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 (ELK) 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 (32.3) dáva možnosť pripomienkovať
Revidované všeobecné kapitoly a kontrolné metódy:
2.2.48. Raman spectroscopy
2.4.35. Extractable elements in plastic materials for pharmaceutical use
3.1.16. Cyclo-olefin polymers
3.1.17. Cyclo-olefin copolymers
Nové monografie:
Notopterygium root/Notopterygii rhizoma et radix (2662)
Propylene glycol monocaprylate/ Propylenglycoli monocaprylas (2799)
Atorvastatin magnesium trihydrate/Atorvastatinum magnesicum trihydricum (2755)
Nebivolol hydrochloride/Nebivololi hydrochloridum (2775)
Ezetimibe/Ezetimibum (2767)
Revidované monografie:
Methods of preparation of homoeopathic stocks and potentisation/Via praeparandi stirpes homoeopathicas et potentificandi (2371)
Arnica flower/Arnicae flos (1391)
Arnica tincture/Arnicae tinctura (1809)
Atorvastatin calcium trihydrate/Atorvastatinum calcicum trihydricum (2191)
Carmellose sodium/Carmellosum natricum (0472)
Chlortalidone/Chlortalidonum (0546)
Cod-liver oil (type A)/Iecoris aselli oleum A (1192)
Domperidone/Domperidonum (1009)
Domperidone maleate/Domperidoni maleas (1008)
Formoterol fumarate dihydrate/Formoteroli fumaras dihydricus (1724)
Hydrochloric acid, concentrated/Acidum hydrochloridum concentratum (0002)
Hydrochloric acid, dilute/Acidum hydrochloridum dilutum (0003)
Paraffin, white soft/Vaselinum album (1799)
Paraffin, yellow soft/Vaselinum flavum (1554)
Stearic acid/Acidum stearicum (1474)
Tetracaine hydrochloride/Tetracaini hydrochloridum (0057)
Botulinum toxin type a for injection/Toxinum botulinicum A ad iniectabile (2113)
Human anti-D immunoglobulin/Immunoglobulinum humanum anti-D (0557)
Human anti-D immunoglobulin for intravenous administration/Immunoglobulinum humanum anti-D ad usum intravenosum (1527)
Clostridium septicum vaccine for veterinary use/Vaccinum Clostridii septici ad usum veterinarium (0364)
Clostridium novyi (type b) vaccine for veterinary use/Vaccinum Clostridii novyi B ad usum veterinarium (0362)
Clostridium perfringens vaccine for veterinary use/Vaccinum Clostridii perfringentis ad usum veterinarium (0363)
Z nasedujúcich monografií bola vyradená skúška na špecifickú toxicitu diftériovej zložky:
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 (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)
Diphtheria and tetanus vaccine (adsorbed)/Vaccinum diphtheriae et tetani adsorbatum (0444)
Diphtheria, tetanus and pertussis (whole cell) vaccine (adsorbed)/Vaccinum diphtheriae, tetani et pertussis ex cellulis integris adsorbatum (0445)
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, 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 and tetanus vaccine (adsorbed, reduced antigen(s) content)/Vaccinum diphtheriae et tetani, antigeni-o(-is) minutum, adsorbatum (0647)
Diphtheria, tetanus, pertussis (whole cell) and poliomyelitis (inactivated) vaccine (adsorbed)/Vaccinum diphtheriae, tetani, pertussis ex cellulis integris et poliomyelitidis inactivatum adsorbatum (2061)
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 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 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), 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 vaccine (adsorbed, reduced antigen content)/Vaccinum diphtheriae, antigeniis minutum, adsorbatum (0646)
Diphtheria vaccine (adsorbed)/Vaccinum diphtheriae adsorbatum (0443)
Úplné znenie aj s vyznačením zmien je dostupné na stránke EDQM https://pharmeuropa.edqm.eu . Termín pripomienkovania je do 30. septembra 2020.
Pripomienky posielajte na Liekopisné oddelenie ŠÚKL (ellen.wiesner@sukl.sk), ktoré sprostredkuje ich doručenie do EDQM.
