DECA DURABOLIN
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
26-04-2024
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Active ingredient:
NANDROLONE DECANOATE
Available from:
NV Organon
Dosage:
50 Mg/Ml
Pharmaceutical form:
Solution for Injection
Authorization date:
2010-07-02
Summary of Product characteristics
IRISH MEDICINES BOARD ACT 1995, AS AMENDED
MEDICINAL PRODUCTS (CONTROL OF PLACING ON THE MARKET) REGULATIONS, 2007, AS AMENDED
PA0964/008/002
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 PA0261/003/004.
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 50 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 50 mg / ml Solution for Injection (syringe)
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains nandrolone decanoate 50 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
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