ETHYPHARM KETOPROFEN SR
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
04-05-2024
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Active ingredient:
KETOPROFEN
Available from:
Ethypharm
Dosage:
200mg Milligram
Pharmaceutical form:
Capsule
Authorization date:
2002-02-08
Summary of Product characteristics
IRISH MEDICINES BOARD ACT 1995
MEDICINAL PRODUCTS(LICENSING AND SALE)REGULATIONS, 1998
(S.I. NO.142 OF 1998)
PA0549/009/002
Case No: 2034767
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
ETHYPHARM SA
17-21 RUE ST. MATTIEU, 78550 HOUDAN, FRANCE
an authorisation, subject to the provisions of the said Regulations, in respect of the product
ETHYPHARM KETOPROFEN SR 200 MG PROLONGED RELEASE HARD CAPSULES
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 20/04/2007 until 14/04/2009.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 24/04/2007_
_CRN 2034767_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ethypharm Ketoprofen SR Capsule 200 mg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains ketoprofen 200mg.
For excipients, see 6.1.
3 PHARMACEUTICAL FORM
Prolonged-release capsule, hard.
Capsule, hard, with opaque grey cap and opaque white body, containing off-white spherical microgranules.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Symptomatic treatment of:
● chronic inflammatory rheumatism, such as rheumatoid arthritis and ankylosing spondylitis,
● osteoarthritis.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Oral use.
Undesirable effects may be minimised by using the lowest effective dose for the
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