Rapid Data Analysis (RDA) – Amfepramone drug utilisation

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/40284
• EU PAS number:
  EUPAS40283
• Study ID:
  40284
• Official title and acronym:
  Rapid Data Analysis (RDA) – Amfepramone drug utilisation
• DARWIN EU® study:
  No
• Study countries:
  Germany
• Study description:
  Amfepramone is an amphethamine-derivative, a sympathomimetic agent with indirect action, belonging to the group of anorexigens. Substances in this group inhibit the hunger centre. However, it has not yet been established whether the action of these drugs in appetite reduction is of primary importance in the treatment of obesity. There are also other effects on the central nervous system and metabolism, connected with the anorexigenic action. The evolution of drug utilisation over time and the trends regarding length of use are currently unknown. This study is therefore aimed at evaluating drug utilisation trends over the last years in Germany and to estimate the usual length of usage and compliance with past regulatory recommendation for short treatment periods of up to 3 months. This RDA was agreed with DK (Rapporteur for the Article 31 referral procedure triggered in 2021) in complement to the study currently performed by DKMA in Danish registries.
• Study status:
  Finalised

Research institutions and networks

Institutions

European Medicines Agency (EMA)

Study timelines

Date when funding contract was signed

Planned: 02/02/2021

Actual: 02/02/2021

Study start date

Planned: 02/02/2021

Actual: 02/02/2021

Date of final study report

Planned: 23/03/2021

Actual: 23/03/2021

Sources of funding

EMA

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable