ALK-Abelló (ALK)

This sponsor has funded 8 studies across 11 countries.

PAS funded by this sponsor.
EU PAS ID Status RMP requirement Title Protocol uploaded Results uploaded
6012 Finalised Not included in RMP A non-interventional observational retrospective study for the study of the risk factors associated to the related to treatment adverse events... Yes No
17245 Ongoing EU RMP category 3 Post-Market Claims-Based Study of Allergic Reactions and Eosinophilic Esophagitis in Marketed Use of GRASTEK? in the United States (MK-7243-025) No No
17248 Ongoing EU RMP category 3 Post-Market Claims-Based Study of Serious Allergic Reactions and Eosinophilic Esophagitis in Marketed Use of RAGWITEK? in the United States... No No
25639 Finalised EU RMP category 3 Post-authorisation safety study of the incidence rate of medication errors before and after the discontinuation of the lower strength vials for... Yes Yes
29289 Finalised EU RMP category 3 Survey on the knowledge and use of the Jext prescriber’s checklist among physicians – a post-authorisation safety study (XX-JX-01) No No
31470 Finalised Not included in RMP ITULAZAX Post Authorization Safety (IPAS) Study: A prospective, non-interventional study assessing the safety and tolerability of ITULAZAX in adults... Yes Yes
36947 Ongoing Not included in RMP Study on feeling according to the patient of allergens specially prepared for individuals (allergenic ‘Named Patient Products’ NPPs) (ERAPP) No No
43753 Planned Not included in RMP A non-interventional observational study assessing the safety and tolerability of ACARIZAX® in adults (18-65 years of age) (RELIEF) No No

PAS by Risk Management Plan (RMP) requirement

ALK-Abelló (ALK)

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.