Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
TOCOPHERYL ACETATE
Seven Seas Health Care Ltd
200 International Unit
Capsule
1989-05-25
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0416/001/001 Case No: 2058899 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to SEVEN SEAS HEALTH CARE LTD HEDON ROAD, MARFLEET, HULL, KINGSTON-UPON-HULL HU9 5NJ, UNITED KINGDOM an authorisation, subject to the provisions of the said Regulations, in respect of the product SEVEN SEAS SUPER VITAMIN E 200 IU CAPSULES 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 25/05/2009. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 29/05/2009_ _CRN 2058899_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Seven Seas Super Vitamin E 200 IU Capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains: Vitamin E (_dl _alpha Tocopheryl Acetate) 200IU Excipients: Soya Bean Oil 71.0mg For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Capsule, soft. (Capsule) Orange, clear, oval, soft gelatin capsules containing an oily solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Vitamin supplement. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults Only: One capsule daily. Method of administration To be taken by oral administration. 4.3 CONTRAINDICATIONS 1. Known hypers Read the complete document