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31/10/2022 COVID-19 vaccines: authorised (updated)
31/10/2022 COVID-19: latest updates (updated)
31/10/2022 Veterinary Medicines (updated)
31/10/2022 Other: Organisation chart: Veterinary Medicines (updated)
31/10/2022 Human medicines European public assessment report (EPAR): Imraldi, adalimumab, Spondylitis, Ankylosing; Arthritis, Rheumatoid; Uveitis; Colitis, Ulcerative; Psoriasis; Arthritis, Psoriatic; Crohn Disease; Hidradenitis Suppurativa; Arthritis, 24/08/2017, Biosimilar, 19, Authorised (updated)
31/10/2022 Orphan designation: N-({Carbamoylmethyl-[3-(2-oxo-pyrrolidin-1-yl)-propyl]-carbamoyl}-methyl)-2-[2-(2-fluoro-phenyl)-ethylamino]-N-isobutyl-acetamide for the: Treatment of optic neuritis, 31/03/2014, Positive (updated)
31/10/2022 Orphan designation: Diflunisal for the: Treatment of ATTR amyloidosis, 21/06/2022, Positive (updated)
31/10/2022 Human medicines European public assessment report (EPAR): Relistor, methylnaltrexone bromide, Opioid-Related Disorders; Constipation, 01/07/2008, 18, Authorised (updated)
28/10/2022 Human medicines European public assessment report (EPAR): Vaxneuvance, pneumococcal polysaccharide conjugate vaccine (adsorbed), Pneumococcal Infections, 13/12/2021, Additional monitoring, 2, Authorised
28/10/2022 Second European Medicines Agency and Nuclear Medicines Europe bilateral meeting , from 11/10/2022 to 11/10/2022
28/10/2022 Human medicines European public assessment report (EPAR): Edurant, rilpivirine hydrochloride, HIV Infections, 28/11/2011, 20, Authorised
28/10/2022 Clinical Trials Information System (CTIS) Webinar - 9 months on and going forward , Online, 13:30 - 17:30 Amsterdam time (CET), from 16/11/2022 to 16/11/2022
28/10/2022 Other: Quick guide: Clinical Study Reports submission - CTIS Training Programme - Module 13
28/10/2022 Other: FAQs: Clinical Study Reports submission - CTIS training programme Module 13
28/10/2022 Other: Timetable: Initial (Full) Marketing Authorisation application accelerated assessment timetables
28/10/2022 Other: European Medicine Agency's Data Protection Notice for the Raw data proof-of-concept pilot
28/10/2022 Big data
28/10/2022 Other: Information about the raw data proof-of-concept pilot for industry
28/10/2022 Other: Pilot participation letter
28/10/2022 Other: Raw data submission cover letter template
28/10/2022 Other: European Medicine Agency's Data Protection Notice for the Raw data proof-of-concept pilot
28/10/2022 News and press releases: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 24 - 27 October 2022
28/10/2022 News and press releases: EMA confirms recommendation to withdraw marketing authorisations for amfepramone medicines
28/10/2022 Referrals document: Amfepramone-containing medicinal products Article-31 referral - EMA recommends withdrawal of marketing authorisation for amfepramone medicines
28/10/2022 News and press releases: EMA business hours over All Saints' Day and All Souls' Day, 1 and 2 November
28/10/2022 Report: CAT quarterly highlights and approved ATMPs - October 2022
28/10/2022 Minutes: Minutes of the CAT meeting 7-9 September 2022
28/10/2022 Eligible patients and consumers organisations
28/10/2022 Other: Key performance indicators (KPIs) to monitor the European clinical trials environment (1-30 September 2022, edition 6)
27/10/2022 Human medicines European public assessment report (EPAR): Raxone, idebenone, Optic Atrophy, Hereditary, Leber, 08/09/2015, Orphan, Additional monitoring, Exceptional circumstances, 8, Authorised
27/10/2022 Human medicines European public assessment report (EPAR): Natpar, parathyroid hormone, Hypoparathyroidism, 24/04/2017, Orphan, Additional monitoring, Conditional approval, 12, Authorised
27/10/2022 Human medicines European public assessment report (EPAR): Lamzede, velmanase alfa, alpha-Mannosidosis, 23/03/2018, Orphan, Additional monitoring, Exceptional circumstances, 5, Authorised
27/10/2022 Human medicines European public assessment report (EPAR): Myalepta, Metreleptin, Lipodystrophy, Familial Partial, 29/07/2018, Orphan, Additional monitoring, Exceptional circumstances, 7, Authorised
27/10/2022 Periodic safety update single assessment: Carbomers : List of nationally authorised medicinal products - PSUSA/00000557/202201
27/10/2022 Union Product Database: webinar on variations not requiring assessment (VNRAs) for marketing authorisation holders , Online, 10:00 - 11:30 Amsterdam time (CEST), from 08/09/2022 to 08/09/2022
27/10/2022 Human medicines European public assessment report (EPAR): Sitagliptin SUN, sitagliptin fumarate, Diabetes Mellitus, Type 2, 09/12/2021, Generic, 1, Authorised
