Leqvio

Medicinal product

(Invented) name

Leqvio

Active substance (s)

Inklisiranas

Strength

284 mg

Pharmaceutical form

injekcinis tirpalas užpildytame švirkšte

Route (s) of administration

leisti po oda

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

C10AX16, inclisiran

Marketing authorisation holder

Novartis Europharm Ltd., Airija

Date of authorisation

2020-12-09

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 in pre-filled syringe	1.5 ml
Inklisiranas	284 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
105428	91528	1091528	užpildytas švirkštas	1,5 ml N1		Receptinis	EU/1/20/1494/001	Netiekiama	-	-	No	-	-
111561	97674	1097674	užpildytas švirkštas	1,5 ml N1 (su adatos apsauga)		Receptinis	EU/1/20/1494/002	Tiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2020-12-09	Registruotas