Is Fremanezumab 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 Fremanezumab, including AJOVY (150 mg/ml, Solution for injection, SAR 1343.05).

Is Fremanezumab approved by the US FDA?

Drugs@FDA lists 1 application product line for Fremanezumab, including AJOVY (Prescription).

Is Fremanezumab authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Fremanezumab: Ajovy.

Are there safety signals or safety updates for Fremanezumab?

EMA PRAC: 7 entries; US FDA: 1 entry (latest 2026-07-09).

Active substance

Fremanezumab

SFDA 1
US FDA 1
EMA 1
Health Canada 2
US price lines 3
Safety 8

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
AJOVY	150 mg/ml	Solution for injection · Subcutaneous use	1 Pre-filled pen	SAR 1343.05	Biological · Prescription	Teva Gmbh	Valid

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

Product	Strength	Form · route	Applicant	Status	First approved
AJOVY	150MG/ML	injectable · injection	TEVA PHARMS USA	Prescription	14 Sep 2018

EMA European Union — centrally authorised medicines

Ajovy Teva GmbH · Authorised · authorised 28 Mar 2019 · ATC N02CD03

Therapeutic indication (EMA)

Ajovy is indicated for 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
AJOVY	02497859	225 MG / 1.5 ML	SOLUTION · SUBCUTANEOUS	TEVA CANADA LIMITED
AJOVY	02509474	225 MG / 1.5 ML	SOLUTION · SUBCUTANEOUS	TEVA CANADA LIMITED

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	AJOVY 225 MG/1.5 ML AUTOINJECT	$508.17066	per ML	23 Sep 2026
US NADAC	AJOVY 225 MG/1.5 ML AUTOINJECTOR (3 PACK)	$507.447	per ML	23 Sep 2026
US NADAC	AJOVY 225 MG/1.5 ML SYRINGE	$508.50721	per ML	23 Sep 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 5 Jun 2026 AJOVY — 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
EMA PRAC 5 May 2022 PRAC signal: Raynaud’s phenomenon
Action for MAH: update of the product information: No
EMA PRAC 13 Jan 2022 PRAC signal: Raynaud’s phenomenon
Action for MAH: update of the product information: No

All safety entries for fremanezumab →

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.