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Date	Content
31/08/2023	Scientific publications
31/08/2023	Third Veterinary Big Data Stakeholder Forum , Amsterdam, from 23/11/2023 to 23/11/2023
31/08/2023	Opinion/decision on a Paediatric investigation plan (PIP): Axumin, Fluciclovine (18F), PM: decision on the application for modification of an agreed PIP, P/0335/2022
31/08/2023	Other: European Medicines Agency’s Data Protection Notice for the user test of the Critical Medical Device Shortages (CMDS) system
31/08/2023	Periodic safety update single assessment: Codeine camphosulphonate / sodium benzoate, codeine camphosulphonate / sulfogaiacol / grindelia soft extract : List of nationally authorised medicinal products - PSUSA/00010542/202212
31/08/2023	Periodic safety update single assessment: Atracurium : List of nationally authorised medicinal products - PSUSA/00000267/202212
31/08/2023	Periodic safety update single assessment: Hypericum perforatum L., herba : List of nationally authorised medicinal products - PSUSA/00001701/202301
31/08/2023	Periodic safety update single assessment: Amisulpride : List of nationally authorised medicinal products - PSUSA/00000167/202301
31/08/2023	Opinion/decision on a Paediatric investigation plan (PIP): Elfabrio, Pegunigalsidase alfa, PM: decision on the application for modification of an agreed PIP, P/0290/2022
31/08/2023	Periodic safety update single assessment: Cisplatin : List of nationally authorised medicinal products - PSUSA-00000778-202212
31/08/2023	Human medicines European public assessment report (EPAR): Adempas, riociguat, Hypertension, Pulmonary, 27/03/2014, 13, Authorised
31/08/2023	Opinion/decision on a Paediatric investigation plan (PIP): emtricitabine,rilpivirine,tenofovir alafenamide, PM: decision on the application for modification of an agreed PIP, P/0356/2022
31/08/2023	Opinion/decision on a Paediatric investigation plan (PIP): Ronapreve, Imdevimab, PM: decision on the application for modification of an agreed PIP, P/0343/2022
31/08/2023	Opinion/decision on a Paediatric investigation plan (PIP): Vamorolone, PM: decision on the application for modification of an agreed PIP, P/0295/2022
31/08/2023	Opinion/decision on a Paediatric investigation plan (PIP): Ronapreve, Casirivimab, PM: decision on the application for modification of an agreed PIP, P/0300/2022
31/08/2023	Opinion/decision on a Paediatric investigation plan (PIP): Vydura, Rimegepant, PM: decision on the application for modification of an agreed PIP, P/0299/2022
31/08/2023	Opinion/decision on a Paediatric investigation plan (PIP): Hepcludex, Bulevirtide, PM: decision on the application for modification of an agreed PIP, P/0270/2022
30/08/2023	Opinion/decision on a Paediatric investigation plan (PIP): lasmiditan, PM: decision on the application for modification of an agreed PIP, P/0056/2021
30/08/2023	Opinion/decision on a Paediatric investigation plan (PIP): bimekizumab, PM: decision on the application for modification of an agreed PIP, P/0339/2022
30/08/2023	Opinion/decision on a Paediatric investigation plan (PIP): Dovprela (previously Pretomanid FGK), Pretomanid, PM: decision on the application for modification of an agreed PIP, P/0292/2022
30/08/2023	Opinion/decision on a Paediatric investigation plan (PIP): Bempedoic acid (ETC-1002), PM: decision on the application for modification of an agreed PIP, P/0351/2022
30/08/2023	Opinion/decision on a Paediatric investigation plan (PIP): Avacopan, PM: decision on the application for modification of an agreed PIP, P/0266/2022
30/08/2023	Withdrawn application: Zefylti, filgrastim, Date of withdrawal: 08/06/2023, Initial authorisation
30/08/2023	Human medicines European public assessment report (EPAR): Eurartesim, piperaquine tetraphosphate, Artenimol, Malaria, 27/10/2011, 13, Authorised
30/08/2023	COVID-19 public health emergency of international concern (2020-23)
