SALAZOPYRIN 250MG/5ML ORAL SUSPENSION.
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
24-04-2024
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Active ingredient:
SULFASALAZINE
Available from:
Rosemont Pharmaceuticals Ltd
Dosage:
250 MG/5ml
Pharmaceutical form:
Oral Suspension
Authorization date:
2009-10-30
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)
PA0312/019/001
Case No: 2073612
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
Transferred from PA0936/040/005.
ROSEMONT PHARMACEUTICALS
ROSEMONT HOUSE, YORKDALE INDUSTRIAL PARK, BRAITHWAITE STREET, LEEDS LS11 9XE, ENGLAND
an authorisation, subject to the provisions of the said Regulations, in respect of the product
SALAZOPYRIN 250MG/5ML ORAL SUSPENSION
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 30/10/2009.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 17/11/2009_
_CRN 2073612_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Salazopyrin 250mg/5ml Oral Suspension.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Salazopyrin Oral Suspension contains 250mg Sulfasalazine in each 5ml.
Excipients:
Each 5 ml dose contains 1.55mg of sodium
Each 5 ml dose contains 6.10mg of ethanol
Each 5 ml dose contains 1.650g of sucrose
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral Suspension.
An orange-yellow coloured suspension with an orange/lemon flavour.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
a)
Induction and maintenance of remission of ulcerative colitis; tre
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