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Post Authorization Safety Study (Pass) Protocol POST AUTHORIZATION SAFETY STUDY (PASS) PROTOCOL TITLE: : Drug Utilization Study of Thiocolchicoside (TCC) containing medicinal products for systemic use in France and Italy: an electronic medical records database study COMPOUND: Thiocolchicoside STUDY NAME: Drug Utilization Study of Thiocolchicoside (TCC) containing medicinal products for systemic use in France and Italy: an electronic medical records database study The Study is conducted by QuintilesIMS Health 90-92 route de la Reine, 92773 Boulogne Billancourt, France “Any and all information presented in this document shall be treated as confidential. The use of such confidential information must be restricted to the recipient for the agreed purpose and must not be disclosed, published or otherwise communicated to any unauthorized persons, for any reasons, in any form whatsoever without the prior written consent of EUQPPV - Amel Benkritly - Global Pharmacovigilance & Epidemiology – Sanofi” Version 5.0 Number: Date: 2nd March 2017 Total number of pages: 104 (including annexes) Page 1 of 52 Post Authorization Safety Study (PASS) Protocol Version 5.0 Date: 2nd March 2017 NAMES AND ADDRESSES OF STUDY MANAGEMENT Name: Christine Falla, Sn Project Manager – QuintilesIMS Address: 90/92, route de la Reine 92100 Boulogne- (Global Medical Affairs - Billancourt, France Clinical Operations) Tel: +33(0)147796346 Fax: +33(0)147798350 E-mail: [email protected] Name: Nicolas Coulombel, Statistician – QuintilesIMS Address: 90/92, route de la Reine 92100 Boulogne- Billancourt, France Tel: +33(0)147797085 Fax: +33(0)147798350 E-mail: [email protected] Name: Sophie L. Jouaville, Sn Medical Writer – Address: QuintilesIMS 90/92, route de la Reine 92100 Boulogne- Billancourt, France Tel: Fax: +33(0)147798367 E-mail: +33(0)147798350 [email protected] PHARMACOVIGILANCE MAH/MAH EUQPPV – Amel Benkritly and Marie-Laure representative: Kürzinger, Address: Sanofi,Global Pharmacovigilance & Epidemiology 1, AVENUE PIERRE BROSSOLETTE - 91385 CHILLY-MAZARIN – France Tel: +33(0)157620769 Fax: +33(0)160497564 E-mail: [email protected] SCIENTIFIC COMMITTEE Name: Christine Falla, Sn Project Manager – CHAIR PERSON Address: QuintilesIMS 90/92, route de la Reine 92100 Boulogne- Billancourt, France Tel: +33(0)147796346 Fax: +33(0)147798350 E-mail: [email protected] QuintilesIMS - confidential Page 2 of 52 Post Authorization Safety Study (PASS) Protocol Version 5.0 Date: 2nd March 2017 PASS Information Title Drug Utilization Study of Thiocolchicoside (TCC) containing medicinal products for systemic use in France and Italy: an electronic medical records databases study Protocol version identifier Version 5.0 Date of last version of protocol 2nd March 2017 EU PAS register number EUPAS11081 Active substance M03BX05 Thiocolchicoside Medicinal Product See Annex 3 Product reference See Annex 3 Procedure number EMEA/H/N/PSP/j/0030 Marketing authorization holder(s) 1. SANOFI AVENTIS GROUPE, a French company or Sponsor company having its registered office at 54 rue La Boétie, 75008 Paris, France; 2. TEOFARMA Srl, Via F.lli Cervi N° 8, I-27010 valle Salimbene, 27010 Pavia, Italy; 3. MYLAN SAS with legal address at 117 Allée des Parcs, 69800 St Priest, France; 4. ANGELINI with legal address at Angelini Farmacêutica Lda, Rua João Chagas, 53 - 3° piso, 1499-040 Cruz Quebrada – Dafundo, Portugal; 5. DOMPE’ FARMACEUTICI S.P.A., with legal address in Via San Martino 12-12/a, 20122 Milan- Italy and Operative office: Via Santa Lucia 6, 20122 Milan, Italy; 6. GENERIS FARMACEUTICA with legal address in Rua João de Deus, 19, 2700-487 Amadora, Portugal; 7. KORANGI, with legal address at Produtos Farmacêuticos Lda. Rua da Vinha, 17P 2765-388 Estoril, Portugal; 8. DAIICHI Sankyo France SAS with legal address at 1, rue Eugène et Armand Peugeot, 92500 Rueil-Malmaison, France; 9. BIOGARAN SAS wth legal address 15, Boulevard Charles de Gaulle, 92707 Colombes Cedex, France; 10. SANDOZ SAS with legal address 49, avenue Georges Pompidou, 92593 Levallois-Perret, France; QuintilesIMS - confidential Page 3 of 52 Post Authorization Safety Study (PASS) Protocol Version 5.0 Date: 2nd March 2017 11. CRISTERS SAS, with legal address 22, Quai Gallieni, 92150 Suresnes, France; 12. EG Labo with legal address at Quintet Bât. A, 12 Rue Barthelemy Danjou, 92100 Boulogne-Billancourt, France; 13. EG S.p.A. with legal address at Milan- Via Pavia, 6- 20136 Milan, Italy; 14. ARROW génériques SAS with legal address 26 avenue Tony Garnier 69007 Lyon, France; 15. DOC Generici S.r.l. with legal address via Turati 40, 20121 Milano, Italy; 16. MDM with legal address viale Papiniano, 22/b, 20123 Milano, Italy; 17. ACRAF S.p.A. with legal address Viale Amelia, 70 - 00181 Roma, Italy; 