Protaphane
insulin human (rDNA)
Table of contents
Overview
This is a summary of the European public assessment report (EPAR) for Protaphane. 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 Protaphane.
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Protaphane : EPAR - Summary for the public (PDF/76.37 KB)
First published: 24/01/2008
Last updated: 23/09/2014 -
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Protaphane : EPAR - Risk-management-plan summary (PDF/51.81 KB)
First published: 20/03/2018
Last updated: 16/06/2020
Authorisation details
Product details | |
---|---|
Name |
Protaphane
|
Agency product number |
EMEA/H/C/000442
|
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 Bagsværd Denmark |
Product information
24/09/2020 Protaphane - EMEA/H/C/000442 - WS/1901
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.