30/08/2023	Opinion/decision on a Paediatric investigation plan (PIP): Vitrakvi, Larotrectinib, PM: decision on the application for modification of an agreed PIP, P/0289/2022
30/08/2023	Human medicines European public assessment report (EPAR): Reyataz, atazanavir (as sulfate), HIV Infections, 01/03/2004, 54, Authorised
30/08/2023	News and press releases: Comirnaty: EMA recommends approval of adapted COVID-19 vaccine targeting Omicron XBB.1.5
30/08/2023	Template or form: QRD Appendix V - Adverse-drug-reaction reporting details
30/08/2023	Regulatory and procedural guideline: Member states contact points for translations review
30/08/2023	How to prepare and review a summary of product characteristics
30/08/2023	Human medicines European public assessment report (EPAR): Qinlock, ripretinib, Gastrointestinal Stromal Tumors, 18/11/2021, , , 5, Authorised
30/08/2023	Human medicines European public assessment report (EPAR): Bavencio, avelumab, Neuroendocrine Tumors, 18/09/2017, , 16, Authorised
30/08/2023	Opinion/decision on a Paediatric investigation plan (PIP): Gold (Au), W: decision granting a waiver in all age groups for all conditions or indications, P/0301/2022
30/08/2023	Opinion/decision on a Paediatric investigation plan (PIP): Doxecitine,Doxribtimine, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0287/2022
30/08/2023	Opinion/decision on a Paediatric investigation plan (PIP): Acetylsalicylic acid,rosuvastatin calcium, W: decision granting a waiver in all age groups for all conditions or indications, P/0281/2022
30/08/2023	Opinion/decision on a Paediatric investigation plan (PIP): atorvastatin,Ezetimibe, W: decision granting a waiver in all age groups for all conditions or indications, P/0272/2022
30/08/2023	Opinion/decision on a Paediatric investigation plan (PIP): fidanacogene elaparvovec, PM: decision on the application for modification of an agreed PIP, P/0277/2022
30/08/2023	Human medicines European public assessment report (EPAR): Cosentyx, Secukinumab, Arthritis, Psoriatic; Psoriasis; Spondylitis, Ankylosing, 14/01/2015, 34, Authorised
30/08/2023	Opinion/decision on a Paediatric investigation plan (PIP): Deucravacitinib, PM: decision on the application for modification of an agreed PIP, P/0278/2022
29/08/2023	ACT EU PA04 - Multi-stakeholder Workshop on ICH E6 R3 - Public Consultation , Online and European Medicines Agency, Amsterdam, the Netherlands, from 13/07/2023 to 14/07/2023
29/08/2023	Opinion/decision on a Paediatric investigation plan (PIP): Rezafungin acetate, PM: decision on the application for modification of an agreed PIP, P/0342/2022
29/08/2023	Referral: Adakveo , crizanlizumab, Article 20 procedures, European Commission final decision, 25/05/2023, 03/08/2023, 29/08/2023
29/08/2023	Opinion/decision on a Paediatric investigation plan (PIP): Autologous CD34+enriched cells from patients with Fanconi anaemia subtype A transduced ex vivo with a lentiviral vector carrying the FANCA gene (PGK-FANCA-WPRE), P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0114/2020
29/08/2023	Opinion/decision on a Paediatric investigation plan (PIP): Etripamil, PM: decision on the application for modification of an agreed PIP, P/0349/2022
29/08/2023	Opinion/decision on a Paediatric investigation plan (PIP): Eptinezumab, PM: decision on the application for modification of an agreed PIP, P/0341/2022
29/08/2023	Human medicines European public assessment report (EPAR): Zolgensma, onasemnogene abeparvovec, Muscular Atrophy, Spinal, 18/05/2020, , , , 12, Authorised
29/08/2023	Report: Medicinal products for human use: monthly figures - July 2023
29/08/2023	Human medicines European public assessment report (EPAR): Rinvoq, upadacitinib, Arthritis, Rheumatoid, 16/12/2019, , , 17, Authorised
29/08/2023	Human medicines European public assessment report (EPAR): Perjeta, pertuzumab, Breast Neoplasms, 04/03/2013, 22, Authorised
