PRÍLOHA 1 NÁZOV, LIEKOVÁ FORMA, KONCENTRÁCIA, CIEĽOVÝ DRUH, SPÔSOB PODANIA LIEKU, DRŽITEĽ POVOLENIA NA UVEDENIE NA TRH
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1 PRÍLOHA 1 NÁZOV, LIEKOVÁ FORMA, KONCENTRÁCIA, CIEĽOVÝ DRUH, SPÔSOB PODANIA LIEKU, DRŽITEĽ POVOLENIA NA UVEDENIE NA TRH
2 Austria Wyeth Lederle Pharma GmbH, Fort Dodge Waidhausengasse 19/9, A-1140, Vienna Austria Contact: Dr. Attila Romváry Tel: Fax: romvara@fdah.com Wyeth Lederle Pharma GmbH, Belgium Health Benelux B.V. Van Houten Industriepark MZ Weesp Benelux B.V.
3 Czech Republic Estonia
4 France Santé e, S.A. 24, Avenue Marcel Dassault, BP 440, Tours Cedex 3 France Contact: Mr. Yves Dehon Tel: Fax: dehony@ahp.com Santé e, S.A. Germany Veterinär GmbH Adenauerstrasse 20, Würselen Germany Contact: Dr. Elisabeth Stangl Tel: Fax: stangle@fdah.com Veterinär GmbH
5 Greece Contact: Dr. Germán Lastra Tel: Fax: Ireland Health Limited Flanders Road, Hedge End, Southampton S030 4QH, UK Contact: Dr. Germán Lastra Tel: Fax: Limited
6 Italy Health SpA Via Nettunense 90, Aprilia Italy Tel: Fax: SpA Lithuania
7 Luxembourg Health Benelux B.V. Van Houten Industriepark MZ Weesp Benelux B.V. Malta
8 Netherlands Health Benelux B.V. Van Houten Industriepark MZ Weesp Benelux B.V. Norway Veterinär GmbH Adenauerstrasse 20, Würselen Germany Contact: Dr. Germán Lastra Tel: Fax: Veterinär GmbH
9 Portugal Veterinària Lda. Rua Dr. António Loureiro Borges, nº2, Arquiparque- Miraflores, Algés Portugal Contact: Dr. Virginia Rodríguez Tel: Fax: Veterinària Lda. Slovak Republic
10 United Kingdom Health Limited Flanders Road, Hedge End, Southampton S030 4QH, UK Contact: Dr. Germán Lastra Tel: Fax: Limited Hungary
11 Spain Veterinaria, S.A. Ctra. Camprodón s/n La Riba Vall de Bianya (Girona) - Spain Contact: Dra Virginia Rodríguez Tel: Fax: rodrigv2@fdah.com Veterinaria, S.A.
12 PRÍLOHA II ODBORNÉ ZÁVERY
13 ODBORNÉ ZÁVERY Počas hodnotenia zmeny typu II na úpravu skúšania potencie myší tak, aby boli splnené požiadavky revidovanej monografie Ph. Eur. (Európskeho liekopisu) pre vakcíny proti červienke (erysipelas), bola šarža vakcíny 8500 prijatá ako referenčná vakcína, a preto táto šarža a šarže pred ňou musia byť prijaté ako šarže spĺňajúce podmienky na udelenie povolenia na uvedenie na trh pre oba produkty. Vzhľadom na po sebe idúce zmeny sa vynorili otázky týkajúce sa ekvivalencie šarží referenčných vakcín. Úpravy referenčných vakcín v rámci tohto konania sa týkajú nahradenia šarže 8500 šaržou 9097 a s tým súvisiaceho nahradenia šarže 9097 šaržou Držiteľ povolenia na uvedenie na trh v oboch prípadoch preukázal, že tieto šarže sa považujú za šarže referenčných vakcín, pretože tieto šarže prešli skúškou účinnosti podľa Ph. Eur. u ošípaných v 1/3 dávke, ktorá poskytuje dôkaz o účinnosti u cieľového druhu zvieraťa, tieto šarže sú ulované so stálym množstvom baktérií, kvantifikovaným schválenou a overenou metódou, šarže prešli skúškou bezpečnosti u cieľového druhu zvieraťa podľa monografie Ph. Eur. 0064, tieto šarže boli obchodnými šaržami vyrobenými podľa výrobných metód a bližšieho popisu opísaného v povolení na uvedenie na trh, účinnosť týchto dvoch referenčných šarží (9097 a 9861) je vyššia ako referenčné sérum PEI a ako šarža referenčnej vakcíny 8500, držiteľ povolenia na uvedenie na trh v dobe, keď sa vykonali nahradenia, dodržal presný štandardný pracovný postup (SOP) pre nahradzovanie. U predložených údajov sa však prejavila veľká variabilita čo sa týka výsledkov skúšok referenčných šarží v skúške sérologickej sily (účinnosti). Ako dôvod sa uviedla vnútorná variabilita v časti in-vivo tejto skúšky kvôli variabilite medzi šaržami myší. Táto variabilita znížila schopnosť skúšky preukázať ekvivalencie medzi referenčnými šaržami. Výbor CVMP sa na základe všetkých dostupných údajov domnieva, že neexistuje obava týkajúca sa bezpečnosti alebo účinnosti tohto produktu. Je však dôležité zaistiť, aby sa hranice splnenia skúšky účinnosti neodchýlili od pôvodných medzných hodnôt. Navyše sa pre tento produkt má v budúcnosti použiť dôslednejšia skúška účinnosti. Výbor CVMP preto odporúča zmenu povolenia na uvedenie na trh. Povolenie(-a) na uvedenie na trh sa má(majú) zemniť tak, aby sa znížila variabilita skúšky sérologickej sily (účinnosti) u myší vhodnými opatreniami, ako napr. nahradením použitia referenčnej vakcíny v skúške sérologickej sily u myší použitím referenčného séra.
PRÍLOHA 1 NÁZOV, LIEKOVÁ FORMA, KONCENTRÁCIA, CIEĽOVÝ DRUH, SPÔSOB PODANIA LIEKU, DRŽITEĽ POVOLENIA NA UVEDENIE NA TRH
PRÍLOHA 1 NÁZOV, LIEKOVÁ FORMA, KONCENTRÁCIA, CIEĽOVÝ DRUH, SPÔSOB PODANIA LIEKU, DRŽITEĽ POVOLENIA NA UVEDENIE NA TRH 1 Austria Wyeth Lederle Pharma GmbH, Fort Dodge Waidhausengasse 19/9, A-1140, Vienna
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