsobenou RSV
Akútna lymfoblastická leukémia
Akútna lymfoblastová leukémia
akútna myeloidná leukémia
Akútna respiračná tieseň
Akútne respiračné zlyhanie
Akútne zlyhanie pečene v teréne chronického poškodenia
Akútny infarkt myokardu
Akútny koronárny syndróm
Alergia na roztoče z domáceho prachu
Alergická rinitída/rinokonjunktivitída vyvolaná roztočmi domáceho prachu s astmou alebo bez astmy
Alergická rinokonjunktivitída
Alzheimer’s disease
Alzheimerova choroba
Anémia
Angína pectoris
Ankylozujúca spondylitída
Antikoncepcia
Arteriosklerotické kardiovaskulárne ochorenie
Asthma
Astma
Aterosklerotická kardiovaskulárna choroba
Aterosklerotické kardiovaskulárne ochorenie
Aterosklerotické kardiovaskulárne ochorenie; Chronické ochorenie obličiek; Systémový zápal
atherosclerosis
Atopická dermatitída
Atypický hemolyticko-uremický syndróm
Autozomálne dominantné polycystické ochorenie obličiek
Axiálna spondylartitída
Axiálna spondyloartritída, Nerádiografická axiálna spondyloartritída, Ankylozujúca spondylitída
Bakteriálna vaginóza
bez indikácie
Bioekvivalenčná štúdia dvoch perorálnych liekových foriem – Metoprolol Saneca 100 mg tablety (Saneca, Slovakia) a Seloken 100 mg tablety (AstraZeneca S.p.A., Italy) – po jednorazovej dávke zdravým účastníkom nalačno.
Bioekvivalenčná štúdia dvoch perorálnych liekových foriem – Zolpidem Saneca 10 mg, filmom obalené tablety (Saneca, Slovakia) a Stilnox 10 mg, filmom obalené tablety (Sanofi-Aventis Slovakia s.r.o., Slovakia) – po jednorazovej dávke zdravým účastníkom nalačno.
Bioekvivalenčná štúdia Ethinylestradiol 0,03 mg / Drospirenone 3 mg mibe filmom obalené tablety (mibe GmbH Arzneimittel, testovaný produkt) vs. Yasmin® film-coated tablets (Bayer Vital GmbH, Germany, referenčný produkt) po jednorazovom podaní zdravým účastníkom ženského pohlavia nalačno.
BIOEQUIVALENCE STUDY on two oral formulations of atorvastatin calcium ATROST 40 mg film-coated tablet (GAP S.A., Greece) and Lipitor® 40 mg film-coated tablet (Pfizer, Greece) - after single dose administration to healthy volunteers under fasting conditions
Bipolárna porucha 1. typu
Bolesti v dôsledku kostných metastáz
Bulózny pemfigoid
C3 glomerulopatia
COVID-19
Crohnova choroba
Cystická fibróza
Deficit a insuficiencia vitamínu D
Demencia Alzheimerovho typu
Demencia pri Alzheimerovej chorobe; Psychóza
Depresia
Depresívna porucha
Detská epilepsia s absenciou, Juvenilná epilepsia s absenciou
Diabetes mellitus
Diabetes mellitus 2. typu
Diabetes mellitus 2. typu, Chronické ochorenie obličiek
Diabetes mellitus II typu
Diabetes mellitus typu I
Diabetes mellitus typu II
Diabetic Nephropathy: Adults (age 18 - 90 years inclusive) with type 2 diabetes, an eGFR of 25-59 mL/min/1.73 m2, and with macroalbuminuria (>300 mg/g) will be randomized.
