Inbrija
levodopa
Table of contents
Overview
Inbrija is a medicine used to treat adults with Parkinson’s disease (a progressive brain disease that causes shaking and muscle stiffness and slows movement).
Inbrija is used to treat symptoms during ‘off’ periods (times when the patient has more difficulty moving about) that occur while the patient is taking their usual treatment of a combination of levodopa and an inhibitor of dopa-decarboxylase.
Inbrija contains the active substance levodopa.
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Inbrija : EPAR - Medicine overview (PDF/105.5 KB)
First published: 30/09/2019
EMA/452546/2019 -
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Inbrija : EPAR - Risk-management-plan summary (PDF/103.4 KB)
First published: 30/09/2019
Authorisation details
Product details | |
---|---|
Name |
Inbrija
|
Agency product number |
EMEA/H/C/004786
|
Active substance |
levodopa
|
International non-proprietary name (INN) or common name |
levodopa
|
Therapeutic area (MeSH) |
Parkinson Disease
|
Anatomical therapeutic chemical (ATC) code |
N04BA01
|
Publication details | |
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Marketing-authorisation holder |
Acorda Therapeutics Ireland Limited
|
Revision |
1
|
Date of issue of marketing authorisation valid throughout the European Union |
19/09/2019
|
Contact address |
Product information
24/09/2020 Inbrija - EMEA/H/C/004786 - PSUSA/00107800/201912
Contents
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
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Pharmacotherapeutic group
Anti-Parkinson drugs
Therapeutic indication
Inbrija is indicated for the intermittent treatment of episodic motor fluctuations (OFF episodes) in adult patients with Parkinson’s disease (PD) treated with a levodopa/dopa-decarboxylase inhibitor.