Oxlumo

Medicinal product

(Invented) name

Oxlumo

Active substance (s)

Lumasiranas

Strength

94,5 mg/0,5 ml

Pharmaceutical form

injekcinis tirpalas

Route (s) of administration

leisti po oda

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

A16AX18, lumasiran

Marketing authorisation holder

Alnylam Netherlands B.V., Nyderlandai

Date of authorisation

2020-11-19

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	0.5 ml
Lumasiranas	94,5 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
105303	91405	1091405	flakonas	0,5 ml N1		Receptinis	EU/1/20/1496/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2020-11-19	Registruotas