Glybera

Medicinal product

(Invented) name

Glybera

Active substance (s)

Alipogenas tiparvovekas

Strength

3x10¹² gk/ml/ml

Pharmaceutical form

injekcinis tirpalas

Route (s) of administration

leisti į raumenis

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

C10AX10, Alipogene tiparvovec

Marketing authorisation holder

uniQure biopharma B.V., Nyderlandai

Date of authorisation

2012-10-25

Date of renewal

Documents

Search in EMA Europe

Stage

Išregistruotas

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
Alipogenas tiparvovekas	3x10¹² gk/ml

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
63443	77883	1077883	flakonas	1 ml N3 (konkrečiai pacientui)		Receptinis	EU/1/12/791/001	Netiekiama	-	-	No	-	-
54268	68258	1068258	flakonas	1 ml N2 (konkrečiai pacientui)		Receptinis	EU/1/12/791/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
	Išregistruotas
2012-10-25	Registruotas