OPDIVO

Medicinal product

(Invented) name

OPDIVO

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)

No

ATC code (s)

L01FF01, Nivolumab

Marketing authorisation holder

Bristol-Myers Squibb Pharma EEIG, Airija

Date of authorisation

2015-06-19

Date of renewal

Documents

Opdivo 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

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
62941	77355	1077355	flakonas	4 ml N1		Receptinis	EU/1/15/1014/001	Netiekiama	2024-12-20	2025-12-31	Yes	2025-01-01	2025-12-31
62942	77356	1077356	flakonas	10 ml N1		Receptinis	EU/1/15/1014/002	Netiekiama	2024-12-20	2025-12-31	Yes	2025-01-01	2025-12-31
99847	85955	1085955	flakonas	24 ml N1		Receptinis	EU/1/15/1014/003	Tiekiama	2025-09-05	-	No	-	-
113265	99384	1099384	flakonas	12 ml N1		Receptinis	EU/1/15/1014/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2015-06-19	Registruotas