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Refacto AF 500 IU powder and solvent for solution for injection in Pre-filled syringe – Summary of Product Characteristics (SmPC) for healthcare professionals

Medicine status: Prescription only (POM) Details

Medicine strength:
500 IU
Other strengths and forms:
Contains active substance:
ATC code:
Similar medicines:

Sources: Original (products.mhra.gov.uk)

Summary of Product Characteristics (SmPC) - Refacto AF 500 IU powder and solvent for solution for injection in Pre-filled syringe

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THEAUTHORISATION

01/01/2021

Sources: Original (products.mhra.gov.uk)

Facts about Refacto AF 500 IU powder and solvent for solution for injection in Pre-filled syringe

Prescription needed? Yes, prescription-only medicine (POM)
Active substance Moroctocog alfa
Strength 500 IU
Pharmaceutical form Powder and solvent for solution for injection
How is it taken Intravenous
Pack sizes 1 pre-filled disposable injection
Is it available? Listed as available (NHS Dictionary of Medicines and Devices – not a record of current supplies)
Drug group (ATC)
  1. B Blood and blood forming organ drugs
    1. B02 Antihemorrhagics
      1. B02B Vitamin K and other hemostatics
        1. B02BD Blood coagulation factors
          1. B02BD02 coagulation factor VIII
Marketing authorisation PLGB 00057/1683
Codes GTIN 5013457021790, 5415062364376 · BNF 02110000

Sources: the MHRA product information (products.mhra.gov.uk) and the NHS Dictionary of Medicines and Devices (dm+d), release 10.2.0 of 19 October 2026, NHS Business Services Authority. Contains public sector information licensed under the Open Government Licence v3.0.