Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: Merus Labs Luxco II S.à R.L., 26-28, rue Edward Steichen, L-2540 Luxembourg
Emselex 7.5 mg prolonged-release tablets.
| Pharmaceutical Form |
|---|
|
Prolonged-release tablet. White round, convex tablet, debossed with “DF” on one side and “7.5” on the reverse. |
Each tablet contains 7.5 mg of darifenacin (as hydrobromide).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Darifenacin |
Darifenacin is a selective muscarinic M3 receptor antagonist (M3 SRA) in vitro. The M3 receptor is the major subtype that controls urinary bladder muscle contraction. It is not known whether this selectivity for the M3 receptor translates into any clinical advantage when treating symptoms of overactive bladder syndrome. |
| List of Excipients |
|---|
|
Tablet core: Calcium hydrogen phosphate, anhydrous Film coat: Polyethylene glycol |
Clear PVC/CTFE/aluminium or PVC/PVDC/aluminium blisters in cartons containing 7, 14, 28, 49, 56 or 98 tablets as unit pack or in multipacks containing 140 (10x14) tablets.
Not all pack sizes may be marketed.
Merus Labs Luxco II S.à R.L., 26-28, rue Edward Steichen, L-2540 Luxembourg
EU/1/04/294/001-006
EU/1/04/294/013
EU/1/04/294/015-020
EU/1/04/294/027
Date of first authorisation: 22 October 2004
Date of latest renewal: 24 September 2009
| Drug | Countries | |
|---|---|---|
| EMSELEX | Austria, Cyprus, Germany, Estonia, Finland, Croatia, Ireland, Lithuania, Mexico, Netherlands, Poland, Romania, Turkey, United Kingdom |
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