Protaphane

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

EMA Page

Authorised Date: Oct 7, 2002
Approval ID: b52f9195cbbd44b3
Products: 1 listed
Opinion Adopted: N/A

Overview Summary

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.

Therapeutic & Classification

Therapeutic Indication

### Therapeutic indication Treatment of diabetes mellitus.

Therapeutic Area (MeSH)

N/A

ATC Code

A10AC01

ATC Item

insulin (human)

Pharmacotherapeutic Group

Drugs used in diabetes

Active Substances

Active Substance (Summary)

Insulin human

INN / Common Names

N/A

Active Substance Details

Substance	CAS	Monograph
Insulin human	N/A	人胰岛素

Quick Info

Approval IDb52f9195cbbd44b3

Product NumberN/A

StatusAuthorised

Authorised DateOct 7, 2002

Opinion AdoptedN/A

Revision #N/A

Names & Aliases

EMA Name

Protaphane

Medicine Name

Protaphane

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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