BIRAVID Film Coated Tablet 200 Milligram
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
23-04-2024
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Active ingredient:
OFLOXACIN
Available from:
Helsinn Birex Therapeutics Ltd
Dosage:
200 Milligram
Pharmaceutical form:
Film Coated Tablet
Authorization date:
2004-10-29
Summary of Product characteristics
IRISH MEDICINES BOARD ACT 1995, AS AMENDED
MEDICINAL PRODUCTS (CONTROL OF PLACING ON THE MARKET) REGULATIONS, 2007, AS AMENDED
PA0915/008/001
Case No: 2086658
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
HELSINN BIREX THERAPEUTICS LTD
DAMASTOWN, MULHUDDART, DUBLIN 15, IRELAND
an authorisation, subject to the provisions of the said Regulations, in respect of the product
BIRAVID 200 MG FILM-COATED TABLETS
the particulars of which are set out in 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 30/07/2010.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 30/07/2010_
_CRN 2086658_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Biravid 200 mg Film-Coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet Contains 200mg ofloxacin
Excipients: Each tablet contains 108.9mg lactose monohydrate.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablets {short term: tablets}
White, round, film-coated tablets 11 mm in diameter, scored on both sides. One side of the tablet debossed ‘FXN’ on
one side of the break-line and ‘200’ on the other side.
The tablet can be divided into equal halves.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Ofloxacin is a synthetic 4-fluoroquinolone antibacterial agent. It is effective
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