Is Atogepant registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 2 valid registrations of Atogepant, including Aquipta (60 mg, Tablet, SAR 1343.05); Aquipta (10 mg, Tablet, SAR 1343.05).

Is Atogepant approved by the US FDA?

Drugs@FDA lists 1 application product line for Atogepant, including QULIPTA (Prescription).

Is Atogepant authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Atogepant: Aquipta.

Are there safety signals or safety updates for Atogepant?

EMA PRAC: 2 entries; US FDA: 1 entry (latest 2026-07-09).

Active substance

Atogepant

SFDA 2
US FDA 1
EMA 1
Health Canada 3
US price lines 3
NHS prices 2
Safety 3

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
Aquipta	60 mg	Tablet · Oral use	28 Blister	SAR 1343.05	NCE · Prescription	Abbvie Limited	Valid
Aquipta	10 mg	Tablet · Oral use	28 Blister	SAR 1343.05	NCE · Prescription	Abbvie Limited	Valid

Indications — CHI Daman Drug Formulary

MIGRAINE/ HEADACHE

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

Product	Strength	Form · route	Applicant	Status	First approved
QULIPTA	10MG; 30MG; 60MG	tablet · oral	ABBVIE	Prescription	28 Sep 2021

EMA European Union — centrally authorised medicines

Aquipta AbbVie Deutschland GmbH & Co. KG · Authorised · authorised 11 Aug 2023 · ATC N02CD07

Therapeutic indication (EMA)

Aquipta is indicated for: - acute treatment of migraine with or without aura in adults - prophylaxis of migraine in adults who have at least 4 migraine days per month.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
QULIPTA	02533979	10 MG	TABLET · ORAL	ABBVIE CORPORATION
QULIPTA	02533987	30 MG	TABLET · ORAL	ABBVIE CORPORATION
QULIPTA	02533995	60 MG	TABLET · ORAL	ABBVIE CORPORATION

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	QULIPTA 10 MG TABLET	$38.35832	per EA	23 Sep 2026
US NADAC	QULIPTA 30 MG TABLET	$38.37771	per EA	23 Sep 2026
US NADAC	QULIPTA 60 MG TABLET	$38.44941	per EA	23 Sep 2026
NHS Drug Tariff	Atogepant 10mg tablets	£182.16	28 tablet	1 Oct 2026
NHS Drug Tariff	Atogepant 60mg tablets	£182.16	28 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: Insomnia
Action for MAH: update of the product information: No
EMA PRAC 9 Jul 2026 PRAC signal: Raynaud’s phenomenon
Action for MAH: update of the product information: No
US FDA 30 Sep 2025 QULIPTA — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for atogepant →

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.