ETRIVEX Cutaneous Emulsion 500 Micrograms/g
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
28-03-2023
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Active ingredient:
CLOBETASOL PROPIONATE
Available from:
Galderma (UK) Ltd
Dosage:
500 Micrograms/g
Pharmaceutical form:
Cutaneous Emulsion
Authorization date:
2005-11-11
Summary of Product characteristics
License
IRISH MEDICINES BOARD ACT 1995
MEDICINAL PRODUCTS(LICENSING AND SALE)REGULATIONS, 1998
(S.I. No.142 of 1998)
PA0590/022/001
Case No: 2033593
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
Galderma (UK) Ltd
Meridien House, 69-71 Clarendon Road, Watford, Herts WD17 1DS, United Kingdom
an authorisation, subject to the provisions of the said Regulations, in respect of the product
Etrivex 500 micrograms/g cutaneous emulsion
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 02/08/2007 until .
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
Irish Medicines Board
______________________________________________________________________________________________________________________
Date Printed 03/08/2007
CRN 2033593
page number: 1
Part II
Summary of Product Characteristics
1 NAME OF THE MEDICINAL PRODUCT
Etrivex 500 micrograms/g cutaneous emulsion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
O
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