AIRTAL 100MG FILM-COATED TABLETS.
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
25-04-2024
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Active ingredient:
ACECLOFENAC
Available from:
Almirall, S.A.
Dosage:
100 Milligram
Pharmaceutical form:
Tablets
Authorization date:
1996-01-08
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)
PA0968/003/001
Case No: 2043804
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
LABORATORIOS ALMIRALL S.A.
GENERAL MITRE, 151, 08022, BARCELONA, SPAIN
an authorisation, subject to the provisions of the said Regulations, in respect of the product
AIRTAL 100MG 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 12/08/2008 until .
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 12/08/2008_
_CRN 2043804_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Airtal 100mg Film-coated Tablets.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
Aceclofenac 100mg
For excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated Tablet
White, round, film-coated tablet, 8mm in diameter, with an ‘A’ embossed on one side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Airtal
®
is indicated for the relief of pain and inflammation in osteoarthritis, rheumatoid arthritis and ankylosing
spondylitis.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Airtal
®
tablets are supplied for oral administration and should be swallowed whole with a sufficient quantity of liquid.
When A
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