ZYNYZ

Medicinal product

(Invented) name

ZYNYZ

Active substance (s)

Retifanlimabas

Strength

500 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)

L01FF10, retifanlimab

Marketing authorisation holder

Incyte Biosciences Distribution B.V., Nyderlandai

Date of authorisation

2024-04-19

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

Viename koncentrato flakone (20 ml) yra	20 ml
Retifanlimabas	500 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
113526	99644	1099644	flakonas	20 ml N1		Receptinis	EU/1/24/1800/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-04-19	Registruotas