Benlysta

Medicinal product

(Invented) name

Benlysta

Active substance (s)

Belimumabas

Strength

200 mg

Pharmaceutical form

injekcinis tirpalas užpildytame švirkštiklyje

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 pen	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
98362	84464	1084464	užpildytas švirkštiklis	1 ml N1		Receptinis	EU/1/11/700/003	Netiekiama	-	-	No	-	-
98363	84465	1084465	užpildytas švirkštiklis	1 ml N4		Receptinis	EU/1/11/700/004	Tiekiama	-	-	No	-	-
98364	84466	1084466	užpildytas švirkštiklis	1 ml N12 (3x4)		Receptinis	EU/1/11/700/005	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2011-07-13	Registruotas