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 20/07/2018

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
18
Date of issue of marketing authorisation valid throughout the European Union
07/10/2002
Contact address
Novo Allé
DK-2880 Bagsvaerd
Denmark

Product information

26/04/2018 Insulatard - EMEA/H/C/000441 - 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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