Allergan

This sponsor has funded 20 studies across 14 countries.

PAS funded by this sponsor.
EU PAS ID Status RMP requirement Title Protocol uploaded Results uploaded
12839 Finalised EU RMP category 3 Linaclotide Utilisation Study in Selected European Populations Yes Yes
15160 Finalised EU RMP category 3 Post-Authorization Safety Study of OZURDEX® (Dexamethasone Intravitreal Implant): A Prospective Observational Study to Evaluate Long-Term Safety in... Yes Yes
15726 Ongoing EU RMP category 3 OBSERVATIONAL POST-AUTHORISATION SAFETY STUDY OF VISTABEL® FOR THE TREATMENT OF CROW’S FEET LINES (CFL) No No
15927 Finalised EU RMP category 3 A Post-Market Clinical Follow-up of EARFOLD® Implantable Clip System in general surgical practice Yes Yes
16104 Ongoing Non-EU RMP-only Drug Use Result Survey of Botox Vista® Injection 50 Units Yes No
16107 Ongoing Non-EU RMP-only The Evaluation of the Safety and Patient Satisfaction with Glash Vista in the Treatment of Patients with Hypotrichosis of the Eyelashes Yes No
16140 Finalised Non-EU RMP-only Evaluation of the Safety and Effectiveness of BOTOX® (Clostridium Botulinum Toxin Type A) in the Treatment of Patients with Urinary Incontinence due... Yes Yes
16150 Finalised Non-EU RMP-only Evaluation of the Safety and Effectiveness of BOTOX® Injection 50 Units (ClostridiumBotulinum Toxin Type A) for the Treatment of Patients with... Yes Yes
16153 Finalised Non-EU RMP-only Evaluation of the Safety and Effectiveness of BOTOX® (Botulinum Toxin Type A) in the Treatment of Patients with Urinary Incontinence due to Neurogenic... Yes Yes
16156 Finalised Non-EU RMP-only An Observational, Prospective Post-Marketing Surveillance Program to Evaluate theSafety Profile of Intravitreal Ozurdex® in the Treatment of Visual... Yes Yes
16159 Finalised Non-EU RMP-only CONTOUR: Condition of Submental Fullness and Treatment Outcomes Registry (A Registry of Submental Fullness, Treatment Options Administered, and... Yes Yes
16675 Finalised Non-EU RMP-only Evaluation of the Safety and Effectiveness of Lastacaft® Ophthalmic Solution 0.25%(Alcaftadine) for the Prevention of Itching Associated with Allergic... Yes Yes
21151 Finalised Non-EU RMP-only Pregnancy Prevention Program Section of the Risk Management Plan for Soriatane® (acitretin): Survey to Assess Physician and Pharmacist Understanding... Yes Yes
22012 Finalised Non-EU RMP-only CONTOUR Australia: Condition of Submental Fullness and Treatment Yes Yes
22236 Ongoing Not included in RMP THE SAVELLA® PREGNANCY REGISTRY (MLN-MD-30 / CMO-EPI-NEU-0539) Yes No
23093 Finalised Non-EU RMP-only Ozurdex® (dexamethasone) Implant Risk Management Plan Injector's Guide Assessment Australia Yes Yes
23762 Ongoing Non-EU RMP-only Evaluation of the Safety and Effectiveness of BELKYRA® Inj. for the Treatment of Patients with Submental Fullness due to Submental Fat: A... Yes No
24861 Finalised EU RMP category 3 Evaluation of the Physician Education Component of the Ozurdex Risk Management Plan Yes Yes
25247 Finalised Non-EU RMP-only A Post-Marketing Surveillance of the Abuse of Eluxadoline using Poison Centre Data in the United States and Canada Yes Yes
32613 Ongoing Not included in RMP A Retrospective Chart Review Study to Evaluate Safety of McGhan Single Lumen Gel-Filled Breast Implants in Patients in China Yes No

PAS by Risk Management Plan (RMP) requirement

Allergan

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.