Bimzelx

Medicinal product

(Invented) name

Bimzelx

Active substance (s)

Bimekizumabas

Strength

160 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)

L04AC21, bimekizumab

Marketing authorisation holder

UCB Pharma S.A., Belgija

Date of authorisation

2021-08-20

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	1 ml
Bimekizumabas	160 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
107122	93225	1093225	užpildytas švirkštas	N1		Receptinis	EU/1/21/1575/001	Netiekiama	-	-	No	-	-
107123	93226	1093226	užpildytas švirkštas	N2		Receptinis	EU/1/21/1575/002	Netiekiama	-	-	No	-	-
107124	93227	1093227	užpildytas švirkštas	N3 (3×1)		Receptinis	EU/1/21/1575/003	Netiekiama	-	-	No	-	-
107125	93228	1093228	užpildytas švirkštas	N4 (2×2)		Receptinis	EU/1/21/1575/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-08-20	Registruotas