Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
CLOPIDOGREL BESILATE
Nucleus ehf.
75 Base Milligrams
Film Coated Tablet
2010-04-23
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA1369/005/001 Case No: 2054999 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to NUCLEUS EHF. BORGARTUNI 30, 105 REYKJAVIK, ICELAND an authorisation, subject to the provisions of the said Regulations, in respect of the product CLOPIDOGREL NUCLEUS 75 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 23/04/2010 until 22/04/2015. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 29/04/2010_ _CRN 2054999_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Clopidogrel Nucleus 75 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 111.86 mg clopidogrel besylate corresponding to 75 mg clopidogrel. Excipients: Each film-coated tablet contains 73.61 mg lactose anhydrous and 0.29 mg lecithin (contains soya oil) (E322). For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Film-coated tablet. Pink 9 mm round, biconvex, film-coated tablet, engraved with “II” on one face. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Clopidogrel is indicated in adults for the prevention of atherothrombotic events in: Patients Read the complete document