Simponi

Medicinal product

(Invented) name

Simponi

Active substance (s)

Golimumabas

Strength

100 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)

L04AB06, Golimumab

Marketing authorisation holder

Janssen Biologics B.V., Nyderlandai

Date of authorisation

2009-10-01

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
Golimumabas	100 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
57953	72075	1072075	užpildytas švirkštas	1 ml N1		Receptinis	EU/1/09/546/007	Netiekiama	-	-	No	-	-
57954	72076	1072076	užpildytas švirkštas	1 ml N3 (3 x 1)		Receptinis	EU/1/09/546/008	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2009-10-01	Registruotas