BREVINOR TABLETS
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
07-05-2024
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Active ingredient:
NORETHISTERONE ETHINYLESTRADIOL
Available from:
Pharmacia Ireland
Dosage:
5/0.036mg Milligram
Pharmaceutical form:
Tablets
Authorization date:
1997-03-07
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)
PA0936/018/001
Case No: 2027670
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
PHARMACIA IRELAND LIMITED
9 RIVERWALK, NATIONAL DIGITAL PARK, CITYWEST BUSINESS CAMPUS, DUBLIN 24, IRELAND
an authorisation, subject to the provisions of the said Regulations, in respect of the product
BREVINOR 500 MICROGRAMS/35 MICROGRAMS TABLETS
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 07/03/2007.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 29/09/2008_
_CRN 2027670_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Brevinor 500 micrograms/35 micrograms Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 500 micrograms Norethisterone and 35 micrograms Ethinylestradiol.
Excipients: also includes Lactose monohydrate 42.21 mg per tablet.
For a full list of excipeints, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
Blue, round, flat tablet with beveled edges, approximately 3/16” diameter, inscribed ‘Searle’ on one side and ‘BX’ on
the other.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Hormonal contraception
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Before starting
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