Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: Biohaven Pharmaceutical Ireland DAC, 6<sup>th</sup> Floor, South Bank House, Barrow Street, Dublin D04 TR29, Ireland
VYDURA 75 mg oral lyophilisate.
| Pharmaceutical Form |
|---|
|
Oral lyophilisate. The oral lyophilisate is white to off-white, circular, diameter 14 mm and debossed with the symbol |
Each oral lyophilisate contains rimegepant sulfate, equivalent to 75 mg rimegepant.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Rimegepant |
Rimegepant selectively binds with high affinity to the human calcitonin gene-related peptide (CGRP) receptor and antagonizes CGRP receptor function. The relationship between pharmacodynamic activity and the mechanism(s) by which rimegepant exerts its clinical effects is unknown. |
| List of Excipients |
|---|
|
Gelatin |
Blisters made of polyvinyl chloride (PVC), oriented polyamide (OPA) and aluminium foil and sealed with a peelable aluminum foil (8-count).
Unit dose blisters made of polyvinyl chloride (PVC), oriented polyamide (OPA) and aluminium foil and sealed with a peelable aluminum foil (2-count).
Pack sizes:
8 × 1 oral lyophilisates in a carton.
Unit dose 2 × 1 oral lyophilisates in a wallet carrier inside a carton.
Not all pack sizes may be marketed.
Biohaven Pharmaceutical Ireland DAC, 6th Floor, South Bank House, Barrow Street, Dublin D04 TR29, Ireland
EU/1/22/1645/001
EU/1/22/1645/002
| Drug | Countries | |
|---|---|---|
| VYDURA | Austria, Estonia, Spain, France, Croatia, Italy, Lithuania, Romania |
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