国: アイルランド
言語: 英語
ソース: HPRA (Health Products Regulatory Authority)
TERTATOLOL HYDROCHLORIDE
Les Laboratoires Servier
TERTATOLOL HYDROCHLORIDE
5 Milligram
Tablets
Product subject to prescription which may be renewed (B)
Withdrawn
0000-00-00
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0568/001/001 Case No: 2066568 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to LES LABORATOIRES SERVIER 22, RUE GARNIER, 92200 NEUILLY-SUR-SEINE, FRANCE an authorisation, subject to the provisions of the said Regulations, in respect of the product ARTEXAL 5 MG 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 31/08/2009. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 05/09/2009_ _CRN 2066568_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Artexal 5 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Tertatolol hydrochloride 5 mg per tablet. Excipients: contains Lactose Monohydrate 37.0mg For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Film coated tablet. White, oblong, film-coated tablets scored on one face. The tablet can be divided into equal halves. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS As a beta adrenoceptor blocker for the treatment of essential hypertension. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Oral administration Adults Only: The usual daily dose is 5 mg in single or divided doses. Hypertension: The usual daily dose is 5 完全なドキュメントを読む