Source: European Medicines Agency (EU) Revision Year: 2021 Publisher: Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium
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’. |
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 Film-coating: Poly(vinyl alcohol) |
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.
Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium
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
| 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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