Benepali

Medicinal product

(Invented) name

Benepali

Active substance (s)

Etanerceptas

Strength

25 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	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
97617	83711	1083711	užpildytas švirkštas	N4		Receptinis	EU/1/15/1074/005	Netiekiama	-	-	No	-	-
97618	83712	1083712	užpildytas švirkštas	N8 (2x4) (grupinė pakuotė)		Receptinis	EU/1/15/1074/006	Netiekiama	-	-	No	-	-
97619	83713	1083713	užpildytas švirkštas	N24 (6x4) (grupinė pakuotė)		Receptinis	EU/1/15/1074/007	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2016-01-14	Registruotas