Inpremzia
insulin human (rDNA)
Table of contents
Overview
The marketing authorisation for Inpremzia has been withdrawn at the request of the marketing-authorisation holder.
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Inpremzia : EPAR - Medicine overview (PDF/706.34 KB)
First published: 30/06/2022
Last updated: 20/04/2023
EMEA/H/C/005331 -
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Inpremzia : EPAR - Risk management plan summary (PDF/718.91 KB)
First published: 30/06/2022
Last updated: 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 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. |
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. |
| 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. |
Product information
04/04/2023 Inpremzia - EMEA/H/C/005331 -
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).
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.