DECA DURABOLIN 50 MG/ML SOLUTION FOR INJECTION (AM
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
24-04-2024
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Active ingredient:
NANDROLONE DECANOATE
Available from:
Organon Laboratories Limited
Dosage:
50 Mg/Ml
Pharmaceutical form:
Solution for Injection
Authorization date:
1980-02-12
Summary of Product characteristics
IRISH MEDICINES BOARD ACT 1995
MEDICINAL PRODUCTS(LICENSING AND SALE)REGULATIONS, 1998
(S.I. NO.142 OF 1998)
PA0261/003/005
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 50 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 11/02/2010.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 12/06/2007_
_CRN 2036546_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Deca Durabolin 50 mg/ml Solution for Injection (ampoule)
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 ml contains nandrolone decanoate 50 mg.
For excipients, see 6.1.
3 PHARMACEUTICAL FORM
Solution for injection
A clear, pale yellow, oily 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 in the management of disseminated mammary carcinoma in the female.
4.2 POSOLOGY AND METHO
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