Ebglyss

Medicinal product

(Invented) name

Ebglyss

Active substance (s)

Lebrikizumabas

Strength

250 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)

D11AH10, lebrikizumab

Marketing authorisation holder

Almirall, S.A., Ispanija

Date of authorisation

2023-11-16

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	2 ml
Lebrikizumabas	250 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
112031	98146	1098146	užpildytas švirkštas	N1		Receptinis	EU/1/23/1765/001	Netiekiama	-	-	No	-	-
112032	98147	1098147	užpildytas švirkštas	N2		Receptinis	EU/1/23/1765/002	Netiekiama	-	-	No	-	-
112033	98148	1098148	užpildytas švirkštas	N3		Receptinis	EU/1/23/1765/003	Netiekiama	-	-	No	-	-
112034	98149	1098149	užpildytas švirkštas	N4 (2×2)		Receptinis	EU/1/23/1765/004	Netiekiama	-	-	No	-	-
112035	98150	1098150	užpildytas švirkštas	N5 (5×1)		Receptinis	EU/1/23/1765/005	Netiekiama	-	-	No	-	-
112036	98151	1098151	užpildytas švirkštas	N6 (3×2)		Receptinis	EU/1/23/1765/006	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2023-11-16	Registruotas