29/08/2023	Supply shortage: Shortage of Abraxane (paclitaxel)
29/08/2023	Human medicines European public assessment report (EPAR): Lupkynis, Voclosporin, Lupus Nephritis, 15/09/2022, , 2, Authorised
29/08/2023	Opinion/decision on a Paediatric investigation plan (PIP): zuranolone, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0358/2022
29/08/2023	Human medicines European public assessment report (EPAR): NovoMix, insulin aspart, Diabetes Mellitus, 01/08/2000, 29, Authorised
28/08/2023	Human medicines European public assessment report (EPAR): Gavreto, pralsetinib, Carcinoma, Non-Small-Cell Lung, 18/11/2021, , , 6, Authorised
28/08/2023	Supply shortage: Trulicity (dulaglutide) supply shortage
28/08/2023	Human medicines European public assessment report (EPAR): Enjaymo, sutimlimab, Hemolysis; Anemia, Hemolytic, Autoimmune, 15/11/2022, , , 3, Authorised
28/08/2023	Human medicines European public assessment report (EPAR): Reblozyl, Luspatercept, Anemia; Myelodysplastic Syndromes; beta-Thalassemia, 25/06/2020, , , 5, Authorised
28/08/2023	Opinion/decision on a Paediatric investigation plan (PIP): Enmetazobactam,cefepime, PM: decision on the application for modification of an agreed PIP, P/0340/2022
28/08/2023	Human medicines European public assessment report (EPAR): Actos, pioglitazone hydrochloride, Diabetes Mellitus, Type 2, 13/10/2000, 30, Authorised
28/08/2023	Opinion/decision on a Paediatric investigation plan (PIP): Imcivree, Setmelanotide, PM: decision on the application for modification of an agreed PIP, P/0348/2022
28/08/2023	Human medicines European public assessment report (EPAR): Cerdelga, eliglustat, Gaucher Disease, 19/01/2015, , , 16, Authorised
28/08/2023	Opinion/decision on a Paediatric investigation plan (PIP): lademirsen, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0336/2022
28/08/2023	Opinion/decision on a Paediatric investigation plan (PIP): Etrasimod L-arginine, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0346/2022
28/08/2023	Opinion/decision on a Paediatric investigation plan (PIP): Aspaveli, Pegcetacoplan, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0284/2022
28/08/2023	Opinion/decision on a Paediatric investigation plan (PIP): Gliadin protease, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0268/2022
28/08/2023	Opinion/decision on a Paediatric investigation plan (PIP): Remibrutinib, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0345/2022
28/08/2023	Opinion/decision on a Paediatric investigation plan (PIP): Nipocalimab, W: decision granting a waiver in all age groups for all conditions or indications, P/0344/2022
28/08/2023	Opinion/decision on a Paediatric investigation plan (PIP): Efruxifermin, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0302/2022
28/08/2023	Opinion/decision on a Paediatric investigation plan (PIP): 2’-O-(2’-methoxyethyl) modified antisense oligonucleotide targeting prekallikrein mRNA (ISIS 721744), P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0274/2022
25/08/2023	Opinion/decision on a Paediatric investigation plan (PIP): 3-[[5-chloro-1-[3-(methylsulfonyl)propyl]-1H-indol-2-yl]methyl]-1-(2,2,2-trifluoroethyl)-1,3-dihydro-3-[[5-chloro-1-[3-(methylsulfonyl)propyl]-1H-indol-2-yl]methyl]-1-(2,2,2-trifluoroethyl)-1,3-dihydro-2H-imidazo[4,5-c]pyridine-2-one (JNJ-53718678), PM: decision on the application for modification of an agreed PIP, P/0030/2021
25/08/2023	Opinion/decision on a Paediatric investigation plan (PIP): Recombinant human monoclonal antibody to GM-CSF (GSK3196165), PM: decision on the application for modification of an agreed PIP, P/0266/2020
25/08/2023	Human medicines European public assessment report (EPAR): Kanuma, sebelipase alfa, Lipid Metabolism, Inborn Errors, 28/08/2015, , , , 10, Authorised
