EURAX HYDROCORTISONE CREAM
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
26-04-2024
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Active ingredient:
CROTAMITON HYDROCORTISONE
Available from:
Novartis Consumer Health UK Limited
Dosage:
10/0.25 %w/w
Pharmaceutical form:
Cream
Authorization date:
1988-05-12
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)
PA0030/014/001
Case No: 2057643
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
NOVARTIS CONSUMER HEALTH UK LIMITED
WIMBLEHURST ROAD, HORSHAM, WEST SUSSEX RH12 5AB, UNITED KINGDOM
an authorisation, subject to the provisions of the said Regulations, in respect of the product
EURAX HYDROCORTISONE CREAM CROTAMITON 10.0 %W/W HYDROCORTISONE 0.25 %W/W
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 08/02/2010.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 08/02/2010_
_CRN 2057643_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Eurax Hydrocortisone Cream
Crotamiton 10.0 %w/w
Hydrocortisone 0.25 %w/w
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Crotamiton 10.0% w/w
Hydrocortisone 0.25% w/w
Excipients:
3 PHARMACEUTICAL FORM
Cream
A white to cream coloured cream giving a homogeneous smear, apart from trapped air bubbles;
odour characteristic of perfume.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
In corticosteroid sensitive dermatoses including intertrigo and in insect bite reactions.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Method of application:
A thin layer of Eurax Hydrocortisone Cre
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