Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands
RAYVOW 50 mg film-coated tablets.
RAYVOW 100 mg film-coated tablets.
RAYVOW 200 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet (tablet). RAYVOW 50 mg film-coated tablets: Light grey, oval tablet of 8.9 × 4.9 mm, debossed with “4312” on one side and “L-50” on the other. RAYVOW 100 mg film-coated tablets: Light purple, oval tablet of 11.2 × 6.15 mm, debossed with “4491” on one side and “L-100” on the other. RAYVOW 200 mg film-coated tablets: Grey, oval tablet of 14.1 × 7.75 mm, debossed with “4736” on one side and “L-200” on the other. |
RAYVOW 50 mg film-coated tablets: Each film-coated tablet contains 50 mg lasmiditan (as succinate).
RAYVOW 100 mg film-coated tablets: Each film-coated tablet contains 100 mg lasmiditan (as succinate).
RAYVOW 200 mg film-coated tablets: Each film-coated tablet contains 200 mg lasmiditan (as succinate).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Lasmiditan |
Lasmiditan is a high affinity, centrally-penetrant, 5-hydroxytriptamine 1F (5-HT1F) receptor agonist. The precise mechanism of action is unknown, however, the therapeutic effects of lasmiditan in the treatment of migraine presumably involve agonistic effects at the 5-HT1F receptor, a decrease of neuropeptide release and an inhibition of pain pathways, including the trigeminal nerve. |
| List of Excipients |
|---|
|
Tablet core: Microcrystalline cellulose Film coating (50 mg and 200 mg): Polyvinyl alcohol Film coating (100 mg): Polyvinyl alcohol |
Polychlorotrifluoroethylene/polyvinyl chloride (PCTFE/PVC) perforated unit dose blisters sealed with an aluminium foil lid in packs of 2 × 1, 4 × 1, 6 × 1, 12 × 1 and 16 × 1 film-coated tablets.
Polyvinyl chloride (PVC) perforated unit dose blisters sealed with an aluminium foil lid in packs of 2 × 1, 4 × 1, 6 × 1, 12 × 1 and 16 × 1 film-coated tablets.
Not all pack sizes may be marketed.
Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands
RAYVOW 50 mg film-coated tablets:
EU/1/21/1587/001
EU/1/21/1587/002
EU/1/21/1587/003
EU/1/21/1587/004
EU/1/21/1587/005
EU/1/21/1587/006
EU/1/21/1587/007
EU/1/21/1587/008
EU/1/21/1587/009
EU/1/21/1587/010
RAYVOW 100 mg film-coated tablets:
EU/1/21/1587/011
EU/1/21/1587/012
EU/1/21/1587/013
EU/1/21/1587/014
EU/1/21/1587/015
EU/1/21/1587/016
EU/1/21/1587/017
EU/1/21/1587/018
EU/1/21/1587/019
EU/1/21/1587/020
RAYVOW 200 mg film-coated tablets:
EU/1/21/1587/021
EU/1/21/1587/022
EU/1/21/1587/023
EU/1/21/1587/024
EU/1/21/1587/025
EU/1/21/1587/026
EU/1/21/1587/027
EU/1/21/1587/028
EU/1/21/1587/029
EU/1/21/1587/030
Date of first authorisation: 17 August 2022
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