Bimzelx

Medicinal product

(Invented) name

Bimzelx

Active substance (s)

Bimekizumabas

Strength

160 mg

Pharmaceutical form

injekcinis tirpalas užpildytame švirkštiklyje

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 pen	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
107126	93229	1093229	užpildytas švirkštiklis	N1		Receptinis	EU/1/21/1575/005	Netiekiama	-	-	No	-	-
107127	93230	1093230	užpildytas švirkštiklis	N2		Receptinis	EU/1/21/1575/006	Netiekiama	-	-	No	-	-
107128	93231	1093231	užpildytas švirkštiklis	N3 (3×1)		Receptinis	EU/1/21/1575/007	Netiekiama	-	-	No	-	-
107129	93232	1093232	užpildytas švirkštiklis	N4 (2×2)		Receptinis	EU/1/21/1575/008	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-08-20	Registruotas