BATRAFEN 10MG/G
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
20-04-2024
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Active ingredient:
CICLOPIROX
Available from:
Sanofi-Aventis Ireland Limited
Dosage:
10 %v/v
Pharmaceutical form:
Shampoo
Authorization date:
2005-08-26
Summary of Product characteristics
IRISH MEDICINES BOARD ACTS 1995 AND 2006
MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007
(S.I. NO.540 OF 2007)
PA0540/032/005
Case No: 2072051
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
SANOFI-AVENTIS IRELAND LIMITED
CITYWEST BUSINESS CAMPUS, DUBLIN 24, IRELAND
an authorisation, subject to the provisions of the said Regulations, in respect of the product
BATRAFEN 10MG/G SHAMPOO
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 05/11/2009 until 25/08/2010.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 05/11/2009_
_CRN 2072051_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Batrafen 10mg/g Shampoo
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One gram shampoo contains 10 mg ciclopirox.
For excipients see section 6.1.
3 PHARMACEUTICAL FORM
Shampoo
Almost colourless to yellowish, translucent solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Batrafen 10mg/g Shampoo is indicated for the treatment of seborrhoeic dermatitis of the scalp.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For cutaneous use.
For the initial treatment of the symptoms of seborrhoeic dermatitis Batrafen 10mg/g Shampoo is applied on the scalp
once or twice a week, depending on severity, for four weeks.
For subseque
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