Opdualag

Medicinal product

(Invented) name

Opdualag

Active substance (s)

Nivolumabas/Relatlimabas

Strength

240 mg/80 mg

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)

L01FY02, nivolumab and relatlimab

Marketing authorisation holder

Bristol-Myers Squibb Pharma EEIG, Airija

Date of authorisation

2022-09-15

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

Concentrate for solution for infusion	1 ml
Nivolumabas	240 mg
Relatlimabas	80 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
109440	95546	1095546	flakonas	20 ml N1		Receptinis	EU/1/22/1679/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-09-15	Registruotas