TAKHZYRO

Medicinal product

(Invented) name

TAKHZYRO

Active substance (s)

Lanadelumabas

Strength

300 mg

Pharmaceutical form

injekcinis tirpalas

Route (s) of administration

leisti po oda

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

ATC code (s)

B06AC05, Lanadelumab

Marketing authorisation holder

Takeda Pharmaceuticals International AG Ireland Branch, Airija

Date of authorisation

2018-11-22

Date of renewal

Documents

Stage

Registruotas

Controlled?

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Solution for injection	2 ml
Lanadelumabas	300 mg

Packages

PAKID	NPAKID	NPAKID-7	Pack type	Pack size	Proposed dispensing/classification	Marketing authorisation no.	Supply status	From	To	Package is in foreign language	From	To
100636	86746	1086746	flakonas	2 ml, švirkštas (3 ml), 18 dydžio ištraukimo adata ir 2 adatos N1	Receptinis	EU/1/18/1340/001	Netiekiama	-	-	No	-	-
103518	89620	1089620	flakonas	2 ml N2 (2x1), 2 (2x1) švirkštai (3 ml) ir 4 (2x2) 18 dydžio ištraukimo adatos (sudėtinė)	Receptinis	EU/1/18/1340/002	Netiekiama	-	-	No	-	-
103519	89621	1089621	flakonas	2 ml N6 (6x1), 6 (6x1) švirkštai (3 ml) ir 12 (6x2) 18 dydžio ištraukimo adatų (sudėtinė)	Receptinis	EU/1/18/1340/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2018-11-22	Registruotas