Quốc gia: Ai-len
Ngôn ngữ: Tiếng Anh
Nguồn: HPRA (Health Products Regulatory Authority)
ESTRADIOL HEMIHYDRATE ESTRADIOL HEMIHYDRATE NORETHISTERONE ACETATE
Novartis Pharmaceuticals UK Ltd
ESTRADIOL HEMIHYDRATE ESTRADIOL HEMIHYDRATE NORETHISTERONE ACETATE
50/250 Microgram/day
Transdermal Patch
Product subject to prescription which may not be renewed (A)
Withdrawn
2009-11-24
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0013/096/002 Case No: 2044026 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to NOVARTIS PHARMACEUTICALS UK LTD FRIMLEY BUSINESS PARK, FRIMLEY, CAMBERLEY, SURREY, GU16 7SR, UNITED KINGDOM an authorisation, subject to the provisions of the said Regulations, in respect of the product SEQUIDOT TRANSDERMAL PATCH 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 23/01/2008 until 22/02/2012. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 13/02/2008_ _CRN 2044026_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT SEQUIDOT, transdermal patch 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Phase I Each patch contains estradiol hemihydrate equivalent to 0.78 mg estradiol in a patch of 5 cm 2 , releasing nominal 50 micrograms estradiol per 24 hours. Phase II Each patch contains estradiol hemihydrate equivalent to 0.51 mg estradiol and 4.80 mg norethisterone acetate in a patch of 16 cm 2 , releasing 50 micrograms estradiol and 250 micrograms norethisterone acetate per 24 hours. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Transdermal patch. _Phase I_ Translucent square p Đọc toàn bộ tài liệu