Kymriah

Medicinal product

(Invented) name

Kymriah

Active substance (s)

Tisagenlekleucelas

Strength

1,2 × 10(×6) – 6 × 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)

L01XL04, tisagenlecleucel

Marketing authorisation holder

Novartis Europharm Ltd., Airija

Date of authorisation

2018-08-23

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 vnt.
Tisagenlekleucelas	1,2 × 10(×6) – 6 × 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
100101	86209	1086209	maišelis	10-50 ml N1 arba daugiau		Receptinis	EU/1/18/1297/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2018-08-23	Registruotas