PASS Information Title Cilostazol drug utilisation study Protocol version Version 2 identifier Date of last version of February 28, 2013 protocol EU PAS register number Registration is planned prior to study initiation once the protocol is final and has received regulatory endorsement by the Committee for Medicinal Products for Human Use (CHMP) Active substance Cilostazol, ATC code B01AC23, Platelet aggregation inhibitors excluding heparin Medicinal product Pletal, Ekistol Product reference UK/H/0291/001 and 002 Procedure number EMEA/H/A-31/1306 Marketing authorisation Otsuka Pharmaceutical Europe Ltd. holder(s) (MAH) Lacer S.A. Joint PASS No Research question and This study protocol was developed in the context of the European objectives Medicines Agency (EMA) referral (article 31 of Council Directive 2001/83/EC) on the risks and benefits of the use of cilostazol. The study objectives are to characterise patients using cilostazol according to demographics, comorbidity, comedications, and duration of treatment. In addition, the study will describe the dosing of cilostazol, the prescribing physician specialties, and the potential off-label prescribing. Country(-ies) of study Spain, United Kingdom, Germany, Sweden Author Jordi Castellsague, MD, MPH; Cristina Varas-Lorenzo, MD, MPH, PhD; Susana Perez-Gutthann, MD, MPH, PhD RTI Health Solutions Trav. Gracia 56 Atico 1 08006 Barcelona, Spain Telephone: +34.93.241.7766 Fax: +34.93.414.2610 E-mail:
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