Kraj: Irlandia
Język: angielski
Źródło: HPRA (Health Products Regulatory Authority)
FOLIC ACID
Seven Seas Ltd
400 Microgram
Capsules, Soft
1997-07-11
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0417/009/001 Case No: 2043293 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 SEVEN SEAS FOLIC ACID 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 12/01/2009. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 12/01/2009_ _CRN 2043293_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Seven Seas Folic Acid 400 microgram soft capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Active ingredient Content per capsule Folic Acid 400 micrograms For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Soft capsule (capsule). Oval capsule with brown opaque shell. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS The specific dose of 400mcg Folic Acid is for the prevention of the first occurrence of Neural Tube Defects, including Spina Bifida, in the developing foetus. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Women planning to become pregnant: One capsule containing 400mcg Folic Acid to be taken da Przeczytaj cały dokument