26/10/2022 Human medicines European public assessment report (EPAR): Galvus, vildagliptin, Diabetes Mellitus, Type 2, 25/09/2007, 22, Authorised
26/10/2022 Human medicines European public assessment report (EPAR): Tasigna, nilotinib, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, 19/11/2007, 42, Authorised
26/10/2022 Human medicines European public assessment report (EPAR): Obizur, susoctocog alfa, Hemophilia A, 11/11/2015, Additional monitoring, Exceptional circumstances, 10, Authorised
26/10/2022 Human medicines European public assessment report (EPAR): Ibrance, palbociclib, Breast Neoplasms, 09/11/2016, Additional monitoring, 14, Authorised
26/10/2022 Other: Composition of the HMA/EMA task force on availability of authorised medicines for human and veterinary use
26/10/2022 Clinical Trials Information System (CTIS) bitesize talk: Notifications - Part 1 , Online, 14:30 - 16:00 Amsterdam time (CEST), from 28/09/2022 to 28/09/2022
26/10/2022 ICH M11 guideline, clinical study protocol template and technical specifications - Scientific guideline
26/10/2022 Scientific guideline: ICH M11 technical specification - Step 2b
26/10/2022 Scientific guideline: ICH M11 guideline, clinical study protocol template and technical specifications - Step 2b
26/10/2022 Scientific guideline: ICH M11 template - Step 2b
26/10/2022 Guideline on core SmPC, labelling and package leaflet for advanced therapy medicinal products (ATMPs) containing genetically modified cells - Scientific guideline
26/10/2022 Minutes: PDCO minutes of the 6-9 September 2022 meeting
26/10/2022 Management Board meeting: 6 October 2022 , European Medicines Agency, Amsterdam, the Netherlands, from 06/10/2022 to 06/10/2022
26/10/2022 Human medicines European public assessment report (EPAR): Mvasi, bevacizumab, Carcinoma, Renal Cell; Peritoneal Neoplasms; Ovarian Neoplasms; Breast Neoplasms; Carcinoma, Non-Small-Cell Lung; Fallopian Tube Neoplasms, 15/01/2018, Biosimilar, 13, Authorised
26/10/2022 Human medicines European public assessment report (EPAR): Dzuveo, sufentanil citrate, Pain, 25/06/2018, 5, Authorised
26/10/2022 Guidance on good manufacturing practice and good distribution practice: Questions and answers
25/10/2022 Human medicines European public assessment report (EPAR): RoActemra, tocilizumab, Arthritis, Rheumatoid; Arthritis, Juvenile Rheumatoid; Cytokine Release Syndrome; Giant Cell Arteritis; COVID-19 virus infection, 15/01/2009, 40, Authorised
25/10/2022 Human medicines European public assessment report (EPAR): Cometriq, cabozantinib, Thyroid Neoplasms, 21/03/2014, Orphan, 26, Authorised
25/10/2022 Human medicines European public assessment report (EPAR): Esperoct, Turoctocog alfa pegol, Hemophilia A, 20/06/2019, Additional monitoring, 3, Authorised
25/10/2022 Human medicines European public assessment report (EPAR): Lutathera, lutetium (177Lu) oxodotreotide, Neuroendocrine Tumors, 26/09/2017, Orphan, 8, Authorised
25/10/2022 Human medicines European public assessment report (EPAR): Cabometyx , cabozantinib (s)-malate, Carcinoma, Renal Cell; Carcinomas, Hepatocellular, 09/09/2016, Accelerated assessment, 15, Authorised
25/10/2022 Human medicines European public assessment report (EPAR): Invanz, ertapenem sodium, Community-Acquired Infections; Streptococcal Infections; Staphylococcal Infections; Gram-Negative Bacterial Infections; Surgical Wound Infection; Pneumonia, Bacterial, 18/04/2002, 26, Authorised
25/10/2022 Human medicines European public assessment report (EPAR): Prialt, ziconotide, Injections, Spinal; Pain, 21/02/2005, 29, Authorised
25/10/2022 Bioanalytical method validation - Scientific guideline
25/10/2022 Human medicines European public assessment report (EPAR): Velmetia, sitagliptin, metformin hydrochloride, Diabetes Mellitus, Type 2, 16/07/2008, 34, Authorised
25/10/2022 Human medicines European public assessment report (EPAR): Xelevia, sitagliptin, Diabetes Mellitus, Type 2, 21/03/2007, 36, Authorised
25/10/2022 Human medicines European public assessment report (EPAR): SomaKit TOC, edotreotide, Neuroendocrine Tumors; Radionuclide Imaging, 08/12/2016, Orphan, 12, Authorised
24/10/2022 Human medicines European public assessment report (EPAR): Vemlidy, tenofovir alafenamide fumarate, Hepatitis B, 09/01/2017, 15, Authorised
24/10/2022 Agenda: Agenda of the PRAC meeting 24-27 October 2022
24/10/2022 Other: Quick guide - Part I : How to evaluate a clinical trial application: assessment and decision - CTIS Training Programme - Module 08
24/10/2022 Other: Quick guide - Part II : How to evaluate a clinical trial application: assessment and decision - CTIS Training Programme - Module 08
