Inpremzia
Withdrawn
This medicine's authorisation has been withdrawn
insulin human (rDNA)
MedicineHumanWithdrawn
- Application under evaluation
- CHMP opinion
- European Commission decision
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The European Public Assessment Report (EPAR) for Inpremzia is updated to indicate that the marketing authorisation is no longer valid.
Product information
04/04/2023
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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 diabetesTherapeutic indication
Inpremzia is indicated for the treatment of diabetes mellitus.
News on Inpremzia
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