Source: European Medicines Agency (EU) Revision Year: 2018 Publisher: Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
Exelon 1.5 mg hard capsules.
Exelon 3.0 mg hard capsules.
Exelon 4.5 mg hard capsules.
Exelon 6.0 mg hard capsules.
| Pharmaceutical Form |
|---|
|
Hard capsules. Exelon 1.5 mg hard capsules: Off-white to slightly yellow powder in a capsule with yellow cap and yellow body, with red imprint “EXELON 1,5 mg” on body. Exelon 3.0 mg hard capsules: Off-white to slightly yellow powder in a capsule with orange cap and orange body, with red imprint “EXELON 3 mg” on body. Exelon 4.5 mg hard capsules: Off-white to slightly yellow powder in a capsule with red cap and red body, with white imprint “EXELON 4,5 mg” on body. Exelon 6.0 mg hard capsules: Off-white to slightly yellow powder in a capsule with red cap and orange body, with red imprint “EXELON 6 mg” on body. |
Exelon 1.5 mg hard capsules: Each capsule contains rivastigmine hydrogen tartrate corresponding to 1.5 mg rivastigmine.
Exelon 3.0 mg hard capsules: Each capsule contains rivastigmine hydrogen tartrate corresponding to 3.0 mg rivastigmine.
Exelon 4.5 mg hard capsules: Each capsule contains rivastigmine hydrogen tartrate corresponding to 4.5 mg rivastigmine.
Exelon 6.0 mg hard capsules: Each capsule contains rivastigmine hydrogen tartrate corresponding to 6.0 mg rivastigmine.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Rivastigmine |
Rivastigmine is an acetyl- and butyrylcholinesterase inhibitor of the carbamate type, thought to facilitate cholinergic neurotransmission by slowing the degradation of acetylcholine released by functionally intact cholinergic neurones. Thus, rivastigmine may have an ameliorative effect on cholinergic-mediated cognitive deficits in dementia associated with Alzheimer’s disease and Parkinson’s disease. |
| List of Excipients |
|---|
|
Gelatin |
Blister of clear PVC tray with blue lidding foil with 14 capsules. Each box contains 28, 56 or 112 capsules.
HDPE bottles with plastic closure with induction innerseal. Each bottle contains 250 capsules.
Not all pack sizes may be marketed.
Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
Exelon 1.5 mg hard capsules:
EU/1/98/066/001-3
EU/1/98/066/014
Exelon 3.0 mg hard capsules:
EU/1/98/066/004-6
EU/1/98/066/015
Exelon 4.5 mg hard capsules:
EU/1/98/066/007-9
EU/1/98/066/016
Exelon 6.0 mg hard capsules:
EU/1/98/066/010-12
EU/1/98/066/017
Date of first authorisation: 12 May 1998
Date of latest renewal: 20 May 2008
| Drug | Countries | |
|---|---|---|
| EXELON | Austria, Australia, Brazil, Canada, Cyprus, Germany, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Ireland, Israel, Italy, Japan, Lithuania, Mexico, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, United States, South Africa |
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