DETRUSITOL Film Coated Tablet 2 Milligram
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
19-04-2024
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Active ingredient:
TOLTERODINE L-TARTRATE
Available from:
B & S Healthcare
Dosage:
2 Milligram
Pharmaceutical form:
Film Coated Tablet
Authorization date:
2006-09-29
Summary of Product characteristics
IRISH MEDICINES BOARD ACT 1995
MEDICINAL PRODUCTS(LICENSING AND SALE)REGULATIONS, 1998
(S.I. NO.142 OF 1998)
PPA1328/061/002
Case No: 2034068
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants
to
B & S HEALTHCARE
UNIT 4, BRADFIELD ROAD, RUISLIP, MIDDLESEX, HA4 0NU, UNITED KINGDOM
an authorisation, subject to the provisions of the said Regulations, in respect of the product
DETRUSITOL 2 MG FILM-COATED TABLET
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 26/03/2007 until 28/09/2011.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 12/04/2007_
_CRN 2034068_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Detrusitol 2 mg Film-coated tablets.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains tolterodine tartrate 2mg corresponding to 1.37mg tolterodine.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
_Product imported from the Netherlands:_
White, round and biconvex, tablet is engraved with arcs above and below the letters DT
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 POSOLOGY AND METHOD OF ADMIN
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