Country: Ireland
Bahasa: Inggeris
Sumber: HPRA (Health Products Regulatory Authority)
DESMOPRESSIN ACETATE
Gebro Pharma GmbH
DESMOPRESSIN ACETATE
0.1 Mg/Ml
Nasal Spray Solution
Withdrawn
2007-03-07
IRISH MEDICINES BOARD ACT 1995 MEDICINAL PRODUCTS(LICENSING AND SALE)REGULATIONS, 1998 (S.I. NO.142 OF 1998) PA1262/001/003 Case No: 2024528 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/ML NASAL SPRAY, SOLUTION, DESMOPRESSIN ACETATE 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 28/11/2006 until 27/04/2011. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 29/11/2006_ _CRN 2024528_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Nocutil 0.1 mg/ml Nasal Spray, solution, Desmopressin acetate 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1ml nasal spray, solution contains 0.1 mg desmopressin acetate (corresponding to 0.089 mg desmopressin). One spray delivers 10micrograms desmopressin acetate. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Nasal spray, solution [Nasal spray] Clear, colourless solution 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the treatment of nocturnal enuresis in children (from 5 years of age) following exclusion of organic causes - as part of a global therapeutic management (e.g. if other, non-pharmaceutical Baca dokumen lengkap