SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|
| FOVEPTA | 200 IU | concentrate for solution for injection · intramuscular, subcutaneous | 1 Pre-filled syringe | SAR 983.20 | Biological · Prescription | BIOTEST | Valid |
| HEPATECT CP | 50 IU/ml | Solution for infusion · Intravenous use | 1 Vial | SAR 1528.40 | Biological · Prescription | BIOTEST | Valid |
| HEPATECT CP | 50 IU/ml | Solution for infusion · Intravenous use | 1 Vial | SAR 382.10 | Biological · Prescription | BIOTEST | Valid |
| HepaGam B | 312 IU/ml | Solution for injection · Intramuscular and intravenous use | 1 Vial | SAR 576.85 | Biological · Prescription | KI BIOPHARMA LLC | Valid |
| HepaGam B | 1560 IU/ml | Solution for injection · Intramuscular and intravenous use | 1 Vial | SAR 2877.70 | Biological · Prescription | KI BIOPHARMA LLC | Valid |
Indications — CHI Daman Drug Formulary
MATERNAL AND CHILD HEALTHCARE- IMMUNIZATION FOR MOTHER AND CHILD; TRAVEL IMMUNIZATION
EMA European Union — centrally authorised medicines
Zutectra Biotest Pharma GmbH · Authorised · authorised 30 Nov 2009 · ATC J06BB04
Therapeutic indication (EMA)
Prevention of hepatitis B virus (HBV) re-infection in HBsAg and HBV-DNA negative adult patients at least one week after liver transplantation for hepatitis B induced liver failure. HBV-DNA negative status should be confirmed within the last 3 months prior to OLT. Patients should be HBsAg negative before treatment start. The concomitant use of adequate virostatic agents should be considered as standard of hepatitis B re-infection prophylaxis.
ImmunoGam Cangene Europe Limited · Withdrawn · authorised 16 Mar 2010 · ATC J06BB04
Therapeutic indication (EMA)
Immunoprophylaxis of Hepatitis B - In case of accidental exposure in non-immunised subjects (including persons whose vaccination isincomplete or status unknown). - In haemodialysed patients, until vaccination has become effective. - In the newborn of a hepatitis B virus carrier-mother. - In subjects who did not show an immune response (no measurable hepatitis B antibodies) after vaccination and for whom a continuous prevention is necessary due to the continuous risk of being infected with hepatitis B. Consideration should also be given to other official guidance on the appropriate use of human hepatitis B immunoglobulin for intramuscular use.
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.