SAVLON ANTISEPTIC 0.5/0.1 %w/w Cream
Land: Irland
Språk: engelska
Källa: HPRA (Health Products Regulatory Authority)
Produktens egenskaper
(SPC)
11-06-2024
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Aktiva substanser:
CETRIMONIUM BROMIDE CHLORHEXIDINE GLUCONATE
Tillgänglig från:
G & A Licensing Limited
INN (International namn):
CETRIMONIUM BROMIDE CHLORHEXIDINE GLUCONATE
Dos:
0.5/0.1 %w/w
Läkemedelsform:
Cream
Receptbelagda typ:
Product not subject to medical prescription
Bemyndigande status:
Withdrawn
Tillstånd datum:
2011-03-24
Produktens egenskaper
IRISH MEDICINES BOARD ACTS 1995 AND 2006
MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007
(S.I. NO.540 OF 2007)
PPA1447/049/001
Case No: 2069001
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
G & A LICENSING LTD
BALLYMURRAY, CO. ROSCOMMON, IRELAND
an authorisation, subject to the provisions of the said Regulations, in respect of the product
SAVLON ANTISEPTIC CREAM
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 08/01/2010.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 12/01/2010_
_CRN 2069001_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Savlon Antiseptic Cream.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredients:
Cetrimide
0.50% w/w
Chlorhexidine Gluconate
0.10% w/w
Excipients:
Cetostearyl alcohol
Methyl hydroxybenzoate E218
Propyl hydroxybenzoate E216
For full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Cream
_Imported from United Kingdom_
Smooth, white, homogenous cream with an antiseptic odour.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For prevention and management of superficial infections in skin tissue including wounds and minor burns.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For cutaneous use.
Apply to the affected area after cleansing.
4.3 CONTRAINDICAT
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