Χώρα: Ιρλανδία
Γλώσσα: Αγγλικά
Πηγή: HPRA (Health Products Regulatory Authority)
TRIAMCINOLONE ACETONIDE
Bristol-Myers Squibb Pharmaceuticals Ltd
TRIAMCINOLONE ACETONIDE
0.1 %w/w
Oromucosal Paste
Product subject to prescription which may not be renewed (A)
Withdrawn
2009-05-31
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0002/018/001 Case No: 2055949 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to BRISTOL-MYERS SQUIBB PHARMACEUTICALS LTD SWORDS, CO. DUBLIN, IRELAND an authorisation, subject to the provisions of the said Regulations, in respect of the product ADCORTYL IN ORABASE 0.1% W/W OROMUCOSAL PASTE 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 16/12/2008. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 16/12/2008_ _CRN 2055949_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Adcortyl in Orabase 0.1% w/w oromucosal paste 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Triamcinolone Acetonide 0.1% w/w. For a full list of excipients see section 6.1 3 PHARMACEUTICAL FORM Oromucosal paste. Smooth, uniform, white to light tan oromucosal paste with characteristic odour. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Adcortyl in Orabase is indicated for aphthous ulcers, ulcerative stomatitis, denture stomatitis, desquamative gingivitis, erosive lichen planus and lesions of the oral mucosa of traumatic origin. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION ADULTS, CHILDREN AND THE ELDERLY: Application 2 Διαβάστε το πλήρες έγγραφο