Actrapid

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

EMA Page

Authorised Date: Oct 7, 2002
Approval ID: ac2eab9b596b86f5
Products: 1 listed
Opinion Adopted: N/A

Overview Summary

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

Therapeutic & Classification

Therapeutic Indication

### Therapeutic indication Treatment of diabetes mellitus.

Therapeutic Area (MeSH)

N/A

ATC Code

A10AB01

ATC Item

insulin (human)

Pharmacotherapeutic Group

Drugs used in diabetes

Active Substances

Active Substance (Summary)

human insulin

INN / Common Names

N/A

Active Substance Details

Substance	CAS	Monograph
human insulin	N/A	人胰岛素

Quick Info

Approval IDac2eab9b596b86f5

Product NumberN/A

StatusAuthorised

Authorised DateOct 7, 2002

Opinion AdoptedN/A

Revision #N/A

Names & Aliases

EMA Name

Actrapid

Medicine Name

Actrapid

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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