Levodopa/Carbidopa/Entacapone Orion

Orion Corporation,Orionintie 1,FI-02200 Espoo,Finland🇪🇺 European Union

EMA Page

Authorised Date: Aug 23, 2011
Approval ID: e4eb5c09898c7c82
Products: 1 listed
Opinion Adopted: N/A

Overview Summary

This is a summary of the European public assessment report (EPAR) for Levodopa/Carbidopa/Entacapone Orion. 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 Levodopa/Carbidopa/Entacapone Orion.

Therapeutic & Classification

Therapeutic Indication

### Therapeutic indication Levodopa/Carbidopa/Entacapone Orion is indicated for the treatment of adult patients with Parkinson's disease and end-of-dose motor fluctuations not stabilised on levodopa / dopa-decarboxylase (DDC)-inhibitor treatment.

Therapeutic Area (MeSH)

N/A

ATC Code

N04BA03

ATC Item

levodopa, decarboxylase inhibitor and COMT inhibitor

Pharmacotherapeutic Group

Nervous system

Active Substances

Active Substance (Summary)

N/A

INN / Common Names

N/A

Active Substance Details

Substance	CAS	Monograph
levodopa	N/A	左旋多巴
carbidopa	N/A	卡比多巴
entacapone	N/A	恩他卡朋

Quick Info

Approval IDe4eb5c09898c7c82

Product NumberN/A

StatusAuthorised

Authorised DateAug 23, 2011

Opinion AdoptedN/A

Revision #N/A

Names & Aliases

EMA Name

Levodopa/Carbidopa/Entacapone Orion

Medicine Name

Levodopa/Carbidopa/Entacapone Orion

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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