Insulatard: Opinion on medicine for use outside EU

insulin human

Opinion on medicine for use outside the European Union
Positive opinion


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
Agency opinion number
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
Publication details
Opinion holder

Novo Nordisk A/S
Novo Alle 1 2880


Date of opinion

Product information



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Pharmacotherapeutic group

Drugs used in diabetes

Therapeutic indication

Treatment of diabetes mellitus

Assessment history

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