Fubelv

Medicinal product

(Invented) name

Fubelv

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

2026-04-23

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

Užpildytame švirkšte yra	1 vnt.
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
120655	106762	1106762	užpildytas švirkštas	N4		Receptinis	EU/1/26/2023/001	Netiekiama	-	-	No	-	-
120656	106763	1106763	užpildytas švirkštas	N12		Receptinis	EU/1/26/2023/002	Netiekiama	-	-	No	-	-
120657	106764	1106764	užpildytas švirkštas	N8 (2×4)		Receptinis	EU/1/26/2023/003	Netiekiama	-	-	No	-	-
120658	106765	1106765	užpildytas švirkštas	N24 (2×12)		Receptinis	EU/1/26/2023/008	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2026-04-23	Registruotas