Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: H. Lundbeck A/S, Ottiliavej 9, 2500 Valby, Denmark
Brintellix 5 mg film-coated tablets.
Brintellix 10 mg film-coated tablets.
Brintellix 15 mg film-coated tablets.
Brintellix 20 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet (tablet). Brintellix 5 mg film-coated tablets: Pink, almond-shaped (5 × 8.4 mm) film-coated tablet engraved with “TL” on one side and “5” on the other side. Brintellix 10 mg film-coated tablets: Yellow, almond-shaped (5 × 8.4 mm) film-coated tablet engraved with “TL” on one side and “10” on the other side. Brintellix 15 mg film-coated tablets: Orange, almond-shaped (5 × 8.4 mm) film-coated tablet engraved with “TL” on one side and “15” on the other side. Brintellix 20 mg film-coated tablets: Red, almond-shaped (5 × 8.4 mm) film-coated tablet engraved with “TL” on one side and “20” on the other side. |
Brintellix 5 mg film-coated tablets: Each film-coated tablet contains vortioxetine hydrobromide equivalent to 5 mg vortioxetine.
Brintellix 10 mg film-coated tablets: Each film-coated tablet contains vortioxetine hydrobromide equivalent to 10 mg vortioxetine.
Brintellix 15 mg film-coated tablets: Each film-coated tablet contains vortioxetine hydrobromide equivalent to 15 mg vortioxetine.
Brintellix 20 mg film-coated tablets: Each film-coated tablet contains vortioxetine hydrobromide equivalent to 20 mg vortioxetine.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Vortioxetine |
Vortioxetine is a 5-HT3, 5-HT7, and 5-HT1D receptor antagonist, 5-HT1B receptor partial agonist, 5-HT1A receptor agonist and inhibitor of the 5-HT transporter, leading to modulation of neurotransmission in several systems, including predominantly the serotonin but probably also the norepinephrine, dopamine, histamine, acetylcholine, GABA and glutamate systems. This multimodal activity is considered responsible for the antidepressant and anxiolytic-like effects and the improvement of cognitive function, learning and memory observed with vortioxetine in animal studies. |
| List of Excipients |
|---|
Brintellix 5 mg film-coated tabletsTablet core: Mannitol Tablet coating: Hypromellose Brintellix 10 mg film-coated tabletsTablet core: Mannitol Tablet coating: Hypromellose Brintellix 15 mg film-coated tabletsTablet core: Mannitol Tablet coating: Hypromellose Brintellix 20 mg film-coated tabletsTablet core: Mannitol Tablet coating: Hypromellose |
Blister: Transparent; PVC/PVdC/aluminium blister.
Pack sizes of 14, 28 and 98 film-coated tablets.
Perforated unit dose blisters: PVC/PVdC/aluminium.
Pack sizes of 56 × 1 and 98 × 1 film-coated tablets.
Multipack containing 126 (9 × 14) and 490 (5 x (98x1)) film-coated tablets.
High-density polyethylene (HDPE) tablet container.
Pack sizes of 100 and 200 film-coated tablets.
Blister: Transparent; PVC/PVdC/aluminium blister.
Pack sizes of 7, 14, 28, 56 and 98 film-coated tablets.
Perforated unit dose blisters: PVC/PVdC/aluminium.
Pack sizes of 56 × 1 and 98 × 1 film-coated tablets.
Multipack containing 126 (9 × 14) and 490 (5 x (98x1)) film-coated tablets.
High-density polyethylene (HDPE) tablet container.
Pack sizes of 100 and 200 film-coated tablets.
Blister: Transparent; PVC/PVdC/aluminium blister.
Pack sizes of 14, 28, 56 and 98 film-coated tablets.
Perforated unit dose blisters: PVC/PVdC/aluminium.
Pack sizes of 56 × 1 and 98 × 1 film-coated tablets.
Multipack containing 490 (5 x (98x1)) film-coated tablets.
High-density polyethylene (HDPE) tablet container.
Pack sizes of 100 and 200 film-coated tablets.
Blister: Transparent; PVC/PVdC/aluminium blister.
Pack sizes of 14, 28, 56 and 98 film-coated tablets.
Perforated unit dose blisters: PVC/PVdC/aluminium.
Pack sizes of 56 × 1 and 98 × 1 film-coated tablets.
Multipack containing 126 (9 × 14) and 490 (5 x (98x1)) film-coated tablets.
High-density polyethylene (HDPE) tablet container.
Pack sizes of 100 and 200 film-coated tablets.
Not all pack sizes may be marketed.
H. Lundbeck A/S, Ottiliavej 9, 2500 Valby, Denmark
EU/1/13/891/027-035
EU/1/13/891/040
Date of first authorisation: 18 December 2013
| Drug | Countries | |
|---|---|---|
| BRINTELLIX | Austria, Brazil, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Ireland, Israel, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, United Kingdom, South Africa |
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