ESTALIS SEQUI
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
24-04-2024
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Active ingredient:
ESTRADIOL HEMIHYDRATE ESTRADIOL HEMIHYDRATE NORETHISTERONE ACETATE
Available from:
Novartis Pharmaceuticals UK Ltd
Dosage:
50/250 Microgram/day
Pharmaceutical form:
Transdermal Patch
Authorization date:
1998-10-16
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)
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
Read the complete document