18. UNION HEALTH S.r.l with legal address in Via Adige 5 – 66020 San Giovanni Teatino – Chieti,Italy; 19. SF GROUP S.r.l with legal address in Via Beniamino Segre 59 - 00134 Roma, Italy; 20. LABORATORIO FARMACEUTICO CT Srl with legal address in Strada Solaro, 75/77 – 18038 Sanremo (IM), Italy; 21. Laboratoire ALTER, 3 Avenue de la Baltique ZA de Courtaboeuf - 91140 Villebon-sur-Yvette, France; 22. EPIFARMA S.r.l. with legal address via San Rocco 6, 85033 Episcopia, Italy; 23. ACARPIA SERVIÇOS FARMACEUTICOS LDA, a Portuguese company having its registered office at 88 Rua dos Murcas, 9000 Funchal, Portugal; 24. SPA - SOCIETA’ PRODOTTI ANTIBIOTICI S.p.A., an Italian company having its registered office at via Biella 8, 20143 Milano, Italy; 25. I.B.N. Savio S.r.l., Via del Mare, 36, 00071 Pomezia (RM), Italy; Joint PASS Yes QuintilesIMS - confidential Page 4 of 52 Post Authorization Safety Study (PASS) Protocol Version 5.0 Date: 2nd March 2017 Research question and objectives The aim of this drug utilization study is to characterise prescribing practices of TCC-containing medicinal products during typical clinical use in representative groups of prescribers and assess main reasons for prescription. The study objectives are: • To describe the demographic and clinical characteristics of the treated patients (i.e. age and gender, co-medications, pregnancy, contraceptive use, lactation) • To describe for which indication TCC is prescribed in routine clinical practice (overall and by age/gender) • To describe the average duration of treatment episodes and the daily doses prescribed according to the route of administration • To compare patients characteristics pre- and post- implementation of RMMs Country(-ies) of study France and Italy Author Sophie L. Jouaville – QuintilesIMS 90/92, route de la Reine 92100 Boulogne-Billancourt, France +33(0)147798367 [email protected] MAH/MAH REPRESENTATIVE EUQPPV - Amel Benkritly, contact person Sanofi - Global Pharmacovigilance & Epidemiology 1, AVENUE PIERRE BROSSOLETTE - 91385 CHILLY- MAZARIN – France +33 (0) 1.57.62.07.69 [email protected] QuintilesIMS - confidential Page 5 of 52 Post Authorization Safety Study (PASS) Protocol Version 5.0 Date: 2nd March 2017 1 TABLE OF CONTENTS 1 TABLE OF CONTENTS .................................................................................................................. 6 2 LIST OF ABBREVIATIONS .......................................................................................................... 10 3 RESPONSIBLE PARTIES ............................................................................................................. 11 4 ABSTRACT .................................................................................................................................... 12 5 AMENDMENTS AND UPDATES .................................................................................................. 15 5.1 AMENDMENT # 1 .......................................................................................................................... 15 5.2 AMENDMENT # 2 .......................................................................................................................... 16 6 MILESTONES ............................................................................................................................... 17 7 RATIONALE AND BACKGROUND ............................................................................................. 18 7.1 BACKGROUND .............................................................................................................................. 18 7.2 RATIONALE ................................................................................................................................... 19 8 RESEARCH QUESTION AND OBJECTIVES ............................................................................... 20 8.1 PRIMARY OBJECTIVE ................................................................................................................... 20 8.2 SECONDARY OBJECTIVES ........................................................................................................... 20 9 RESEARCH METHODS ................................................................................................................ 21 9.1 STUDY DESIGN ............................................................................................................................. 21 9.2 SETTING ........................................................................................................................................ 21 9.2.1 Baseline Period .............................................................................................................................. 21 9.2.2 Study Follow-up
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