Country: Irlanda
Lingwa: Ingliż
Sors: HPRA (Health Products Regulatory Authority)
ACAMPROSATE CALCIUM
B & S Healthcare
ACAMPROSATE CALCIUM
333 Milligram
Tablets Gastro-Resistant
Withdrawn
0000-00-00
IRISH MEDICINES BOARD ACT 1995 MEDICINAL PRODUCTS(LICENSING AND SALE)REGULATIONS, 1998 (S.I. NO.142 OF 1998) PPA1328/073/001 Case No: 2029776 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to B & S HEALTHCARE UNIT 4, BRADFIELD ROAD, RUISLIP, MIDDLESEX, HA4 0NU, UNITED KINGDOM an authorisation, subject to the provisions of the said Regulations, in respect of the product CAMPRAL EC 333 MG GASTRO-RESISTANT 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 30/03/2007 until 29/03/2012. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 12/04/2007_ _CRN 2029776_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Campral EC 333 mg Gastro-resistant tablets. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each gastro-resistant tablet contains 333.0 mg acamprosate calcium. For a full list of excipients see section 6.1. 3 PHARMACEUTICAL FORM Gastro-resistant tablet _Product imported from The Netherlands and Portugal:_ White coated gastro-resistant tablet marked with ‘333’ on one side 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Campral EC is indicated as therapy to maintain abstinence in alcohol dependent patients. It should be combined with counselling. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Adults:_ Within the age Aqra d-dokument sħiħ