ESTALIS 50/250 50/250 Microgram/day Transdermal Patch
देश: आयरलैंड
भाषा: अंग्रेज़ी
स्रोत: HPRA (Health Products Regulatory Authority)
उत्पाद विशेषताएं
(SPC)
07-06-2024
इस उत्पाद के लिए कुछ दस्तावेज़ वर्तमान में उपलब्ध नहीं हैं, आप हमारी ग्राहक सेवा को अनुरोध भेज सकते हैं और जैसे ही हम उन्हें प्राप्त करने में सक्षम होंगे, हम आपको सूचित करेंगे।
अनुरोध भेजा।
अनुरोध भेजा।
सक्रिय संघटक:
ESTRADIOL HEMIHYDRATE NORETHISTERONE ACETATE
थमां उपलब्ध:
Novartis Pharmaceuticals UK Ltd
INN (इंटरनेशनल नाम):
ESTRADIOL HEMIHYDRATE NORETHISTERONE ACETATE
डोज़:
50/250 Microgram/day
फार्मास्यूटिकल फॉर्म:
Transdermal Patch
प्रिस्क्रिप्शन प्रकार:
Product subject to prescription which may be renewed (B)
प्राधिकरण का दर्जा:
Withdrawn
प्राधिकरण की तारीख:
2009-11-24
उत्पाद विशेषताएं
IRISH MEDICINES BOARD ACTS 1995 AND 2006
MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007
(S.I. NO.540 OF 2007)
PA0013/095/001
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 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 50 micrograms/250 micrograms/24 hours, transdermal patch
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Estalis 50 micrograms/250 micrograms/24 hours transdermal 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 250 micrograms norethisterone acetate per 24 hours.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Transdermal patch.
Translucent round patches with a polymeric backing on one side and a release lin
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