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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.

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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 RMP Telmisartan (hydrochlorothiazide) Pharmaceutical industry 10/04/12 Closed 03/05/12 275 Januvia (sitagliptin) AR General Public 10/04/12 Closed 10/04/12 13 Replagal (agalsidase alfa) Dossier Media 11/04/12 Closed 16/05/12 0 Quinoflox; Selenate Referrals Legal 03/04/12 Closed 17/04/12 0 Epivir (lamivudine) Dossier Legal 12/04/12 Closed 07/05/12 48 Combivir (lamivudine / zidovudine) Dossier Legal 12/04/12 Closed 04/05/12 11 Module 2.5 + 2.7 + 5 (study CHMP LoQ, CHMP LoOI NO25026), LoQ Responses, LoOI Zelboraf (vemurafenib) Responses, RMP Pharmaceutical industry 17/04/12 Batch Release 26/10/12 127 SPC (Adult use) Academia/Research Humira (adalimumab) institute 17/04/12 Closed 17/04/12 0 Biosimilar Guideline - Quality Guideline Legal 23/04/12 Closed 14/05/12 56 Guideline Biosimilar Guideline - Non-Clinical & Clinical Issues Legal 23/04/12 Closed 04/05/12 44 Biosimilar Guideline - 3rd Party comments Guideline Legal 25/04/12 Closed 04/05/12 29 ATMP data Academia/Research CAT-ATMP institute 24/04/12 Closed 22/05/12 8 ADR Gilenya (fingolimod) Pharmaceutical industry 25/04/12 Closed 21/05/12 2,490 ADR Velcade (bortezomib) Healthcare Professional 24/04/12 Closed 09/05/12 32 RMP Esbriet (pirfenidone) Pharmaceutical industry 30/04/12 Closed 03/05/12 0 Binocrit (epoetin alpha) Correspondence Legal 04/05/12 Closed 10/05/12 2 Studies MS studies Patients organisation 08/05/12 Closed 08/06/12 0 PSUR Gilenya (fingolimod) Pharmaceutical industry 10/05/12 Closed 09/07/12 1,247 PecFent (fentanyl); Instanyl (fentanyl) PSUR, AR Media 14/05/12 Closed 27/07/12 215 Decitabine SA Regulator outside EU 15/05/12 Closed 22/06/12 0 Studies Octagam Pharmaceutical industry 15/05/12 Closed 08/06/12 13 CHMP Var AR Lucentis (ranibizumab) Healthcare Professional 20/05/12 Closed 07/06/12 25 Citalopram; Escitalopram AR Media 18/05/12 Closed 11/06/12 68 Comparability Guideline 3rd party documents Legal 22/05/12 Closed 07/06/12 41 CHMP Var AR Lucentis (ranibizumab) Pharmaceutical industry 22/05/12 Closed 07/06/12 25 Biosimilar Guideline - Immunogenicity Guideline Legal 23/05/12 Closed 07/06/12 174 AR ATMP classification Healthcare Professional 23/05/12 Closed 11/06/12 6 Zyvox (linezolid) PSUR General Public 23/05/12 Closed 23/05/12 0 Correspondence Buflomedil Pharmaceutical industry 24/05/12 Closed 31/05/12 5 Gilenya (fingolimod) Module 2.5, PSUR, RMP General Public 01/06/12 Closed 26/11/12 3,486 AR Levomethadone Pharmaceutical industry 25/05/12 Closed 07/06/12 0 Side effects Academia/Research Trilostane institute 28/05/12 Closed 19/06/12 2,796 Byetta () EPAR Media 30/05/12 Closed 12/06/12 36 Inspection reports Inspection Reports Media 30/05/12 Closed 15/06/12 8 Mesilate salts; Sulfonic acid salts QWP reports Consultant 31/05/12 Closed 01/08/12 8 Mesilate salts; Sulfonic acid salts SWP reports Consultant 31/05/12 Closed 11/06/12 0 GCP Inspections Inspection Reports Consultant 11/05/12 Closed 10/07/12 10 Presentation slides EnPR Pharmaceutical industry 04/06/12 Closed 07/06/12 0 Silgard (human papillomavirus vaccine); Cervarix CSR Not-for-profit (human papillomavirus vaccine) organisation 07/06/12 Closed 22/06/12 330 Eviplera (emtricitabine / rilpivirine / tenofovir Module 1.1 + 2.4 + 2.5 + 2.6 + disoproxil) 2.7 Pharmaceutical industry 08/06/12 Batch Release 19/12/12 775 CHPM opnion Ketoconazole Pharmaceutical industry 08/06/12 Closed 20/06/12 45 Roaccutane (isotretinoin) Dossier Media 09/06/12 Closed 20/06/12 13,540 Duloxetines: CHMP AR Ariclaim; Cymbalta Media 11/06/12 Closed 12/06/12 0 Module 1 + 2 + 3 + 4 + 5 (Var), D60 Rapp AR, D80 CHMP Cymbalta (duloxetine) RSI Responses Comments, D90 RSI Consultant 13/06/12 Batch Release 15/03/13 47,764 Xyrem () AR Consultant 13/06/12 Closed 19/04/13 29,682 Xarelto (rivaroxaban) PSUR (latest) CHMP AR Media 13/06/12 Closed 20/07/12 3,004 Binocrit (epoetin alpha) Labelling Media 15/06/12 Closed 25/07/12 13 Enantiomer 3rd party documents Legal 18/06/12 Closed 02/07/12 1

