Almirall

This sponsor has funded 6 studies across 5 countries.

PAS funded by this sponsor.
EU PAS ID Status RMP requirement Title Protocol uploaded Results uploaded
4902 Finalised Unspecified Evaluation of patients with chronic obstructive pulmonary disease (COPD) and chronic kidney disease (CKD) who would benefit from aclidinium bromide... Yes No
6559 Finalised EU RMP category 3 Aclidinium Bromide Drug Utilisation Post-Authorisation Safety Studies (DUS): Common Protocol for Aclidinium (DUS1) and Aclidinium/Formoterol... No No
6573 Finalised Unspecified Real-life effectiveness evaluation of the long-acting muscarinic antagonist aclidinium bromide (Eklira®) for the management of COPD in a routine UK... Yes Yes
28457 Ongoing EU RMP category 3 An Observational Post-Authorisation Safety Study of Skilarence in European Psoriasis Registers Yes No
29842 Finalised EU RMP category 3 Retrospective chart review to assess the effectiveness of the Skilarence® risk minimisation activities in daily practice – a post-authorisation safety... No No
37946 Ongoing EU RMP category 3 Tildrakizumab Post-Authorisation Safety Study (PASS) in European Psoriasis Registries (M-14745-40) No No

PAS by Risk Management Plan (RMP) requirement

Almirall

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.