Trodelvy

Medicinal product

(Invented) name

Trodelvy

Active substance (s)

Sacituzumabas govitekanas

Strength

200 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)

L01FX17, Sacituzumab govitecan

Marketing authorisation holder

Gilead Sciences Ireland UC, Airija

Date of authorisation

2021-11-22

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

Powder for concentrate for solution for infusion	1 vnt.
Sacituzumabas govitekanas	200 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
107587	93692	1093692	flakonas	N1		Receptinis	EU/1/21/1592/001	Tiekiama	2025-08-18	-	Yes	2025-07-18	2025-08-31

Stadijos

Data	Stadija
2021-11-22	Registruotas