MORPHINE SULPHATE
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
04-05-2024
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Active ingredient:
MORPHINE SULPHATE
Available from:
Pharmachemie BV
Dosage:
200 Milligram
Pharmaceutical form:
Tablet Prolonged Release
Authorization date:
2007-06-29
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)
PA0937/009/001
Case No: 2062385
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
PHARMACHEMIE BV
SWENSWEG 5, P.O BOX 552, HAARLEM, 2003 RN, NETHERLANDS
an authorisation, subject to the provisions of the said Regulations, in respect of the product
MORPHINE SULPHATE 200 MG PROLONGED RELEASE FILM-COATED 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 21/04/2009 until 28/06/2012.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 27/04/2009_
_CRN 2062385_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Morphine sulphate 200 mg prolonged-release film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each prolonged-release tablet contains 200 mg morphine sulphate corresponding to 150 mg morphine.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged-release tablet.
White to off-white film-coated tablets
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of severe pain, particularly cancer pain and post-operative pain.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The prolonged-release tablets are for oral use. They should be swallowed completely
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