ETHIRFIN Tablet Prolonged Release 60 Milligram
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
26-04-2024
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Active ingredient:
MORPHINE SULFATE
Available from:
Ethypharm
Dosage:
60 Milligram
Pharmaceutical form:
Tablet Prolonged Release
Authorization date:
2006-01-09
Summary of Product characteristics
IRISH MEDICINES BOARD ACT 1995
MEDICINAL PRODUCTS(LICENSING AND SALE)REGULATIONS, 1998
(S.I. NO.142 OF 1998)
PA0549/015/003
Case No: 2038354
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
ETHIRFIN 60 MILLIGRAM TABLET PROLONGED RELEASE
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 26/06/2007 until 08/01/2011.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 27/06/2007_
_CRN 2038354_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
ETHIRFIN 60 mg, prolonged-release capsules, hard
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard, prolonged release capsule contains morphine sulphate 60mg.
For excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged-release capsule, hard
Capsule with violet opaque cap and white opaque body with '60' printed in black on the body, containing off-white to
yellowish spherical microgranules.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Severe chronic stable pain.
This medicinal product is not suitable for initiating treatment, therefore the use should be limited to patients already
controlled by immediate release morphine o
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