Is Eptinezumab 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 Eptinezumab, including Vyepti (100 mg/ml, Concentrate for solution for infusion, SAR 4029.15).

Is Eptinezumab approved by the US FDA?

Drugs@FDA lists 1 application product line for Eptinezumab, including VYEPTI (Prescription).

Is Eptinezumab authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Eptinezumab: Vyepti.

Are there safety signals or safety updates for Eptinezumab?

EMA PRAC: 5 entries; US FDA: 1 entry (latest 2026-07-09).

Active substance

Eptinezumab

SFDA 1
US FDA 1
EMA 1
Health Canada 2
Safety 6

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
Vyepti	100 mg/ml	Concentrate for solution for infusion · Intravenous use	1 Vial	SAR 4029.15	Biological · Prescription	H. LUNDBECK	Valid

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

Product	Strength	Form · route	Applicant	Status	First approved
VYEPTI	100MG/ML	injectable · injection	Lundbeck Seattle BioPharmaceuticals, Inc.	Prescription	21 Feb 2020

EMA European Union — centrally authorised medicines

Vyepti H. Lundbeck A/S · Authorised · authorised 24 Jan 2022 · ATC N02CD

Therapeutic indication (EMA)

Vyepti is indicated for the 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
VYEPTI	02510839	100 MG / ML	SOLUTION · INTRAVENOUS	LUNDBECK CANADA INC
VYEPTI	02542269	300 MG / 3 ML	SOLUTION · INTRAVENOUS	LUNDBECK CANADA INC

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 5 Jun 2026 VYEPTI — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
EMA PRAC 31 Oct 2024 PRAC signal: Insomnia
Action for MAH: update of the product information: No
EMA PRAC 3 Oct 2024 PRAC signal: Erectile dysfunction
Action for MAH: update of the product information: No
EMA PRAC 16 May 2024 PRAC signal: Insomnia
Action for MAH: update of the product information: No
EMA PRAC 11 Apr 2024 PRAC signal: Erectile dysfunction
Action for MAH: update of the product information: No

All safety entries for eptinezumab →

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.