HETRONIFLY

Medicinal product

(Invented) name

HETRONIFLY

Active substance (s)

Serplulimabas

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)

L01FF12, serplulimab

Marketing authorisation holder

Accord Healthcare S.L.U., Ispanija

Date of authorisation

2025-02-03

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

1 koncentrato ml yra:	10 ml
Serplulimabas	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
116526	102625	1102625	flakonas	10 ml N1		Receptinis	EU/1/24/1870/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2025-02-03	Registruotas