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 COMP Opinion, LoQs, Minutes Zilcamva (maribavir) Pharmaceutical industry 18/06/12 Closed 20/06/12 0 Orphan drug dossier Esbriet (pirfenidone) Pharmaceutical industry 20/06/12 Closed 03/07/12 556 ERA Ceftazidime Pharmaceutical industry 20/06/12 Closed 20/06/12 0 Inspection Reports Phv Inspection Reports Pharmaceutical industry 22/06/12 Closed 29/06/12 0 RMP Glivec (imatinib) Pharmaceutical industry 22/06/12 Closed 26/07/12 167 Vincenzo Salvatore Mixed documents Media 26/06/12 Closed 01/08/12 14 Humira (adalimumab) All ATDs Legal 26/06/12 Closed 17/07/12 0 PSUR Naglazyme (galsulfase) Patients organisation 26/06/12 Closed 18/07/12 0 Diflucan (fluconazole) AR Media 28/06/12 Closed 09/08/12 511 AR Tolperisone Pharmaceutical industry 28/06/12 Closed 12/07/12 0 Inspection Report Inspection Reports Consultant 28/06/12 Closed 29/06/12 0 SR PDCO decisions Pharmaceutical industry 29/06/12 Closed 10/07/12 60 Public procurements List of tenders Consultant 10/07/12 Closed 16/07/12 10 Xavier Luria Oller Mixed documents Media 04/07/12 Closed 30/07/12 26 Staphylococcus Designation Media 04/07/12 Closed 16/07/12 0 Lantus () AR Media 01/07/12 Closed 04/07/12 35 Byetta: Module 4.2.3.4 + 4.2.3.5 Bydureon: Module 4.2.3.2 + 4.2.3.4 + 4.2.3.5 Byetta (exenatide); Bydureon (exenatide) Pharmaceutical industry 05/07/12 Closed 26/11/12 21,321 MabCampath (alemtuzumab); Yervoy (ipilimumab); (Co-)Rapp D80 AR, D150 JAR Arzerra (ofatumumab) Pharmaceutical industry 09/07/12 Closed 30/07/12 919 Biosimilar Guideline - Comparability & Quality 3rd party documents Legal 10/07/12 Closed 17/07/12 13 PDCO decisions PDCO Decisions Media 09/07/12 Closed 10/07/12 9 PIP Hizentra (human normal immunoglobulin) Pharmaceutical industry 11/07/12 Closed 17/07/12 0 Validation check lists SME Validation Pharmaceutical industry 17/07/12 Closed 07/08/12 78 Nimesulide Meeting minutes Media 19/07/12 Closed 31/08/12 3 Infanrix Hexa Dossier General Public 19/07/12 Closed 27/07/12 107 Zinacef; Zinnaf AR Consultant 20/07/12 Closed 24/07/12 0 Keppra (levetiracetam) CHMP conclusions on PSUR Consultant 20/07/12 Closed 03/08/12 2 Studies Calcitonin Healthcare Professional 23/07/12 Closed 29/08/12 0 MAA CHMP Opinion Forxiga () Pharmaceutical industry 13/07/12 Closed 10/08/12 0 List of own documents Boehringer Ingelheim Pharmaceutical industry 23/07/12 Closed 25/07/12 0 Fendimetrazina Dossier General Public 16/07/12 Closed 01/08/12 46 HRT CHMP reports Legal 24/07/12 Closed 27/07/12 25 Module 1 + 2 + 3 + 4 + 5 AR, CHMP Opinion, CHMP Minutes, WP Minutes, SAGs Minutes, CHMP Comments, SA, Revlimid (lenalidomide) Co-Rapp reports, RSI Legal 25/07/12 Batch Release 04/04/13 1,400 RMP Actos (pioglitazone) Pharmaceutical industry 26/07/12 Closed 06/08/12 0 Remicade (infliximab) PIP Legal 26/07/12 Closed 21/09/12 0 Dossier Vidaza (azacitidine) Pharmaceutical industry 26/07/12 Closed 10/08/12 0 Studies, AR Calcitonin Healthcare Professional 27/07/12 Closed 14/08/12 0 CSR Anti-retroviral therapy in HIV-infected populations Healthcare Professional 30/07/12 Closed 22/08/12 1,534 Studies Calcitonin Healthcare Professional 30/07/12 Closed 20/08/12 0 RMP Innovator Products Pharmaceutical industry 31/07/12 Closed 09/11/12 2,031 Remicade (infliximab) SPC, PIP Legal 31/07/12 Closed 23/10/12 2,646 PIP Vandetanib Pharmaceutical industry 01/08/12 Closed 03/08/12 0 Module 5 Anti-depressants: Citalopram, Escitalopram, Fluoxetine, Fluvoxamine, Paroxetine, Sertraline, , Milnacipran, Academia/Research Mirtazapine, Duloxetine, Reboxetine, institute 01/08/12 Batch Release 05/03/13 65,904

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 MRL Report Academia/Research Altrenogest institute 02/08/12 Closed 15/08/12 979 Studies Calcitonin Healthcare Professional 08/08/12 Closed 20/08/12 0 CSR Januvia (sitagliptin) Pharmaceutical industry 03/08/12 Closed 15/08/12 5,641 Dossier Indacaterol (onbrez breezhaler) Pharmaceutical industry 06/08/12 Closed 06/11/12 1,204 Resending of 2010+2011 replies Acomplia (rimonabant) Legal 08/08/12 Closed 08/08/12 0 Module 1 + 2 + 3 + 4 + 5 Esbriet (pirfenidone) Pharmaceutical industry 09/08/12 Pending Pending 0 Ketek (telithromycin); Byetta (exenatide) GCP Media 10/08/12 Closed 31/08/12 200 Rebif (interferon beta-1a); Extavia (interferon beta- PSUR, RMP, Module 2.5 1a); Pegasys (peginterferon alfa-2a); Cimzia (certolizumab pegol); Advate (octocog alfa); BeneFIX (nonacog alfa) Pharmaceutical industry 10/08/12 Closed 29/01/13 13,118 Protelos (strontium ranelate) AR Media 10/08/12 Closed 20/08/12 59 CHMP