Metreleptin

Myalepta 5,8 MG Polvo Para Solucion Inyectable

5,8 mg polvo para solución inyectableSpainMarketedAuthorised 5 Nov 2018

Product informationAsk Osler about it

In other countries

The same active substances on other registers, the same brand first.

Authorised centrally in the EU

This national listing belongs to a medicine the European Commission authorised for the whole EU.

MyaleptaEuropean UnionAuthorised

Two medicines in one question?

Name two or more medicines and Osler runs an interaction check. A severe interaction is stated at the very top of the answer.

Discover Osler

Metreleptin

Myalepta 5,8 MG Polvo Para Solucion Inyectable

5,8 mg polvo para solución inyectableSpainMarketedAuthorised 5 Nov 2018

Product informationAsk Osler about it

In other countries

The same active substances on other registers, the same brand first.

Authorised centrally in the EU

This national listing belongs to a medicine the European Commission authorised for the whole EU.

MyaleptaEuropean UnionAuthorised

Two medicines in one question?

Name two or more medicines and Osler runs an interaction check. A severe interaction is stated at the very top of the answer.

Discover Osler

Myalepta 11.3 mg poeder voor oplossing voor injectieNetherlands · Poeder voor oplossing voor injectie · Chiesi Farmaceutici S.p.A.

MyaleptUnited States · 11.3MG · injectable · Chiesi Farmaceutici SPA

MyaleptBrazil · Chiesi Farmacêutica Ltda

MyaleptBrazil · Amryt Brasil Comercio e Importacao de Medicamentos Ltda

Packs

Pack	Code	Status
MYALEPTA 5,8 MG POLVO PARA SOLUCION INYECTABLE 30 viales	723922

Documents

The official texts, at the regulator.

Sources and licences

Compiled by Prognia from the public register below; the register’s text is the official one.

Agencia Española de Medicamentos y Productos Sanitarios

Fuente de la información: Agencia Española de Medicamentos y Productos Sanitarios www.aemps.gob.es; CIMA medicamentos, acquired 11 October 2026 UTC; each source response/update date retained.

Licence: AEMPS explicit public open-data reuse for citizens and companies; source attribution and update date required · Added 12 Oct 2026

Report an error or request removalCorrections from the holder or the register are welcome.

Prognia shows this product information for reference and learning. It is not treatment advice and can lag behind the official text. Always check the current product information and local protocols before prescribing.

At a glance

Active substance: Metreleptin
Strength: 5,8 mg
Dosage form: polvo para solución inyectable
Route: vía subcutánea
Register: Spain (AEMPS)
Status: Marketed
Status in the register: Autorizado, comercializado
Authorised: 5 Nov 2018
Registration: 1181276006
Marketing authorisation holder: Chiesi Farmaceutici S.P.A.
Procedure: EU centralised
Supply: Uso Hospitalario
EU number: EU/1/18/1276

Spain