SEQUIDOT 50/250 Microgram/day Transdermal Patch

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

ESTRADIOL HEMIHYDRATE ESTRADIOL HEMIHYDRATE NORETHISTERONE ACETATE

Available from:

Novartis Pharmaceuticals UK Ltd

INN (International Name):

ESTRADIOL HEMIHYDRATE ESTRADIOL HEMIHYDRATE NORETHISTERONE ACETATE

Dosage:

50/250 Microgram/day

Pharmaceutical form:

Transdermal Patch

Prescription type:

Product subject to prescription which may not be renewed (A)

Authorization status:

Withdrawn

Authorization date:

2009-11-24

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)
PA0013/096/002
Case No: 2044026
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
NOVARTIS PHARMACEUTICALS UK 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
SEQUIDOT 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 23/01/2008 until 22/02/2012.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 13/02/2008_
_CRN 2044026_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
SEQUIDOT, transdermal patch
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Phase I
Each patch contains estradiol hemihydrate equivalent to 0.78 mg estradiol in a patch of 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 50 micrograms estradiol and 250 micrograms norethisterone acetate per 24 hours.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Transdermal patch.
_Phase I_
Translucent square p