Ülke: İrlanda
Dil: İngilizce
Kaynak: HPRA (Health Products Regulatory Authority)
RETINOL PALMITATE COLECALCIFEROL FERRIC AMMONIUM CITRATE POTASSIUM GLYCEROPHOSPHATE CALCIUM GLYCEROPHOSPHATE MANGANESE SULFATE COPPER SULFATE
Seven Seas Ltd
Oral Emulsion
1995-07-13
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0417/007/001 Case No: 2068893 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 MINADEX TONIC HALF STRENGTH ORAL EMULSION 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 10/09/2009 until 12/07/2010. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 10/09/2009_ _CRN 2068893_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Minadex Tonic Half Strength Oral Emulsion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION For excipients, see section 6.1. 3 PHARMACEUTICAL FORM Oral emulsion Yellowish to green translucent oral emulsion with an odour and taste of orange. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS As a treatment for vitamin and mineral deficiency and as an appetite stimulant during and after illness. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Method of Administration: Oral. Dosage: Children 6 months to 3 years: 2 teaspoonfuls (10ml) twice daily. Children 3 years to 12 years: 2 teaspoonfuls (10ml) three times da Belgenin tamamını okuyun