Medicinal product (lyophilisate) for acute treatment of migraine attacks with or without aura and for prophylactic treatment of episodic migraines in adults
Public Summary SwissPAR dated 30.01.2024
Vydura® (active substance: rimegepant)
First authorisation in Switzerland: 18 October 2023
Information on authorisation
The medicinal product Vydura contains the active substance rimegepant and is taken as a lyophilisate (powder). It is placed on or under the tongue and dissolves in the mouth.
Vydura is used in adults to relieve acute migraine attacks with or without aura (visual or other sensory disturbances before the attack itself).
It is also taken preventively to reduce the number of migraine attacks.
In deciding whether to authorise the medicinal product Vydura, Swissmedic took into account the assessments of the European Medicines Agency (EMA), the US Food and Drug Administration (FDA) and the corresponding medicinal product information texts.
Since the assessment of the clinical data was based on the assessment reports of the foreign authorities, the preconditions for a SwissPAR (Swiss Public Assessment Report – a detailed report for professionals) and a resulting Public Summary SwissPAR are not met. Swissmedic refers to the authorisations of the foreign reference authorities.
Further information on the medicinal product
Information for healthcare professionals:
Information for patients (package leaflet):
Healthcare professionals can answer any further questions.
Printable version
Vydura® (active substance: rimegepant) (PDF, 536 kB, 30.01.2024)First authorisation
The date of revision of this text corresponds to that of the SwissPAR. New information concerning the authorised medicinal product in question will not be incorporated into the Public Summary SwissPAR.
Swissmedic monitors medicinal products authorised in Switzerland. Swissmedic initiates the necessary action in the event of newly discovered adverse drug reactions or other safety-relevant signals.
New findings that could impair the quality, efficacy or safety of this medicinal product are recorded and published by Swissmedic. If necessary, the medicinal product information is adapted.