Trabectedin Accord

Medicinal product

(Invented) name

Trabectedin Accord

Active substance (s)

Trabektedinas

Strength

1 mg

Pharmaceutical form

milteliai infuzinio tirpalo koncentratui

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L01CX01, Trabectedin

Marketing authorisation holder

Accord Healthcare S.L.U., Ispanija

Date of authorisation

2025-04-25

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Flakone yra:	1 vnt.
Trabektedinas	1 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
117357	103460	1103460	flakonas	N1		Receptinis	EU/1/24/1902/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2025-04-25	Registruotas