diabetická nefropatia
Diabetická neuropatická bolesť
Diabetická retinopatia
Diabetický makulárny edém
Difúzny veľkobunkový B-lymfóm
Diverzifikovaný liposarkóm, Leiomyosarkóm
Dyslipidémia
Endometrióza
English Asthma
Eozinofilná ezofagitída
Epilepsia
Erozívna ezofagitída
Ewingov sarkóm
Fokálna segmentálna glomeruloskleróza
Folikulárny lymfóm
Gastroezofageálny reflux
Gastrointestinálny stromálny tumor
Generalizované tonicko-klonické záchvaty
Geografická atrofia
Glaukóm a očná hypertenzia
healthy volunteers (intended for symptomatic treatment of Lambert-Eaton myasthenic syndrome) mild, moderate and severe renal impairment (intended for symptomatic treatment of Lambert-Eaton myasthenic syndrome)
Heart Failure
Hemofília typu A
hepatic impaired patients
hepatic impaired patients and healthy volunteers
HER2 negatívny nádor prsníka s pozitívnymi estrogénovými receptormi
Hereditárna hemochromatóza
Hereditárny angioedém
Herpes labialis Double-blind, randomised, controlled parallel group comparison of a Propolis special extract GH 2002 cream (Herpetino® Balsam) and an aciclovir 5% containing cream. Up to 10 days treatment; examinations on Days 0, 2, 3, 4, and 5; additional examinations on Day 8±1 and on Day 10 for patients still requiring therapy at the previous visit. Primary efficacy: Time in days until lesions are completely encrusted or epithelised
Heterozygotná familiárna hypercholesterolémia
Hidradenitis suppurativa
HPV infekcia
Hypercholesterolémia
Hypercholesterolemia or Low HDL-C
Hypercholesterolémia, Dislipidémia
Hyperkaliémia
Hyperlipidémia
Hypertenzia
Choroba štepu proti hostiteľovi
Chronic Heart Failure (HF) with Reduced Ejection Fraction
Chronic Myeloid Leukemia in Chronic Phase
chronic obstructive pulmonary disease (COPD)
Chronická fáza chronickej myeloidnej leukémie
Chronická choroba obličiek
Chronická indukovateľná urtikária
chronická ložisková psoriáza
Chronická lymfocytová leukémia (CLL)
Chronická migréna
Chronická myelocytová leukémia
Chronická obštrukčná choroba pľúc
chronická spontánna urtikária
Chronická spontánna urtikária/idiopatická urtikária
Chronická tromboembolická pľúcna hypertenzia
Chronická tromboembolická pľúcna hypertenzia
Chronická zápalová demyelinizačná polyneuropatia
Chronická zápalová demyelinizačná polyradikuloneuropatia
Chronické ochorenie obličiek
Chronické ochorenie obličiek, Albuminúria
Chronické srdcové zlyhanie
Chronické venózne ochorenie
Chronický ekzém rúk
Chronický kašeľ
Chronický kašeľ refraktérny
Idiopathic generalized epilepsy
Idiopatická pľúcna fibróza
idiopatická zápalová myopatia
IgA nefropatia
Infarkt myokardu s eleváciou ST segmentu
Infekcia chrípky typu A
Infekcia v mieste chirurgického zákroku
Infekcie močových ciest
infekcie vyvolané gramnegatívnymi patogénmi
Intrakraniálne krvácanie; Fibrilácia predsiení
Ischemická cievna mozgová príhoda
Ischemická cievna mozgová príhoda spojená s fibriláciou predsiení
Juvenilná idiopatická artritída
Karcinóm hlavy a krku
Karcinóm pankreasu
Karcinóm prostaty
Karcinóm prostaty (PSMA)
Karcinóm prsníka
Karcinóm prsníka, Liposarkóm, Adenokarcinóm pľúc, Kolorektálny karcinóm, Karcinóm prostaty
Kardiovaskulárne komplikácie u diabetických pacientov
Kardiovaskulárne ochorenie
Kastračne rezistentný karcinóm prostaty
Klasický Hodgkinov lymfóm
Kolorektálny karcinóm
Komplikovaná infekcia močových ciest; Akútna pyelonefritída
Krátkozrakosť
Ložisková psoriáza
Lupusová nefritída
Lymfoblastový lymfóm
Lymfóm z plášťových buniek
Lymfóm z plášťových buniek, Lymfóm z marginálnej zóny, Waldenströmová makroglobulinémia
Malígny melanóm
Malobunkový karcinóm pľúc
Melanóm
Menopause hormone therapy
Metastatický hormonálne senzitívny karcinóm prostaty
Metastatický karcinóm prostaty
Metastatický karcinóm prsníka
Metastatický kastračne citlivý karcinóm prostaty
metastatický kastračne rezistentný karcinóm prostaty (mCRPC).
