EPIESTROL-SEPTEM Transdermal Patch 25 mg/24ho Milligram
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
20-04-2024
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Active ingredient:
ESTRADIOL HEMIHYDRATE
Available from:
Rottapharm Ltd
Dosage:
25 mg/24ho Milligram
Pharmaceutical form:
Transdermal Patch
Authorization date:
2006-10-20
Summary of Product characteristics
IRISH MEDICINES BOARD ACTS 1995 AND 2006
MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007
(S.I. NO.540 OF 2007)
PA0868/007/001
Case No: 2051977
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
ROTTAPHARM LTD
DAMASTOWN INDUSTRIAL PARK, MULHUDDART, DUBLIN 15, IRELAND
an authorisation, subject to the provisions of the said Regulations, in respect of the product
EPIESTROL - SEPTEM 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 01/12/2008.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 16/09/2009_
_CRN 2051977_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
EPIESTROL -Septem 25 micrograms/24hours Transdermal Patch
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One transdermal patch contains:
2.58 mg of estradiol hemihydrate equivalent to 2.5 mg estradiol/11.25 cm
2
delivering 25 µg of estradiol in 24 hours.
Excipient(s):
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Transdermal patch. Each patch is transparent, colourless, slightly opaque with an elliptical shape and a printed
identification code, and covered by a rectangular, transparent protective liner.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Hormone replacement therapy
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