CARVYKTI

Medicinal product

(Invented) name

CARVYKTI

Active substance (s)

Ciltakabtagenas autoleucelas

Strength

3,2×10(×6) – 1,0×10(×8)

Pharmaceutical form

infuzinė dispersija

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L01XL05, ciltacabtagene autoleucel

Marketing authorisation holder

Janssen-Cilag International N.V., Belgija

Date of authorisation

2022-05-25

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	100 ml
Ciltakabtagenas autoleucelas	3,2×10(×6) – 1,0×10(×8)

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
108839	94945	1094945	maišelis	30 ml ar 70 ml N1		Receptinis	EU/1/22/1648/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-05-25	Registruotas