Abecma

Medicinal product

(Invented) name

Abecma

Active substance (s)

Idekabtagenas vikleucelas

Strength

260–500x10(6) ląst.

Pharmaceutical form

infuzinė dispersija

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L01XL07, idecabtagene vicleucel

Marketing authorisation holder

Bristol-Myers Squibb Pharma EEIG, Airija

Date of authorisation

2021-08-18

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

Dispersion for infusion	1 ml
Idekabtagenas vikleucelas	260–500x10(6) ląst.

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
107135	93238	1093238	maišelis	10-30 ml, 30-70 ml, 55-100 ml N1		Receptinis	EU/1/21/1539/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-08-18	Registruotas