reports Lactobacillus tampons Pharmaceutical industry 10/08/12 Closed 03/09/12 11 Zimulti/Acomplia (rimonabant) Dossier Legal 10/08/12 Closed 29/11/12 2,618 Remicade (infliximab) CSR Consultant 12/08/12 Closed 03/09/12 66 Avastin (bevacizumab) Module 2.4+2.6 Consultant 16/08/12 Closed 27/09/12 337 Correspondence EMA & MAH, Correspondence EMA & 3rd MAH Presentations to EMA parties, EMA internal Humira (adalimumab) correspondence Legal 17/08/12 Closed 29/10/12 0 Havrix Vaccine PSUR General Public 18/08/12 Closed 11/12/12 3,974 Remicade (infliximab) CTD module 4 Consultant 20/08/12 Closed 03/09/12 299 Protelos (strontium ranelate) AR Media 21/08/12 Closed 05/09/12 12 Financial, budget and fee Pharmacovigilance fees estimates Legal 21/08/12 Closed 29/11/12 40 Humira (adalimumab); Enbrel (etanercept); Simponi Module 2.5 + 5 CHMP Opinion (golimumab) Pharmaceutical industry 21/08/12 Closed 09/11/12 337 Calcitonin Studies General Public 22/08/12 Closed 22/08/12 0 Tasigna (nilotinib) Orphan designation EU NCA 20/08/12 Closed 07/09/12 684 Module 4.2.3.3 Forcaltonin (calcitonin salmon recombinant) Pharmaceutical industry 24/08/12 Closed 27/09/12 4 Intanza (influenza vaccine); Optaflu (influenza SPC vaccine) Media 23/08/12 Closed 29/08/12 0 Biopoin (epoetin theta) Module 1 + 2 + 3 + 4 + 5 General Public 10/09/12 Batch Release 04/04/13 2,080 Module 5 (Animal studies) Academia/Research Tamiflu (oseltamivir) institute 02/09/12 Closed 20/11/12 2,149 Zyvox (linezolid) PSUR General Public 02/09/12 Closed 21/09/12 75 Module 2 CHMP LoQ, ARs, Minutes from Academia/Research Binocrit (epoetin alpha) Oral Hearings institute 04/09/12 Batch Release 04/04/13 280 Module 2 CHMP LoQ, ARs, Minutes from Academia/Research Nivestim (filgrastim) Oral Hearings institute 04/09/12 Pending Pending 0 Module 2 CHMP LoQ, ARs, Minutes from Academia/Research Retacrit (epoetin zeta) Oral Hearings institute 04/09/12 Closed 08/03/13 1,096 Module 2, AR Academia/Research Tevagrastim (filgrastim) institute 04/09/12 Closed 05/04/13 716 Module 2 CHMP LoQ, ARs, Minutes from Academia/Research Zarzio (filgrastim) Oral Hearings institute 04/09/12 Pending Pending 0 Dossier Sutent (sunitinib) Pharmaceutical industry 05/09/12 Closed 13/09/12 388 Dossier Alimta (pemetrexed) Pharmaceutical industry 05/09/12 Closed 19/10/12 2,885 Keppra (levetiracetam) SPC, Specifications (quality?) Regulator outside EU 06/09/12 Closed 07/09/12 167 Tavanic (levofloxacin) Referrals Media 06/09/12 Closed 21/11/12 865 Zinnat (cefuroxime axetil) CHMP AR Media 06/09/12 Closed 21/11/12 779 Tazocin (piperacillin; tazobactam) Referrals Media 06/09/12 Closed 13/02/13 948 Merial (fipronil, praziquantel, s methoprene, EVVet reports eprinomectin) General Public 01/06/12 Closed 18/09/12 16 Calcitonin CSR General Public 07/09/12 Closed 27/09/12 0 AR Calcitonin Pharmaceutical industry 10/09/12 Closed 03/10/12 432 Ketek (telithromycin) PSUR (latest) Rapp AR Media 10/09/12 Closed 18/10/12 2,356 IRR for study V87P4 Inspection Reports General Public 27/09/12 Closed 02/10/12 0 Zinnat (cefuroxime axetil) EPAR Consultant 10/09/12 Closed 01/10/12 71 Teduglitide (Revestive) EPAR General Public 11/09/12 Closed 11/09/12 0 Zinforo (ceftaroline fosamil) EPAR Consultant 13/09/12 Closed 14/09/12 0

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 CHMP LoQ, LoI Brilique (ticagrelor) Pharmaceutical industry 14/09/12 Closed 25/10/12 2,044 Roche Inspection Inspection Reports Legal 14/09/12 Closed 18/09/12 0 Votubia (everolimus) PL, Mock-ups Media 18/09/12 Closed 27/09/12 17 CHMP Var AR Lucentis (ranibizumab) Pharmaceutical industry 14/09/12 Closed 01/10/12 25 CSR Cystadane (betaine anhydrous) Pharmaceutical industry 25/09/12 Closed 16/10/12 10 PSUR 7 CHMP AR Pradaxa (dabigatran etexilate) Pharmaceutical industry 19/09/12 Closed 14/12/12 1,000 Angiox (bivalirudin) PIL Legal 19/09/12 Closed 12/10/12 0 Levemir () EPAR, AR Media 20/09/12 Closed 12/10/12 0 RMP Mirapexin (pramipexole); Sifrol (pramipexole) Pharmaceutical industry 20/09/12 Closed 12/10/12 648 RMP AR Zavesca (miglustat) Pharmaceutical industry 25/09/12 Closed 02/10/12 13 RMP Dossier Levodopa; Carbidopa; Entacapone Pharmaceutical industry 25/09/12 Closed 29/10/12 0 Dossier Clopidgorel BMS Pharmaceutical industry 25/09/12 Closed 29/10/12 0 Zinacef (cefuroxime sodium); Zinnat (cefuroxime EPAR axetil) Consultant 25/09/12 Closed 01/10/12 