TOVEDESO Prolonged-release tablet Ref.[7701] Active ingredients: Desfesoterodine

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2017  Publisher: TEVA UK Limited, Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG, United Kingdom

Product name and form

Tovedeso 3.5 mg Prolonged-release Tablets.

Pharmaceutical Form

Prolonged-release tablet.

The 3.5 mg tablets are light blue, oval, biconvex, film-coated, with dimensions of 11.6 mm x 6.35 mm and embossed on one side with ‘3.5’.

Qualitative and quantitative composition

Each prolonged-release tablet contains desfesoterodine succinate 3.5 mg corresponding to 2.6 mg of desfesoterodine.

Excipients with known effect: Each prolonged-release tablet contains 11.175 mg of lactose monohydrate.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Desfesoterodine

Desfesoterodine is a competitive, specific muscarinic receptor antagonist. It is the primary active metabolite of fesoterodine, and regarded as main active pharmacological principle of fesoterodine; fesoterodine is considered as prodrug of desfesoterodine. The affinity of desfesoterodine for the muscarinic receptors is 2 orders of magnitude greater than that of fesoterodine.

List of Excipients

Microcrystalline cellulose (Type 101)
Povidone 25
Hypromellose 2208
Microcelac 100 (containing lactose monohydrate and microcrystalline
cellulose)
Magnesium stearate
Hypromellose 2910
Glycerol 85%
Titanium dioxide (E171)
Indigo carmine aluminium lake (E132)

Pack sizes and marketing

Aluminium-aluminium blisters containing 14, 28, 56, 84, 98, 100 or 112 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

TEVA UK Limited, Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG, United Kingdom

Marketing authorization dates and numbers

PL 00289/2063

28/07/2017

Drugs

Drug Countries
TOVEDESO Germany, Spain, Croatia

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