OPDIVO

Medicinal product

(Invented) name

OPDIVO

Active substance (s)

Nivolumabas

Strength

300 mg

Pharmaceutical form

injekcinis tirpalas

Route (s) of administration

leisti po oda

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L01FF01, Nivolumab

Marketing authorisation holder

Bristol-Myers Squibb/Pfizer EEIG, Airija

Date of authorisation

2015-06-19

Date of renewal

Documents

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

Flakone (2,5 ml injekcinio tirpalo) yra	2.5 ml
Nivolumabas	300 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
120586	106690	1106690	flakonas	2,5 ml N1		Receptinis	EU/1/15/1014/006	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2015-06-19	Registruotas