Keytruda

Medicinal product

(Invented) name

Keytruda

Active substance (s)

Pembrolizumabas

Strength

50 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)

L01FF02, Pembrolizumab

Marketing authorisation holder

Merck Sharp & Dohme B.V., Nyderlandai

Date of authorisation

2015-07-17

Date of renewal

Documents

Keytruda mokomoji medziaga pacientams.pdf

Keytruda paciento kortele.pdf

Search in EMA Europe

Stage

Išregistruotas

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.
Pembrolizumabas	50 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
63172	77587	1077587	flakonas	N1		Receptinis	EU/1/15/1024/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
	Išregistruotas
2015-07-17	Registruotas