Vydura

Medicinal product

(Invented) name

Vydura

Active substance (s)

Rimegepantas

Strength

75 mg

Pharmaceutical form

geriamasis liofilizatas

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

N02CD06, rimegepant

Marketing authorisation holder

Pfizer Europe MA EEIG, Belgija

Date of authorisation

2022-04-25

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Oral lyophilisate	1 vnt.
Rimegepantas	75 mg

Packages

PAKID	NPAKID	NPAKID-7	Pack type	Pack size	Type of packaging	Proposed dispensing/classification	Marketing authorisation no.	Supply status	From	To	Package is in foreign language	From	To	Mock-up
108535	94639	1094639	dalomoji lizdinė plokštelė	N2×1		Receptinis	EU/1/22/1645/001	Tiekiama	-	-	No	-	-
108536	94640	1094640	dalomoji lizdinė plokštelė	N8×1		Receptinis	EU/1/22/1645/002	Netiekiama	2025-12-22	2026-03-24	No	-	-
108758	94864	1094864	dalomoji lizdinė plokštelė	N16x1		Receptinis	EU/1/22/1645/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-04-25	Registruotas