FETANEX Transdermal Patch 25 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:
Rowex Ltd
Dosage:
25 Microgram
Pharmaceutical form:
Transdermal Patch
Authorization date:
2008-11-14
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)
PA0711/137/002
Case No: 2066768
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
ROWEX LTD
BANTRY, CO. CORK, IRELAND
an authorisation, subject to the provisions of the said Regulations, in respect of the product
FETANEX 25 MICROGRAM/HOUR TRANSDERMAL PATCH
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 25/06/2009 until 13/11/2013.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 13/08/2009_
_CRN 2066768_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Fetanex 25 microgram/hour transdermal patch
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each patch releases 25 micrograms fentanyl per hour. Each patch of 10.5 cm² contains 4.2 mg fentanyl.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Transdermal patch
Transparent rounded oblong transdermal patch with imprint on the backing film:
“fentanyl 25 µg/h”
The patch consists of a release liner (to be removed prior to application of the patch) and two functional layers: one self-adhesive
matrix layer containing fentanyl and a backing film impermeable to water.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATION
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