SALAZOPYRIN Suppositories 500 Milligram
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
24-04-2024
Some documents for this product are not currently available, you can send a request to our customer service and we will notify you as soon as we are able to obtain them.
Send request.
Send request.
Active ingredient:
SULFASALAZINE
Available from:
Pharmacia Laboratories Limited
Dosage:
500 Milligram
Pharmaceutical form:
Suppositories
Authorization date:
1997-04-01
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)
PA0187/051/002
Case No: 2064836
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
PHARMACIA LABORATORIES LIMITED
RAMSGATE ROAD, SANDWICH, KENT, CT13 9NJ, UNITED KINGDOM
an authorisation, subject to the provisions of the said Regulations, in respect of the product
SALAZOPYRIN 500 MG SUPPOSITORIES
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 28/08/2009.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 05/09/2009_
_CRN 2064836_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Salazopyrin 500 mg Suppositories
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each suppository contains 500 mg of sulphasalazine.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Suppository
The suppositories are odourless, orange/yellow in colour and torpedo-shaped.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Induction and maintenance of remission of such conditions as ulcerative colitis, proctocolitis, proctitis and Crohn’s
disease.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
ADULTS AND THE ELDERLY
Two suppositories to be inserted after defaecation in the morning and in the evening. After
Read the complete document
