Skysona

Medicinal product

(Invented) name

Skysona

Active substance (s)

Elivaldogenas autotemcelas

Strength

2–30×10(6) ląst./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)

Nesuteiktas, Netaikoma ar nesuteiktas

Marketing authorisation holder

bluebird bio (Netherlands) B.V., Nyderlandai

Date of authorisation

2021-07-16

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

Dispersion for infusion	1 ml
Elivaldogenas autotemcelas	2–30×10(6) ląst./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
106979	93082	1093082	maišelis	maždaug 20 ml N1		Receptinis	EU/1/21/1563/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-11-19	Išregistruotas
2021-07-16	Registruotas