Metastatický kolorektálny karcinóm
metastatický melanóm
Metastatický melanóm alebo neresekovateľný lokálne pokročilý melanóm pozitívny na mutáciu V600e/K génu Braf /
Mierna až stredne závažná Alzheimerova choroba
Migréna
Mild and Moderate Hepatic Impaired Patients and Healthy Volunteers (Intended for Treatment Of Moderate to Severe Acute Pain)
Mild and moderate hepatic impairment, healthy volunteers (intend for treatment of Nonalcoholic Steatohepatitis (NASH) with Liver Fibrosis)
MILD AND MODERATE HEPATIC IMPAIRMENT, HEALTHY VOLUNTEERS (INTENDED FOR TREATMENT OF EPILEPSY)
MILD, MODERATE AND SEVERE RENAL IMPAIRMENT, HEALTHY VOLUNTEERS (INTENDED FOR TREATMENT OF ANXIETY, EPILEPSY)
Mild, moderate, severe hepatic impaired subjects and healthy volunteers
Mild, moderate, severe renal impaired subjects and healthy volunteers. (IMP is intended for treatment of cardiovascular diseases - Pulmonary arterial hypertension)
Mnohopočetný myelóm
Myópia
Nádorové ochorenia
Nádorové ochorenie, kachexia
Nealkoholická steatohepatitída
Nealkoholová steatohepatitída
Necystická fibrózna bronchiektázia
Nedostatočne kontrolovaný diabetes mellitus 2. typu
Nedostatok rastového hormónu
Nefropatia
Nemalobunkový karcinóm pľúc
Nemalobunkový karcinóm pľúc (NSCLC)
Nemalobunkový karcinóm pľúc v štádiu III
Neovaskulárna (vlhká) vekom podmienená degenerácia makuly
Neovaskulárna vekom podmienená degenerácia makuly
Neovaskulárna vekom podmienená makulárna degenerácia
Neproliferatívna diabetická retinopatia
Neresekovateľný alebo metastatický kožný melanóm
neskoršia forma Pompeho choroby
Neskorý nástup sepsy
Neskvamocelulárny nemalobunkový karcinóm pľúc
Neskvamózna nemalobunková rakovina pľúc (NSCLC)
Neskvamózny nemalobunkový karcinóm pľúc (NSCLC)
Neuroblastóm
Neurogénna detruzorová hyperaktivita
Neuropatická bolesť spojená s diabetickou periférnou neuropatiou
Neuropatická bolesť spôsobená lumbosakrálnou radikulopatiou
Niemann-Pickova choroba typu C (NPC)
non - Hodgkinov lymfóm
Non-Hodgkinov lymfóm
Non-Small Cell Lung Cancer
Nozokomiálna pneumónia
Obezita
Očné ochorenie spôsobené poruchou štítnej žľazy
Odmietnutie transplantovanej obličky
Ochorenie vyvolané koronavírusom (COVID-19)
Oklúzia vetvy sietnicovej žily
Operácia katarakty
Osteoarthritis of the hip or knee
osteoartritická bolesť kolenného kĺbu
Osteoartróza kolena
Osteopénia
Parkinsonova choroba
Paroxyzmálna nočná hemoglobinúria
Patients with an advanced solid tumor combined with moderate hepatic impairment and patients with an advanced solid tumor with normal hepatic function will be enrolled.
Pilotná bioekvivalenčná štúdia dvoch perorálnych liekových foriem bezafibrátu s riadeným uvolňovaním – Bezafibrat Genericon 400 mg filmom obalené tablety s predĺženým uvolňovaním (Genericon Pharma Gesellschaft m.b.H., Rakúsko) a Bezalip® 400 mg filmom obalené tablety s predĺženým uvolňovaním (Actavis, Island) – po jednorazovej dávke zdravým účastníkom po jedle.
Pivotálna štúdia bioekvivalencie dvoch perorálnych liekových foriem bezafibrátu s riadeným uvoľňovaním-Bezafibrat Genericon 400 mg filmom obalené tablety s predĺženým uvoľňovaním (Genericon Pharma Gesellschaft m.b.H., Austria) a Bezalip® 400 mg filmom obalené tablety s predĺženým uvoľňovaním (Actavis, Island)-po jednorazovej dávke zdravým účastníkom nalačno.
Pivotálna štúdia bioekvivalencie dvoch perorálnych liekových foriem bezafibrátu s riadeným uvoľňovaním-Bezafibrat Genericon 400 mg filmom obalené tablety s predĺženým uvoľňovaním (Genericon Pharma Gesellschaft m.b.H., Austria) a Bezalip® 400 mg filmom obalené tablety s predĺženým uvoľňovaním (Actavis, Island)-po jednorazovej dávke zdravým účastníkom po jedle.
