NovoEight

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

EMA Page

Authorised Date: Nov 13, 2013
Approval ID: 16b530c3ad47ada4
Products: 1 listed
Opinion Adopted: N/A

Overview Summary

NovoEight is a medicine used to treat and prevent bleeding in patients with haemophilia A an inherited bleeding disorder caused by lack of factor VIII. The medicine contains the active substance turoctocog alfa

Therapeutic & Classification

Therapeutic Indication

### Therapeutic indication Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency). Novoeight can be used for all age groups.

Therapeutic Area (MeSH)

N/A

ATC Code

B02BD02

ATC Item

coagulation factor VIII

Pharmacotherapeutic Group

coagulation factor VIII

Active Substances

Active Substance (Summary)

turoctocog alfa

INN / Common Names

N/A

Active Substance Details

Substance	CAS	Monograph
turoctocog alfa	N/A	Turoctocog alfa

Quick Info

Approval ID16b530c3ad47ada4

Product NumberN/A

StatusAuthorised

Authorised DateNov 13, 2013

Opinion AdoptedN/A

Revision #N/A

Names & Aliases

EMA Name

NovoEight

Medicine Name

NovoEight

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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