Všetky ochorenia 1. Acne 1. Acne vulgaris 1. Acute coronary syndrome 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. Alergická rinitída, 2. Alergická konjunktivitída 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. 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. 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. 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. CML 1. Gastrointestinal stromal tumor, 2. Gastrointestinal stromal tumour, 3. Neoplasms benign, malignant and unspecified (incl cysts and polyps) 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 impairment 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. Hidradenitis suppurativa 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. Ileitis terminal 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. Leg ulcer 1. Leukemia lymphoblastic acute 1. Lung cancer 1. Lung cancer non-small cell stage III 1. Lung carcinoma cell type unspecified stage IV 1. Lymphoblastic lymphoma 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. 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. 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, 2. Overweight 1. Oesophageal adenocarcinoma, 2. Adenocarcinoma gastric 1. Onychomycosis 1. Opioid induced constipation 1. Oral contraception 1. Osteopenia 1. Osteoporosis postmenopausal 1. Other and unspecified alcohol dependence 1. Ovarian cancer NOS 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. 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. Sensorineural hearing loss 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. 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. 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 Acute heart failure Acute Myeloid Leukemia Agitácia u pacientov s demenciou Alzheimerovho typu Akromegália Akútna cystitída Akútna infekcia dýchacích ciest spôsobenou RSV akútna myeloidná leukémia 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 Alzheimer’s disease Alzheimerova choroba Anémia Angína pectoris Ankylozujúca spondylitída Antikoncepcia Arteriosklerotické kardiovaskulárne ochorenie Asthma Astma atherosclerosis Atopická dermatitída 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 COVID-19 Crohnova choroba Cystická fibróza Deficit a insuficiencia vitamínu D Demencia Alzheimerovho typu Depresívna porucha Diabetes mellitus Diabetes mellitus 2. typu Diabetes mellitus 2. typu, Chronické ochorenie obličiek Diabetes mellitus II typu 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 retinopatia Diabetický makulárny edém Difúzny veľkobunkový B-lymfóm Diverzifikovaný liposarkóm, Leiomyosarkóm Dyslipidémia English Asthma Epilepsia Fokálna segmentálna glomeruloskleróza Gastroezofageálny reflux Generalizované tonicko-klonické záchvaty 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 Hidradenitis suppurativa hormone receptor positive breast cancer, hormone naive, breast, cancer, neoplasm breast cancer, metastatic, tumour, neoplasm Hypercholesterolémia Hypercholesterolemia or Low HDL-C Hypercholesterolémia, Dislipidémia Hyperkaliémia Hyperlipidémia 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 lymfocytová leukémia (CLL) Chronická obštrukčná choroba pľúc Chronická spontánna urtikária Chronická tromboembolická pľúcna hypertenzia Chronická tromboembolická pľúcna hypertenzia Chronická zápalová demyelinizačná polyradikuloneuropatia Chronické ochorenie obličiek, Albuminúria Chronické srdcové zlyhanie Chronické venózne ochorenie Chronický kašeľ refraktérny Idiopatická pľúcna fibróza Infarkt myokardu s eleváciou ST segmentu Infekcia chrípky typu A Infekcie močových ciest infekcie vyvolané gramnegatívnymi patogénmi Ischemická cievna mozgová príhoda Ischemická cievna mozgová príhoda spojená s fibriláciou predsiení Juvenilná idiopatická artritída Karcinóm hlavy a krku Karcinóm prostaty Karcinóm prostaty (PSMA) Karcinóm prsníka Kardiovaskulárne komplikácie u diabetických pacientov Kardiovaskulárne ochorenie Kastračne rezistentný karcinóm prostaty Krátkozrakosť Lupusová nefritída Lymfóm z plášťových buniek Lymfóm z plášťových buniek, Lymfóm z marginálnej zóny, Waldenströmová makroglobulinémia Malígny melanóm Malobunkový karcinóm pľúc 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 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 Nádorové ochorenia Nealkoholická steatohepatitída Nealkoholová steatohepatitída Necystická fibrózna bronchiektázia Nedostatočne kontrolovaný diabetes mellitus 2. typu Nedostatok rastového hormónu Nefropatia Nemalobunkový karcinóm pľúc Nemalobunkový karcinóm pľúc v štádiu III Neovaskulárna vekom podmienená degenerácia makuly Neovaskulárna vekom podmienená makulárna degenerácia neskoršia forma Pompeho choroby Neskvamocelulárny nemalobunkový karcinóm pľúc Neskvamózna nemalobunková rakovina pľúc (NSCLC) Neuropatická bolesť spojená s diabetickou periférnou neuropatiou Neuropatická bolesť spôsobená lumbosakrálnou radikulopatiou non - Hodgkinov lymfóm Non-Hodgkinov lymfóm Non-Small Cell Lung Cancer Nozokomiálna pneumónia Odmietnutie transplantovanej obličky Ochorenie vyvolané koronavírusom (COVID-19) Oklúzia vetvy sietnicovej žily Operácia katarakty Osteoarthritis of the hip or knee osteoartritická bolesť kolenného kĺbu Parkinsonova choroba paroxyzmálna supraventrikulárna tachykardia 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 Pokročilý alebo metastatický uroteliálny alebo non-uroteliálny karcinóm močových ciest Pokročilý karcinóm prsníka Porucha autistického spektra Postmenopauzálna osteoporóza Primárna biliárna cholangitída 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 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 Retinal Vein Occlusion Retinopatia nedonosených Retinopatia nedonosených detí Reumatoidná artritída Seasonal allergic rhinoconjunctivitis and asthma Sekundárna progresívna skleróza multiplex serózny karcinómom vaječníkov s vysokým stupňom malignity bez potvrdenej zárodočnej mutácie BRCA, ktorý je rezistentný alebo refraktérny voči platine. Schizofrénia Skleróza multiplex Skvamózna intraepitelová lézia vysokého stupňa skvamózny nemalobunkový karcinóm pľúc Solídny nádor srdcové zlyhanie, kardiovaskulárne ochorenia Srdcové zlyhávanie Srdcové zlyhávanie so zachovanou ejekčnou frakciou Symptomatická endometrióza Syndróm familiárnej chylomikronémie Syndróm primárnej imunodeficiencie 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. 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 Trojnásobne negatívny karcinóm prsníka Ulcerative Colitis Ulceratívna kolitída Ulceratívna proktitída Ulcerózna kolitída Ulcerózna kolitída Uroteliálny karcinón Vekom podmienená degenerácia makuly Veľká depresívna porucha Venózna trombóza Vertigo Vulvovaginálna candidóza vyšetrenie CNS pomocou MRI Zápcha vyvolaná opioidmi Zdravý dobrovolníci.
Prvé podanie určené k zhodnoteniu znášanlivosti a základných farmakokinetických parametrov.
