Tepkinly

Medicinal product

(Invented) name

Tepkinly

Active substance (s)

Epkoritamabas

Strength

48 mg

Pharmaceutical form

injekcinis tirpalas

Route (s) of administration

leisti po oda

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L01FX27, epcoritamab

Marketing authorisation holder

AbbVie Deutschland GmbH & Co. KG , Vokietija

Date of authorisation

2023-09-22

Date of renewal

Documents

Tepkinly 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	0.8 ml
Epkoritamabas	48 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
111722	97836	1097836	flakonas	N1		Receptinis	EU/1/23/1759/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2023-09-22	Registruotas