Kadcyla

Medicinal product

(Invented) name

Kadcyla

Active substance (s)

Trastuzumabas emtansinas

Strength

160 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)

L01FD03, trastuzumab emtansine

Marketing authorisation holder

Roche Registration GmbH, Vokietija

Date of authorisation

2013-11-15

Date of renewal

Documents

Kadcyla mokomoji medziaga sveikatos prieziuros specialistams.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

Powder for concentrate for solution for infusion	1 vnt.
Trastuzumabas emtansinas	160 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
58001	72124	1072124	flakonas	N1		Receptinis	EU/1/13/885/002	Tiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2013-11-15	Registruotas