Actavis

This sponsor has funded 6 studies across 4 countries.

PAS funded by this sponsor.
EU PAS ID Status RMP requirement Title Protocol uploaded Results uploaded
11475 Planned Unspecified Postmarketing non-interventional safety study on medicinal products containing active substance sildenafil No No
11481 Planned Unspecified Postmarketing non-interventional safety study on medicinal products containing aromatase inhibitors, Anastrozol Actavis 1 mg, Exemestan Actavis 25 mg,... No No
12041 Planned Unspecified Postmarketing non-interventional safety study on medicinal product Buprenorphine Actavis 35; 52,5; 70 microgram/h transdermal patch in Czech Republic,... No No
12171 Ongoing EU RMP category 1 Retrospective Cohort Study on the Risk of Venous Thromboembolism with the use of combined oral contraceptives containing Chlormadinone... No No
13107 Finalised Unspecified Observational Program to Study Prescribing Practices of Montelast, 10 mg Film-coated Tablets (manufactured by Actavis Ltd., Malta for Actavis Group... No No
13117 Finalised Not included in RMP Efficiency and Safety of Six Month Oglition® Therapy of Patients with Diabetes Mellitus type 2 No Yes

PAS by Risk Management Plan (RMP) requirement

Actavis

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.