Orfadin

Medicinal product

(Invented) name

Orfadin

Active substance (s)

Nitizinonas

Strength

4 mg/ml

Pharmaceutical form

geriamasis tirpalas

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

Swedish Orphan Biovitrum International AB, Švedija

Date of authorisation

2005-02-21

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Oral suspension	1 ml
Nitizinonas	4 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
63793	78237	1078237	buteliukas	90 ml N1		Receptinis	EU/1/04/303/005	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2005-02-21	Registruotas