Land: Ierland
Taal: Engels
Bron: HPRA (Health Products Regulatory Authority)
LEVOTHYROXINE SODIUM
PCO Manufacturing
50mcg Microgram
Tablets
2005-04-15
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PPA0465/120/001A Case No: 2078726 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to PCO MANUFACTURING LIMITED UNIT 10, ASHBOURNE BUSINESS PARK, RATH, ASHBOURNE, CO. MEATH, IRELAND an authorisation, subject to the provisions of the said Regulations, in respect of the product ELTROXIN 50 MICROGRAMS TABLETS. 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 19/03/2010 until 14/04/2010. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 21/03/2010_ _CRN 2078726_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Eltroxin 50 micrograms Tablets. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 50 micrograms levothyroxine sodium (thyroxine sodium). Excipient: Lactose For full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Tablet. _Product imported from the UK:_ White, round tablets with ‘ELTROXIN 50’ on one side and a breakline on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Recommended clinical indications: Control of hypothyroidism, congenital hypothyroidism and juvenile myxoedema. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _ADULTS: _Initially 50 to Lees het volledige document