71 RMP Omeprazole Pharmaceutical industry 26/09/12 Closed 01/10/12 0 AR Thymi herba/Primula radix Pharmaceutical industry 28/09/12 Closed 04/10/12 32 Referrals Trimetazidine Pharmaceutical industry 28/09/12 Closed 19/10/12 3 Remicade (infliximab) CSR Consultant 01/10/12 Closed 13/02/13 601 Remicade (infliximab) AR, Dossier, PIP Legal 01/10/12 Closed 06/11/12 2,520 Module 2.7 Initial MAA + all Avastin (bevacuzimab) updates Consultant 02/10/12 Batch Release 15/03/13 685 Biosimilars Q&A Other 15/10/12 Closed 16/10/12 2 CHMP Reports CHMP reports Legal 03/10/12 Closed 04/10/12 0 CHMP AR (incl attachments) Var Norvir (ritonavir) II/0114 Media 03/10/12 Closed 12/10/12 172 CSR Calcitonin Pharmaceutical industry 02/10/12 Closed 12/10/12 0 PV data Zuprevo (tildipirosin) Pharmaceutical industry 01/10/12 Closed 05/10/12 19 Dossier Inlyta (axitinib) Pharmaceutical industry 05/10/12 Closed 15/02/13 588 Adenuric (febuxostat) Dossier Regulator outside EU 08/10/12 Closed 29/10/12 0 PDCO Decisions Orencia (abatacept) Pharmaceutical industry 08/10/12 Closed 22/10/12 10 Kivexa (abacavir / lamivudine) CSR Legal 08/10/12 Closed 05/11/12 2,683 Correspondence Somatropin Pharmaceutical industry 04/10/12 Closed 08/11/12 1 Module 5, MAH responses, ToC (Co-)Rapp Art 20 report, CHMP Actos (pioglitazone) comments, Minutes Legal 23/10/12 Batch Release 27/03/13 406 Dossier Calcitonin Pharmaceutical industry 11/10/12 Closed 13/11/12 0 Consultation Ferriprox (deferiprone) EU Institution (EC etc) 11/10/12 Closed 11/10/12 0 Galvus (vildagliptine) AR, Var Media 11/10/12 Closed 25/10/12 171 Lentiviral vector COMP opinion Legal 15/10/12 Closed 17/10/12 4 All ATDs Biopoin (epoetin theta) Pharmaceutical industry 15/10/12 Closed 26/10/12 1 Toxicity data Academia/Research Anti-malaria medicines institute 15/10/12 Closed 14/12/12 5,105 Sycrest (asenapine) PSUR, AR Media 16/10/12 Closed 07/02/13 962 MabThera (rituximab) Module 5 Consultant 16/10/12 Pending Pending 0 RotaTeq (rotavirus vaccine); Zostvax (shingles Dossier vaccine) Consultant 16/10/12 Closed 17/10/12 0 Summary Reports Orphan designation products Pharmaceutical industry 17/10/12 Closed 17/10/12 0 Replagal (agalsidase alfa); Fabrazyme (agalsidase AR Academia/Research beta) institute 17/10/12 Closed 30/10/12 68 Urtica CHMP reports EU NCA 18/10/12 Closed 27/11/12 0 Infanrix Hexa Withdrawal announcement General Public 12/10/12 Closed 06/11/12 9 CHMP Guideline CHMP Guideline General Public 16/10/12 Closed 19/10/12 32 AR, Correspondence, CHMP Pandemrix (pandemic influenza vaccine) reports Media 22/10/12 Closed 25/01/13 0

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 RMP Mono Tildem (diltiazem) Pharmaceutical industry 19/10/12 Closed 29/10/12 0 PSUR Academia/Research Prolia (denosumab) institute 23/10/12 Closed 26/11/12 0 PSURs Academia/Research Tamiflu (oseltamivir) institute 23/10/12 Batch Release 18/03/13 11,377 List of studies Academia/Research Priority list institute 24/10/12 Closed 12/11/12 41 Ketek (telithromycin) PSUR 21 Media 25/10/12 Closed 05/11/12 0 SWP reports PEGylated drug products Pharmaceutical industry 26/10/12 Closed 15/11/12 0 COMP minutes Nimorazole Pharmaceutical industry 30/10/12 Closed 05/11/12 119 PSUR Kaletra (lopinavir / ritonavir) Healthcare Professional 05/11/12 Closed 13/12/12 488 Inspection reports Inspection reports Media 05/11/12 Closed 26/11/12 3 Paediatric Vaccines EPARs? General Public 06/11/12 Closed 13/11/12 0 All ATDs & Responses + Humira (adalimumab) Documents released Legal 08/11/12 Closed 13/11/12 8,707 Decision for suspension Aprotinin Pharmaceutical industry 08/11/12 Closed 07/12/12 0 ATDs Enbrel (etanercept) Pharmaceutical industry 12/11/12 Closed 12/11/12 0 GCP Inspection reports General Public 12/11/12 Closed 28/11/12 0 Hexaxim (diphtheria, tetanus, pertussis, hepatitis B) SPC, EPAR Regulator outside EU 09/11/12 Closed 12/11/12 0 Module 5 (Pivotal Studies) Academia/Research Humira (adalimumab) institute 13/11/12 Closed 28/05/13 0 CSR Calcitonin Pharmaceutical industry 22/11/12 Closed 10/12/12 0 RMP Travatan (travoprost) Pharmaceutical industry 14/11/12 Closed 04/12/12 800 LoQ Responses, RMP, PSUR, PIP, D120 + 180 + 210 CHMP AR, Module 1 + 2, eCTD ToC COMP AR Colobreathe (colistimethate sodium) Consultant 14/11/12 Pending Pending 0 LoQ Responses, RMP, PSUR, PIP, D120 + 180 + 210 CHMP AR, Module 1 + 2, eCTD ToC COMP AR