PYRALVEX OROMUCOSAL SOLUTION
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
16-05-2024
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Active ingredient:
SALICYLIC ACID
Available from:
Norgine Limited
Dosage:
0.5 %w/v, %v/v
Pharmaceutical form:
Oromucosal Solution
Authorization date:
1983-04-01
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)
PA0102/015/001
Case No: 2039740
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
NORGINE LIMITED
CHAPLIN HOUSE, WIDEWATER PLACE, MOORHALL ROAD, HAREFIELD, UXBRIDGE, MIDDLESEX UB9 6NS, UNITED KINGDOM
an authorisation, subject to the provisions of the said Regulations, in respect of the product
PYRALVEX OROMUCOSAL SOLUTION
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 21/08/2007 until 31/03/2008.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 22/09/2007_
_CRN 2039740_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Pyralvex Oromucosal Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Pyralvex contains the following active substances in each 1ml of solution:
For excipients, see 6.1
3 PHARMACEUTICAL FORM
Brown oromucosal solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the symptomatic relief of pain associated with recurrent mouth ulcers and denture irritation.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_ADULTS (INCLUDING THE ELDERLY_): To be applied to the inflamed oral mucosa (after removing any dentures) three or four
times daily using the brush provided. Avoid
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