Is Rimegepant registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 1 valid registration of Rimegepant, including Nurtec (75 mg, Tablet, orally disintegrating, SAR 607.00).

Is Rimegepant approved by the US FDA?

Drugs@FDA lists 1 application product line for Rimegepant, including NURTEC ODT (Prescription).

Is Rimegepant authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Rimegepant: Vydura.

Are there safety signals or safety updates for Rimegepant?

EMA PRAC: 1 entry; US FDA: 1 entry (latest 2026-07-09).

Active substance

Rimegepant

SFDA 1
US FDA 1
EMA 1
Health Canada 1
US price lines 1
NHS prices 2
Safety 2

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
Nurtec	75 mg	Tablet, orally disintegrating · Oral use	8 Blister	SAR 607.00	NCE · Prescription	Pfizer Europe MA EEIG	Valid

Indications — CHI Daman Drug Formulary

MIGRAINE/ HEADACHE

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
NURTEC ODT	EQ 75MG BASE	tablet, orally disintegrating · oral	PFIZER	Prescription	27 Feb 2020

EMA European Union — centrally authorised medicines

Vydura Pfizer Europe MA EEIG · Authorised · authorised 25 Apr 2022 · ATC N02CD06

Therapeutic indication (EMA)

Vydura is indicated for the Acute treatment of migraine with or without aura in adults; Preventative treatment of episodic migraine in adults who have at least 4 migraine attacks per month.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
NURTEC ODT	02543605	75 MG	TABLET (ORALLY-DISINTEGRATING) · ORAL	PFIZER CANADA ULC

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	NURTEC ODT 75 MG TABLET	$128.66977	per EA	23 Sep 2026
NHS Drug Tariff	Rimegepant 75mg oral lyophilisates sugar free	£25.80	2 tablet	1 Oct 2026
NHS Drug Tariff	Rimegepant 75mg oral lyophilisates sugar free	£103.20	8 tablet	1 Oct 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

Safety signals and safety-related labeling changes

EMA PRAC 9 Jul 2026 PRAC signal: Raynaud’s phenomenon
Action for MAH: update of the product information: No
US FDA 16 Mar 2026 NURTEC ODT — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for rimegepant →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.