MYOCRISIN Solution for Injection 50mg/0.5 Millilitre
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
19-04-2024
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Active ingredient:
SODIUM AUROTHIOMALATE
Available from:
May & Baker Limited
Dosage:
50mg/0.5 Millilitre
Pharmaceutical form:
Solution for Injection
Authorization date:
1983-04-01
Summary of Product characteristics
IRISH MEDICINES BOARD ACT 1995
MEDICINAL PRODUCTS(LICENSING AND SALE)REGULATIONS, 1998
(S.I. NO.142 OF 1998)
PA0040/068/005
Case No: 2030701
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
MAY & BAKER LIMITED
RPR HOUSE, 50 KINGS HILL AVENUE, WEST MALLING, KENT ME19 4AH, UNITED KINGDOM
an authorisation, subject to the provisions of the said Regulations, in respect of the product
MYOCRISIN INJECTION 50 MG (10% W/V)
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 31/01/2007 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 01/02/2007_
_CRN 2030701_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Myocrisin Injection 50mg (10%w/v)
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Sodium Aurothiomalate, 50 mg in 0.5 ml.
For excipients see 6.1.
3 PHARMACEUTICAL FORM
Solution for Injection
A pale yellow aqueous solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For use in the management of active progressive rheumatoid arthritis, including progressive juvenile rheumatoid
arthritis especially if polyarticular or sero-positive. In some cases of chronic discoid lupus erythematosus unresponsive
to anti-malarials a response may be obtained with this drug.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Myocri
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