SUSTANON 250 AMPOULES 30/60/60/1 Mg/Ml Solution for Injection
Land: Irland
Sprog: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
Produktets egenskaber
(SPC)
31-05-2024
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Aktiv bestanddel:
TESTOSTERONE PROPIONATE TESTOSTERONE PHENYLPROPIONATE TESTOSTERONE ISOCAPROATE TESTOSTERONE DECANOATE
Tilgængelig fra:
Organon Laboratories Limited
INN (International Name):
TESTOSTERONE PROPIONATE TESTOSTERONE PHENYLPROPIONATE TESTOSTERONE ISOCAPROATE TESTOSTERONE DECANOATE
Dosering:
30/60/60/1 Mg/Ml
Lægemiddelform:
Solution for Injection
Autorisation status:
Withdrawn
Autorisation dato:
2008-12-04
Produktets egenskaber
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:
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