Mixtard

RSS

insulin human (rDNA)

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

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).

This EPAR was last updated on 11/06/2018

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
17
Date of issue of marketing authorisation valid throughout the European Union
06/10/2002
Contact address
Novo Allé
DK-2880 Bagsvaerd
Denmark

Product information

25/04/2018 Mixtard - EMEA/H/C/000428 - WS/1375

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

Drugs used in diabetes

Therapeutic indication

Treatment of diabetes mellitus.

Assessment history

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