Pripomienkovanie článkov Európskeho liekopisu
Štátny ústav pre kontrolu liečiv informuje odbornú verejnosť o možnosti pripomienkovania návrhov nových a revidovaných článkov pred ich zaradením do Európskeho liekopisu. Európsky liekopis stanovuje záväzné normy na posúdenie kvality liečiv, pomocných látok a liekových foriem. Pri príprave nových monografií a revízii pôvodných článkov EDQM Európska liekopisná komisia spolupracuje s výrobcami a inými zainteresovanými stranami s cieľom zosúladiť požiadavky na kvalitu so súčasnými vedeckými poznatkami. Pri vypracovaní monografií sa používajú viaceré postupy, vo všetkých prípadoch je však návrh novej monografie predložený na pripomienkovanie na stránke Pharmeuropa.
Aktuálne vydanie Pharmeuropa (31.2) dáva možnosť pripomienkovať
Revidované články:
2.2.49. Falling ball and automatic rolling ball viscometer methods
5.1.10. Guidelines for using the test for bacterial endotoxins
Aciclovir/Aciclovirum (0968)
Aprotinin concentrated solution/Aprotinini solutio concentrat (0579)
Borax/Borax (0013)
Calcium carbonate/Calcii carbonas (0014)
Calcium lactate monohydrate/Calcii lactas monohydricus (2117)
Calcium lactate pentahydrate/Calcii lactas pentahydricus (0468)
Calcium lactate trihydrate/ Calcii lactas trihydricus (0469)
Calcium panthotenate/ Calcii pantothenas (0470)
Calcium sulfate dihydrate/Calcii sulfas dihydricus (0982)
Ciclosporin/Ciclosporinum (0994)
Codergocrine mesilate/Codergocrini mesilas (2060)
Daunorubicin hydrochloride/Daunorubicini hydrochloridum (0662)
Dexpanthenol/Dexpanthenolum (0761)
Diphtheria and tetanus vaccine (adsorbed)/Vaccinum diphtheriae et tetani adsorbatum (0444)
Diphtheria and tetanus vaccine (adsorbed, reduced antigen(s) content)/Vaccinum diphtheriae et tetani, antigeni-o(-is) minutum, adsorbatum (0647)
Diphtheria, tetanus and hepatitis B (rDNA) vaccine (adsorbed)/Vaccinum diphtheriae, tetani et hepatitidis B (ADNr) adsorbatum (2062)
Diphtheria, tetanus and pertussis (acellular, component) vaccine (adsorbed)/Vaccinum diphtheriae, tetani et pertussis sine cellulis ex elementis praeparatum adsorbatum (1931)
Diphtheria, tetanus and pertussis (acellular, component) vaccine (adsorbed, reduced antigen(s) content)/Vaccinum diphtheriae, tetani et pertussis sine cellulis ex elementis praeparatum, antigeni-o(-is) minutum, adsorbatum (2764)
Diphtheria, tetanus and pertussis (whole cell) vaccine (adsorbed)/Vaccinum diphtheriae, tetani et pertussis ex cellulis integris adsorbatum (0445)
Diphtheria, tetanus and poliomyelitis (inactivated) vaccine (adsorbed reduced antigen(s) content)/Vaccinum diphtheriae, tetani et poliomyelitidis inactivatum, antigeni-o(-is) minutum, adsorbatum (2328)
Diphtheria, tetanus, pertussis (acellular, component) and haemophilus type b conjugate vaccine (adsorbed)/Vaccinum diphtheriae, tetani, pertussis sine cellulis ex elementis praeparatum et haemophili stirpis b coniugatum adsorbatum (1932)
Diphtheria, tetanus, pertussis (acellular, component) and hepatitis B (rDNA) vaccine (adsorbed)/Vaccinum diphtheriae, tetani, pertussis sine cellulis ex elementis praeparatum et hepatitidis B (ADNr) adsorbatum (1933)
Diphtheria, tetanus, pertussis (acellular, component) and poliomyelitis (inactivated) vaccine (adsorbed)/Vaccinum diphtheriae, tetani, pertussis sine cellulis ex elementis praeparatum et poliomyelitidis inactivatum adsorbatum (1934)
Diphtheria, tetanus, pertussis (acellular, component) and poliomyelitis (inactivated) vaccine (adsorbed, reduced antigen(s) content)/Vaccinum diphtheriae, tetani, pertussis sine cellulis ex elementis praeparatum et poliomyelitidis inactivatum, antigeni-o(-is) minutum, adsorbatum (2329)
Diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and haemophilus type b conjugate vaccine (adsorbed)/Vaccinum diphtheriae, tetani, pertussis sine cellulis ex elementis praeparatum, hepatitidis B (ADNr), poliomyelitidis inactivatum et haemophili stirpis b coniugatum adsorbatum (2067)
Diphtheria, tetanus, pertussis (acellular, component), poliomyelitis (inactivated) and haemophilus type b conjugate vaccine (adsorbed)/Vaccinum diphtheriae, tetani, pertussis sine cellulis ex elementis praeparatum, poliomyelitidis inactivatum et haemophili stirpis b coniugatum adsorbatum (2065)
