Երկիր: Իռլանդիա
Լեզու: անգլերեն
Աղբյուրը: HPRA (Health Products Regulatory Authority)
SALICYLIC ACID
Norgine Limited
0.5 %w/v, %v/v
Oromucosal Solution
1983-04-01
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 Կարդացեք ամբողջական փաստաթուղթը