Insulatard: Opinion on medicine for use outside EU
insulin human
Table of contents
Opinion on medicine for use outside the European Union
Positive opinion
Overview
Insulatard is a medicine for treating diabetes. It contains human insulin as its active substance.
This overview is for Insulatard intended for use outside the EU. An identical product with the same name is authorised in the European Union. For Insulatard intended for use outside EU there is an additional storage option requiring less refrigeration.
Opinion details
Product details | |
---|---|
Name of medicinal product |
Insulatard
|
Agency opinion number |
H-W-005780
|
Opinion status |
Positive opinion
|
Active substance |
Insulin human (RDNA)
|
International non-proprietary name (INN) or common name |
insulin human
|
Therapeutic area (MeSH) |
Diabetes Mellitus
|
Anatomical therapeutic chemical (ATC) code |
A10AC01
|
Publication details | |
---|---|
Opinion holder |
Novo Nordisk A/S
|
Date of opinion |
22/04/2022
|
Product information
Insulatard
Contents
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturer responsible for batch release
- Annex IIB - Recommendations to the opinion holder - conditions of use
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
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Pharmacotherapeutic group
Pharmacotherapeutic group
Drugs used in diabetes
Therapeutic indication
Therapeutic indication
Treatment of diabetes mellitus
Assessment history
-
List item
Insulatard : Public assessment report (PDF/689.63 KB)
Adopted
First published: 28/07/2022
EMA/255082/2022 -
List item
Insulatard : All presentations (PDF/60 KB)
First published: 28/07/2022 -
List item
CHMP summary of positive opinion for Insulatard (PDF/128.42 KB)
Adopted
First published: 22/04/2022
EMA/CHMP/223184/2022