Țară: Irlanda
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Sursă: HPRA (Health Products Regulatory Authority)
ACETYLSALICYLIC ACID CAFFEINE
Pfizer Consumer Healthcare Ltd
ACETYLSALICYLIC ACID CAFFEINE
500mg, 50m Milligram
Tablets
Product not subject to medical prescription
Withdrawn
2012-02-29
IRISH MEDICINES BOARD ACT 1995, AS AMENDED MEDICINAL PRODUCTS (CONTROL OF PLACING ON THE MARKET) REGULATIONS, 2007, AS AMENDED PA0172/004/007 Case No: 2086521 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to PFIZER CONSUMER HEALTHCARE LTD RAMSGATE ROAD, SANDWICH, KENT, CT13 9NJ, UNITED KINGDOM an authorisation, subject to the provisions of the said Regulations, in respect of the product ANIALL 500/50 MG TABLETS the particulars of which are set out in 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 28/07/2010 until 06/09/2012. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 28/07/2010_ _CRN 2086521_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Aniall 500 / 50 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each Tablet contains: Aspirin (Acetylsalicylic acid) 500 mg Caffeine 50 mg For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Tablet. White, round, biconvex tablets, with diametrically opposite notches, engraved on both sides with “AMX”. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the treatment of headaches, neuralgia, rheumatic pain, period pain, dental pain, and the symptoms of colds and flu. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Oral. ADULTS AND CHILDREN OVER 12 YEARS: 1 tablet every three to four hours. Do not exc Citiți documentul complet