Nitisinone MDK

Medicinal product

(Invented) name

Nitisinone MDK

Active substance (s)

Nitizinonas

Strength

2 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	2 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
97705	83800	1083800	buteliukas	N60		Receptinis	EU/1/17/1217/001	Netiekiama	-	-	No	-	-

Stadijos

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