Upstaza

Medicinal product

(Invented) name

Upstaza

Active substance (s)

Eladokagenas eksuparvovekas

Strength

2,8 × 10(×11) vg/0,5 ml

Pharmaceutical form

infuzinis tirpalas

Route (s) of administration

leisti į smegenų kiautą

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

A16AB26, eladocagene exuparvovec

Marketing authorisation holder

PTC Therapeutics International Limited, Airija

Date of authorisation

2022-07-18

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	0.5 ml
Eladokagenas eksuparvovekas	2,8 × 10(×11) vg/0,5 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
109018	95124	1095124	flakonas	N1		Receptinis	EU/1/22/1653/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-07-18	Registruotas