Ebvallo

Medicinal product

(Invented) name

Ebvallo

Active substance (s)

Tabelekleucelas

Strength

2,8×10(×7)–7,3×10(×7) ląst./ml

Pharmaceutical form

injekcinė dispersija

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L01XL09, tabelecleucel

Marketing authorisation holder

Pierre Fabre Medicament, Prancūzija

Date of authorisation

2022-12-16

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

Dispersion for injection	1 ml
Tabelekleucelas	2,8×10(×7)–7,3×10(×7) ląst./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
110017	96126	1096126	flakonas	1 ml N1 - N6		Receptinis	EU/1/22/1700/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-12-16	Registruotas