Diphtheria, tetanus, pertussis (whole cell) and poliomyelitis (inactivated) vaccine (adsorbed)/Vaccinum diphtheriae, tetani, pertussis ex cellulis integris et poliomyelitidis inactivatum adsorbatum (2061)
Diphtheria, tetanus, pertussis (whole cell), poliomyelitis (inactivated) and haemophilus type b conjugate vaccine (adsorbed)/Vaccinum diphtheriae, tetani, pertussis ex cellulis integris, poliomyelitidis inactivatum et haemophili stirpis b coniugatum adsorbatum (2066)
Disodium phosphate dihydrate/Dinatrii phosphas dihydricus (0602)
Disodium phosphate dodecahydrate/Dinatrii phosphas dodecahydricus (0118)
Erythromycin/Erythromycinum (0179)
Ether/Aether (0650)
Ether, anaesthetic/Aether anaestheticus (0367)
Fluticasone propionate/Fluticasoni propionas (1750)
Gallium (68GA) PSMA-11 injection/Gallii (68Ga) PSMA-11 solutio iniectabilis (3044)
Hawthorn leaf and flower/Crataegi folium cum flore (1432)
Hawthorn leaf and flower dry extract/Crataegi folii cum flore extractum siccum (1865)
Hawthorn leaf and flower liquid extract quntified/Crataegi folii cum flore extractum fluidum quantificatum(1864)
Homoeopathic preparations/Praeparationes homoeopathicae (2868)
Human albumin solution/Albumini humani solutio (0255)
Hypromellose phthalate/Hypromellosi phthalas (0347)
Ibandronate sodium monohydrate/Ibandronatum natricum monohydricum (2771)
Magnesium hydroxide/Magnesii hydroxidum (0039)
Magnesium chloride hexahydrate/Magnesii chloridum hexahydricum (0402)
Magnesium phosphoricum for homoeopathic preparations/Magnesii hydrogenophosphas trihydricus ad praeparationes homoeopathicas (2505)
Magnesium sulfate heptahydrate/Magnesii sulfas heptahydricus (0044)
Methylprednisolone/Methylprednisolonum (0561)
Oromucosal preparations/Praeparationes buccales (1807)
Paraffin,white soft/Vaselinum album (1799)
Paraffin,yellow soft/Vaselinum flavum (1554)
Pentobarbital/Pentobarbitalum (0200)
Pentobarbital sodium/Pentobarbitalum natricum (0419)
Potassium hydrogen tartrate/Kalii hydrogenotartras (1984)
Potassium chloride/Kalii chloridum (0185)
Rabeprazole sodium/Rabeprazolum natricum (2868)
Raltegravir tablets/ Raltegraviri compressi (2938)
Sanguinaria for homoeopathic preparations/Sanguinaria canadensis ad praeparationes homoeopathicas (2687)
Silver, colloidal, for external use/Argentum colloidale ad usum externum (2281)
Sodium acetate trihydrate/Natrii acetas trihydricus (0411)
Sodium carbonate/Natrii carbonas (0773)
Sodium carbonate decahydrate/Natrii carbonas decahydricus (0191)
Sodium carbonate monohydrate/Natrii carbonas monohydricus (0192)
Sodium dihydrogen phosphate dihydrate/Natrii dihydrogenophosphas dihydricus (0194)
Sodium iodide (131I) capsules for diagnostic use/Natrii iodidi (131I) capsulae ad usum diagnosticum (0938)
Sodium iodide (131I) capsules for therapeutic use/Natrii iodidi (131I) capsulae ad usum therapeuticum (2116)
Sodium iodide (131I) solution/Natrii iodidi (131I) solutio (0281)
Sodium lactate solution/Natrii lactatis solutio (1151)
Sodium (S)-lactate solution/Natrii (S)-lactatis solutio (2033)
Sodium metabisulfite/Natrii metabisulfis (0849)
Substances for pharmaceutical use/Corpora ad usum pharmaceuticum (2034)
Sulfur for external use/Sulfur ad usum externum (0953)
Tetanus vaccine (adsorbed)/Vaccinum tetani adsorbatum (0452)
Tetanus vaccine for veterinary use/Vaccinum tetani ad usum veterinarium (0697)
Ticagrelor/Ticagrelorum (3087)
Wheat starch/Tritici amylum (0359)
Zanthoxylum bungeanum pericarp/Zanthoxyli bungeani pericarpium (2656)
Nové monografie:
DL-Lysine acetylsalicylate/DL-Lysini acetylsalicylas (2812)
Morinda root/Morindae officinalis radix (2977)
Regorafenib tablets/Regorafenibi compressi (3023)
Riociguat/Riociguatum (3078)
Riociguat tablets/Riociguati compressi (3079)
Rivaroxaban tablets/Rivaroxabani compressi (3021)
Sorafenib tablets/Sorafenibi compressi (3022)
Sorafenib tosilate/Sorafenibi tosilas (2931)
Úplné znenie aj s vyznačením zmien je dostupné na stránke EDQM http://pharmeuropa.edqm.eu Termín pripomienkovania je do 30. júna 2019.
Pripomienky posielajte na Liekopisné oddelenie ŠÚKL (elena.mostenicka@sukl.sk), ktoré sprostredkuje ich doručenie do EDQM.
