Nityr

Medicinal product

(Invented) name

Nityr

Active substance (s)

Nitizinonas

Strength

10 mg

Pharmaceutical form

tabletės

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

Cycle Pharmaceuticals (Europe) Ltd., Airija

Date of authorisation

2018-07-26

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

Tablet	1 vnt.
Nitizinonas	10 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
99858	85966	1085966	buteliukas	N60		Receptinis	EU/1/18/1290/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-06-06	Išregistruotas
2018-07-26	Registruotas