24/10/2022 PRAC recommendation on signal: PRAC recommendations on signals adopted at the 26-29 September 2022 PRAC meeting
24/10/2022 PRAC recommendation on signal: New product information wording: extracts from PRAC recommendations on signals adopted at the 26-29 September 2022 PRAC meeting
24/10/2022 Human medicines European public assessment report (EPAR): Dasatinib Accordpharma, dasatinib, Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Myelogenous, Chronic, BCR-ABL Positive, 24/03/2022, Generic, 1, Authorised
24/10/2022 Human medicines European public assessment report (EPAR): Opdivo, nivolumab, Melanoma; Hodgkin Disease; Carcinoma, Renal Cell; Carcinoma, Non-Small-Cell Lung; Carcinoma, Transitional Cell; Squamous Cell Carcinoma of Head and Neck; Urologic Neoplasms; Mesothelioma; Colorectal Neoplasms, 19/06/2015, 50, Authorised
24/10/2022 Human medicines European public assessment report (EPAR): Yervoy, Ipilimumab, Melanoma; Carcinoma, Renal Cell; Carcinoma, Non-Small-Cell Lung; Mesothelioma, Malignant; Colorectal Neoplasms, 13/07/2011, 49, Authorised
24/10/2022 Human medicines European public assessment report (EPAR): Fingolimod Mylan, fingolimod hydrochloride , Multiple Sclerosis, Relapsing-Remitting, 18/08/2021, Generic, 2, Authorised
24/10/2022 Human medicines European public assessment report (EPAR): Imvanex, modified vaccinia Ankara - Bavarian Nordic (MVA-BN) virus, Smallpox Vaccine; Monkeypox virus, 31/07/2013, Additional monitoring, Exceptional circumstances, 22, Authorised
21/10/2022 Human medicines European public assessment report (EPAR): Kalydeco, ivacaftor, Cystic Fibrosis, 23/07/2012, Accelerated assessment, 34, Authorised
21/10/2022 Human medicines European public assessment report (EPAR): Vazkepa, Icosapent ethyl, Dyslipidemias, 26/03/2021, Additional monitoring, 4, Authorised
21/10/2022 Human medicines European public assessment report (EPAR): Jinarc, Tolvaptan, Polycystic Kidney, Autosomal Dominant, 27/05/2015, Additional monitoring, 20, Authorised
21/10/2022 Human medicines European public assessment report (EPAR): Iclusig, ponatinib, Leukemia, Myeloid; Leukemia, Lymphoid, 01/07/2013, Orphan, Accelerated assessment, 24, Authorised
21/10/2022 Orphan designation: Recombinant adeno-associated viral vector containing the human RPGR gene for the: Treatment of retinitis pigmentosa caused by mutations in the RPGR gene, 30/05/2016, Positive
21/10/2022 Orphan designation: Ovine specific immunoglobulin (Fab) fragments raised against Vipera berus veno for the: Treatment of snakebite envenomation, 09/10/2015, Positive
21/10/2022 Orphan designation: Adeno-associated virus serotype HSC15 expressing human arylsulfatase A gene for the: treatment of metachromatic leukodystrophy, 26/06/2020, Positive
21/10/2022 Orphan designation: Variant of recombinant human fibroblast growth factor 19 for the: Treatment of primary biliary cirrhosis, 22/08/2014, Positive
21/10/2022 Treatments and vaccines for COVID-19
21/10/2022 EMA regular press briefing on COVID-19 and monkeypox , Online, 11:00 - 11:30 Amsterdam time (CEST), from 26/10/2022 to 26/10/2022
21/10/2022 Periodic safety update single assessment: Bupropion : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00000461/202112
21/10/2022 Periodic safety update single assessment: Bupropion : List of nationally authorised medicinal products - PSUSA/00000461/202112
21/10/2022 Orphan designation: 1-(3-methylbutanoyl)-L-aspartyl-L-threonyl-L-histidyl-L-phenylalanyl-L-prolyl-(L-cystinyl-L-isoleucyl-[(N6-(S)-4-carboxy-4-palmitamidobutanoyl)-L-lysinyl]-L-phenylalanyl-L-glutamyl-L-prolyl-L-arginyl-L-serinyl-L-lysinyl-L-glycinyl-L-cystinyl)-L-lysinamide, disulfide, acetate salt for the: Treatment of beta thalassaemia intermedia and major, 24/08/2018, Withdrawn
21/10/2022 Human medicines European public assessment report (EPAR): Siklos, hydroxycarbamide, Anemia, Sickle Cell, 29/06/2007, 22, Authorised
21/10/2022 Periodic safety update single assessment: Botulinum toxin a : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00000426/202112
21/10/2022 Periodic safety update single assessment: Botulinum toxin a : List of nationally authorised medicinal products - PSUSA/00000426/202112
21/10/2022 Newsletter: Clinical Trials Highlights - October 2022
21/10/2022 Template or form: Signal assessment report - template
21/10/2022 Periodic safety update single assessment: Valaciclovir : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00003086/202112
21/10/2022 Periodic safety update single assessment: Valaciclovir : List of nationally authorised medicinal products - PSUSA/00003086/202112
