Regkirona

Medicinal product

(Invented) name

Regkirona

Active substance (s)

Regdanvimabas

Strength

60 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)

J06BD06, regdanvimab

Marketing authorisation holder

Celltrion Healthcare Hungary Kft., Vengrija

Date of authorisation

2021-11-12

Date of renewal

Documents

Search in EMA Europe

Stage

Išregistruotas

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
Regdanvimabas	60 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
107523	93628	1093628	flakonas	16 ml N1		Receptinis	EU/1/21/1597/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2025-04-14	Išregistruotas
2021-11-12	Registruotas