VASOGEN %w/w Cream
Land: Irland
Språk: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
Preparatomtale
(SPC)
30-05-2024
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Aktiv ingrediens:
DIMETICONE ZINC OXIDE CALAMINE
Tilgjengelig fra:
Forest Laboratories UK Ltd
INN (International Name):
DIMETICONE ZINC OXIDE CALAMINE
Dosering :
%w/w
Legemiddelform:
Cream
Resept typen:
Product not subject to medical prescription
Autorisasjon status:
Withdrawn
Autorisasjon dato:
0000-00-00
Preparatomtale
IRISH MEDICINES BOARD ACTS 1995 AND 2006
MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007
(S.I. NO.540 OF 2007)
PA0100/044/001
Case No: 2071722
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
FOREST LABORATORIES UK LTD
RIVERBRIDGE HOUSE, CROSSWAYS BUSINESS P, KENT, DA2 6SL, UNITED KINGDOM
an authorisation, subject to the provisions of the said Regulations, in respect of the product
VASOGEN CREAM (DIMETICONE 20% W/W, ZINC OXIDE 7.5% W/W AND CALAMINE 1.5% W/W)
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 25/09/2009.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 25/09/2009_
_CRN 2071722_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Vasogen Cream (Dimeticone 20% w/w, zinc oxide 7.5 % w/w and calamine 1.5% w/w)
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cream
A pale pink cream.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For use as a barrier cream where protection from water, irritants or body exudates is needed in conditions such as
nappy rash, bedsores and for local protection of the skin around the stoma after ileostomy and colostomy.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For topical use. A
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