REVIA Tablets 50 Milligram
País: Irlanda
Língua: inglês
Origem: HPRA (Health Products Regulatory Authority)
Características técnicas
(SPC)
06-06-2024
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Ingredientes ativos:
NALTREXONE HYDROCHLORIDE
Disponível em:
Bristol-Myers Squibb Pharmaceuticals Ltd
Dosagem:
50 Milligram
Forma farmacêutica:
Tablets
Data de autorização:
2001-12-03
Características técnicas
IRISH MEDICINES BOARD ACT 1995
MEDICINAL PRODUCTS(LICENSING AND SALE)REGULATIONS, 1998
(S.I. NO.142 OF 1998)
PA0002/074/001
Case No: 2029213
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
BRISTOL-MYERS SQUIBB
SWORDS, CO. DUBLIN, IRELAND
an authorisation, subject to the provisions of the said Regulations, in respect of the product
REVIA 50 MG FILM-COATED TABLETS
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 03/12/2006.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 23/05/2007_
_CRN 2029213_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Revia 50 mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 50 mg naltrexone hydrochloride.
Excipients: Lactose monohydrate, 204 mg per tablet
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Pale yellow, capsule-shaped tablets, debossed on one side with ‘R11’ and scored and debossed with ‘50’ on the other
side.
The scoreline is only to facilitate breaking for ease of swallowing and not to divide into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For use within a comprehensive treatment programme for alcohol dependence to reduce the risk of relapse,
support abstinence
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