Inpremzia

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Withdrawn

This medicine's authorisation has been withdrawn

insulin human (rDNA)
MedicineHumanWithdrawn

Romanian is available via eTranslation, the European Commission's machine translation service.

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The European Public Assessment Report (EPAR) for Inpremzia is updated to indicate that the marketing authorisation is no longer valid.

Inpremzia : EPAR - Medicine overview

Reference Number: EMEA/H/C/005331

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Malti (MT) (755.61 KB - PDF)

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slovenščina (SL) (747.71 KB - PDF)

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suomi (FI) (694.89 KB - PDF)

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svenska (SV) (695.38 KB - PDF)

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Inpremzia : EPAR - Risk management plan summary

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Product information

Inpremzia : EPAR - Product Information

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čeština (CS) (1.54 MB - PDF)

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eesti (ET) (1.01 MB - PDF)

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ελληνικά (EL) (1.85 MB - PDF)

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magyar (HU) (1.58 MB - PDF)

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Malti (MT) (1.61 MB - PDF)

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Nederlands (NL) (1.05 MB - PDF)

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slovenčina (SK) (1.56 MB - PDF)

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slovenščina (SL) (1.56 MB - PDF)

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suomi (FI) (1.02 MB - PDF)

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04/04/2023
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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).

Inpremzia : EPAR - All Authorised Presentations

English (EN) (616.14 KB - PDF)

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български (BG) (641.03 KB - PDF)

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español (ES) (611.68 KB - PDF)

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čeština (CS) (630.55 KB - PDF)

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dansk (DA) (617.03 KB - PDF)

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Deutsch (DE) (613.74 KB - PDF)

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eesti (ET) (609.79 KB - PDF)

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ελληνικά (EL) (639.06 KB - PDF)

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français (FR) (615.53 KB - PDF)

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hrvatski (HR) (612.8 KB - PDF)

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italiano (IT) (610.05 KB - PDF)

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latviešu (LV) (632.83 KB - PDF)

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lietuvių (LT) (614.3 KB - PDF)

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magyar (HU) (628.54 KB - PDF)

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Malti (MT) (632.3 KB - PDF)

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slovenčina (SK) (634.14 KB - PDF)

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slovenščina (SL) (628.79 KB - PDF)

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suomi (FI) (608.23 KB - PDF)

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svenska (SV) (611.32 KB - PDF)

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Íslenska (IS) (613.28 KB - PDF)

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norsk (NO) (613.53 KB - PDF)

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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

Inpremzia : EPAR - Public Assessment Report

Reference Number: EMA/127616/2022

English (EN) (2.32 MB - PDF)

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CHMP summary of positive opinion for Inpremzia

Adopted Reference Number: EMA/CHMP/113249/2022

English (EN) (702.86 KB - PDF)

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