Hemlibra

Medicinal product

(Invented) name

Hemlibra

Active substance (s)

Emicizumabas

Strength

30 mg/ml

Pharmaceutical form

injekcinis tirpalas

Route (s) of administration

leisti po oda

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

B02BX06, Emicizumab

Marketing authorisation holder

Roche Registration GmbH, Vokietija

Date of authorisation

2018-02-23

Date of renewal

Documents

Hemlibra mokomoji medziaga laboratorines medicinos specialistams.pdf

Hemlibra paciento kortele.pdf

Hemlibra mokomoji medziaga sveikatos prieziuros specialistams.pdf

Hemlibra mokomoji medziaga pacientams.pdf

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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	1 ml
Emicizumabas	30 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
99116	85222	1085222	flakonas	1 ml N1		Receptinis	EU/1/18/1271/001	Tiekiama	-	-	No	-	-
112785	98904	1098904	flakonas	0,4 ml N1		Receptinis	EU/1/18/1271/006	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2018-02-23	Registruotas