METFORMIN Film Coated Tablet 500 Milligram
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
17-04-2024
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Active ingredient:
METFORMIN HYDROCHLORIDE
Available from:
Morningside Healthcare Limited
Dosage:
500 Milligram
Pharmaceutical form:
Film Coated Tablet
Authorization date:
2007-08-24
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)
PA1333/001/001
Case No: 2040752
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
MORNINGSIDE HEALTHCARE LIMITED
115 NARBOROUGH ROAD, LEICESTER LE3 0PA, UNITED KINGDOM
an authorisation, subject to the provisions of the said Regulations, in respect of the product
METFORMIN HYDROCHLORIDE 500MG FILM COATED TABLETS
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 until 23/08/2012.
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 2040752_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Metformin Hydrochloride 500mg film coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film coated tablet contains Metformin Hydrochloride 500 mg
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Film-coated tablet.
White, circular, bi-convex film-coated tablet with diameter of 11mm.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
THERAPEUTIC INDICATIONS
Treatment of type 2 diabetes mellitus in adults, particularly in overweight patients, when dietary management and
exercise alone does not result in adequate glycemic control.
o
IN ADULTS, METFORMIN ma
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