BATRAFEN Cutaneous Solution 10 %v/v
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
24-04-2024
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Active ingredient:
CICLOPIROX OLAMINE
Available from:
Sanofi-Aventis Ireland Limited
Dosage:
10 %v/v
Pharmaceutical form:
Cutaneous Solution
Authorization date:
2009-01-09
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)
PA0540/032/006
Case No: 2064842
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 1% W/V CUTANEOUS SOLUTION
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 10/07/2009 until 17/12/2010.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 10/07/2009_
_CRN 2064842_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Batrafen 1% w/v Cutaneous Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains 10 mg ciclopiroxolamine in an alcoholic aqueous base.
For excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cutaneous Solution
Colourless to faintly yellow solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
All fungal infections of the skin where rapid drying is an advantage.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Batrafen solution should be gently rubbed into the infected area twice a day.
4.3 CONTRAINDICATIONS
Batrafen solution should not be used in patients with known hypersensitivity to any c
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