Држава: Ирска
Језик: Енглески
Извор: HPRA (Health Products Regulatory Authority)
ASCORBIC ACID
Seven Seas Ltd
ASCORBIC ACID
500 Milligram
Tablets Effervescent
Product not subject to medical prescription
Withdrawn
0000-00-00
IRISH MEDICINES BOARD ACT 1995, AS AMENDED MEDICINAL PRODUCTS (CONTROL OF PLACING ON THE MARKET) REGULATIONS, 2007, AS AMENDED PA0417/016/004 Case No: 2061607 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 HALIBORANGE VITAMIN C 500MG EFFERVESCENT TABLETS (LEMON FLAVOUR) the particulars of which are set out in 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 06/08/2009. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 16/08/2010_ _CRN 2061607_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Haliborange Vitamin C 500 mg Effervescent Tablets (Lemon Flavour) 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Ascorbic Acid 500 mg. Also contains: sucrose 1.030g, glucose 2.0mg, Sodium 264.64mg. For a full list of excipients see section 6.1. 3 PHARMACEUTICAL FORM Effervescent tablet Round, unvaulted, speckled, yellowish effervescent tablets with a lemon flavour. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Prophylaxis and treatment of ascorbic acid deficiency. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults and children over 12 years: One tablet to be taken daily. Do not exceed stated dose. The tablet should be di Прочитајте комплетан документ