Inbrija

Medicinal product

(Invented) name

Inbrija

Active substance (s)

Levodopa

Strength

33 mg

Pharmaceutical form

įkvepiamieji milteliai (kietosios kapsulės)

Route (s) of administration

įkvėpti

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

N04BA01, Levodopa

Marketing authorisation holder

Acorda Therapeutics Ireland Limited, Airija

Date of authorisation

2019-09-19

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Inhalation powder, hard capsules	1 vnt.
Levodopa	33 mg

Packages

PAKID	NPAKID	NPAKID-7	Pack type	Pack size	Type of packaging	Proposed dispensing/classification	Marketing authorisation no.	Supply status	From	To	Package is in foreign language	From	To	Mock-up
102411	88511	1088511	dalomoji lizdinė plokštelė	N60×1 ir inhaliatorius		Receptinis	EU/1/19/1390/001	Netiekiama	-	-	No	-	-
102412	88512	1088512	dalomoji lizdinė plokštelė	N92×1 ir inhaliatorius		Receptinis	EU/1/19/1390/002	Netiekiama	-	-	No	-	-
110974	97085	1097085	dalomoji lizdinė plokštelė	N16×1 ir inhaliatorius		Receptinis	EU/1/19/1390/003	Netiekiama	-	-	No	-	-
110975	97086	1097086	dalomoji lizdinė plokštelė	N32×1 ir inhaliatorius		Receptinis	EU/1/19/1390/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2019-09-19	Registruotas