Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
ETONOGESTREL ETHINYLESTRADIOL
Organon (Ireland) Limited
0.120/0.01 Milligram
Vaginal Device
2002-05-31
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0061/029/001 Case No: 2070080 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to ORGANON (IRELAND) LIMITED PO BOX 2857, DRYNAM ROAD, SWORDS, CO. DUBLIN, IRELAND an authorisation, subject to the provisions of the said Regulations, in respect of the product NUVARING 0.120 MG/0.015 MG PER 24 HOURS, VAGINAL DELIVERY SYSTEM 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 11/11/2009. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 17/11/2009_ _CRN 2070080_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT NuvaRing 0.120 mg/0.015 mg per 24 hours, vaginal delivery system 2 QUALITATIVE AND QUANTITATIVE COMPOSITION NuvaRing contains 11.7 mg etonogestrel and 2.7 mg ethinylestradiol. The ring releases etonogestrel and ethinylestradiol at an average amount of 0.120 mg and 0.015 mg, respectively per 24 hours, over a period of 3 weeks. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Vaginal delivery system. NuvaRing is flexible, transparent, colourless to almost colorless ring, with an outer diameter of 54 mm and a cross- sectional diameter of 4 mm. 4 CLINICAL P Read the complete document