Land: Irland
Språk: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
LEVONORGESTREL
Medimpex (UK) Limited
1500 Microgram
Tablets
2006-02-03
IRISH MEDICINES BOARD ACT 1995, AS AMENDED MEDICINAL PRODUCTS (CONTROL OF PLACING ON THE MARKET) REGULATIONS, 2007, AS AMENDED PA0818/004/002 Case No: 2059506 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to MEDIMPEX (UK) LIMITED 127 SHIRLAND ROAD, LONDON W9 2EP, ENGLAND an authorisation, subject to the provisions of the said Regulations, in respect of the product LEVONELLE 1500 MICROGRAM TABLET 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 13/06/2009. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 28/06/2010_ _CRN 2059506_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Levonelle 1500 microgram Tablet 2 QUALITATIVE AND QUANTITATIVE COMPOSITION The tablet contains 1500 microgram of levonorgestrel Excipients: Contains Lactose Monohydrate 142.5mg For a full list of excipients see section 6.1 3 PHARMACEUTICAL FORM Tablet The tablet is round and white with an impressed mark of "G00" on one side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Emergency contraception within 72 hours of unprotected sexual intercourse or failure of a contraceptive method. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For oral administration: One tablet should be taken as soon as possible, preferably within 12 hours, and no later than 72 hours after Les hele dokumentet