20/10/2022 Human medicines European public assessment report (EPAR): Ogluo, Glucagon, Diabetes Mellitus, 11/02/2021, 3, Authorised
20/10/2022 Human medicines European public assessment report (EPAR): Firazyr, icatibant, Angioedemas, Hereditary, 11/07/2008, 21, Authorised
20/10/2022 Human medicines European public assessment report (EPAR): Vpriv, velaglucerase alfa, Gaucher Disease, 26/08/2010, Accelerated assessment, 19, Authorised
20/10/2022 Human medicines European public assessment report (EPAR): Thalidomide Lipomed, Thalidomide, Multiple Myeloma, 19/09/2022, Authorised
20/10/2022 Other: Clinical Trial Information System (CTIS) evaluation timelines
20/10/2022 Human medicines European public assessment report (EPAR): Lorviqua, Lorlatinib, Carcinoma, Non-Small-Cell Lung, 06/05/2019, Additional monitoring, Conditional approval, 10, Authorised
20/10/2022 Plasma master file certificates
20/10/2022 Human medicines European public assessment report (EPAR): Isentress, Raltegravir, HIV Infections, 19/12/2007, Accelerated assessment, 42, Authorised
20/10/2022 Human medicines European public assessment report (EPAR): Ravicti, glycerol phenylbutyrate, Urea Cycle Disorders, Inborn, 26/11/2015, Orphan, 15, Authorised
20/10/2022 Human medicines European public assessment report (EPAR): Invirase, saquinavir, HIV Infections, 03/10/1996, 49, Authorised
19/10/2022 Human medicines European public assessment report (EPAR): Nexavar, sorafenib, Carcinoma, Hepatocellular; Carcinoma, Renal Cell, 19/07/2006, Orphan, 31, Authorised
19/10/2022 News and press releases: EMA recommends approval of Comirnaty and Spikevax COVID-19 vaccines for children from 6 months of age
19/10/2022 Summary of opinion: Comirnaty, tozinameran, riltozinameran and tozinameran, famtozinameran and tozinameran, COVID-19 mRNA Vaccine (nucleoside modified), 19/10/2022, Positive
19/10/2022 Human medicines European public assessment report (EPAR): Bavencio, avelumab, Neuroendocrine Tumors, 18/09/2017, Additional monitoring, 14, Authorised
19/10/2022 Human medicines European public assessment report (EPAR): Vocabria, Cabotegavir sodium, Cabotegravir, HIV Infections, 17/12/2020, Additional monitoring, 7, Authorised
19/10/2022 News and press releases: EMA recommends approval of second adapted Spikevax vaccine
19/10/2022 Supply shortage: Ozempic (semaglutide) supply shortage
19/10/2022 Ninth Meeting of the Nitrosamine Implementation Oversight Group , from 21/11/2022 to 21/11/2022
19/10/2022 Periodic safety update single assessment: Ciclosporin (systemic use) : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00000745/202112
19/10/2022 Fourth Meeting of the Nitrosamine Implementation Oversight Group , from 30/11/2022 to 30/11/2022
19/10/2022 Periodic safety update single assessment: Ciclosporin (systemic use) : List of nationally authorised medicinal products - PSUSA/00000745/202112
19/10/2022 Union Product Database
19/10/2022 Annex to CHMP highlights: Recommendations on eligibility to PRIME scheme - Adopted at the CHMP meeting of 10-13 October 2022
19/10/2022 Human Variations eAF (DADI) go-live Q&A session , Online, 14:00 - 15:00 Amsterdam time (CEST), from 27/10/2022 to 27/10/2022
19/10/2022 Direct healthcare professional communication (DHPC): Ozempic (semaglutide) solution for injection in pre-filled pen: supply shortage, Active substance: semaglutide, DHPC type: Medicine shortage, Last updated: 19/10/2022
18/10/2022 Human medicines European public assessment report (EPAR): Idacio, adalimumab, Arthritis, Rheumatoid; Arthritis, Psoriatic; Psoriasis; Spondylitis, Ankylosing; Uveitis; Hidradenitis Suppurativa; Colitis, Ulcerative; Crohn Disease; Arthritis, Juvenile Rheumatoid, 02/04/2019, Additional monitoring, Biosimilar, 10, Authorised
18/10/2022 Human medicines European public assessment report (EPAR): Glubrava, metformin hydrochloride, pioglitazone hydrochloride, Diabetes Mellitus, Type 2, 11/12/2007, 19, Withdrawn
18/10/2022 Human medicines European public assessment report (EPAR): Saphnelo, anifrolumab, Lupus Erythematosus, Systemic, 14/02/2022, Additional monitoring, 1, Authorised
18/10/2022 Human Variations electronic application forms Q&A Clinics – Session 2 , Online, 11:00 - 11:30 Amsterdam time (CEST), from 22/11/2022 to 22/11/2022
18/10/2022 Human Variations electronic application forms Q&A Clinics – Session 1 , Online, 11:00 - 11:30 Amsterdam time (CEST), from 15/11/2022 to 15/11/2022
18/10/2022 Human medicines European public assessment report (EPAR): Tecartus, Autologous peripheral blood T cells CD4 and CD8 selected and CD3 and CD28 activated transduced with retroviral vector expressing anti-CD19 CD28/CD3-zeta chimeric antigen receptor and cultured, Lymphoma, Mantle-Cell, 14/12/2020, Orphan, Additional monitoring, Conditional approval, 2, Authorised
