Givlaari

Medicinal product

(Invented) name

Givlaari

Active substance (s)

Givosiranas

Strength

189 mg/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)

A16AX16, Givosiran

Marketing authorisation holder

Alnylam Netherlands B.V., Nyderlandai

Date of authorisation

2020-03-02

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	1 ml
Givosiranas	189 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
103417	89519	1089519	flakonas	1 ml N1		Receptinis	EU/1/20/1428/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2020-03-02	Registruotas