Fiasp

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 Fiasp. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Fiasp.

For practical information about using Fiasp, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 27/04/2018

Authorisation details

Product details
Name
Fiasp
Agency product number
EMEA/H/C/004046
Active substance
insulin aspart
International non-proprietary name (INN) or common name
insulin aspart
Therapeutic area (MeSH)
Diabetes Mellitus
Anatomical therapeutic chemical (ATC) code
A10AB05
Additional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Publication details
Marketing-authorisation holder
Novo Nordisk A/S
Revision
1
Date of issue of marketing authorisation valid throughout the European Union
09/01/2017
Contact address
Novo Alle
2880 Bagsvaerd
Denmark

Product information

12/04/2018 Fiasp - EMEA/H/C/004046 - II/0003/G

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

  • Insulins and analogues for injection
  • fast acting

Therapeutic indication

Treatment of diabetes mellitus in adults.

Assessment history

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