Is Erenumab 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 Erenumab, including Aimovig (70 mg, Solution for injection in pre-filled pen, SAR 1343.05); Aimovig (140 mg, Solution for injection in pre-filled pen, SAR 1343.05).

Is Erenumab approved by the US FDA?

Drugs@FDA lists 1 application product line for Erenumab, including AIMOVIG (Prescription).

Is Erenumab authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Erenumab: Aimovig.

Are there safety signals or safety updates for Erenumab?

EMA PRAC: 8 entries; US FDA: 1 entry (latest 2026-07-09).

Active substance

Erenumab

SFDA 2
US FDA 1
EMA 1
Health Canada 2
US price lines 2
Safety 9

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
Aimovig	70 mg	Solution for injection in pre-filled pen · Subcutaneous use	1 Pre-filled pen	SAR 1343.05	Biological · Prescription	Novartis Europharm Limited	Valid
Aimovig	140 mg	Solution for injection in pre-filled pen · Subcutaneous use	1 Pre-filled pen	SAR 1343.05	Biological · Prescription	Novartis Europharm 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
AIMOVIG	70MG/ML	injectable · injection	AMGEN INC	Prescription	17 May 2018

EMA European Union — centrally authorised medicines

Aimovig Novartis Europharm Limited · Authorised · authorised 26 Jul 2018 · ATC N02CD01

Therapeutic indication (EMA)

Aimovig is indicated for prophylaxis of migraine in adults who have at least 4 migraine days per month when initiating treatment with Aimovig.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
AIMOVIG	02479613	70 MG / ML	SOLUTION · SUBCUTANEOUS	NOVARTIS PHARMACEUTICALS CANADA INC
AIMOVIG	02487306	140 MG / ML	SOLUTION · SUBCUTANEOUS	NOVARTIS PHARMACEUTICALS CANADA INC

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	AIMOVIG 140 MG/ML AUTOINJECTOR	$753.32586	per ML	23 Sep 2026
US NADAC	AIMOVIG 70 MG/ML AUTOINJECTOR	$753.57097	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 21 Mar 2025 AIMOVIG — 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 16 May 2024 PRAC signal: Hypertension
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 erenumab →

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.