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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
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