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The Curtailment of the European Medicines Agency’S Policy on Access to Documents Supplementary Online Content Doshi P. Transparency interrupted: the curtailment of the European Medicines Agency’s policy on access to documents. JAMA Intern Med. Published online August 19, 2013. doi:10.1001/jamainternmed.2013.9989 eAppendix. Table of European Medicines Agency Freedom of Information Requests Snapshot Dated June 4, 2013 This supplementary material has been provided by the authors to give readers additional information about their work. © 2013 American Medical Association. All rights reserved. Downloaded From: https://jamanetwork.com/ on 10/02/2021 Category of documents Category of documents Affiliation according to Closed Product / subject Pages requested requested social and occupational Received Pending Replied released DOSSIER NON-DOSSIER profile Open Mixed documents Academia/Research Avandia (rosiglitazone) institute 14/12/10 Closed 13/01/11 1,048 Somatropin Studies Other 13/12/10 Closed 14/01/11 0 Tasocitinib Dossier, SA Legal 16/12/10 Closed 18/01/11 0 Duloxetines: Module 5 Ariclaim; Cymbalta; Xeristar; Yentreve Healthcare professional 15/12/10 Closed 16/05/11 13,731 Infanrix HepB Mixed documents Legal 16/12/10 Closed 16/02/11 247 AR, minutes, Dossier, CSR Avonex (interferon beta-1a) Healthcare professional 30/11/10 Closed 04/02/11 18 Travatan (travoprost) AR, PSUR Media 21/12/10 Closed 21/01/11 474 PhVWP H1N1 (pandemic influenza vaccine) EU Institution (EC etc) 20/10/10 Closed 08/02/11 42 Plavix (clopidogrel) CSR Media 04/01/11 Closed 06/09/12 70,291 Referral documents Agreal (veralipride) Patients organisation 07/12/10 Closed 10/03/11 404 Anorectics; Benfluorex (Mediator) Minutes, Opinion General Public 14/01/11 Closed 14/01/11 208 DOI DoI Pharmaceutical industry 07/01/11 Closed 28/01/11 4 Inspection Reports Inspection Reports Pharmaceutical industry 07/01/11 Closed 20/01/11 0 Tovias (fesoterodine); Emselex (darifenacin Dossier, Mix hydrobromide) Pharmaceutical industry 10/01/11 Closed 01/06/12 13,616 Tredaptive (nicotinic acid / laropiprant) Mixed documents General Public 30/11/10 Closed 05/05/11 780 Acomplia (rimonabant) CSR Legal 17/02/10 Closed 03/02/11 101,769 Erbitux (cetuximab); Movectro (cladribine) Mixed documents Other 01/12/10 Closed 03/02/11 402 Mixed documents Benfluorex (Mediator) EU Institution (EC etc) 06/01/11 Closed 01/02/11 60 Module 5 Academia/Research Tamiflu (oseltamivir); Relenza (zanamivir) institute 11/01/11 Closed 26/05/11 25,485 CSR Academia/Research Acomplia (rimonabant); Xenical (orlistat) institute 17/12/10 Closed 31/01/11 110,484 PhVWP PhVWP Pharmaceutical industry 24/01/11 Closed 31/01/11 9 Benfluorex (Mediator) Mixed documents Legal 25/01/11 Closed 15/02/11 5 Movectro (cladribine) CSR Media 26/01/11 Closed 07/02/11 0 COMP Litak (cladribine) Pharmaceutical industry 27/01/11 Closed 10/03/11 42 Inspection reports Inspection reports Pharmaceutical industry 28/01/11 Closed 08/02/11 0 Minutes Orphan designation products Pharmaceutical industry 28/01/11 Closed 18/02/11 10 AR Lumiracoxib (lumiracoxib) Pharmaceutical industry 03/02/11 Closed 24/02/11 129 Tasocitinib SA Legal 04/02/11 Closed 17/02/11 0 Combivir (lamivudine / zidovudine) Dossier, Mixed documents Legal 03/02/11 Closed 26/05/11 318 Thomas Lönngren Correspondence Media 07/02/11 Closed 16/02/11 2 AR NSAIDs Pharmaceutical industry 07/02/11 Closed 25/02/11 39 CSR Academia/Research Valdoxan (agomelatine) institute 10/02/11 Closed 16/05/11 39,149 PDCO Summary Rep Brilique (ticagrelor); Clopidogrel (clopidogrel) Pharmaceutical industry 11/02/11 Closed 15/02/11 0 Module 5 Academia/Research Duloxetines 10/02/11 Batch Release 25/02/13 institute 70,011 Movectro (cladribine) CSR Media 11/02/11 Closed 03/03/11 254,251 Arielle North DOI Media 11/02/11 Closed 15/02/11 5 CHMP SA Academia/Research Xarelto (rivaroxaban) institute 29/12/10 Closed 14/03/11 23 Lyrica (pregabalin) PSUR Media 15/02/11 Closed 26/04/11 2,378 Zyprexa (olanzapine) PSUR Media 15/02/11 Closed 29/03/11 2,022 Somatropin Referral documents Regulator outside EU 17/02/11 Closed 28/02/11 0 Benfluorex (Mediator) Mixed documents Media 24/02/11 Closed 31/05/11 136 AR, OP Academia/Research Amfepramone institute 04/02/11 Closed 24/02/11 117 Somatropin SAGhE study, Referral Regulator outside EU 18/02/11 Closed 02/03/11 0 AR, minutes, CSR Avonex (interferon beta-1a) Healthcare professional 25/02/11 Closed 18/04/13 806 Thomas Lönngren Correspondence Media 22/02/11 Closed 15/03/11 0 Correspondence Thomas Lönngren EU Institution (EC etc) 10/02/11 Closed 01/03/11 2 Agreal (veralipride) Referral documents General Public 04/02/11 Closed 10/03/11 404 Downloaded From: https://jamanetwork.com/ on 10/02/2021 Category of documents Category of documents Affiliation according to Closed Product / subject Pages requested requested social and occupational Received Pending Replied released DOSSIER NON-DOSSIER profile Open Agreal (veralipride) Referral documents General Public 09/02/11 Closed 10/03/11 404 Thomas Lönngren Correspondence Media 11/02/11 Closed 04/03/11 0 Correspondence Thomas Lönngren EU Institution (EC etc) 07/03/11 Closed 11/03/11 0 Contracts Academia/Research EMA contracts institute 19/08/11 Closed 29/09/11 0 SAGhE study, Referral Somatropin Pharmaceutical industry 13/01/11 Closed 04/03/11 0 Modafinil DHPC Media 03/03/11 Closed 10/03/11 2 DHPC Simponi (golimumab) Healthcare Professional 09/03/11 Closed 28/03/11 1 PSUR Feligen (feline vaccine); Leucogen (feline vaccine) EU NCA 09/03/11 Closed 15/03/11 0 Roaccutane (isotretinoin) XML, Variables Media 01/03/11 Closed 22/03/11 64 Referral documents Buflomedil Pharmaceutical industry 21/03/11 Closed 09/09/11 1,080 Combivir (lamivudine / zidovudine) Dossier, Mixed documents Legal 21/03/11 Closed 25/03/11 49 LoU Lucentis (ranibizumab) Pharmaceutical industry 21/03/11 Closed 12/04/11 5 AR Abilify (aripiprazole) Pharmaceutical industry 22/03/11 Closed 13/04/11 26 Presentations GCP Pharmaceutical industry 08/03/11 Closed 17/05/11 134 PIP Vfend (voriconazole); Eclasta; Candidas Pharmaceutical industry 28/03/11 Closed 19/04/11 77 Fluoroquinolones PhVWP docs Regulator outside EU 11/03/11 Closed 27/04/11 54 Tarceva (erlotinib) DoI, SAG Minutes Media 29/03/11 Closed 20/04/11 39 Valdoxan (agomelatine) PSUR Media 29/03/11 Closed 16/05/11 335 Vantas AR Media 29/03/11 Closed 12/04/11 11 SAGhE study, Referral Somatropin Pharmaceutical industry 30/03/11 Closed 19/04/11 0 3rd party documents