Страна: Ірландія
мова: англійська
Джерело: HPRA (Health Products Regulatory Authority)
EICOSAPENTAENOIC ACID DOCOSAHEXANOIC ACID
Seven Seas Ltd
170/115 Milligram
Capsules, Soft
1986-07-28
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0417/001/001 Case No: 2042904 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 MAXEPA 170 MG/115 MG SOFT 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 12/11/2007. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 13/11/2007_ _CRN 2042904_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT MaxEPA 170 mg/ 115 mg Soft Capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains: Eicosapentaenoic Acid (EPA) 170 mg Docosahexaenoic Acid (DHA) 115 mg For full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Soft capsule Clear, colourless, oblong soft gelatin capsules containing 1 gram of clear, golden oil. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For use in patients for whom a reduction in plasma triglyceride levels is judged to be desirable. It should be used in conjunction with appropriate dietary measures. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults: The usual dose is 5 Прочитайте повний документ