Artesunate Amivas

Medicinal product

(Invented) name

Artesunate Amivas

Active substance (s)

Artesunatas

Strength

110 mg

Pharmaceutical form

milteliai ir tirpiklis injekciniam tirpalui

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

P01BE03, Artesunate

Marketing authorisation holder

Amivas Ireland Limited, Airija

Date of authorisation

2021-11-22

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

Powder and solvent for solution for injection	1 vnt.
Artesunatas	110 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
107706	93811	1093811	flakonas	milteliai, tirpiklio flakonas (12 ml) N2		Receptinis	EU/1/21/1582/001	Netiekiama	-	-	No	-	-
107707	93812	1093812	flakonas	milteliai, tirpiklio flakonas (12 ml) N4		Receptinis	EU/1/21/1582/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-11-22	Registruotas