Strimvelis

Medicinal product

(Invented) name

Strimvelis

Active substance (s)

Autologinėmis CD34+ ląstelėmis praturtinta frakcija

Strength

1-10 x 10(×6)/ml

Pharmaceutical form

infuzinė dispersija

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L03AX, Other immunostimulants

Marketing authorisation holder

Fondazione Telethon ETS, Italija

Date of authorisation

2016-05-26

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

Dispersion for infusion	1 ml
Autologinėmis CD34+ ląstelėmis praturtinta frakcija	1-10 x 10(×6)

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
65950	80463	1080463	maišelis	N1		Receptinis	EU/1/16/1097/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2016-05-26	Registruotas