CANESTEN DERMATOLOGICAL 1%w/w %w/w Cutaneous Powder
Država: Irska
Jezik: angleščina
Source: HPRA (Health Products Regulatory Authority)
Lastnosti izdelka
(SPC)
24-04-2024
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Aktivna sestavina:
CLOTRIMAZOLE
Dostopno od:
Bayer PLC
INN (mednarodno ime):
CLOTRIMAZOLE
Odmerek:
1%w/w %w/w
Farmacevtska oblika:
Cutaneous Powder
Status dovoljenje:
Withdrawn
Datum dovoljenje:
2008-02-22
Lastnosti izdelka
IRISH MEDICINES BOARD ACTS 1995 AND 2006
MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007
(S.I. NO.540 OF 2007)
PA0021/004/006
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 DERMATOLOGICAL POWDER
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 until 20/09/2008.
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 Dermatological Powder
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Clotrimazole 1% w/w.
For excipients, see 6.1.
3 PHARMACEUTICAL FORM
Cutaneous powder
White, fine powder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Canesten Dermatological Powder should be used as an adjunct in the management of infections caused by
microorganisms sensitive to clotrimazole and as a prophylactic against re-infection.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Canesten Dermatological Powder should be sprinkled onto the infected areas two to three times daily after using
Canesten Cream or Canesten Dermatologica
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