Χώρα: Ιρλανδία
Γλώσσα: Αγγλικά
Πηγή: HPRA (Health Products Regulatory Authority)
ESTRADIOL HEMIHYDRATE ESTRADIOL HEMIHYDRATE NORETHISTERONE ACETATE
Novartis Pharmaceuticals UK Ltd
50/250 Microgram/day
Transdermal Patch
1998-10-16
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0013/096/001 Case No: 2041044 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to NOVARTIS PHARMACEUTICALS 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 ESTALIS SEQUI 50 MICROGRAMS/250 MICROGRAMS/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 06/03/2008. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 24/03/2009_ _CRN 2041044_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Estalis Sequi 50 micrograms/250 micrograms/24 hours, Transdermal Patch 2 QUALITATIVE AND QUANTITATIVE COMPOSITION _Phase I_ Each patch contains estradiol hemihydrate equivalent to 4.33 mg estradiol in a patch of 14.5 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 nominal 50 micrograms estradiol and nominal 250 micrograms norethisterone acetate per 24 hours. For a full list of excipients, see Διαβάστε το πλήρες έγγραφο