Země: Irsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
SODIUM PICOSULFATE
Madaus GmbH
5 Milligram
Lozenges
2007-11-30
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA1288/004/001 Case No: 2042926 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to Transferred from PA0375/005/001. MADAUS GMBH 51101 COLOGNE, GERMANY an authorisation, subject to the provisions of the said Regulations, in respect of the product AGIOLAX PICO 5MG LOZENGES 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 30/11/2007 until 03/02/2010. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 01/12/2007_ _CRN 2042926_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Agiolax Pico 5mg Lozenges 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 lozenge contains: Sodium picosulfate monohydrate equivalent to Sodium picosulfate, anhydrous 5 mg. For excipients, see 6.1. 3 PHARMACEUTICAL FORM Lozenges A rectangular yellow lozenge with a break-line. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For use in cases of constipation and illnesses requiring an easy defaecation. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults, elderly people, children over 12 years: 1-2 lozenges once per day. Children over 4 years: after consulting a physician ½ lozenge once per day. The lozenges should preferably b Přečtěte si celý dokument