Regulatory PathRegulatory requirements compared

Active substance

Anti d immunoglobulin

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
RHOPHYLAC 300MCG-2ML SOL. FOR INJ.IN PFS300 µgSolution for injection · Intravenous use1 Injection SyringeSAR 228.75Biological · PrescriptionCSL BEHRINGValid
D-GAM 250IU VIAL250 IU/mlSolution for injection · Intravenous use1 VialSAR 132.80Biological · PrescriptionBIO-PRODUCT LABWithdrawn by MAH · Not Marketed
PARTOBULIN SDF 1250 I.U-MLPRELOADED SYR.1250 IU/mlSolution · Intravenous use1 Pre-filled syringeSAR 246.00Biological · PrescriptionTakeda Manufacturing AGWithdrawn by MAH · Not Marketed
RHESONATIVE 250 MCG-2ML VIAL125 µ/mlInjection · Intravenous use1 VialSAR 102.40Biological · PrescriptionOCTAPHARMAWithdrawn by MAH · Not Marketed
Indications — CHI Daman Drug Formulary

IMMUNE THROMBOCYPTOPENIC PUPURA; MATERNAL AND CHILD HEALTHCARE-UNEXPLAINED VAGINAL BLEEDING AFTER 13 WEEKS

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
WINRHO SDF02302551600 UNIT / VIALSOLUTION · INTRAVENOUS; INTRAMUSCULARKI BIOPHARMA LLC
WINRHO SDF023025781500 UNIT / VIALSOLUTION · INTRAMUSCULAR; INTRAVENOUSKI BIOPHARMA LLC

WHO WHO Model List of Essential Medicines (2025)

  • 11.2. Human immunoglobulins · core
    Maternal care for red cell antibodies; Rh incompatibility reaction
    Parenteral > General injections > IV: 250 µg in single-dose vial | Parenteral > General injections > IM: 250 µg in single-dose vial

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.