Numient

Medicinal product

(Invented) name

Numient

Active substance (s)

Levodopa/Karbidopa

Strength

95 mg/23,75 mg

Pharmaceutical form

modifikuoto atpalaidavimo kietosios kapsulės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

N04BA02, Levodopa and decarboxylase inhibitor

Marketing authorisation holder

Amneal Pharma Europe Ltd., Airija

Date of authorisation

2015-11-19

Date of renewal

Documents

Search in EMA Europe

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Modified-release hard capsules	1 vnt.
Levodopa	95 mg
Karbidopa	23,75 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
64614	79098	1079098	buteliukas	N25		Receptinis	EU/1/15/1044/001	Netiekiama	-	-	No	-	-
64615	79099	1079099	buteliukas	N100		Receptinis	EU/1/15/1044/002	Netiekiama	-	-	No	-	-
64616	79100	1079100	buteliukas	N240		Receptinis	EU/1/15/1044/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2019-04-04	Išregistruotas
2015-11-19	Registruotas