Spinraza

Medicinal product

(Invented) name

Spinraza

Active substance (s)

Nusinersenas

Strength

12 mg

Pharmaceutical form

injekcinis tirpalas

Route (s) of administration

leisti į povoratinklinę ertmę

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

M09AX07, Nusinersen

Marketing authorisation holder

Biogen Netherlands B.V., Nyderlandai

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 injection	5 ml
Nusinersenas	12 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
68453	83031	1083031	flakonas	N1		Receptinis	EU/1/17/1188/001	Tiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2017-05-30	Registruotas