Country: Írland
Tungumál: enska
Heimild: HPRA (Health Products Regulatory Authority)
ACICLOVIR
B & S Healthcare
200 Milligram
Dispersible film-coated tablets
2007-05-18
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PPA1328/067/002 Case No: 2028983 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 ZOVIRAX 200 MG DISPERSIBLE 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 18/05/2007 until 17/05/2012. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 26/09/2007_ _CRN 2028983_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Zovirax 200 mg Dispersible Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 200 mg aciclovir. For full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Dispersible, film-coated tablet. (Dispersible tablet) _Product imported from Germany:_ White, round tablets branded with ‘GX CF3’ on one side and plain on the other. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Zovirax Tablets 200mg are indicated for the treatment of Herpes simplex virus infections of the skin and mucous membranes including initial and recurrent genital Herpes. Zovirax Tablets 200mg Lestu allt skjalið