Ország: Írország
Nyelv: angol
Forrás: HPRA (Health Products Regulatory Authority)
TESTOSTERONE PROPIONATE TESTOSTERONE PHENYLPROPIONATE TESTOSTERONE ISOCAPROATE TESTOSTERONE DECANOATE
Organon Laboratories Limited
TESTOSTERONE PROPIONATE TESTOSTERONE PHENYLPROPIONATE TESTOSTERONE ISOCAPROATE TESTOSTERONE DECANOATE
30/60/60/1 Mg/Ml
Solution for Injection
Withdrawn
2008-12-04
IRISH MEDICINES BOARD ACT 1995 MEDICINAL PRODUCTS(LICENSING AND SALE)REGULATIONS, 1998 (S.I. NO.142 OF 1998) PA0261/009/003 Case No: 2037733 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 SUSTANON '250' AMPOULE SOLUTION FOR INJECTION 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 17/07/2007 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 18/07/2007_ _CRN 2037733_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Sustanon 250 Ampoule Solution for Injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ampoule of Sustanon 250 contains 30 mg/ml testosterone propionate, 60 mg/ml testosterone phenylpropionate, 60 mg/ml testosterone isocaproate and 100 mg/ml testosterone decanoate. Sustanon 250 has a content equivalent to 176 mg of testosterone. For excipients, see 6.1. 3 PHARMACEUTICAL FORM Solution for injection A clear pale yellow solution for injection. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS In men testosterone therapy may be indicated in osteoporosis caused by androgen deficiency. In males: Olvassa el a teljes dokumentumot