Mixtard
insulin human (rDNA)
Table of contents
Overview
This is a summary of the European public assessment report (EPAR). It explains how the Committee for Medicinal products for Human Use (CHMP) assessed the studies performed, to reach its recommendations on how to use the medicine.
If you need more information about your medical condition or your treatment, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more information on the basis of the CHMP recommendations, read the scientific discussion (also part of the EPAR).
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List item
Mixtard : EPAR - Summary for the public (PDF/81.06 KB)
First published: 04/02/2008
Last updated: 19/09/2014 -
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List item
Mixtard : EPAR - Risk-management-plan summary (PDF/52.24 KB)
First published: 20/03/2018
Last updated: 16/06/2020
Authorisation details
Product details | |
---|---|
Name |
Mixtard
|
Agency product number |
EMEA/H/C/000428
|
Active substance |
Insulin human
|
International non-proprietary name (INN) or common name |
insulin human (rDNA)
|
Therapeutic area (MeSH) |
Diabetes Mellitus
|
Anatomical therapeutic chemical (ATC) code |
A10AD01
|
Publication details | |
---|---|
Marketing-authorisation holder |
Novo Nordisk A/S
|
Revision |
19
|
Date of issue of marketing authorisation valid throughout the European Union |
07/10/2002
|
Contact address |
Novo Allé |
Product information
24/09/2020 Mixtard - EMEA/H/C/000428 - WS/1901
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
Treatment of diabetes mellitus.