ETUDE POST AUTORISATION NON INTERVENTIONNELLE EN VIE REELLE DE SECURITE DES PATIENTS TRAITES PAR BACLOFÈNE ZENTIVA (BACLOFÈNE) (baclosafe)

Study identification

• EU PAS number:
  EUPAS45165
• Study ID:
  49247
• Official title and acronym:
  ETUDE POST AUTORISATION NON INTERVENTIONNELLE EN VIE REELLE DE SECURITE DES PATIENTS TRAITES PAR BACLOFÈNE ZENTIVA (BACLOFÈNE) (baclosafe)
• DARWIN EU® study:
  No
• Study countries:
  France
• Study status:
  Ongoing

Research institutions and networks

Institutions

Hospice de Lyon

Study timelines

Date when funding contract was signed

Planned:12/05/2021

Actual:12/05/2021

Study start date

Planned:04/10/2022

Actual:04/10/2022

Date of final study report

Planned:30/10/2025

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Zentiva

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)