GENOXEN Tablets 250 Milligram
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
19-04-2024
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Active ingredient:
NAPROXEN
Available from:
Mercury Pharmaceuticals (Ireland) Ltd
Dosage:
250 Milligram
Pharmaceutical form:
Tablets
Authorization date:
1986-07-04
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)
PA0073/090/001
Case No: 2049103
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
ANTIGEN PHARMACEUTICALS LTD
CHANDLER HOUSE, CASTLE STREET, ROSCREA, CO TIPPERARY, IRELAND
an authorisation, subject to the provisions of the said Regulations, in respect of the product
GENOXEN 250 MG 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 28/01/2009.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 07/04/2009_
_CRN 2049103_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Genoxen 250 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 250 mg of Naproxen.
Excipient: Each tablet contains 45mg lactose monohydrate
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
Yellow, flat, round, uncoated tablet with bevelled edges and embossed with 'N/250' on one side and 'a' on the other.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
As an anti-inflammatory analgesic in the management of osteoarthritis, rheumatoid arthritis (including juvenile
rheumatoid arthritis or Still's disease), ankylosing spondylitis and acute gout. Also in tenosynovitis,
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