Pharmaceuticals - Union Register

  

Union Register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Myalepta   
Auth. number : EU/1/18/1276
Active substance : metreleptin
Orphan market exclusivity for "Treatment of Familial Partial Lipodystrophy" (based on designation EU/3/12/1022) started on 1/08/2018
   10 years of market exclusivity
   This orphan market exclusivity will expire on 1/08/2028
Orphan market exclusivity for "Treatment of Barraquer-Simons syndrome" (based on designation EU/3/12/1023) started on 1/08/2018
   10 years of market exclusivity
   This orphan market exclusivity will expire on 1/08/2028
Orphan market exclusivity for "Treatment of Lawrence syndrome" (based on designation EU/3/12/1024) started on 1/08/2018
   10 years of market exclusivity
   This orphan market exclusivity will expire on 1/08/2028
Orphan market exclusivity for "Treatment of Berardinelli-Seip syndrome" (based on designation EU/3/12/1025) started on 1/08/2018
   10 years of market exclusivity
   This orphan market exclusivity will expire on 1/08/2028
ATC: Anatomical main group: A - Alimentary tract and metabolism
Therapeutic subgroup: A16 - Other alimentary tract and metabolism products
Pharmacological subgroup: A16A - Other alimentary tract and metabolism products
Chemical subgroup: A16AA - Amino acids and derivatives
Chemical substance: A16AA07 - metreleptin
(See WHO ATC Index)
Indication: Myalepta is indicated as an adjunct to diet as a replacement therapy to treat the complications of leptin deficiency in lipodystrophy (LD) patients:
• with confirmed congenital generalised LD (Berardinelli-Seip syndrome) or acquired generalised LD (Lawrence syndrome) in adults and children 2 years of age and above
• with confirmed familial partial LD or acquired partial LD (Barraquer-Simons syndrome), in adults and children 12 years of age and above for whom standard treatments have failed to achieve adequate metabolic control.
Marketing Authorisation Holder: Aegerion Pharmaceuticals B.V.
Atrium Building, 8th Floor, Strawinskylaan 3127, 1077 ZX Amsterdam, Nederland

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Union Register.

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
1/08/2018 Centralised - Authorisation EMEA/H/C/4218 (2018)5202 of 30/07/2018
4/10/2018 Centralised - Variation EMEA/H/C/4218/IB/1/G
26/03/2019 Centralised - Variation EMEA/H/C/4218/IAIN/05