Country: Իռլանդիա
language: անգլերեն
source: HPRA (Health Products Regulatory Authority)
NANDROLONE DECANOATE
NV Organon
NANDROLONE DECANOATE
25 Mg/Ml
Solution for Injection
Product subject to prescription which may not be renewed (A)
Withdrawn
2012-07-12
IRISH MEDICINES BOARD ACT 1995, AS AMENDED MEDICINAL PRODUCTS (CONTROL OF PLACING ON THE MARKET) REGULATIONS, 2007, AS AMENDED PA0964/008/001 Case No: 2082307 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to Transferred from PA0261/003/003. NV ORGANON KLOOSTERSTRAAT 6, 5349 AB OSS, NETHERLANDS an authorisation, subject to the provisions of the said Regulations, in respect of the product DECA DURABOLIN 25 MG/ML SOLUTION FOR INJECTION (SYRINGE) the particulars of which are set out in 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 02/07/2010. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 02/07/2010_ _CRN 2082307_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Deca Durabolin 25 mg / ml Solution for Injection (syringe) 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains nandrolone decanoate 25 mg. Excipients: Also contains 0.1ml of Benzyl alcohol and up to 1ml of arachis oil. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for Injection A clear pale yellow to yellow oily sterile solution for injection. 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 read_full_document