Nitisinone MDK

Medicinal product

(Invented) name

Nitisinone MDK

Active substance (s)

Nitizinonas

Strength

20 mg

Pharmaceutical form

kietosios kapsulės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

A16AX04, Nitisinone

Marketing authorisation holder

MendeliKABS Europe Limited, Airija

Date of authorisation

2017-08-24

Date of renewal

Documents

Search in EMA Europe

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Hard capsule	1 vnt.
Nitizinonas	20 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
107821	93926	1093926	buteliukas	N60		Receptinis	EU/1/17/1217/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2023-03-01	Išregistruotas
2017-08-24	Registruotas