Nivolumab BMS

Medicinal product

(Invented) name

Nivolumab BMS

Active substance (s)

Nivolumabas

Strength

10 mg/ml

Pharmaceutical form

koncentratas infuziniam tirpalui

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

ATC code (s)

L01FF01, Nivolumab

Marketing authorisation holder

Bristol-Myers Squibb/Pfizer EEIG, Jungtinė Karalystė

Date of authorisation

2015-07-20

Date of renewal

Documents

Stage

Išregistruotas

Controlled?

Controlled substance type

Legal basis

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Concentrate for solution for infusion	1 ml
Nivolumabas	10 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
63175	77590	1077590	flakonas	N1 (40 mg/4 ml)		Receptinis	EU/1/15/1026/001	Netiekiama	-	-	No	-	-
63176	77591	1077591	flakonas	N1 (100 mg/10 ml)		Receptinis	EU/1/15/1026/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
	Išregistruotas
2015-07-20	Registruotas