Country: Írland
Tungumál: enska
Heimild: HPRA (Health Products Regulatory Authority)
ESTRADIOL HEMIHYDRATE
Novartis Pharmaceuticals UK Ltd
25 Microgram/day
Transdermal Patch
1993-05-31
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0013/070/001 Case No: 2049910 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 ESTRADERM TTS 25MCG/24 HOURS 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 31/05/2008. 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 2049910_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Estraderm TTS 25mcg/24 hours Transdermal Patch 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One Estraderm TTS 25 transdermal patch contains 2 mg estradiol (as hemihydrate). The patch has an absorption rate of estradiol of approximately 25 micrograms per day from an active surface area of 5 cm 2 . For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Transdermal Patch. A thin, round, flat transparent patch with protective release liner. The backing film is printed with the code ‘CG DWD’. The outside diameter is 38 mm and the active surface area is Lestu allt skjalið