Nchi: Ayalandi
Lugha: Kiingereza
Chanzo: HPRA (Health Products Regulatory Authority)
ESTRADIOL
Bayer Limited
25 Microgram/day
Transdermal Patch
2007-10-19
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA1410/015/003 Case No: 2029216 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to BAYER LIMITED THE ATRIUM, BLACKTHORN ROAD, DUBLIN 18, IRELAND an authorisation, subject to the provisions of the said Regulations, in respect of the product CLIMARA 25 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 15/04/2008. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 08/04/2008_ _CRN 2029216_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Climara 25 micrograms/24 hours Transdermal Patch 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 6.5cm 2 patch contains 1.97 mg estradiol (formed from 2.04 mg estradiol hemihydrate), releasing a nominal 25 micrograms of estradiol per 24 hours. For excipients, see section 6.1. 3 PHARMACEUTICAL FORM Transdermal patch. Oval transdermal patch with a translucent homogenous matrix on a transparent carrier film. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Hormone replacement therapy (HRT) for oestrogen deficiency symptoms in postmenopausal women more than 1 year postmenopause. The experience treating women older than 65 ye Soma hati kamili