LOCOID Cream 0.1 %w/w
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
10-05-2024
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Active ingredient:
HYDROCORTISONE BUTYRATE
Available from:
PCO Manufacturing
Dosage:
0.1 %w/w
Pharmaceutical form:
Cream
Authorization date:
2006-11-10
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)
PPA0465/177/001
Case No: 2054664
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
PCO MANUFACTURING LIMITED
UNIT 10, ASHBOURNE BUSINESS PARK, RATH, ASHBOURNE, CO. MEATH, IRELAND
an authorisation, subject to the provisions of the said Regulations, in respect of the product
LOCOID 0.1 % W/W 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 20/10/2008 until 09/11/2011.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 20/10/2008_
_CRN 2054664_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Locoid 0.1% w/w Cream
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
The cream contains 0.1% w/w Hydrocortisone Butyrate
Excipients: Cetostearyl Alcohol
Propyl parahydroxybenzoate (E216)
Butyl parahydroxybenzoate
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cream
_Product imported from France:_
A white, aqueous-based cream.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
The product is recommended for clinical use in the treatment of conditions responsive to topical corticosteroids e.g.
eczema, dermatitis and psoriasis.
Topical corticosteroids are not generally indicated in pso
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