Myalepta

Medicinal product

(Invented) name

Myalepta

Active substance (s)

Metreleptinas

Strength

11,3 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 dozavimo kortele pacientui.pdf

Myalepta mokomoji medziaga pacientui.pdf

Myalepta vartojimo instrukcijos 11.3mg.pdf

Myalepta mokomoji medziaga sveikatos prieziuros specialistui.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	11,3 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
99935	86043	1086043	flakonas	N1		Receptinis	EU/1/18/1276/001	Netiekiama	-	-	No	-	-
99936	86044	1086044	flakonas	N30		Receptinis	EU/1/18/1276/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2018-08-06	Registruotas