25/08/2023	Human medicines European public assessment report (EPAR): Xultophy, insulin degludec, liraglutide, Diabetes Mellitus, Type 2, 18/09/2014, 16, Authorised
25/08/2023	Human medicines European public assessment report (EPAR): Eladynos, abaloparatide, Osteoporosis, Postmenopausal; Osteoporosis, 12/12/2022, , 2, Authorised
25/08/2023	Human medicines European public assessment report (EPAR): Arava, leflunomide, Arthritis, Rheumatoid; Arthritis, Psoriatic, 02/09/1999, 41, Authorised
25/08/2023	Human medicines European public assessment report (EPAR): Kisqali, ribociclib succinate, Breast Neoplasms, 22/08/2017, 14, Authorised
25/08/2023	Opinion/decision on a Paediatric investigation plan (PIP): (1R,2R)-2-[4-(5-methyl-1H-pyrazol-3-yl) benzoyl]-N-(4-oxo-6,7-dihydro-5H-pyrazolo [1,5-a]pyrazin-3-yl)cyclohexanecarboxamide (AZD5718), P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0269/2022
25/08/2023	Human medicines European public assessment report (EPAR): Duloxetine Mylan, duloxetine, Neuralgia; Diabetic Neuropathies; Depressive Disorder, Major; Anxiety Disorders, 19/06/2015, , 18, Authorised
25/08/2023	Human medicines European public assessment report (EPAR): Piqray, Alpelisib, Breast Neoplasms, 27/07/2020, , 9, Authorised
25/08/2023	Opinion/decision on a Paediatric investigation plan (PIP): RSV preF protein, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0350/2022
25/08/2023	Human medicines European public assessment report (EPAR): Efmody, hydrocortisone, Adrenal Hyperplasia, Congenital, 27/05/2021, 3, Authorised
25/08/2023	Human medicines European public assessment report (EPAR): Ecansya (previously Capecitabine Krka), capecitabine, Colonic Neoplasms; Breast Neoplasms; Colorectal Neoplasms; Stomach Neoplasms, 20/04/2012, , 15, Authorised
25/08/2023	Human medicines European public assessment report (EPAR): Diacomit, stiripentol, Myoclonic Epilepsy, Juvenile, 03/01/2007, 11/02/2009, 18, Authorised
25/08/2023	Human medicines European public assessment report (EPAR): Aquipta, atogepant, Migraine Disorders, 11/08/2023, , Authorised
25/08/2023	Periodic safety update single assessment: Apomorphine : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00000227/202211
25/08/2023	Periodic safety update single assessment: Apomorphine : List of nationally authorised medicinal products - PSUSA/00000227/202211
25/08/2023	Human medicines European public assessment report (EPAR): Regkirona, Regdanvimab, COVID-19 virus infection, 12/11/2021, , 8, Authorised
25/08/2023	Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) , Online, 13:00 - 14:00 Amsterdam time (CEST), from 14/07/2023 to 14/07/2023
24/08/2023	Human medicines European public assessment report (EPAR): Nuvaxovid, SARS-CoV-2 recombinant spike protein, COVID-19 virus infection, 20/12/2021, , 10, Authorised
24/08/2023	Opinion/decision on a Paediatric investigation plan (PIP): ritlecitinib, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0333/2022
24/08/2023	Opinion/decision on a Paediatric investigation plan (PIP): Deucravacitinib, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0286/2022
24/08/2023	Opinion/decision on a Paediatric investigation plan (PIP): tezepelumab, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0355/2022
24/08/2023	Opinion/decision on a Paediatric investigation plan (PIP): Vibegron, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0288/2022
24/08/2023	Human medicines European public assessment report (EPAR): Veklury, remdesivir, COVID-19 virus infection, 03/07/2020, , 21, Authorised
24/08/2023	Opinion/decision on a Paediatric investigation plan (PIP): RoActemra, tocilizumab, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0354/2022
24/08/2023	Human medicines European public assessment report (EPAR): Tolucombi, Telmisartan, hydrochlorothiazide, Hypertension, 13/03/2013, , 11, Authorised
24/08/2023	Supply shortage: Saxenda (liraglutide) supply shortage