Cayston (aztreonam) Consultant 14/11/12 Pending Pending 0 LoQ Responses, LoOI Responses, SA, CHMP LoQ, CHMP LoOI, JAR, RMP, Module 2, List of post- approval commitments, PIP Dificlir (fidaxomicin) Consultant 14/11/12 Batch Release 07/03/13 20,714 RMPs RMPs Media 14/11/12 Closed 17/01/13 0 Tovanor Breezhaler (glycopyrronium bromide) Dossier Legal 15/11/12 Closed 01/02/13 2 Seebri Breezhaler (glycopyrronium bromide) Dossier Legal 15/11/12 Closed 06/12/12 0 Enurev Breezhaler (glycopyrronium bromide) Dossier Legal 15/11/12 Closed 01/02/13 2 MabCampath (alemtuzumab) ToC Module 1-5 Legal 15/11/12 Closed 12/12/12 29 Module 1.8.2 + 1.10 + 2.4 + 2.5 + 2.6.6 + 2.7.2 + 2.7.3 + 2.7.4 Forxiga (dapagliflozin) Pharmaceutical industry 19/11/12 Batch Release 19/12/12 3,284 Pandemrix (pandemic influenza vaccine) AR Media 19/11/12 Closed 21/01/13 0 Chemical substances CHMP decisions Legal 21/11/12 Closed 13/12/12 11 HMPC decisions Thymi herba/Primulae radix Pharmaceutical industry 23/11/12 Closed 10/12/12 0 Lucentis (ranibizumab) CHMP Var AR Consultant 23/11/12 Closed 12/12/12 25 Osteoporosis CPMP Guideline Legal 22/11/12 Closed 26/11/12 8 MAH documents Third-party documents Pharmaceutical industry 20/11/12 Closed 06/12/12 0 AR Academia/Research Diovan (valsartan) institute 15/11/12 Closed 06/12/12 13 Complaint Ombudsman EU Institution (EC etc) 27/11/12 Closed 13/12/12 0 Module 4 Cimzia (certolizumab pegol) Pharmaceutical industry 29/11/12 Closed 22/01/13 421 AR Academia/Research Irbesartan Zentiva institute 30/11/12 Closed 10/12/12 16 Obinutuzumab COMP opinion Consultant 30/11/12 Closed 19/12/12 0 RMP Academia/Research Xgeva (denosumab) institute 06/12/12 Closed 28/01/13 1,099 PSUR Academia/Research Prolia (denosumab) institute 03/12/12 Closed 01/02/13 1,268 Byetta (exenatide) Module 2.7 + 4 SA, DoI, AR, LoQ, LoOI Media 11/12/12 Batch Release 29/04/13 2,507 Bydureon (exenatide) Module 2.7 + 4 SA, DoI, AR, LoQ, LoOI Media 11/12/12 Batch Release 29/04/13 5,944 Module 1 + 2 + 3 + 4 + 5 from Fluenz (influenza vaccine) Initial MAA Pharmaceutical industry 05/12/12 Batch Release 13/03/13 681

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 CHMP Opinion+AR, D90 RSI, Torisel (Temsirolimus) SAG, CHMP minutes+ToD Pharmaceutical industry 06/12/12 Batch Release 29/04/13 83 Module 1.2 + 2.2 + 2.4 + 2.5 + Eylea (aflibercept) 2.6 + 2.7 + 3 + 5 Consultant 06/12/12 Batch Release 09/04/13 83 Module 1.2 + 2.2 + 2.4 + 2.5 + Lucentis (ranibizumab) 2.6 + 2.7 + 3 + 5 Consultant 06/12/12 Batch Release 03/04/13 1,164 CHMP Similarity report, SA, Protocal Assistance, (Co-)Rapp D80 AR, D120 LoQ, D150 JAR, D180 LoOI, Overview final JAR, CHMP AR+Opinion+Minutes, SAG advise Pixuvri (pixantrone dimaleate) Pharmaceutical industry 06/12/12 Batch Release 03/04/13 121 (Co-)Rapp D80 AR, D120 LoQ, D150 JAR, CHMP LoOI, JAR, CHMP LoQ, CHMP AR+Opinion+Minutes, SAG Adcetris (brentuximab vedotin) advise+Minutes Pharmaceutical industry 06/12/12 Batch Release 04/04/13 177 Module 3.2.S.3 + 3.2.S.4 + 3.2.S.2.6 + 3.2.P.2 + 3.2.P.5.4 Cimzia (certolizumab pegol) Pharmaceutical industry 07/12/12 Closed 14/12/12 0 QRD Templates QRD Templates Consultant 07/12/12 Closed 11/12/12 533 ATMP data Academia/Research Betagraft institute 28/11/12 Closed 17/12/12 14 Studies Academia/Research Irbesartan Zentiva institute 11/12/12 Closed 14/01/13 131 MS Vaccines ADR General Public 12/12/12 Closed 21/02/13 20,837 Module 2.2 + 2.4 + 2.5 + 2.6 + Forxiga (dapagliflozin) 2.7 + 3 + 4 + 5 Consultant 14/12/12 Batch Release 19/12/12 2,234 ToC Module 1-5, Module 2 + 5, SA Afinitor (everolimus) RMP Pharmaceutical industry 19/12/12 Batch Release 13/03/13 385 Alum absorbed vaccines Correspondence Legal 19/12/12 Closed 25/01/13 12 AR General Public 19/12/12 Closed 14/01/13 0 Avastin (bevacizumab) CHMP AR Consultant 19/12/12 Closed 14/01/13 0 DuoPlavin ToC+Module 2.6 + 2.7 Legal 21/12/12 Closed 28/05/13 0 Seebri Breezhaler Specimens, Mock-ups Media 21/12/12 Closed 28/01/13 27 Januvia Module 2.7 + 4 Media 04/01/13 Batch Release 29/04/13 2,757 Lyxumia () Module 2.7 + 4 Media 04/01/13 Batch Release 29/04/13 2,210 Trajenta Module 2.7 + 4 Media 04/01/13 Batch Release 29/04/13 5,247 Jentadueto Module 2.7 + 4 Media 04/01/13 Batch Release 29/04/13 3,864 Spiriva (tiotropium bromide) Module 5 Dossier Consultant 05/01/13 Closed 08/01/13 0 Adcetris (brentuximab vedotin) AR appendix I Legal 