Benepali

Medicinal product

(Invented) name

Benepali

Active substance (s)

Etanerceptas

Strength

50 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)

L04AB01, Etanercept

Marketing authorisation holder

Samsung Bioepis NL B.V., Nyderlandai

Date of authorisation

2016-01-14

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(4)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Solution for injection in pre-filled syringe	1 ml
Etanerceptas	50 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
64782	79271	1079271	užpildytas švirkštas	1 ml N4		Receptinis	EU/1/15/1074/001	Netiekiama	-	-	No	-	-
65379	79883	1079883	užpildytas švirkštas	1 ml N12 (3x4) (grupinė pakuotė)		Receptinis	EU/1/15/1074/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2016-01-14	Registruotas