Keytruda

Medicinal product

(Invented) name

Keytruda

Active substance (s)

Pembrolizumabas

Strength

25 mg/ml

Pharmaceutical form

koncentratas infuziniam tirpalui

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 paciento kortele.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

1 ml koncentrato yra	1 ml
Pembrolizumabas	25 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
66666	81202	1081202	flakonas	4 ml N1		Receptinis	EU/1/15/1024/002	Tiekiama	-	-	No	-	-
116523	102622	1102622	flakonas	4 ml N2		Receptinis	EU/1/15/1024/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2015-07-17	Registruotas