08/01/13 Closed 01/02/13 2 Vepacel CHMP reports Legal 08/01/13 Closed 24/01/13 5 Memantine Merz (memantine hydrochloride) CHMP reports Legal 08/01/13 Closed 22/01/13 44 PSUR Enbrel (etanercept) Pharmaceutical industry 09/01/13 Closed 14/01/13 0 Cetero Module 5 Media 09/01/13 Batch Release 26/04/13 232 CHMP AR, CAT Opinion, CAT AR Atorvastatin Pharmaceutical industry 09/01/13 Closed 18/02/13 0 CHMP AR, CAT Opinion, CAT AR Pharmaceutical industry 09/01/13 Closed 18/02/13 0 Atripla (efavirenz / emtricitabine / tenofovir Module 2 + 3 + 4 + 5 disoproxil fumarate) Pharmaceutical industry 10/01/13 Batch Release 09/04/13 1,261 Betaferon (interferon beta-1b) PSUR Legal 11/01/13 Pending Pending 0 Rebif (interferon beta-1a) PSUR Legal 11/01/13 Batch Release 08/02/13 478 PSUR Infanrix Hexa Healthcare professional 12/01/13 Closed 04/02/13 303 Contraceptive patch (ethinyl estradiol / levonorgestrel) CSR General Public 11/01/12 Closed 15/01/13 0 Contraceptive patch (ethinyl estradiol / gestodene) CSR General Public 11/01/12 Closed 15/01/13 0 MoU EMA & NCAs MoU EU NCA 14/01/13 Closed 15/01/13 4 RMP Herceptin (trastuzumab) Pharmaceutical industry 14/01/13 Closed 04/02/13 148 RMP CSR Diacerein Pharmaceutical industry 14/01/13 Closed 17/01/13 0 RMP Studies Glycerol formal Pharmaceutical industry 14/01/13 Closed 07/02/13 642 Module 5 (RELY study) Academia/Research Pradaxa (dabigatran) institute 14/01/13 Batch Release 20/03/13 5,332 Module 5 (AVERROES, Academia/Research Apixaban (apixaban) ARISTOTLE study) institute 14/01/13 Pending Pending 0 Module 5 (ROCKET) Academia/Research Xarelto (rivaroxaban) institute 14/01/13 Closed 25/02/13 296 RMP Herceptin (trastuzumab) Pharmaceutical industry 07/01/13 Closed 01/02/13 148

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 Avastin (bevacizumab) RMP CHMP AR EU NCA 09/01/13 Closed 28/01/13 17 Avastin (bevacizumab) RMP CHMP AR EU NCA 15/01/13 Closed 28/01/13 17 Module 2.5 + 2.7.4 + 2.7.3 + 2.4 + 2.6 Module 5 Module 3.2.P.1 Zyclara (iniquimod) PSUR (latest), PIP, RMP Consultant 15/01/13 Batch Release 15/03/13 169 Module 2.5 + 2.7.4 + 2.7.3 + 2.4 + 2.6 Module 5 Module 3.2.P.1 Picato (ingenol mebutate) PSUR (latest), PIP, RMP Consultant 15/01/13 Batch Release 15/03/13 423 CAT Classification Salmonella Typhi Pharmaceutical industry 15/01/13 Closed 28/01/13 11 Orphan Drug dossier Dacogen (Decibatine) Pharmaceutical industry 16/01/13 Closed 06/02/13 91 Victoza () Module 2.7+4 SA, DoI, AR, LoQ, LoOI Media 16/01/13 Batch Release 24/05/13 6,963 Withdrawn EPAR EPAR Consultant 21/01/13 Closed 19/03/13 0 CSR Clopidogrel apotex (Clopidogrel ) Healthcare professional 21/01/13 Closed 28/01/13 645 Minutes, Statements Art 10b Pharmaceutical industry 18/01/13 Closed 05/02/13 0 Abilify (aripiprazole) AR Media 22/01/13 Closed 08/02/13 0 Cialis (tadalafil) AR Media 22/01/13 Closed 08/02/13 0 Eucreas (/metformin hydrochloride) AR Media 22/01/13 Closed 11/02/13 0 Galvus (vildagliptin) AR Media 22/01/13 Closed 11/02/13 0 Humira (adalimumab) CHMP AR Media 22/01/13 Closed 08/02/13 0 AR Komboglyze (/metformin hydrochloride) Media 22/01/13 Closed 08/02/13 0 Orphan Drug dossier Vidaza (azacitidine) Pharmaceutical industry 23/01/13 Closed 07/02/13 108 Orphan Drug dossier Ceplene (histamine dihydrochloride) Pharmaceutical industry 23/01/13 Closed 07/02/13 110 Orphan Drug dossier N.N (Vosaroxin) Pharmaceutical industry 23/01/13 Closed 12/02/13 0 CHMP protocol Trimetazidine Art.31 referral Pharmaceutical industry 24/01/13 Closed 13/02/13 3 Avastin (bevacizumab) PSUR (latest), RMP (latest) Consultant 25/01/13 Pending Pending 0 RoActemra (tocilizumab) PSUR, RMP Consultant 25/01/13 Pending Pending 0 Stelara (ustekinumab) PSUR, RMP Consultant 25/01/13 Closed 27/03/13 256 Kineret (anakinra) PSUR, RMP Consultant 25/01/13 Closed 12/02/13 100 MabThera / Rituxan (rituximab) PSUR, RMP Consultant 25/01/13 Pending Pending 0 Tysabri (natalizumab) PSUR, RMP Consultant 25/01/13 Pending Pending 0 Avonex (interferon beta-1a) PSUR, RMP Consultant 25/01/13 Pending Pending 0 Spiriva (tiotropium bromide) PSUR, RMP Consultant 25/01/13 Closed 28/01/13 0 Vynase ( dimesylate) PSUR, RMP Consultant 25/01/13 Closed 01/02/13 0 Prolia / Xgeva (denosumab) PSUR, RMP Consultant 25/01/13 Closed 27/03/13 2,364 Seretide (salmeterol & fluticasone propionate) PSUR, RMP Consultant 25/01/13 Closed 28/01/13 0 CSR Fexofenadine