Voxzogo

Medicinal product

(Invented) name

Voxzogo

Active substance (s)

Vosoritidas

Strength

0,4 mg

Pharmaceutical form

milteliai ir tirpiklis injekciniam tirpalui

Route (s) of administration

leisti po oda

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

M05BX07, vosoritide

Marketing authorisation holder

BioMarin International Limited, Airija

Date of authorisation

2021-08-26

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

Powder and solvent for solution for injection	0.5 ml
Vosoritidas	0,4 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
107177	93281	1093281	flakonas	milteliai (0,4 mg); tirpiklio švirkštas (0,5 ml); adata; švirkštas N10		Receptinis	EU/1/21/1577/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-08-26	Registruotas