DELSYM Oral Suspension
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
19-04-2024
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Active ingredient:
DEXTROMETHORPHAN HYDROBROMIDE
Available from:
Bayer Limited
Pharmaceutical form:
Oral Suspension
Authorization date:
2008-11-21
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)
PA1410/043/001
Case No: 2043419
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
Transferred from PA0021/066/001.
BAYER LIMITED
THE ATRIUM, BLACKTHORN ROAD, DUBLIN 18, IRELAND
an authorisation, subject to the provisions of the said Regulations, in respect of the product
DELSYM (CONTROLLED RELEASE) 30MG/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 21/11/2008.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 21/11/2008_
_CRN 2043419_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Delsym (Controlled Release) 30mg/5 ml Oral Suspension.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 ml of suspension contains dextromethorphan resin complex * equivalent to 30 mg of dextromethorphan
hydrobromide.
*Dextromethorphan resin complex as coated dextromethorphan polistirex and uncoated dextromethorphan polistirex.
Excipients: Each 5ml contains sucrose (granulated sugar) 600mg, sunset yellow (E110) 0.115mg, methyl
paradroxybenzoate (E218) 7.5 mg, propyl parahydroxybenzoate (E216) 1.5mg and high fructose corn syrup 1.5g.
For a full list of excipients, see section 6.1.
3 PHARMA
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