Is Interferon beta 1b 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 Interferon beta 1b, including BETAFERON 8MIU\ML VIAL (8000000 IU/ml, Powder and solvent for solution for injection, SAR 3071.60).

Is Interferon beta 1b approved by the US FDA?

Drugs@FDA lists 1 application product line for Interferon beta 1b, including BETASERON (Prescription).

Is Interferon beta 1b authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Interferon beta 1b: Betaferon.

Are there safety signals or safety updates for Interferon beta 1b?

EMA PRAC: 3 entries; US FDA: 1 entry (latest 2023-07-28).

Active substance

Interferon beta 1b

SFDA 1
US FDA 1
EMA 2
Health Canada 1
US price lines 1
Safety 4

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
BETAFERON 8MIU\ML VIAL	8000000 IU/ml	Powder and solvent for solution for injection · Subcutaneous use	15 Vial	SAR 3071.60	Biological · Prescription	BAYER AG	Valid

Indications — CHI Daman Drug Formulary

MULTIPLE SCLEROSIS

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

Product	Strength	Form · route	Applicant	Status	First approved
BETASERON	0.3 MG	vial · subcutaneous	BAYER HEALTHCARE PHARMS	Prescription	23 Jul 1993

EMA European Union — centrally authorised medicines

Betaferon Bayer AG · Authorised · authorised 30 Nov 1995 · ATC L03AB08

Therapeutic indication (EMA)

Betaferon is indicated for the treatment of patients with a single demyelinating event with an active inflammatory process, if it is severe enough to warrant treatment with intravenous corticosteroids, if alternative diagnoses have been excluded, and if they are determined to be at high risk of developing clinically definite multiple sclerosis; patients with relapsing-remitting multiple sclerosis and two or more relapses within the last two years; patients with secondary progressive multiple sclerosis with active disease, evidenced by relapses.

Extavia Novartis Europharm Limited · Withdrawn · authorised 20 May 2008 · ATC L03AB08

Therapeutic indication (EMA)

Extavia is indicated for the treatment of: patients with a single demyelinating event with an active inflammatory process, if it is severe enough to warrant treatment with intravenous corticosteroids, if alternative diagnoses have been excluded, and if they are determined to be at high risk of developing clinically definite multiple sclerosis; patients with relapsing-remitting multiple sclerosis and two or more relapses within the last two years; patients with secondary progressive multiple sclerosis with active disease, evidenced by relapses.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
BETASERON	02169649	0.3 MG / VIAL	POWDER FOR SOLUTION · SUBCUTANEOUS	BAYER INC

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	BETASERON 0.3 MG KIT	$725.97471	per EA	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

US FDA 28 Jul 2023 BETASERON — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
EMA PRAC 10 Apr 2015 PRAC signal: Pulmonary arterial hypertension
Action for MAH: update of the product information: Yes
EMA PRAC 4 Dec 2014 PRAC signal: Pulmonary arterial hypertension
Action for MAH: update of the product information: No
EMA PRAC 11 Sep 2014 PRAC signal: Pulmonary arterial hypertension
Action for MAH: update of the product information: No

All safety entries for interferon beta 1b →

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.