LOCOID C
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
20-04-2024
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Active ingredient:
HYDROCORTISONE BUTYRATE CHLORQUINALDOL
Available from:
Astellas Pharma Co. Ltd
Dosage:
0.1 %w/w, %v/v
Pharmaceutical form:
Cream
Authorization date:
2005-09-30
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)
PA1241/004/001
Case No: 2036420
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
ASTELLAS PHARMA CO. LTD
25 THE COURTYARD, KILCARBERY BUSINESS PARK, CLONDALKIN, DUBLIN 22, IRELAND
an authorisation, subject to the provisions of the said Regulations, in respect of the product
LOCOID C 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 14/10/2007.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 23/10/2007_
_CRN 2036420_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Locoid C Cream
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
The cream contains Hydrocortisone butyrate 0.1% w/w and Chlorquinaldol 3.0% w/w.
Excipients: contains cetostearyl alcohol 7.20% w/w
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cream
Buff-white, aqueous-based cream.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
The product is recommended for clinical use in treatment of conditions responsive to topical corticosteroids, e.g.
eczema, dermatitis and psoriasis where there is concurrent infection by a micro-organism susceptible to chlorquinaldol,
or where such infection is to be prevent
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