Nazione: Irlanda
Lingua: inglese
Fonte: HPRA (Health Products Regulatory Authority)
IBUPROFEN
Pfizer Consumer Healthcare Ltd
200 Milligram
Coated Tablets
1997-10-31
IRISH MEDICINES BOARD ACT 1995, AS AMENDED MEDICINAL PRODUCTS (CONTROL OF PLACING ON THE MARKET) REGULATIONS, 2007, AS AMENDED PA0172/029/001 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 ADVIL 200 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. 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 Advil 200 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains Ibuprofen 200 mg. Excipients: Also contains sucrose, methyl parahydroxybenzoate (E 218) + propylparahydroxybenzoate (E 216) For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Coated tablet (tablet) A pinkish brown, sugar coated tablet with ‘Advil’ printed in black on one side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Short term management of pain and fever conditions such as: Acute pain from dysmenorrhoea. Dental pain. Muscular pain. Headaches. Colds and flu symptoms. Backache. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults, the elderl Leggi il documento completo