Држава: Ирска
Језик: Енглески
Извор: HPRA (Health Products Regulatory Authority)
ACICLOVIR
Stada Arzneimittel AG
ACICLOVIR
50 mg/g
Cream
Withdrawn
2008-04-15
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0593/015/001 Case No: 2041180 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to STADA ARZNEIMITTEL AG STADASTRASSE 2-18, D-61118 BAD VILBEL, GERMANY an authorisation, subject to the provisions of the said Regulations, in respect of the product ACYCLOSTAD 50 MG/G CREAM 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 05/12/2007. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 07/12/2007_ _CRN 2041180_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Acyclostad 50mg/g cream 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Acyclostad 50 mg/g cream contains 50 mg of aciclovir per gram of cream. Excipient: 50mg/g cetyl alcohol and 150mg/g propylene glycol For a full list of excipients, see 6.1. 3 PHARMACEUTICAL FORM Cream White to off-white cream. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of immunocompetent patients with skin infections caused by herpes simplex virus in particular in initial genital herpes. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Acyclostad 50 mg/g cream should be applied to infected skin areas 5 times daily at approximately 4 hourly intervals, omittin Прочитајте комплетан документ