|DATE OF MEETING||: 12 November 1997|
|M.A. No.||: 00032/0222-3|
|COMPANY||: PHARMACIA AND UPJOHN LIMITED|
|PRODUCT||: DETRUSITOL 1 MG AND 2 MG TABLETS|
|ACTIVE CONSTITUENT||: TOLTERODINE L-TARTRATE|
|THERAPEUTIC CLASS||: Anticholinergic for urinary incontinence|
|KEY WORDS||: Anticholinergic, urinary incontinence, antimuscarinic, bladder|
On the evidence before them the Committee advised the grant of Marketing Authorizations for these preparations provided that the company complies with the following conditions:
SUMMARY OF PRODUCT CHARACTERISTICS (SPC)
1 In the table in Section 5. 1, Pharmacodynamic Properties, the first two variables "Patient perception of the troubles on a 6-degree scale" and 'Number of patients with no or minimal troubles after treatment (%)" should be omitted as they are not self explanatory and were not the primary efficacy variable of the clinical studies.
2 The indication in Section 4 1 should be limited to idiopathic detrusor instability as neurogenic bladder disease has not been studied separately.
3 The risks of CYP3A4 inhibition in poor metabolisers should be addressed in the SPC
4 Myasthenia gravis should be included as a contraindication in the SPC.
Part I B Summary of Product Characteristics (SPC), Labelling Details and Patient Information Leaflet (PIL)
5 The following amendments to the pharmaceutical aspects of the SPC are required:
5 1 In Section 1, the names of the products should be amended to differentiate between the strengths available.
5 2 The pharmaceutical form should be given as 'film-coated tablet' in Section 3.
6 Some pharmaceutical aspects of the labelling details and patient information leaflet require amendment to the satisfaction of the Secretariat in keeping with national guidelines
Part 1IB Method of Manufacture
Part IIC Control of Starting Materials
8. Certificates of Analysis should be provided for the excipients.
Part IIF Stability of the Drug Substance
9 The retest period of 3 years for the drug substance should be reduced in keeping with the long-tem data available for the production batches.
CLICK HERE TO GO BACK TO COVERING LETTER