国: アイルランド
言語: 英語
ソース: HPRA (Health Products Regulatory Authority)
OLANZAPINE
Pliva Pharma Limited
15 Milligram
Film Coated Tablet
2008-12-08
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0585/031/009 Case No: 2046200 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to PLIVA PHARMA LIMITED VISION HOUSE, BEDFORD ROAD, PETERSFIELD, HAMPSHIRE GU32 3QB, UNITED KINGDOM an authorisation, subject to the provisions of the said Regulations, in respect of the product OLANZAPINE PLIVA 15 MG FILM-COATED TABLETS The particulars of which are set out in Part I and Part II of the attached Schedule. The authorisation is also subject to the general conditions as may be specified in the said Regulations as listed on the reverse of this document. This authorisation, unless previously revoked, shall continue in force from 08/12/2008 until 07/12/2013. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 11/12/2008_ _CRN 2046200_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Olanzapine Pliva 15 mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 15mg Olanzapine. Excipient(s): Each 15mg film-coated tablet contains 219.90mg lactose monohydrate. Each 15mg film-coated tablet contains 0.01mg sunset yellow (E110). For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. Olanzapine 15mg Film-coated tablets are blue, round, biconvex, film-coated tablets, embossed with b’ on one side and ‘564’ on the other. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Olanzapine is ind 完全なドキュメントを読む