Tresiba

Novo Nordisk A/S,Novo Allé,DK-2880 Bagsvaerd,Denmark🇪🇺 European Union

EMA Page

Authorised Date: Jan 20, 2013
Approval ID: a24e309c2f4a22c2
Products: 1 listed
Opinion Adopted: N/A

Overview Summary

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.

Therapeutic & Classification

Therapeutic Indication

### Therapeutic indication Treatment of diabetes mellitus in adults.

Therapeutic Area (MeSH)

N/A

ATC Code

A10AE06

ATC Item

insulin degludec

Pharmacotherapeutic Group

Drugs used in diabetes

Active Substances

Active Substance (Summary)

insulin degludec

INN / Common Names

N/A

Active Substance Details

Substance	CAS	Monograph
insulin degludec	N/A	德谷胰岛素

Quick Info

Approval IDa24e309c2f4a22c2

Product NumberN/A

StatusAuthorised

Authorised DateJan 20, 2013

Opinion AdoptedN/A

Revision #N/A

Names & Aliases

EMA Name

Tresiba

Medicine Name

Tresiba

Aliases

N/A

Regulatory Flags

Orphan medicineUnknown

Generic medicineUnknown

BiosimilarUnknown

Conditional approvalUnknown

Exceptional circumstancesUnknown

Accelerated assessmentUnknown

Additional monitoringUnknown

Advanced therapyUnknown

Source Links

EMA Source

No risk management plan link.

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