Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
NANDROLONE DECANOATE
Organon Laboratories Limited
25 Mg/Ml
Solution for Injection
1979-04-01
IRISH MEDICINES BOARD ACT 1995 MEDICINAL PRODUCTS(LICENSING AND SALE)REGULATIONS, 1998 (S.I. NO.142 OF 1998) PA0261/003/002 Case No: 2036546 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to ORGANON LABORATORIES LIMITED CAMBRIDGE SCIENCE PARK, MILTON ROAD, CAMBRIDGE CB4 0FL, UNITED KINGDOM an authorisation, subject to the provisions of the said Regulations, in respect of the product DECA DURABOLIN 25 MG / ML SOLUTION FOR INJECTION (AMPOULE) 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 08/06/2007 until 31/03/2009. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 12/06/2007_ _CRN 2036546_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Deca Durabolin 25 mg / ml Solution for Injection (ampoule) 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains nandrolone decanoate 25 mg. For excipients, see 6.1. 3 PHARMACEUTICAL FORM Solution for Injection 1 ml Type I clear glass ‘Ringsnap’ ampoule containing a clear pale yellow to yellow oily solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS In the management of conditions associated with catabolism and negative nitrogen balance such as debility, burns, osteoporosis, refractory anaemia and renal failure. As an adjunct in the management of disseminat Read the complete document