TAKHZYRO

Medicinal product

(Invented) name

TAKHZYRO

Active substance (s)

Lanadelumabas

Strength

300 mg

Pharmaceutical form

injekcinis tirpalas užpildytame švirkštiklyje

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

Užpildytame švirkštiklyje (2 ml tirpalo) yra	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
116990	103091	1103091	užpildytas švirkštiklis	2 ml N1	Receptinis	EU/1/18/1340/010	Netiekiama	-	-	No	-	-
116992	103093	1103093	užpildytas švirkštiklis	2 ml N2	Receptinis	EU/1/18/1340/011	Netiekiama	-	-	No	-	-
116994	103095	1103095	užpildytas švirkštiklis	N6 (3×2)	Receptinis	EU/1/18/1340/012	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2018-11-22	Registruotas