ADCORTYL IN ORABASE 0.1% W/W OROMUCOSAL PASTE
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
26-04-2024
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Active ingredient:
TRIAMCINOLONE ACETONIDE
Available from:
Bristol-Myers Squibb Pharmaceuticals Ltd
Dosage:
0.1 %w/w
Pharmaceutical form:
Oromucosal Paste
Authorization date:
1978-04-01
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)
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
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