Source: European Medicines Agency (EU) Revision Year: 2021 Publisher: Mylan Pharmaceuticals Limited, Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN Ireland
Rasagiline Mylan 1 mg tablets.
| Pharmaceutical Form |
|---|
|
Tablet. White to off-white, oblong (approximately 11.5 mm x 6 mm) biconvex tablets, debossed with ‘R9SE’ on one side and ‘1’ on the other side. |
Each tablet contains rasagiline tartrate corresponding to 1 mg rasagiline.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Rasagiline |
Rasagiline was shown to be a potent, irreversible MAO-B selective inhibitor, which may cause an increase in extracellular levels of dopamine in the striatum. The elevated dopamine level and subsequent increased dopaminergic activity are likely to mediate rasagiline’s beneficial effects seen in models of dopaminergic motor dysfunction. |
| List of Excipients |
|---|
|
Cellulose, microcrystalline |
oPA/Al/PVC/Al. Blister packs of 7, 10, 28, 30, 100 or 112 tablets
PVC/PVDC/Al. Blister packs of 7, 10, 28, 30, 100 or 112 tablets
PVC/PVDC/Al. Perforated unit dose blister packs of 7 × 1, 10 × 1, 28 × 1, 30 × 1, 100 × 1 or 112 × 1.
Not all pack sizes may be marketed.
Mylan Pharmaceuticals Limited, Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN Ireland
EU/1/16/1090/001 (7 tablets – oPA/alu/PVC/alu)
EU/1/16/1090/002 (10 tablets – oPA/alu/PVC/alu)
EU/1/16/1090/003 (28 tablets – oPA/alu/PVC/alu)
EU/1/16/1090/004 (30 tablets – oPA/alu/PVC/alu)
EU/1/16/1090/005 (100 tablets – oPA/alu/PVC/alu)
EU/1/16/1090/006 (112 tablets – oPA/alu/PVC/alu)
EU/1/16/1090/007 (7 tablets – PVC/PVDC/alu)
EU/1/16/1090/008 (10 tablets – PVC/PVDC/alu)
EU/1/16/1090/009 (28 tablets – PVC/PVDC/alu)
EU/1/16/1090/010 (30 tablets – PVC/PVDC/alu)
EU/1/16/1090/011 (100 tablets – PVC/PVDC/alu)
EU/1/16/1090/012 (112 tablets – PVC/PVDC/alu)
EU/1/16/1090/013 (7 tablets – PVC/PVDC/alu)
EU/1/16/1090/014 (10 tablets – PVC/PVDC/alu)
EU/1/16/1090/015 (28 tablets – PVC/PVDC/alu)
EU/1/16/1090/016 (30 tablets – PVC/PVDC/alu)
EU/1/16/1090/017 (100 tablets – PVC/PVDC/alu)
EU/1/16/1090/018 (112 tablets – PVC/PVDC/alu)
Date of first authorisation: 4 April 2016
Date of latest renewal: 20 November 2020
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