CICATRIN Cream
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
29-04-2024
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Active ingredient:
NEOMYCIN SULFATE BACITRACIN ZINC CYSTEINE THREONINE AMINOACETIC ACID
Available from:
GlaxoSmithKline (Ireland) Limited
INN (International Name):
NEOMYCIN SULFATE BACITRACIN ZINC CYSTEINE THREONINE AMINOACETIC ACID
Pharmaceutical form:
Cream
Prescription type:
Product subject to prescription which may not be renewed (A)
Authorization status:
Withdrawn
Authorization date:
2010-12-01
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)
PA1077/054/001
Case No: 2039664
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
GLAXOSMITHKLINE (IRELAND) LTD
STONEMASONS WAY, RATHFARNHAM, DUBLIN 16, IRELAND
an authorisation, subject to the provisions of the said Regulations, in respect of the product
CICATRIN 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 21/11/2007.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 22/11/2007_
_CRN 2039664_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Cicatrin Cream
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram of cream contains:
Neomycin Sulphate
3,300 units
Bacitracin Zinc
250 units
Glycine
10 mg
L(+) Cysteine
2 mg
DL-Threonine
1 mg
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cream.
A translucent deep yellow to brownish-yellow cream.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Cicatrin Cream is broad-spectrum bactericidal preparations active against pathogens commonly found in infections of
the skin. They are indicated in the prevention or treatment of superficial skin infection. These include:
Prophylaxis in minor burns, cuts, scratches and abrasion
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