Enhertu

Medicinal product

(Invented) name

Enhertu

Active substance (s)

Trastuzumabas derukstekanas

Strength

100 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)

L01FD04, trastuzumab deruxtecan

Marketing authorisation holder

Daiichi Sankyo Europe GmbH, Vokietija

Date of authorisation

2021-01-18

Date of renewal

Documents

Enhertu paciento kortele.pdf

Enhertu mokomoji medziaga sveikatos prieziuros specialistams.pdf

Enhertu mokomoji medziaga sveikatos prieziuros specialistams 2.pdf

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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 ml
Trastuzumabas derukstekanas	100 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
105664	91764	1091764	flakonas	N1		Receptinis	EU/1/20/1508/001	Tiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-01-18	Registruotas