TOVIAZ Prolonged-release tablet Ref.[8503] Active ingredients: Fesoterodine

Source: European Medicines Agency (EU)  Revision Year: 2021  Publisher: Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium

Product name and form

TOVIAZ 4 mg prolonged-release tablets.

TOVIAZ 8 mg prolonged-release tablets.

Pharmaceutical Form

Prolonged-release tablet.

TOVIAZ 4 mg tablets: The 4 mg tablets are light blue, oval, biconvex, film-coated, and engraved on one side with the letters ‘FS’.

TOVIAZ 8 mg tablets: The 8 mg tablets are blue, oval, biconvex, film-coated, and engraved on one side with the letters ‘FT’.

Qualitative and quantitative composition

TOVIAZ 4 mg tablets: Each prolonged-release tablet contains fesoterodine fumarate 4 mg corresponding to 3.1 mg of fesoterodine.

TOVIAZ 8 mg tablets: Each prolonged-release tablet contains fesoterodine fumarate 8 mg corresponding to 6.2 mg of fesoterodine.

Excipients with known effect:

TOVIAZ 4 mg tablets: Each 4 mg prolonged-release tablet contains 0.525 mg of soya lecithin and 91.125 mg of lactose.

TOVIAZ 8 mg tablets: Each 8 mg prolonged-release tablet contains 0.525 mg of soya lecithin and 58.125 mg of lactose.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Fesoterodine

Fesoterodine is a competitive, specific muscarinic receptor antagonist. It is rapidly and extensively hydrolysed by non-specific plasma esterases to the 5-hydroxymethyl derivative, its primary active metabolite, which is the main active pharmacological principle of fesoterodine.

List of Excipients

Tablet core:

Xylitol
Lactose monohydrate
Microcrystalline cellulose
Hypromellose
Glycerol dibehenate
Talc

Film-coating:

Poly(vinyl alcohol)
Titanium dioxide (E171)
Macrogol (3350)
Talc
Soya lecithin
Indigo carmine aluminium lake (E132)

Pack sizes and marketing

TOVIAZ 4 mg and 8 mg tablets are packed in aluminium-aluminium blisters in cartons containing 7, 14, 28, 30, 56, 84, 98 or 100 tablets. In addition, TOVIAZ 4 mg and 8 mg tablets are also packed in HDPE bottles containing 30 or 90 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium

Marketing authorization dates and numbers

TOVIAZ 4 mg tablets:

EU/1/07/386/001-005
EU/1/07/386/011
EU/1/07/386/013-014
EU/1/07/386/017
EU/1/07/386/019

TOVIAZ 8 mg tablets:

EU/1/07/386/006-010
EU/1/07/386/012
EU/1/07/386/015-016
EU/1/07/386/018
EU/1/07/386/020

Date of first authorisation: 20 April 2007
Date of latest renewal: 15 March 2012

Drugs

Drug Countries
TOVIAZ Austria, Canada, Cyprus, Germany, Estonia, Spain, Finland, France, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Netherlands, Poland, Turkey, United Kingdom, United States

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