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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
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