País: Irlanda
Idioma: inglés
Fuente: HPRA (Health Products Regulatory Authority)
DESMOPRESSIN ACETATE
Gebro Pharma GmbH
DESMOPRESSIN ACETATE
0.1 Milligram
Tablets
Withdrawn
2009-09-25
IRISH MEDICINES BOARD ACT 1995 MEDICINAL PRODUCTS(LICENSING AND SALE)REGULATIONS, 1998 (S.I. NO.142 OF 1998) PA1262/001/001 Case No: 2037250 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to GEBRO PHARMA GMBH 6391 FIEBERBRUNN, AUSTRIA an authorisation, subject to the provisions of the said Regulations, in respect of the product NOCUTIL 0.1 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 18/06/2007 until 06/04/2011. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 19/06/2007_ _CRN 2037250_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Nocutil 0.1 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 0.1 mg desmopressin acetate. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet Uncoated, white, round, convex tablets scored on one side. The scoreline is only to facilitate breaking for ease of swallowing in exceptional cases and not to divide into equal doses. Both half tablets should be taken as one dose. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the treatment of primary nocturnal enuresis in children (from 5 years of age) following exclusion of organic causes - as part of overall therapeutic management (e.g. if other, non-pharmaceut Leer el documento completo