ROCTAVIAN

Medicinal product

(Invented) name

ROCTAVIAN

Active substance (s)

Valoktokogenas roksaparvovekas

Strength

2×10(13) vektoriaus genomų/ml

Pharmaceutical form

infuzinis tirpalas

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

B02BD15, valoctocogene roxaparvovec

Marketing authorisation holder

BioMarin International Limited, Airija

Date of authorisation

2022-08-24

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

Solution for infusion	1 ml
Valoktokogenas roksaparvovekas	2×10(13) vektoriaus genomų/ml

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
109305	95411	1095411	flakonas	8 ml N1		Receptinis	EU/1/22/1668/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-08-24	Registruotas