Страна: Ирландия
Язык: английский
Источник: HPRA (Health Products Regulatory Authority)
ASCORBIC ACID
Seven Seas Health Care Ltd
200 Milligram
Capsule
1991-08-26
IRISH MEDICINES BOARD ACT 1995 MEDICINAL PRODUCTS(LICENSING AND SALE)REGULATIONS, 1998 (S.I. NO.142 OF 1998) PA0416/005/001 Case No: 2020855 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 VITAMIN C PLUS 200 MG SOFT CAPSULE 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 26/08/2006. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 05/12/2006_ _CRN 2020855_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Vitamin C Plus 200 mg soft capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 200mg ascorbic acid Excipients: Soya-bean oil 213.50mg Sorbitol solution For full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Soft capsule Purple/maroon, opaque, oval soft geletain capsules containing a pale, brown filling. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Prophylaxis and treatment of ascorbic acid deficiency. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults: one capsule daily Children (4-12 years): one capsule daily Do not exceed stated dose. Oral administration 4.3 CONTRAINDICATIONS Ascorbic Aci Прочитать полный документ