Inpremzia

RSS

insulin human (rDNA)

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for Inpremzia has been withdrawn at the request of the marketing-authorisation holder.

This EPAR was last updated on 20/04/2023

Authorisation details

Product details
Name
Inpremzia
Agency product number
EMEA/H/C/005331
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
Additional monitoringAdditional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

BiosimilarBiosimilar

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.

Publication details
Marketing-authorisation holder
Baxter Holding B.V.
Date of issue of marketing authorisation valid throughout the European Union
25/04/2022
Contact address

Baxter Holding B.V.
Kobaltweg 49
3542 CE
Utrecht
Netherlands

Product information

04/04/2023 Inpremzia - EMEA/H/C/005331 -

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Select ‘available languages’ to access the language you need.

 

Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Drugs used in diabetes

Therapeutic indication

Inpremzia is indicated for the treatment of diabetes mellitus.

Assessment history

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