Actraphane

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 Actraphane. 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 Actraphane.

This EPAR was last updated on 08/06/2018

Authorisation details

Product details
Name
Actraphane
Agency product number
EMEA/H/C/000427
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 Actraphane - EMEA/H/C/000427 - 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

How useful was this page?

Add your rating