Aucatzyl

Medicinal product

(Invented) name

Aucatzyl

Active substance (s)

Obekabtagenas autoleucelas

Strength

410 × 10(×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)

L01XL12, obecabtagene autoleucel

Marketing authorisation holder

Autolus GmbH, Vokietija

Date of authorisation

2025-07-17

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

Konkrečiam pacientui skirtame maišelyje yra	1 vnt.
Obekabtagenas autoleucelas	410 × 10(×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
118153	104261	1104261	maišelis	10 ml; 10-20 ml; 30-70 ml N3 (arba daugiau)		Receptinis	EU/1/25/1951/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2025-07-17	Registruotas