Regulatory PathRegulatory requirements compared

Active substance

Plasma protein fraction

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
OCTAPLAS LG 45-70MG/ML45-70 mg/mlSolution for infusion · Intravenous use1 BagSAR 614.10Biological · PrescriptionOCTAPHARMA AGValid
PENTAGLOBIN50 mg/mlSolution for infusion · Intravenous use1 AmpouleSAR 2241.40Biological · PrescriptionBIOTESTValid
PENTAGLOBIN50 mg/mlSolution for infusion · Intravenous use1 AmpouleSAR 1120.70Biological · PrescriptionBIOTESTValid
PENTAGLOBIN AMP I.V50 mg/mlSolution for infusion · Intravenous use1 AmpouleSAR 224.15Biological · PrescriptionBIOTESTValid
PLASMA PROTEIN FRACTION 5% SOLUTION5 %Solution for injection · Intravenous use1 BottleSAR 278.00Biological · PrescriptionOCTAPHARMAValid
PLASMANATE 5% SOLUTION FOR I.V. INJECTION5 %Solution for injection · Intravenous use1 AmpouleSAR 158.90Biological · PrescriptionGRIFOLS THERAPEUTICS INCValid
OCTAPLAS9.0 - 14.0 gSolution · Intravenous use1 BagSAR 519.10Biological · PrescriptionOCTAPHARMAWithdrawn by MAH · Not Marketed
PLASMA PROTEIN FRACTION 5% VIAL5 %Solution for injection · Intravenous use1 VialSAR 247.90Biological · PrescriptionBIOTESTWithdrawn by MAH · Not Marketed
Indications — CHI Daman Drug Formulary

DYSPEPSIA; HEMOPHILIA A, HEMOPHILIA B, VON WILLEBRAND DISEASE, ACQUIRED HEMOPHILIA; PEPTIC ULCER

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.