FEMSEVEN SEQUI Microgram Transdermal Patch
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
03-05-2024
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Active ingredient:
ESTRADIOL HEMIHYDRATE LEVONORGESTREL
Available from:
Merck Serono Limited
INN (International Name):
ESTRADIOL HEMIHYDRATE LEVONORGESTREL
Dosage:
Microgram
Pharmaceutical form:
Transdermal Patch
Prescription type:
Product subject to prescription which may not be renewed (A)
Authorization status:
Withdrawn
Authorization date:
2010-04-14
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)
PA0654/010/001
Case No: 2075955
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
MERCK SERONO LIMITED
BEDFONT CROSS, STANWELL ROAD, FELTHAM, MIDDLESEX, TW14 8NX, UNITED KINGDOM
an authorisation, subject to the provisions of the said Regulations, in respect of the product
FEMSEVEN SEQUI 50 MICROGRAMS/10 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 09/04/2010 until 26/09/2010.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 12/04/2010_
_CRN 2075955_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
FemSeven Sequi 50 micrograms/10 micrograms/24 hours, transdermal patch
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Phase 1:
Each patch contains 1.5 mg of estradiol hemihydrate in a patch size of 15 cm
2
, releasing 50 micrograms of estradiol
per 24 hours.
Phase 2:
Each patch contains 1.5 mg of estradiol hemihydrate and 1.5 mg of levonorgestrel in a patch size of 15 cm
2
, releasing
50 micrograms of estradiol and 10 micrograms of levonorgestrel per 24 hours.
For excipients, see 6.1.
3 PHARMACEUTICAL FORM
Transdermal patch
Octagonal, transparent,
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