Country: Ирска
Језик: Енглески
Извор: HPRA (Health Products Regulatory Authority)
GESTODENE ETHINYLESTRADIOL
Clonmel Healthcare Ltd
75/30 Milligram
Tablets
2007-09-21
IRISH MEDICINES BOARD ACT 1995, AS AMENDED MEDICINAL PRODUCTS (CONTROL OF PLACING ON THE MARKET) REGULATIONS, 2007, AS AMENDED PA0126/170/002 Case No: 2077080 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to CLONMEL HEALTHCARE LIMITED WATERFORD ROAD, CLONMEL, CO. TIPPERARY, IRELAND an authorisation, subject to the provisions of the said Regulations, in respect of the product ESTELLE 30 MICROGRAMS/75 MICROGRAMS COATED TABLETS 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 30/06/2010 until 20/09/2012. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 30/06/2010_ _CRN 2077080_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Estelle 30 micrograms/75 micrograms Coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 30 micrograms ethinylestradiol and 75 micrograms gestodene. Excipients: contains 38 mg lactose monohydrate and 20 mg sucrose. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Coated tablet. White, round, biconvex sugar coated tablets, both sides are without imprinting. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Oral contraception. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _How to take Estelle:_ The tablets should be taken in the order indicated on the package, every day at app Прочитајте комплетан документ