18/10/2022 Extraordinary meeting of the Committee for Medicinal Products for Human Use (CHMP): 19 October 2022 , Online, from 19/10/2022 to 19/10/2022
18/10/2022 Human medicines European public assessment report (EPAR): Rasagiline Mylan, rasagiline tartrate, Parkinson Disease, 04/04/2016, Generic, 6, Authorised
18/10/2022 Periodic safety update single assessment: Betamethasone : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00000391/202101
18/10/2022 Human medicines European public assessment report (EPAR): Evrenzo, Roxadustat, Anemia; Kidney Failure, Chronic, 18/08/2021, Additional monitoring, 2, Authorised
18/10/2022 Human medicines European public assessment report (EPAR): Pregabalin Mylan, pregabalin, Anxiety Disorders; Epilepsy, 24/06/2015, Generic, 15, Authorised
18/10/2022 Human medicines European public assessment report (EPAR): VeraSeal, human fibrinogen, human thrombin, Hemostasis, Surgical, 10/11/2017, 6, Authorised
18/10/2022 Human medicines European public assessment report (EPAR): Norvir, ritonavir, HIV Infections, 25/08/1996, 68, Authorised
18/10/2022 Human medicines European public assessment report (EPAR): Lonquex, lipegfilgrastim, Neutropenia, 25/07/2013, 24, Authorised
18/10/2022 Summary of opinion: Plerixafor Accord, plerixafor, 13/10/2022, Positive
18/10/2022 Human medicines European public assessment report (EPAR): Deltyba, Delamanid, Tuberculosis, Multidrug-Resistant, 27/04/2014, 25/07/2013, Orphan, Additional monitoring, Conditional approval, 22, Authorised
17/10/2022 Referral: Rubraca , rucaparib, Article 20 procedures, European Commission final decision, 21/07/2022, 21/09/2022, 17/10/2022
17/10/2022 Human medicines European public assessment report (EPAR): Trazimera, trastuzumab, Stomach Neoplasms; Breast Neoplasms, 26/07/2018, Additional monitoring, Biosimilar, 11, Authorised
17/10/2022 Human medicines European public assessment report (EPAR): Reyataz, atazanavir (as sulfate), HIV Infections, 01/03/2004, 53, Authorised
17/10/2022 Withdrawn application: Hervelous, trastuzumab, Date of withdrawal: 14/09/2022, Initial authorisation
17/10/2022 Interested Parties to the HMPC
17/10/2022 Report: Hearing with the Association of the European Self-Medication Industry (AESGP) during the HMPC May 2022 meeting
17/10/2022 Human medicines European public assessment report (EPAR): Opdualag, nivolumab, Relatlimab, Melanoma, 15/09/2022, Additional monitoring, Authorised
17/10/2022 Human Medicines
17/10/2022 Other: Organisation chart: Human Medicines
17/10/2022 Human medicines European public assessment report (EPAR): Takhzyro, lanadelumab, Angioedemas, Hereditary, 22/11/2018, Orphan, Accelerated assessment, Additional monitoring, 9, Authorised
17/10/2022 Human medicines European public assessment report (EPAR): Trogarzo, Ibalizumab, HIV Infections, 26/09/2019, Additional monitoring, 7, Authorised
17/10/2022 Human medicines European public assessment report (EPAR): Glidipion (previously Pioglitazone Actavis Group), pioglitazone hydrochloride, Diabetes Mellitus, Type 2, 15/03/2012, Generic, 8, Withdrawn
17/10/2022 Human medicines European public assessment report (EPAR): Sustiva, efavirenz, HIV Infections, 28/05/1999, 46, Authorised
17/10/2022 Human medicines European public assessment report (EPAR): Glustin, pioglitazone hydrochloride, Diabetes Mellitus, Type 2, 11/10/2000, 28, Withdrawn
17/10/2022 Human medicines European public assessment report (EPAR): BeneFIX, Nonacog alfa, Hemophilia B, 27/08/1997, 42, Authorised
17/10/2022 Multi-stakeholder workshop: Patient experience data in medicines development and regulatory decision-making , European Medicines Agency, Amsterdam, the Netherlands, from 21/09/2022 to 21/09/2022
17/10/2022 Human medicines European public assessment report (EPAR): Repatha, Evolocumab, Dyslipidemias; Hypercholesterolemia, 17/07/2015, 22, Authorised
17/10/2022 Human medicines European public assessment report (EPAR): Ilumetri, tildrakizumab, Psoriasis, 17/09/2018, Additional monitoring, 7, Authorised
17/10/2022 Human medicines European public assessment report (EPAR): Nplate, romiplostim, Purpura, Thrombocytopenic, Idiopathic, 04/02/2009, 26, Authorised
17/10/2022 Human medicines European public assessment report (EPAR): Memantine Mylan, memantine hydrochloride, Alzheimer Disease, 21/04/2013, Generic, 9, Authorised
17/10/2022 Human medicines European public assessment report (EPAR): Vimpat, lacosamide, Epilepsy, 29/08/2008, 42, Authorised
14/10/2022 Template or form: CHMP protocol assistance scientific advice briefing document template
