Waylivra

Medicinal product

(Invented) name

Waylivra

Active substance (s)

Volanesorsenas

Strength

285 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)

C10AX18, volanesorsen

Marketing authorisation holder

Akcea Therapeutics Ireland Ltd., Airija

Date of authorisation

2019-05-03

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
Volanesorsenas	285 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
101603	87707	1087707	užpildytas švirkštas	N1		Receptinis	EU/1/19/1360/001	Netiekiama	-	-	No	-	-
101604	87708	1087708	užpildytas švirkštas	N4		Receptinis	EU/1/19/1360/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2019-05-03	Registruotas