Pľúcna artériová hypertenzia
Pneumokoková imunizácia
Pneumónia
Pokročilý alebo metastatický uroteliálny alebo non-uroteliálny karcinóm močových ciest
Pokročilý alebo recidivujúci karcinóm endometria
Pokročilý karcinóm prsníka
Polycystický ovariálny syndróm
Porucha autistického spektra
Postmenopauzálna osteoporóza
Postmenopauzálne symptómy
Prediabetický syndróm
Predný infarkt myokardu s ST eleváciami
Prevencia cievnej mozgovej príhody; Prevencia systémovej embolizácie; Fibrilácia predsiení
Prevencia ischemickej cievnej mozgovej príhody; Ischemická cievna mozgová príhoda; Tranzitórny ischemický atak (TIA)
Primárna biliárna cholangitída
Primárna hypertenzia
Primárne imunodeficiencie
Primárne imunodeficiencie (PID)
Primárny glaukóm s otvoreným uhlom, Očná hypertenzia
Primary immunodeficiency
Progresívna supranukleárna paralýza
Psoriatická artritída
Psoriáza
Rakovina prostaty
rakovina vaječníkov
Recidivujúca depresívna porucha
Recidivujúci non- Hodgkinov lymfóm
Refractory histologically confirmed extracranial primary germ cell cancer, seminoma, or nonseminoma germ cell tumours
Refraktérny lymfóm z plášťových buniek
Relabujúca roztrúsená skleróza
Relaps remitujúca skleróza multiplex
Relapsed or Refractory B Cell Acute Lymphoblastic Leukemia
Relapsujúca - remitujúca skleróza multiplex
Relapsujúca roztrúsená skleróza
Relapsujúca skleróza multiplex
renal impaired patients and healthy subjects
Renal impairment
Respiračná syncyciálna vírusová infekcia
Retinal Vein Occlusion
Retinopatia nedonosených
Retinopatia nedonosených detí
reumatoidná artritída
Rezistentná hypertenzia
Seasonal allergic rhinoconjunctivitis and asthma
Sekundárna progresívna skleróza multiplex
Senzorineurálna strata sluchu
serózny karcinómom vaječníkov s vysokým stupňom malignity bez potvrdenej zárodočnej mutácie BRCA, ktorý je rezistentný alebo refraktérny voči platine.
Schizofrénia
Sjögrenov syndróm
Skleróza multiplex
Skvamózna intraepitelová lézia vysokého stupňa
skvamózny nemalobunkový karcinóm pľúc
Solídny nádor
Spastická paréza
Spondyloartritída
srdcové zlyhanie, kardiovaskulárne ochorenia
Srdcové zlyhávanie
Srdcové zlyhávanie so zachovanou ejekčnou frakciou
Stimulačný test rastového hormónu
Stredne ťažká až ťažká ulcerózna kolitída
Symptomatická endometrióza
Syndróm familiárnej chylomikronémie
Syndróm primárnej imunodeficiencie
Systémový lupus erythematosus
Štúdia bioekvivalencie dvoch perorálnych liekových foriem - Duloxgamma 60 mg tvrdé gastrorezistentné kapsuly (Wörwag, Germany) a Cymbalta® 60 mg tvrdé gastrorezistentné kapsuly (Eli Lilly) – po jednorazovej dávke zdravým účastníkom nalačno.
Štúdia bioekvivalencie dvoch perorálnych liekových foriem - Duloxgamma 60 mg tvrdé gastrorezistentné kapsuly (Wörwag, Germany) a Cymbalta® 60 mg tvrdé gastrorezistentné kapsuly (Eli Lilly) – po jednorazovej dávke zdravým účastníkom po jedle.
Tardívna dyskinéza
Tardivné dyskinézie
Ťažká preeklampsia
Testing for adrenal cortical adenomas in male and female patients Testing for uterine endometrial stromal sarcromas in all female patients
To induce appropriate protection against pneumococcal disease. To assess non-inferiority of OPA response for serotype 19A after booster dose of PCV13 administered between 11-12 months of age in subjects primed with 10Pn-PD-DiT vs those primed with PCV13.
Triple-negatívny karcinóm prsníka
Trojito negatívny karcinóm prsníka
Trojnásobne negatívny karcinóm prsníka
Ulcerative Colitis
Ulceratívna kolitída
Ulceratívna proktitída
Ulcerózna kolitída
Ulcerózna kolitída
Ulcerózna kolitída; Crohnova choroba
Uroteliálny karcinón
Vazomotorické symptómy (návaly horúčavy)
Včasná Alzheimerova choroba
Vekom podmienená degenerácia makuly
Veľká depresívna porucha
Venózna trombóza
Vertigo
Vlhká (neovaskuláran) vekom podmienená degenerácia makuly
Vlhká (neovaskulárna) vekom podmienená degenerácia makuly
Vlhká vekom podmienená degenerácia makuly
Vulvovaginálna candidóza
vyšetrenie CNS pomocou MRI
Zápcha vyvolaná opioidmi
Závažná hypertriglyceridémia
Zdravý dobrovolníci. Prvé podanie určené k zhodnoteniu znášanlivosti a základných farmakokinetických parametrov.
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