Nepexto

Medicinal product

(Invented) name

Nepexto

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

Biosimilar Collaborations Ireland Limited, Airija

Date of authorisation

2020-05-20

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	0.5 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
104237	90341	1090341	užpildytas švirkštas	ir alkoholiu suvilgyti tamponai N4		Receptinis	EU/1/20/1436/001	Netiekiama	-	-	No	-	-
104238	90342	1090342	užpildytas švirkštas	ir alkoholiu suvilgyti tamponai N12		Receptinis	EU/1/20/1436/002	Netiekiama	-	-	No	-	-
104767	90868	1090868	užpildytas švirkštas	ir alkoholiu suvilgyti tamponai N24 (2x12)		Receptinis	EU/1/20/1436/007	Netiekiama	-	-	No	-	-
105390	91490	1091490	užpildytas švirkštas	ir alkoholiu suvilgyti tamponai N8 (2x4)		Receptinis	EU/1/20/1436/008	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2020-05-20	Registruotas