DETRUSITOL SR 4 Milligram Prolonged Release Capsules

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

TOLTERODINE L-TARTRATE TOLTERODINE

Tilgjengelig fra:

Profind Wholesale Ltd

INN (International Name):

TOLTERODINE L-TARTRATE TOLTERODINE

Dosering :

4 Milligram

Legemiddelform:

Prolonged Release Capsules

Resept typen:

Product subject to prescription which may be renewed (B)

Autorisasjon status:

Withdrawn

Autorisasjon dato:

2013-01-29

Preparatomtale

IRISH MEDICINES BOARD ACT 1995, AS AMENDED
MEDICINAL PRODUCTS (CONTROL OF PLACING ON THE MARKET) REGULATIONS, 2007, AS AMENDED
PPA1500/021/001
Case No: 2083742
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
PROFIND WHOLESALE LTD.
UNIT 625, KILSHANE AVENUE, NORTHWEST BUSINESS PARK, DUBLIN 15, IRELAND
an authorisation, subject to the provisions of the said Regulations, in respect of the product
DETRUSITOL SR 4MG, PROLONGED-RELEASE CAPSULES, HARD
the particulars of which are set out in 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 28/07/2010.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 28/07/2010_
_CRN 2083742_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Detrusitol SR 4mg, prolonged-release capsules, hard.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each prolonged-release capsule contains tolterodine tartrate 4mg corresponding to 2.74mg tolterodine.
Excipients: Sucrose
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged-release capsule, hard.
_Product imported from the UK:_
Blue, prolonged-release capsule with white printing (symbol and 4).
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Symptomatic treatment of urge incontinence and/or increased urinary frequency and urgency as may occur in patients
with overactive bladder syndrome.
4.2 PO