Land: Irland
Sprache: Englisch
Quelle: HPRA (Health Products Regulatory Authority)
ACETYLSALICYLIC ACID CAFFEINE
Seven Seas Ltd
ACETYLSALICYLIC ACID CAFFEINE
325/22 Milligram
Tablets
Product not subject to medical prescription
Withdrawn
0000-00-00
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0417/017/001 Case No: 2067888 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to SEVEN SEAS LTD HEDON ROAD, MARFLEET, KINGSTON-UPON-HULL HU9 5NJ, ENGLAND an authorisation, subject to the provisions of the said Regulations, in respect of the product PHENSIC 325MG/22MG 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 15/03/2010. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 19/03/2010_ _CRN 2067888_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Phensic 325mg/22mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION _For excipients, see section 6.1_ 3 PHARMACEUTICAL FORM Tablet. Smooth, white, capsule-shaped tablet. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Indicated for the management of pain and fever such as may be associated with musculoskeletal disorders, headache, toothache, and for the relief of cold and flu symptoms. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Directions for Use Oral administration Recommended Dose Adults and Adolescents aged 16 years and over Two tablets every 3 – 4 hours as required Do not exceed 12 tablets in any period of 24 hours. Do Lesen Sie das vollständige Dokument