DICLOFENAC SODIUM
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
23-04-2024
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Active ingredient:
DICLOFENAC
Available from:
Winthrop Pharmaceuticals UK Limited
Dosage:
25 Milligram
Pharmaceutical form:
Tablets Gastro-Resistant
Authorization date:
1998-07-13
Summary of Product characteristics
IRISH MEDICINES BOARD ACT 1995
MEDICINAL PRODUCTS(LICENSING AND SALE)REGULATIONS, 1998
(S.I. NO.142 OF 1998)
PA1046/007/001
Case No: 2034402
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
WINTHROP PHARMACEUTICALS UK LIMITED
ONE ONSLOW STREET, GUILDFORD, SURREY, GU1 4YS, UNITED KINGDOM
an authorisation, subject to the provisions of the said Regulations, in respect of the product
DICLOFENAC SODIUM 25 MILLIGRAM TABLETS GASTRO-RESISTANT
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 05/07/2007 until 12/07/2008.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 06/07/2007_
_CRN 2034402_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Diclofenac Sodium 25mg Gastro-Resistant Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Diclofenac sodium 25 mg.
For excipients, see 6.1.
3 PHARMACEUTICAL FORM
Gastro-resistant tablet.
Biconvex, mustard yellow coloured gastro-resistant coated tablets with S/26 one side and plain on the other.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
In the symptomatic management of rheumatoid arthritis including juvenile chronic arthritis, osteoarthrosis, ankylosing
spondylitis, psoriatic arthropathy, low back pain, and acute musculoskeletal disorders including periarthritis, tendinitis,
tenosynovitis
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