Tresiba

RSS

insulin degludec

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

Overview

This is a summary of the European public assessment report (EPAR) for Tresiba. 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 Tresiba.

This EPAR was last updated on 15/01/2021

Authorisation details

Product details
Name
Tresiba
Agency product number
EMEA/H/C/002498
Active substance
insulin degludec
International non-proprietary name (INN) or common name
insulin degludec
Therapeutic area (MeSH)
Diabetes Mellitus
Anatomical therapeutic chemical (ATC) code
A10AE06
Publication details
Marketing-authorisation holder
Novo Nordisk A/S
Revision
14
Date of issue of marketing authorisation valid throughout the European Union
20/01/2013
Contact address

Novo Allé
DK-2880 Bagsvaerd
Denmark

Product information

06/11/2020 Tresiba - EMEA/H/C/002498 - II/0047

Contents

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Pharmacotherapeutic group

Drugs used in diabetes

Therapeutic indication

Treatment of diabetes mellitus in adults.

Assessment history

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