NovoMix

RSS

insulin aspart

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

Overview

This is a summary of the European Public Assessment Report (EPAR) for NovoMix. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for NovoMix. For more information about treatment with NovoMix, read the Package Leaflet (also part of the EPAR) or contact your doctor or pharmacist.

This EPAR was last updated on 13/06/2018

Authorisation details

Product details
Name
NovoMix
Agency product number
EMEA/H/C/000308
Active substance
insulin aspart
International non-proprietary name (INN) or common name
insulin aspart
Therapeutic area (MeSH)
Diabetes Mellitus
Anatomical therapeutic chemical (ATC) code
A10AD05
Publication details
Marketing-authorisation holder
Novo Nordisk A/S
Revision
26
Date of issue of marketing authorisation valid throughout the European Union
31/07/2000
Contact address
Novo Allé
DK-2880 Bagsværd
Denmark

Product information

11/04/2018 NovoMix - EMEA/H/C/000308 - IB/0093

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

How useful was this page?

Add your rating