Pharmaceutical industry 25/01/13 Closed 20/02/13 78 LoQ Responses Terfenadine Pharmaceutical industry 25/01/13 Pending Pending 0 Hexaxim (diphtheria, tetanus, pertussis, hepatitis b, Module 2.5 + 2.7, RMP LoQs, LoOIs, (Co-)Rapp AR, poliomyelitis, haemophilus influenzae type b CHMP written comments conjugate vaccine) Pharmaceutical industry 28/01/13 Batch Release 06/03/13 68 wAMD posology report Lucentis (ranibizumab) Pharmaceutical industry 31/01/13 Closed 01/02/13 0 HMPC Minutes Thyme herb/Primula Pharmaceutical industry 29/01/13 Closed 04/02/13 0 Zoely (nomegestrol/estradiol) Module 5 General Public 01/02/13 Closed 08/05/13 0 AR Academia/Research Ciprofloxacin institute 04/02/13 Closed 05/02/13 0 AR Academia/Research Propanolol institute 04/02/13 Closed 05/02/13 0 SPC Plavix (clopidogrel) Pharmaceutical industry 29/01/13 Closed 26/02/13 21 SA, DoI, AR, LoQ, LoI, CSR Media 04/02/13 Closed 27/03/13 0 Vildegliptin SA, DoI, AR, LoQ, LoI, CSR Media 04/02/13 Closed 27/03/13 0 Doxycycline SA, AR General Public 07/02/13 Closed 14/02/13 7 Metacam (meloxicam) PSUR, AR General Public 14/02/13 Closed 07/03/13 101

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 Module 5 Aclasta / Zometa / Actavis / Hospira / Zoledronic Academia/Research acid medic / Zoledronic acid mylan (zoledronic acid) institute 10/02/13 Closed 28/05/13 0 Module 5 Academia/Research Tamiflu (oseltamivir) institute 12/02/13 Pending Pending 0 Module 3.2 Cymbalta (Duloxetine) Pharmaceutical industry 12/02/13 Closed 21/02/13 0 CPMP Guideline CPMP Guideline EU NCA 12/02/13 Closed 25/02/13 0 ADR Academia/Research Asthma Medications institute 12/02/13 Closed 26/03/13 0 Imatinib Teva AS Legal 13/02/13 Closed 10/04/13 18 Tasigna (nilotinib) AS Legal 13/02/13 Closed 10/04/13 227 Incivo (telaprevir) CSR General Public 13/02/13 Closed 01/03/13 8 EMA/UK Seat Agreement Academia/Research EMA/UK Seat Agreement institute 13/02/13 Closed 04/03/13 6 Module 2.5 + 2.7, Co-Rapp AR, CHMP written comments, CHMP Prevanar 13 (pneumococcal polysaccharide AR & RSIs, CHMP Opinion conjugate vaccine (13-valent, adsorbed)) Pharmaceutical industry 13/02/13 Pending Pending 0 PDCO summary report Jakavi () Pharmaceutical industry 14/02/13 Closed 05/03/13 38 CVMP EPMAR Not-for-profit Phenylbutazone organisation 18/02/13 Closed 18/02/13 9 PSUR, CSR Academia/Research Suboxone (buprenorphine) institute 27/02/13 Closed 12/03/13 0 CSR Academia/Research CSRs institute 19/02/13 Closed 20/03/13 0 Humira (adalimumab) Divergent Opinion EU NCA 22/02/13 Closed 26/02/13 3 Module 2 +5, RMP CHMP final response, D120 LoQ Zyclara (iniquimod) Pharmaceutical industry 28/02/13 Pending Pending 0 Module 5.3.4 + 5.3.5 + 5.3.6 Academia/Research Cayston (azetreonam lysine) institute 25/02/13 Closed 28/05/13 0 Module 5.3.4 + 5.3.5 + 5.3.6 Academia/Research Zinforo (ceftaroline fosamil) institute 25/02/13 Closed 28/05/13 0 Module 5.3.4 + 5.3.5 + 5.3.6 Academia/Research Colobreathe (colistimethate sodium) institute 25/02/13 Closed 28/05/13 0 Module 5.3.4 + 5.3.5 + 5.3.6 Academia/Research Cubicin (daptomycin) institute 25/02/13 Closed 28/05/13 0 Module 5.3.4 + 5.3.5 + 5.3.6 Academia/Research Doribax (doripenem) institute 25/02/13 Closed 28/05/13 0 Module 5.3.4 + 5.3.5 + 5.3.6 Academia/Research Invanz (ertapenem sodium) institute 25/02/13 Closed 28/05/13 0 Module 5.3.4 + 5.3.5 + 5.3.6 Academia/Research Dificlir (fidaxomicin) institute 25/02/13 Closed 28/05/13 0 Module 5.3.4 + 5.3.5 + 5.3.6 Academia/Research Altargo (retapamulin) institute 25/02/13 Closed 28/05/13 0 Module 5.3.4 + 5.3.5 + 5.3.6 Academia/Research Vibativ (telavancin) institute 25/02/13 Closed 28/05/13 0 Module 5.3.4 + 5.3.5 + 5.3.6 Academia/Research Ketek (telithromycin) institute 25/02/13 Closed 28/05/13 0 Module 5.3.4 + 5.3.5 + 5.3.6 Academia/Research Tygacil (tigecycline) institute 25/02/13 Closed 28/05/13 0 Module 5.3.4 + 5.3.5 + 5.3.6 Academia/Research Tobi Podhaler (tobramycin) institute 25/02/13 Closed 28/05/13 0 Module 5.3.4 + 5.3.5 + 5.3.6 Academia/Research Trovan IV (alatrofloxacin mesylate) institute 25/02/13 Closed 28/05/13 0 Module 5.3.4 + 5.3.5 + 5.3.6 Academia/Research Turvel IV (alatrofloxacin mesylate) institute 25/02/13 Closed 28/05/13 0 Module 5.3.4 + 5.3.5 + 5.3.6 Academia/Research Levviax (telithromycin) institute 25/02/13 Closed 28/05/13 0 Module 5.3.4 + 5.3.5 + 5.3.6 Academia/Research Trovan (trovafloxacin) institute 