Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
ANASTRAZOLE
Docpharma BVBA
1 Milligram
Film Coated Tablet
2009-12-22
IRISH MEDICINES BOARD ACT 1995, AS AMENDED MEDICINAL PRODUCTS (CONTROL OF PLACING ON THE MARKET) REGULATIONS, 2007, AS AMENDED PA1506/001/001 Case No: 2087363 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to DOCPHARMA NV AMBACHTENLAAN 13 H / INTERLEUVENLAAN 66, 3001 HEVERLEE, BELGIUM an authorisation, subject to the provisions of the said Regulations, in respect of the product ANASTROZOLE DOCPHARMA 1MG FILM-COATED TABLETS the particulars of which are set out in 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 24/08/2010 until 21/12/2014. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 24/08/2010_ _CRN 2087363_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Anastrozole Docpharma 1 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 1 mg anastrozole as active substance. Excipients: Each tablet contains 90.3 mg lactose (as lactose monohydrate). For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. White, round, biconvex, film-coated tablets. Debossed with ‘1’ on one side and plain on the reverse side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of advanced breast cancer in postmenopausal women. Efficacy has not been demonstrated in oestrogen receptor-negative patients unless they had Read the complete document