Myalepta

Medicinal product

(Invented) name

Myalepta

Active substance (s)

Metreleptinas

Strength

5,8 mg

Pharmaceutical form

milteliai injekciniam tirpalui

Route (s) of administration

leisti po oda

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

A16AA07, Metreleptin

Marketing authorisation holder

Chiesi Farmaceutici S.p.A., Italija

Date of authorisation

2018-08-06

Date of renewal

Documents

Myalepta vartojimo instrukcijos 5.8mg.pdf

Myalepta dozavimo kortele pacientui.pdf

Myalepta mokomoji medziaga sveikatos prieziuros specialistui.pdf

Myalepta mokomoji medziaga pacientui.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

Powder for solution for injection	1 vnt.
Metreleptinas	5,8 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
100643	86753	1086753	flakonas	N1		Receptinis	EU/1/18/1276/005	Netiekiama	-	-	No	-	-
100644	86754	1086754	flakonas	N30		Receptinis	EU/1/18/1276/006	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2018-08-06	Registruotas