25/02/13 Closed 28/05/13 0 Module 5.3.4 + 5.3.5 + 5.3.6 Academia/Research Turvel (trovafloxacin) institute 25/02/13 Closed 28/05/13 0 Onamer M (Polyquaternium 1) Excipient Master File Legal 26/02/13 Closed 19/03/13 0 D80 (C0-)Rapp AR, D150 JAR, D170 CHMP Written comments Xalkori (crizotinib) Pharmaceutical industry 26/02/13 Pending Pending 0 Module 1 + 2 + 3 + 4 + 5 CVs, Nominations, DoI, Risk Level Pradaxa (dabigatran etexilate) Asessment, AR Media 26/02/13 Batch Release 19/04/13 1,361 Inlyta (axitinib) RMP Consultant 22/03/13 Closed 04/04/13 230 Nexavar () RMP Consultant 22/03/13 Pending Pending 0 Votrient (pazopanib) RMP Consultant 22/03/13 Pending Pending 0

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 Module 4.2.3.2 + 4.2.3.4 + Lyxumia (lixisenatide) 4.2.3.5 Pharmaceutical industry 18/03/13 Closed 28/05/13 0 AR Academia/Research Ciprofloxacin institute 06/03/13 Closed 06/03/13 0 AR Academia/Research Propanolol institute 06/03/13 Closed 06/03/13 0 Cialis (tadalafil) AR Media 06/03/13 Closed 13/03/13 9 Galvus (incl Pancreas data) Module 2.7 + 4 SA, DoI, AR, LoQ, LoOI Media 11/03/13 Batch Release 29/04/13 2,100 Jakavi (ruxolitinib) Specimens, Mock-ups Media 12/03/13 Closed 04/04/13 5 Module 5 Academia/Research Topamax () institute 15/03/13 Closed 28/05/13 0 Module 5 Academia/Research Cimzia (certolizumab pegol) institute 12/03/13 Closed 28/05/13 0 Modules tba Ribavirin Healthcare professional 13/03/13 Closed 19/04/13 0 Modules tba Olanzapine Healthcare professional 13/03/13 Closed 19/04/13 0 Module 5 Tarceva (erlotinib) Pharmaceutical industry 14/03/13 Closed 28/05/13 0 Module 5 Humira (adalimumab) Pharmaceutical industry 15/03/13 Closed 19/03/13 0 Correspondence EMA & MAH Humira (adalimumab) (Decision letter) Legal 11/03/13 Closed 03/04/13 2 ADR Yellox (bromfenac) Pharmaceutical industry 25/02/13 Closed 09/04/13 32 Gabapentin Module 5 Legal 15/03/13 Closed 28/05/13 0 Correspondence EMA & MAH Humira (adalimumab) (Decision letter) Media 19/03/13 Closed 03/04/13 2 Esbriet (pirfenidone) Decision letters Media 19/03/13 Closed 03/04/13 2 RMP Exelon (rivastigmine) Pharmaceutical industry 19/03/13 Closed 09/04/13 197 Ilaris (canakinumab) Correspondence EMA & MAH Legal 19/03/13 Closed 24/04/13 15 Module 1.6 (ERA) Prontax Pharmaceutical industry 20/03/13 Closed 28/05/13 0 QWP Meeting Minutes Omacor Pharmaceutical industry 20/03/13 Closed 09/04/13 25 Module 5, Consent forms, All AR Xarelto (rivaroxaban) Protocols Media 21/03/13 Pending Pending 0 Correspondence EMA & MAH (Decision letter + Consultation Humira (adalimumab) letters) General Public 21/03/13 Closed 03/05/13 5 Humira (adalimumab) All ATDs Legal 25/03/13 Closed 08/04/13 10 Inspection reports Inspection reports Media 22/03/13 Closed 26/03/13 12 Tecfidera (dimethyl fumarate) AR, CHMP reports Legal 26/03/13 Closed 19/04/13 0 Fampyra (fampridine) Specimens, Mock-ups Media 26/03/13 Closed 15/04/13 10 Gilenya (fingolimod) SPC, PIL Media 26/03/13 Closed 12/04/13 0 Patient records???? Academia/Research Beclometasone institute 26/03/13 Closed 24/04/13 0 CoAprovel (irbesartan, hydrochlorothiazide) Correspondence EMA & MAH Legal 26/03/13 Pending Pending 0 Correspondence EMA & MAH Correspondence EMA & 3rd parties, EMA internal DuoPlavin correspondence Legal 27/03/13 Pending Pending 0 Exforge HCT Module 2 + 4 + 5 (ToC) Legal 03/04/13 Closed 28/05/13 0 Copalia HCT Module 2 + 4 + 5 (ToC) Legal 03/04/13 Closed 28/05/13 0 Dafiro HCT Module 2 + 4 + 5 (ToC) Legal 03/04/13 Closed 28/05/13 0 Correspondence EMA & MAH Humira (adalimumab) (Decision letter) Legal 03/04/13 Closed 05/04/13 1 D45 CHMP rapp AR, D106 CHMP Cialis (tadalafil) (Co-)Rapp AR Media 05/04/13 Closed 11/04/13 148 Ixiaro (japanese encephalitis vaccine (inactivated, AR adsorbed)) Media 05/04/13 Closed 12/04/13 0 RMP Azopt (brinzolamide) Pharmaceutical industry 05/04/13 Closed 12/04/13 383 RMP Suboxone (buprenorphine/) Pharmaceutical industry 05/04/13 Closed 12/04/13 183 Module 2.7 Lyxumia (lixisenatide) Pharmaceutical industry 08/04/13 Closed 28/05/13 0 Module 5 Academia/Research Apixaban (apixaban) institute 08/04/13 Closed 28/05/13 0 Module 5 Academia/Research Xarelto (rivaroxaban) institute 08/04/13 Closed 28/05/13 0 Module 5 Academia/Research Ximelagatran/ Megalatran (Exanta) institute 08/04/13 Closed 28/05/13 0

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