Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
TOLTERODINE L-TARTRATE
B & S Healthcare
4 Milligram
Prolonged Release Capsules
2010-01-15
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PPA1328/061/003 Case No: 2071688 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 SR 4 MG PROLONGED-RELEASE HARD CAPSULES 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 15/01/2010. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 24/01/2010_ _CRN 2071688_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Detrusitol SR 4 mg prolonged-release hard capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each prolonged-release capsule contains tolterodine tartrate 4 mg corresponding to 2.74 mg tolterodine. Each 4 mg prolonged-release capsule contains a maximum of 123.07 mg of sucrose. For a full list of excipients see section 6.1 3 PHARMACEUTICAL FORM Prolonged-release capsule, hard _Product Imported from the UK:_ The 4 mg prolonged-release capsule is blue with white printing (symbol and 4). 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Symptomatic treatment of urge incontinence and/or increased Read the complete document