14/10/2022 Scientific advice and protocol assistance
14/10/2022 Regulatory and procedural guideline: European Medicines Agency guidance for applicants seeking scientific advice and protocol assistance with track-changes
14/10/2022 Report: European Medicines Agency mid-year report 2022 (January-June 2022)
14/10/2022 Human medicines European public assessment report (EPAR): Humira, adalimumab, Spondylitis, Ankylosing; Arthritis, Juvenile Rheumatoid; Uveitis; Colitis, Ulcerative; Psoriasis; Arthritis, Psoriatic; Crohn Disease; Arthritis, Rheumatoid, 08/09/2003, 89, Authorised
14/10/2022 Summary of opinion: Eladynos, abaloparatide, 13/10/2022, Positive
14/10/2022 Summary of opinion: Lyumjev (previously Liumjev), insulin lispro, 13/10/2022, Positive
14/10/2022 Summary of opinion: Spevigo, spesolimab, 13/10/2022, Positive
14/10/2022 Summary of opinion: Livmarli, Maralixibat chloride, 13/10/2022, Positive
14/10/2022 News and press releases: First therapy to treat transplant patients with post-transplant lymphoproliferative disease
14/10/2022 Summary of opinion: Brukinsa, zanubrutinib, 13/10/2022, Positive
14/10/2022 Summary of opinion: Dimethyl fumarate Teva, dimethyl fumarate, 13/10/2022, Positive
14/10/2022 Summary of opinion: Pemetrexed Baxter, pemetrexed, 13/10/2022, Positive
14/10/2022 Summary of opinion: Xydalba, dalbavancin, 13/10/2022, Positive
14/10/2022 Summary of opinion: Pluvicto, lutetium (177Lu) vipivotide tetraxetan, 13/10/2022, Positive
14/10/2022 News and press releases: New vaccine to protect people in the EU and worldwide against dengue
14/10/2022 Summary of opinion: Qdenga, dengue tetravalent vaccine (live, attenuated), 13/10/2022, Positive
14/10/2022 Withdrawn application: Tuznue, trastuzumab, Date of withdrawal: 14/09/2022, Initial authorisation
14/10/2022 News and press releases: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 10-13 October 2022
14/10/2022 Summary of opinion: Locametz, gozetotide, 13/10/2022, Positive
14/10/2022 Summary of opinion: Libtayo, cemiplimab, 13/10/2022, Positive
14/10/2022 Summary of opinion: Ebvallo, tabelecleucel, 13/10/2022, Positive
14/10/2022 Herbal medicinal product: Vaccinii macrocarpi fructus, Vaccinii macrocarpi fructus, PF: Assessment close to finalisation (pre-final)
14/10/2022 Herbal medicinal product: Tribuli terrestris herba, Tribuli terrestris herba, D: Draft under discussion
14/10/2022 Herbal medicinal product: Foeniculi dulcis fructus, Foeniculi dulcis fructus, F: Assessment finalised
14/10/2022 Other: Notification on arrangements for requesting EMA certificates through urgent and standard procedure for December 2022
14/10/2022 Other: Instructor's guide: How to create, submit and withdraw a Clinical Trial Application - CTIS Training Programme - Module 10
14/10/2022 Scientific guideline: Reflection paper on criteria for determining that an active substance is essential when considered in the context of Article 37(2)(j) of Regulation (EU) 2019/6
14/10/2022 Overview of comments: Overview of comments received on 'Reflection paper on criteria for determining that an active substance is essential when considered in the context of Article 37(2)(j) of Regulation 2019/6'
14/10/2022 Opinions and letters of support on the qualification of novel methodologies for medicine development
13/10/2022 Human medicines European public assessment report (EPAR): Dupixent, dupilumab, Dermatitis, Atopic, 26/09/2017, 18, Authorised
13/10/2022 Human medicines European public assessment report (EPAR): Quofenix, delafloxacin meglumine, Community-Acquired Infections, 16/12/2019, Additional monitoring, 5, Authorised
13/10/2022 Report: Medicinal products for human use: monthly figures - September 2022
13/10/2022 Report: Applications for new human medicines under evaluation by the CHMP: October 2022
13/10/2022 Human medicines European public assessment report (EPAR): Kaletra, lopinavir, ritonavir, HIV Infections, 19/03/2001, 59, Authorised
13/10/2022 Orphan designation: Teclistamab for the: Treatment of multiple myeloma, 19/07/2022, Withdrawn
13/10/2022 Human medicines European public assessment report (EPAR): Rivastigmine 1 A Pharma, rivastigmine, Alzheimer Disease; Dementia; Parkinson Disease, 11/12/2009, 14, Authorised
13/10/2022 Human medicines European public assessment report (EPAR): Vabysmo, Faricimab, Wet Macular Degeneration; Macular Edema; Diabetes Complications, 15/09/2022, Additional monitoring, Authorised
13/10/2022 Human medicines European public assessment report (EPAR): Brintellix, Vortioxetine, Depressive Disorder, Major, 18/12/2013, 19, Authorised
