Krystexxa

Medicinal product

(Invented) name

Krystexxa

Active substance (s)

Peglotikazė

Strength

8 mg/ml

Pharmaceutical form

koncentratas infuziniam tirpalui

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

M04AX02, Pegloticase

Marketing authorisation holder

Crealta Pharmaceuticals Ireland Limited, Airija

Date of authorisation

2013-01-08

Date of renewal

Documents

Search in EMA Europe

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Concentrate for solution for infusion	1 ml
Peglotikazė	8 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
55184	69217	1069217	flakonas	1 ml N1		Receptinis	EU/1/12/810/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
	Išregistruotas
2013-01-08	Registruotas