Inpremzia

Withdrawn

This medicine's authorisation has been withdrawn

insulin human (rDNA)

Overview

On 4 April 2023, the European Commission withdrew the marketing authorisation for Inpremzia (insulin human (rDNA)) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Baxter Holding B.V., which notified the European Commission of its decision not to market the product in the European Union for commercial reasons. 

Inpremzia was granted marketing authorisation in the EU on 25 April 2022 for treatment of patients with diabetes mellitus who require intravenous insulin. 

Inpremzia is a biosimilar medicinal product. It is highly similar to the reference product Actrapid (human insulin), which is authorised in the EU to treat diabetes mellitus. 

The European Public Assessment Report (EPAR) for Inpremzia is updated to indicate that the marketing authorisation is no longer valid.

Inpremzia : EPAR - Medicine overview

Reference Number: EMEA/H/C/005331

Inpremzia : EPAR - Risk management plan summary

Product information

Inpremzia : EPAR - Product Information

Inpremzia : EPAR - All Authorised Presentations

Product details

• Name of medicine:
  Inpremzia
• Active substance:
  insulin human (rDNA)
• International non-proprietary name (INN) or common name:
  insulin human (rDNA)
• Therapeutic area (MeSH):
  Diabetes Mellitus
• Anatomical therapeutic chemical (ATC) code:
  A10AB01

Pharmacotherapeutic group

Drugs used in diabetes

Therapeutic indication

Inpremzia is indicated for the treatment of diabetes mellitus.

Authorisation details

• EMA product number:
  EMEA/H/C/005331
• Biosimilar:

  This is a biosimilar medicine, which is a biological medicine highly similar to another already approved biological medicine called the ‘reference medicine’. For more information, see Biosimilar medicines.

• Marketing authorisation holder:
  Baxter Holding B.V.

  Kobaltweg 49; 3542 CE; Utrecht; Netherlands

• Opinion adopted:
  24/02/2022
• Marketing authorisation issued:
  25/04/2022

Assessment history

Initial marketing authorisation documents

Inpremzia : EPAR - Public Assessment Report

Reference Number: EMA/127616/2022

CHMP summary of positive opinion for Inpremzia

Adopted Reference Number: EMA/CHMP/113249/2022