Ipsen

This sponsor has funded 19 studies across 16 countries.

PAS funded by this sponsor.
EU PAS ID Status RMP requirement Title Protocol uploaded Results uploaded
3800 Finalised Not included in RMP Intima Media Thickness in children with growth hormone treatment Yes Yes
7708 Ongoing EU RMP category 2 Global Patient Registry to Monitor Long-term Safety and Effectiveness of Increlex® in Children and Adolescents With Severe Primary Insulin-like Growth... No No
7866 Finalised Not included in RMP Post-approval observational prospective study to evaluate the prevalence of the metabolic syndrome in prostate cancer patients both before and after a... Yes Yes
7870 Finalised Not included in RMP Post-marketing observational study to prospectively evaluate the prevalence of cognitive changes in patients suffering of PCa before starting and... No Yes
7895 Finalised Not included in RMP Study on the fertility of women treated with triptorelin for precocious puberty in their childhood (PREFER) No No
7938 Finalised Not included in RMP Assessment of safety of Diphereline® SR 11.25 mg in Polish patients with prostate cancer (A-38-52014-163) No No
7944 Finalised Not included in RMP Follow-up of adult patients treated with growth hormone NUTROPIN Aq® (Nutropin in Adults) No No
7948 Finalised EU RMP category 3 International Cooperative Growth Study Post Marketing Surveillance Program For Nutropin Aq® [Somatropin (rDNA Origin) Injection] (iNCGS) Yes Yes
7982 Finalised Not included in RMP An Observational, Multicentre, Open Label, Non Interventional Programme to Assess the Long-term Safety and Efficacy of Somatuline® Autogel® in the... Yes Yes
7986 Finalised Not included in RMP An Observational, multicentre, open label, non interventional programme to assess the long-term safety and efficacy of Somatuline® Autogel® in the... Yes Yes
9361 Finalised EU RMP category 2 A multicentre, European, observational, Drug Utilisation Study (DUS) of BLI800 (Eziclen®/Izinova®) as a bowel cleansing preparation (DUS (Drug... Yes Yes
19464 Finalised EU RMP category 3 Prospective non interventional study of cabozantinib tablets in adults with advanced renal cell carcinoma following prior vascular endothelial growth... Yes Yes
27784 Finalised Not included in RMP Post marketing surveillance (non-interventional study) for evaluating the efficacy and safety of Dysport Czech patients suffering from post-stroke arm... Yes Yes
35332 Finalised Not included in RMP An observational, multicentre, open label, non-interventional programme to assess the long-term safety and efficacy of Somatuline® Autogel® in the... Yes Yes
35337 Finalised Not included in RMP An Observational, Multicentre, Open label, Post-Marketing Surveillance Program to assess the long-term safety and efficacy of Somatuline® Autogel® in... Yes Yes
35503 Finalised Not included in RMP A post marketing surveillance survey of Dysport for evaluating safety of Dysport in Korean patients suffering from Spasticity or Dystonia Yes Yes
36791 Finalised Not included in RMP Diphereline Post Marketing Surveillance Study No Yes
107722 Ongoing Not included in RMP Effectiveness and Safety of SMART BoNT-A therapy with Dysport® in patients with post-stroke chronic upper limb spasticity in real-life setting... No No
108004 Ongoing Not included in RMP CABOCARE: Study of Cabozantinib as Monotherapy or in Combination With Nivolumab in Patients With Advanced or Metastatic Renal Cell Carcinoma Under... No No

PAS by Risk Management Plan (RMP) requirement

Ipsen

The RMP for a medical product outlines strategies to identify, assess, and mitigate risks, including PAS for further evaluation.

Category 1 studies are imposed as condition of marketing authorisation.
Category 2 studies are imposed as specific obligation of marketing authorisation.
Category 3 studies are required under other circumstances.