Reblozyl

Medicinal product

(Invented) name

Reblozyl

Active substance (s)

Luspaterceptas

Strength

25 mg

Pharmaceutical form

milteliai injekciniam tirpalui

Route (s) of administration

leisti po oda

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

B03XA06, luspatercept

Marketing authorisation holder

Bristol-Myers Squibb Pharma EEIG, Airija

Date of authorisation

2020-06-26

Date of renewal

Documents

Reblozyl kontrolinis sarasas sveikatos prieziuros specialistams.pdf

Reblozyl paciento kortele.pdf

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

Powder for solution for injection	1 vnt.
Luspaterceptas	25 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
104623	90725	1090725	flakonas	N1		Receptinis	EU/1/20/1452/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2020-06-26	Registruotas