Feraheme Pharmaceutical industry 24/03/11 Closed 31/03/11 0 Methylphenidate Letter Media 31/03/11 Closed 11/04/11 0 SWP Guideline Legal 16/04/11 Closed 11/05/11 12 HMPC HMPC Pharmaceutical industry 14/04/11 Closed 10/05/11 15 PIP Midostaurin Pharmaceutical industry 14/04/11 Closed 24/04/11 0 Thomas Lönngren Correspondence Media 19/04/11 Closed 13/05/11 1 Cymbalta (duloxetine) PSUR Legal 21/04/11 Closed 10/01/12 4,027 Minutes, Report Telematics Pharmaceutical industry 20/04/11 Closed 20/06/11 18 Report Telematics Pharmaceutical industry 21/04/11 Closed 20/06/11 18 Tienam AR Media 21/04/11 Closed 18/05/11 59 Vantas AR Media 21/04/11 Closed 17/05/11 38 Agreal (veralipride) AR, Minutes, LoQ, LoOI General Public 19/04/11 Closed 25/05/11 496 AR Triclabendazole (ivermectin, triclabendazole) Pharmaceutical industry 05/04/11 Closed 13/04/11 0 MoU MoU Pharmaceutical industry 03/05/11 Closed 09/06/11 4 Diacomit (stiripentol); Fabrazyme (agalsidase beta); COMP Pedea (ibuprofen) Patients organisation 09/05/11 Closed 13/05/11 32 Minutes Pandemrix (pandemic influenza vaccine) EU Institution (EC etc) 06/05/11 Closed 27/05/11 2 Fluoroquinolones PhVWP AR Regulator outside EU 23/03/11 Closed 27/04/11 54 SA Palexia Pharmaceutical industry 31/05/11 Closed 22/07/11 0 PIP Circadin (melatonin) Healthcare Professional 13/05/11 Closed 06/06/11 0 RoActemra (tocilizumab) AR, CTD Legal 16/05/11 Closed 13/02/12 30,788 Minutes Buflomedil Pharmaceutical industry 18/05/11 Closed 30/05/11 0 Efexor Referral General Public 19/05/11 Closed 03/04/12 7,741 AR, PIP Mircera (methoxy polyethylene glycol-epoetin beta) Pharmaceutical industry 20/05/11 Closed 14/11/11 3,711 Remicade (infliximab) Correpondence, CTR, AR Legal 24/05/11 Closed 06/12/12 46,979 Valdoxan (agomelatine) PSUR Media 29/03/11 Closed 16/05/11 185 Mixed documents Academia/Research Actos (pioglitazone) institute 20/06/11 Closed 11/01/12 0 Paracetamol PhVWP AR Media 31/05/11 Closed 27/06/11 31 Downloaded From: https://jamanetwork.com/ on 10/02/2021 Category of documents Category of documents Affiliation according to Closed Product / subject Pages requested requested social and occupational Received Pending Replied released DOSSIER NON-DOSSIER profile Open Acomplia (rimonabant) AR, Dossier General Public 13/05/11 Closed 10/08/11 108,890 Minutes H1N1 (pandemic influenza vaccine) EU Institution (EC etc) 07/06/11 Closed 28/06/11 6 AR Academia/Research Xolair (omalizumab) institute 19/05/11 Closed 07/07/11 195 Isomeride DOI Media 20/06/11 Closed 22/06/11 1 Presentation Ken Woods Pharmaceutical industry 20/06/11 Closed 22/06/11 19 IFAH paper, study Academia/Research RD114 institute 24/06/11 Closed 14/07/11 1 Mixed documents EllaOne (ulipristal acetate) Healthcare Professional 28/06/11 Closed 25/11/11 0 PIP, PDCO Clopidogrel (clopidogrel) Pharmaceutical industry 26/06/11 Closed 25/07/11 110 Referral Tranexamic acid Pharmaceutical industry 29/06/11 Closed 27/07/11 64 Dossier Prevenar Pharmaceutical industry 05/07/11 Closed 18/11/11 3,892 QWP QWP Pharmaceutical industry 13/07/11 Closed 14/07/11 5 Cymbalta (duloxetine) PSUR Legal 25/03/11 Closed 11/01/12 4,027 DOI Xgeva (denosumab) Pharmaceutical industry 27/07/11 Closed 09/08/11 44 CSR
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