CANESTEN Cutaneous Solution 1 %w/v
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
20-04-2024
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Active ingredient:
CLOTRIMAZOLE
Available from:
Bayer PLC
Dosage:
1 %w/v
Pharmaceutical form:
Cutaneous Solution
Authorization date:
1977-04-01
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)
PA0021/004/003
Case No: 2038189
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
BAYER PLC
BAYER HOUSE, STRAWBERRY HILL, NEWBURY, BERKSHIRE RG14 1JA, UNITED KINGDOM
an authorisation, subject to the provisions of the said Regulations, in respect of the product
CANESTEN 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 26/07/2007.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 22/09/2007_
_CRN 2038189_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Canesten Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Contains clotrimazole 1.0% w/v (equivalent to 10mg/ml).
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cutaneous solution
A clear, colourless solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
A broad spectrum antifungal for use in the topical treatment of infections due to superficial dermatophytes, Candida
species and other fungi sensitive to the anti-infective: Trichomonas, Staphylococci and Bacteroides. The drug has no
effect on Lactobacilli.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Canesten solution should be thinly and evenly applie
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