TECVAYLI

Medicinal product

(Invented) name

TECVAYLI

Active substance (s)

Teklistamabas

Strength

10 mg/ml

Pharmaceutical form

injekcinis tirpalas

Route (s) of administration

leisti po oda

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L01FX24, teclistamab

Marketing authorisation holder

Janssen-Cilag International N.V., Belgija

Date of authorisation

2022-08-23

Date of renewal

Documents

Tecvayli paciento kortele.pdf

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

Solution for injection	1 ml
Teklistamabas	10 mg

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
109304	95410	1095410	flakonas	3 ml N1		Receptinis	EU/1/22/1675/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-08-23	Registruotas