Country: আয়ার্লণ্ড
ভাষা: ইংরেজি
সূত্র: HPRA (Health Products Regulatory Authority)
ACECLOFENAC
Almirall, S.A.
100 Milligram
Tablets
1996-01-08
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 সম্পূর্ণ নথি পড়ুন