BALMOSA CREAM
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
25-04-2024
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Active ingredient:
MENTHOL CAMPHOR METHYL SALICYLATE
Available from:
Galen Consumer Ltd.
Pharmaceutical form:
Cream
Authorization date:
2007-11-23
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)
PA1443/001/001
Case No: 2043305
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
Transferred from PA0100/015/001.
GALEN CONSUMER LTD.
212-220 ADDINGTON ROAD, SELSDON, SOUTH CROYDON, SURREY CR2 8LD, UNITED KINGDOM
an authorisation, subject to the provisions of the said Regulations, in respect of the product
BALMOSA 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 23/11/2007 until 31/03/2008.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 27/11/2007_
_CRN 2043305_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Balmosa Cream
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
3 PHARMACEUTICAL FORM
Cream
Smooth homogeneous off-white cream with characteristic odour.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the topical management of the symptoms of musculofibroarticular disorders such as rheumatism, fibrositis,
lumbago, sciatica and unbroken chilblains.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Gently rub into the painful area and keep covered, if possible.
4.3 CONTRAINDICATIONS
Patients with a history of hypersensitivity to any of the active substances or excipients.
4.4 SPECIAL
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