Ronapreve

Medicinal product

(Invented) name

Ronapreve

Active substance (s)

Kasirivimabas+Imdevimabas

Strength

120 mg/ml + 120 mg/ml

Pharmaceutical form

injekcinis ar infuzinis tirpalas

Route (s) of administration

leisti į veną, leisti po oda

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

J06BD07, casirivimab and imdevimab

Marketing authorisation holder

Roche Registration GmbH, Vokietija

Date of authorisation

2021-11-12

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

Solution for injection or infusion	1 ml
Kasirivimabas	120 mg
Solution for injection or infusion	1 ml
Imdevimabas	120 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
107525	93630	1093630	flakonas	11,1 ml N1+N1 (daugiadozis)		Receptinis	EU/1/21/1601/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-11-12	Registruotas