Brineura

Medicinal product

(Invented) name

Brineura

Active substance (s)

Cerliponazė alfa

Strength

150 mg

Pharmaceutical form

infuzinis tirpalas

Route (s) of administration

leisti į smegenų skilvelius

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

A16AB17, Cerliponase alfa

Marketing authorisation holder

BioMarin International Limited, Airija

Date of authorisation

2017-05-30

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 infusion	5 ml
Cerliponazė alfa	150 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
68454	83032	1083032	flakonas	N2+1 (3 flakonai x 5 ml: 2 infuzinio tirpalo ir 1 praplovimo tirpalo)		Receptinis	EU/1/17/1192/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2017-05-30	Registruotas