Numient

Medicinal product

(Invented) name

Numient

Active substance (s)

Levodopa/Karbidopa

Strength

195 mg/48,75 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	195 mg
Karbidopa	48,75 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
64620	79104	1079104	buteliukas	N25		Receptinis	EU/1/15/1044/007	Netiekiama	-	-	No	-	-
64621	79105	1079105	buteliukas	N100		Receptinis	EU/1/15/1044/008	Netiekiama	-	-	No	-	-
64622	79106	1079106	buteliukas	N240		Receptinis	EU/1/15/1044/009	Netiekiama	-	-	No	-	-

Stadijos

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