Tecartus

Medicinal product

(Invented) name

Tecartus

Active substance (s)

Breksukabtagenas autoleucelas (CAR+ gyvybingos T ląstelės)

Strength

0,4–2×10(8) 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)

L01XL06, brexucabtagene autoleucel

Marketing authorisation holder

Kite Pharma EU B.V., Nyderlandai

Date of authorisation

2020-12-14

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	68 ml
Breksukabtagenas autoleucelas (CAR+ gyvybingos T ląstelės)	0,4–2×10(8) 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
105597	91697	1091697	maišelis	68 ml N1		Receptinis	EU/1/20/1492/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2020-12-14	Registruotas