13/10/2022 Human medicines European public assessment report (EPAR): Fycompa, perampanel, Epilepsies, Partial, 23/07/2012, 29, Authorised
13/10/2022 Human medicines European public assessment report (EPAR): Oxlumo, Lumasiran sodium, Hyperoxaluria, Primary, 19/11/2020, Orphan, Additional monitoring, 3, Authorised
13/10/2022 Human medicines European public assessment report (EPAR): Rivastigmine Sandoz, rivastigmine, Dementia; Alzheimer Disease; Parkinson Disease, 10/12/2009, 13, Authorised
13/10/2022 Human medicines European public assessment report (EPAR): Rivastigmine Hexal, rivastigmine, Dementia; Alzheimer Disease; Parkinson Disease, 11/12/2009, 14, Authorised
13/10/2022 EPAR - All authorised presentations: Rivastigmine Sandoz : EPAR - All Authorised presentations
13/10/2022 EPAR - All authorised presentations: Rivastigmine Hexal : EPAR - All Authorised presentations
12/10/2022 Newsletter: Human medicines highlights - September 2022
12/10/2022 Newsletter: Human medicines highlights - September 2022
12/10/2022 Human medicines European public assessment report (EPAR): Benepali, etanercept, Arthritis, Psoriatic; Arthritis, Rheumatoid; Psoriasis, 13/01/2016, Biosimilar, 17, Authorised
12/10/2022 Human medicines European public assessment report (EPAR): Cancidas (previously Caspofungin MSD), caspofungin (as acetate), Candidiasis; Aspergillosis, 23/10/2001, 29, Authorised
12/10/2022 Human medicines European public assessment report (EPAR): Karvea, irbesartan, Hypertension, 26/08/1997, 44, Authorised
12/10/2022 Orphan designation: N-Hydroxy-4-(3-methyl-2-(S)-phenyl-butyrylamino) benzamide for the: Treatment of meningioma, 06/06/2012, Positive
12/10/2022 Orphan designation: N-Hydroxy-4-(3-methyl-2-(S)-phenyl-butyrylamino) benzamide for the: Treatment of schwannoma, 06/06/2012, Positive
12/10/2022 Human medicines European public assessment report (EPAR): Orladeyo, berotralstat dihydrochloride, Angioedemas, Hereditary, 30/04/2021, 2, Authorised
12/10/2022 Human medicines European public assessment report (EPAR): Aprovel, irbesartan, Hypertension, 26/08/1997, 46, Authorised
12/10/2022 Human medicines European public assessment report (EPAR): Evkeeza, Evinacumab, Hypercholesterolemia, 17/06/2021, Additional monitoring, Exceptional circumstances, 2, Authorised
12/10/2022 Human medicines European public assessment report (EPAR): Byfavo, remimazolam, Conscious Sedation, 26/03/2021, Additional monitoring, 2, Authorised
12/10/2022 Human medicines European public assessment report (EPAR): Ritonavir Mylan, ritonavir, HIV Infections, 09/11/2017, Generic, 13, Authorised
12/10/2022 Minutes: Minutes of the 116th meeting of the Management Board: 15-16 June 2022
12/10/2022 Orphan designation: synthetic double-stranded siRNA oligonucleotide targeted against transthyretin mRNA, with six phosphorothioate linkages in the backbone, and nine 2'-fluoro and thirty-five 2'-O-methyl nucleoside residues in the sequence, which is covalently linked via a phosphodiester group to a ligand containing three N-acetylgalactosamine residues (Vutrisiran) for the: Treatment of transthyretin-mediated amyloidosis (ATTR amyloidosis), 25/05/2018, Positive
12/10/2022 Human medicines European public assessment report (EPAR): Amvuttra, vutrisiran sodium, Amyloid Neuropathies, Familial, 15/09/2022, Orphan, Additional monitoring, Authorised
12/10/2022 Human medicines European public assessment report (EPAR): Bexsero, outer membrane vesicles from neisseria meningitidis group b (strain nz 98/254), recombinant Neisseria meningitidis group B fHbp fusion protein, recombinant Neisseria meningitidis group B NadA protein, recombinant Neisseria meningitidis group B NHBA fusion protein, Meningitis, Meningococcal, 13/01/2013, 30, Authorised
12/10/2022 Report: Pilot on early dialogue with patient organisations for orphan marketing authorisation applications: Outcome Report
12/10/2022 DADI PDF electronic application forms (eAF) training webinar , Online, 11:00 - 12:30 Amsterdam time (CEST), from 02/09/2022 to 02/09/2022
12/10/2022 DADI PDF electronic application forms (eAF) training webinar , Online, 11:00 - 12:30 Amsterdam time (CEST), from 26/07/2022 to 26/07/2022
12/10/2022 Orphan designation: [Gly2]-recombinant human glucagon-like peptide for the: Treatment of short bowel syndrome, 12/12/2001, Positive
12/10/2022 Paediatric Committee (PDCO): 11-14 October 2022 , Virtual meeting, from 11/10/2022 to 14/10/2022
12/10/2022 Clinical Trials Information System (CTIS): Walk-in clinic , Online, 16:00 - 16:45 Amsterdam time (CEST), from 20/09/2022 to 20/09/2022
