Inpremzia

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insulin human (rDNA)

Authorised
This medicine is authorised for use in the European Union.

Overview

Inpremzia is a medicine used to treat people with diabetes who need insulin to keep their blood glucose (sugar) level controlled. It contains the active substance insulin human.

Inpremzia is a ‘biosimilar medicine’. This means that Inpremzia is highly similar to another biological medicine (the ‘reference medicine’) that is already authorised in the EU. The reference medicine for Inpremzia is Actrapid. For more information on biosimilar medicines, see here.

This EPAR was last updated on 23/02/2022

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

Inpremzia - EMEA/H/C/005331 -

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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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