Is Peginterferon beta 1a 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 Peginterferon beta 1a, including PLEGRIDY 125 mcg solution for injection (125 µg, Solution for injection in pre-filled pen, SAR 3455.70); PLEGRIDY 63-94 mcg solution for injection (63 µg, Solution for injection in pre-filled pen, SAR 3455.70).

Is Peginterferon beta 1a approved by the US FDA?

Drugs@FDA lists 1 application product line for Peginterferon beta 1a, including PLEGRIDY (Prescription).

Is Peginterferon beta 1a authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Peginterferon beta 1a: Plegridy.

Are there safety signals or safety updates for Peginterferon beta 1a?

EMA PRAC: 2 entries; US FDA: 1 entry (latest 2023-07-28).

Active substance

Peginterferon beta 1a

SFDA 2
US FDA 1
EMA 1
Health Canada 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
PLEGRIDY 125 mcg solution for injection	125 µg	Solution for injection in pre-filled pen · Subcutaneous use	2 Pre-filled syringe	SAR 3455.70	Biological · Prescription	Biogen Idec B.V-Natherland	Valid
PLEGRIDY 63-94 mcg solution for injection	63 µg	Solution for injection in pre-filled pen · Subcutaneous use	2 Pre-filled syringe	SAR 3455.70	Biological · Prescription	Biogen Idec B.V-Natherland	Valid

Indications — CHI Daman Drug Formulary

MULTIPLE SCLEROSIS; MYELOFIBROSIS-SYMPTOMATIC, LOW-RISK

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

Product	Strength	Form · route	Applicant	Status	First approved
PLEGRIDY	125MICROGRAMS/0.5ML	injectable · injection	BIOGEN IDEC INC	Prescription	15 Aug 2014

EMA European Union — centrally authorised medicines

Plegridy Biogen Netherlands B.V. · Authorised · authorised 18 Jul 2014 · ATC L03AB13

Therapeutic indication (EMA)

Treatment of relapsing remitting multiple sclerosis in adult patients.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
PLEGRIDY	02444399	125 MCG / 0.5 ML	LIQUID · SUBCUTANEOUS	BIOGEN CANADA INC
PLEGRIDY	02444402	63 MCG / 0.5 ML; 94 MCG / 0.5 ML	LIQUID; KIT · SUBCUTANEOUS	BIOGEN CANADA INC

Safety signals and safety-related labeling changes

US FDA 28 Jul 2023 PLEGRIDY — 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

All safety entries for peginterferon beta 1a →

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.