Benlysta

Medicinal product

(Invented) name

Benlysta

Active substance (s)

Belimumabas

Strength

200 mg

Pharmaceutical form

injekcinis tirpalas užpildytame švirkšte

Route (s) of administration

leisti po oda

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L04AG04, Belimumab

Marketing authorisation holder

GlaxoSmithKline (Ireland) Limited , Airija

Date of authorisation

2011-07-13

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 in pre-filled syringe	1 ml
Belimumabas	200 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
98365	84467	1084467	užpildytas švirkštas	1 ml N1		Receptinis	EU/1/11/700/006	Netiekiama	-	-	No	-	-
98366	84468	1084468	užpildytas švirkštas	1 ml N4		Receptinis	EU/1/11/700/007	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2011-07-13	Registruotas