12/10/2022 Referrals document: Nitrosamines EMEA-H-A5(3)-1490 - Questions and answers for marketing authorisation holders / applicants on the CHMP Opinion for the Article 5(3) of Regulation (EC) No 726/2004 referral on nitrosamine impurities in human medicinal products
12/10/2022 Human medicines European public assessment report (EPAR): Blenrep, belantamab mafodotin, Multiple Myeloma, 25/08/2020, Orphan, Additional monitoring, Conditional approval, 4, Authorised
12/10/2022 Human medicines European public assessment report (EPAR): Xyrem, sodium oxybate, Cataplexy; Narcolepsy, 13/10/2005, 36, Authorised
11/10/2022 Website outages and upgrades
11/10/2022 IRIS for Good Pharmacovigilance practice (GVP) inspections training session for industry users , Online, 10:00 - 11:30 Amsterdam time (CEST), from 07/09/2022 to 07/09/2022
11/10/2022 Minutes: Minutes of the European Medicines Agency/European Network for Health Technology Assessment meeting - June 2022
11/10/2022 Human medicines European public assessment report (EPAR): Azarga, brinzolamide, timolol maleate, Glaucoma, Open-Angle; Ocular Hypertension, 25/11/2008, 16, Authorised
11/10/2022 Human medicines European public assessment report (EPAR): Lucentis, ranibizumab, Wet Macular Degeneration; Macular Edema; Diabetes Complications; Myopia, Degenerative, 22/01/2007, 39, Authorised
11/10/2022 Human medicines European public assessment report (EPAR): Nucala, Mepolizumab, Asthma, 01/12/2015, 18, Authorised
11/10/2022 Human medicines European public assessment report (EPAR): Tygacil, Tigecycline, Bacterial Infections; Skin Diseases, Bacterial; Soft Tissue Infections, 24/04/2006, 34, Authorised
11/10/2022 Other: European Medicines Agency practical guidance on the application form for centralised type IA and IB variations
11/10/2022 Human medicines European public assessment report (EPAR): Avonex, interferon beta-1a, Multiple Sclerosis, 13/03/1997, 35, Authorised
11/10/2022 Human medicines European public assessment report (EPAR): Cibinqo, Abrocitinib, Dermatitis, Atopic, 09/12/2021, Patient safety, Additional monitoring, 2, Authorised
11/10/2022 Human medicines European public assessment report (EPAR): Privigen, human normal immunoglobulin (IVIg), Purpura, Thrombocytopenic, Idiopathic; Bone Marrow Transplantation; Immunologic Deficiency Syndromes; Guillain-Barre Syndrome; Mucocutaneous Lymph Node Syndrome, 24/04/2008, 30, Authorised
11/10/2022 EMA Account Management training webinar , Online, 10:30 - 12:30 Amsterdam time (CEST), from 03/10/2022 to 03/10/2022
11/10/2022 Human medicines European public assessment report (EPAR): Pifeltro, doravirine, HIV Infections, 22/11/2018, Additional monitoring, 7, Authorised
11/10/2022 Human medicines European public assessment report (EPAR): Delstrigo, doravirine, lamivudine, tenofovir disoproxil fumarate, HIV Infections, 22/11/2018, Additional monitoring, 9, Authorised
11/10/2022 Orphan designation: Adeno-associated virus serotype HSC 15 expressing human iduronate 2-sulfatase for the: Treatment of mucopolysaccharidosis type II (Hunter Syndrome), 16/03/2022, Positive
11/10/2022 Human medicines European public assessment report (EPAR): Hetlioz, tasimelteon, Sleep Disorders, Circadian Rhythm, 03/07/2015, Orphan, 9, Authorised
11/10/2022 Orphan designation: Adeno-associated virus serotype HSC15, containing human homology arms, expressing human phenylalanine hydroxylase for the: Treatment of phenylalanine hydroxylase deficiency, 16/03/2022, Positive
11/10/2022 Orphan designation: Adeno-associated virus serotype HSC15 expressing human phenylalanine hydroxylase for the: Treatment of phenylalanine hydroxylase deficiency, 14/12/2018, Positive
11/10/2022 Orphan designation: 4-hydroxy-2,2,6,6-tetramethylpiperidine-N-oxyl for the: Treatment of familial cerebral cavernous malformations, 12/12/2017, Positive
11/10/2022 Orphan designation: Recombinant adeno-associated viral vector expressing the human CNGA3 gene for the: Treatment of achromatopsia caused by mutations in the CNGA3 gene, 09/10/2015, Positive
11/10/2022 Human medicines European public assessment report (EPAR): Entyvio, vedolizumab, Colitis, Ulcerative; Crohn Disease, 22/05/2014, 22, Authorised
11/10/2022 Orphan designation: Adeno-associated viral vector serotype rh10 containing the human factor IX gene for the treatment of haemophilia B- for the: Treatment of haemophilia B, 14/12/2015, Withdrawn
11/10/2022 Human medicines European public assessment report (EPAR): Granupas (previously Para-aminosalicylic acid Lucane), Para-aminosalicylic acid, Tuberculosis, 07/04/2014, Orphan, 10, Authorised
11/10/2022 Other: IRIS guide for applicants - How to create and submit scientific applications, for industry and individual applicants