Active substance
Interferon alfa 2a
- SFDA 7
- Safety 5
SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|---|---|---|---|---|---|---|
| ROFERON-A 18MN.IU VIAL | 18000000 IU | Injection · Intramuscular use | 5 Vial | SAR 3445.95 | Biological · Prescription | ROCHE | Withdrawn by MAH · Not Marketed |
| ROFERON-A 3MIU-0.5 ML | 3000000 IU | Injection · Intramuscular use | 1 Pre-filled syringe | SAR 106.00 | Biological · Prescription | ROCHE | Withdrawn by MAH · Not Marketed |
| ROFERON-A 3MIU-0.5 ML | 3000000 IU | Injection · Intramuscular use | 5 Vial | SAR 506.90 | Biological · Prescription | ROCHE | Withdrawn by MAH · Not Marketed |
| ROFERON-A 4.5MIU-0.5ML | 4500000 IU | Injection · Intramuscular use | 5 Vial | SAR 648.25 | Biological · Prescription | ROCHE | Withdrawn by MAH · Not Marketed |
| ROFERON-A 4.5MIU-0.5ML | 4500000 IU | Injection · Intramuscular use | 1 Pre-filled syringe | SAR 118.95 | Biological · Prescription | ROCHE | Withdrawn by MAH · Not Marketed |
| ROFERON-A 9MIU-0.5ML | 9000000 IU | Injection · Intramuscular use | 5 Vial | SAR 2000.30 | Biological · Prescription | ROCHE | Withdrawn by MAH · Not Marketed |
| ROFERON-A 9MIU-0.5ML | 9000000 IU | Injection · Intramuscular use | 1 Pre-filled syringe | SAR 237.85 | Biological · Prescription | ROCHE | Withdrawn by MAH · Not Marketed |
Safety signals and safety-related labeling changes
- EMA PRAC 3 Sep 2020 PRAC signal: Neuromyelitis optica spectrum disorder
Action for MAH: update of the product information: Yes - EMA PRAC 12 Mar 2020 PRAC signal: Neuromyelitis optica spectrum disorder
Action for MAH: update of the product information: No - 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
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.