Insulatard

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) for Insulatard. 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 Insulatard.

This EPAR was last updated on 23/11/2020

Authorisation details

Product details
Name
Insulatard
Agency product number
EMEA/H/C/000441
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
A10AC01
Publication details
Marketing-authorisation holder
Novo Nordisk A/S
Revision
20
Date of issue of marketing authorisation valid throughout the European Union
07/10/2002
Contact address

Novo Allé
DK-2880 Bagsvaerd
Denmark

Product information

24/09/2020 Insulatard - EMEA/H/C/000441 - WS/1901

Other EU languages available icon 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.

Assessment history

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