ABSTRAL Tablet Sublingual 50 Microgram
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
20-04-2024
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Active ingredient:
FENTANYL
Available from:
ProStrakan Limited
Dosage:
50 Microgram
Pharmaceutical form:
Tablet Sublingual
Authorization date:
2009-05-22
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)
PA1049/006/001
Case No: 2059445
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
PROSTRAKAN LIMITED
GALABANK BUSINESS PARK, GALASHIELS, TD1 1QH, UNITED KINGDOM
an authorisation, subject to the provisions of the said Regulations, in respect of the product
ABSTRAL 50 MICROGRAM SUBLINGUAL TABLETS
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 29/09/2009 until 21/05/2014.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 29/09/2009_
_CRN 2059445_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Abstral 50 microgram sublingual tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each sublingual tablet contains:
50 micrograms fentanyl (as citrate)
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Sublingual tablet
50 microgram sublingual tablet is a white pentagon-shaped tablet
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Management of breakthrough pain in adult patients using opioid therapy for chronic cancer pain. Breakthrough pain is
a transient exacerbation of otherwise controlled chronic background pain.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Abstral should onl
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