24/08/2023	Supply shortage: Tresiba (insulin degludec) supply shortage
24/08/2023	Other: EVVET - EVWEB user manual
24/08/2023	Periodic safety update single assessment: Yellow fever vaccine (live) : List of nationally authorised medicinal products - PSUSA/00003135/202212
24/08/2023	Human medicines European public assessment report (EPAR): Advate, octocog alfa, Hemophilia A, 02/03/2004, 31, Authorised
23/08/2023	Human medicines European public assessment report (EPAR): Enbrel, etanercept, Spondylitis, Ankylosing; Arthritis, Juvenile Rheumatoid; Arthritis, Psoriatic; Psoriasis; Arthritis, Rheumatoid, 02/02/2000, 71, Authorised
23/08/2023	Human medicines European public assessment report (EPAR): Dengvaxia, chimeric yellow fever dengue virus serotype 1 (live, attenuated), chimeric yellow fever dengue virus serotype 2 (live, attenuated), chimeric yellow fever dengue virus serotype 3 (live, attenuated), chimeric yellow fever dengue virus serotype 4 (live, attenuated), Dengue, 12/12/2018, 5, Authorised
23/08/2023	Human medicines European public assessment report (EPAR): Ervebo, recombinant vesicular stomatitis virus (strain indiana) with a deletion of the envelope glycoprotein, replaced with the zaire ebolavirus (strain kikwit 1995) surface glycoprotein, Hemorrhagic Fever, Ebola, 11/11/2019, , 8, Authorised
23/08/2023	Human medicines European public assessment report (EPAR): Artesunate Amivas, artesunate, Malaria, 22/11/2021, , , 2, Authorised
23/08/2023	Human medicines European public assessment report (EPAR): Tecovirimat SIGA, Tecovirimat, Poxviridae Infections; Cowpox; Monkeypox; Vaccinia; Smallpox, 06/01/2022, , 2, Authorised
22/08/2023	Opinion/decision on a Paediatric investigation plan (PIP): Iscalimab, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0222/2021
22/08/2023	Human medicines European public assessment report (EPAR): Aubagio, Teriflunomide, Multiple Sclerosis, 26/08/2013, 26, Authorised
21/08/2023	Human medicines European public assessment report (EPAR): Kinpeygo, budesonide, micronised, Glomerulonephritis, IGA, 15/07/2022, , , , 5, Authorised
21/08/2023	Human medicines European public assessment report (EPAR): Binocrit, epoetin alfa, Anemia; Kidney Failure, Chronic, 28/08/2007, , 21, Authorised
21/08/2023	Human medicines European public assessment report (EPAR): Soliris, Eculizumab, Hemoglobinuria, Paroxysmal, 20/06/2007, , , 36, Authorised
21/08/2023	Human medicines European public assessment report (EPAR): Abseamed, epoetin alfa, Anemia; Kidney Failure, Chronic; Cancer, 27/08/2007, 18/06/2009, , 22, Authorised
21/08/2023	Human medicines European public assessment report (EPAR): Epoetin Alfa Hexal, epoetin alfa, Anemia; Kidney Failure, Chronic; Cancer, 27/08/2007, , 23, Authorised
21/08/2023	Q&A: Good clinical practice (GCP)
18/08/2023	Human medicines European public assessment report (EPAR): Fingolimod Accord, fingolimod hydrochloride , Multiple Sclerosis, Relapsing-Remitting, 25/06/2020, , 4, Authorised
18/08/2023	Human medicines European public assessment report (EPAR): Ovaleap, follitropin alfa, Anovulation, 27/09/2013, , 10, Authorised
18/08/2023	Human medicines European public assessment report (EPAR): Azilect, rasagiline, Parkinson Disease, 21/02/2005, 23, Authorised
18/08/2023	Other: Contact details of national competent authorities for requests of translation exemptions falling under Art. 63.3 of Directive 2001/83/EC and cases of shortages
18/08/2023	Other: Member states contact points for review of national versions of the content of mobile scanning and other technologies
18/08/2023	Human medicines European public assessment report (EPAR): Evusheld, tixagevimab, cilgavimab, COVID-19 virus infection, 25/03/2022, , 3, Authorised
18/08/2023	Other: Contact details of national competent authorities for requests to use a sticker to place the Unique Identifier on the outer/immediate packaging of centrally approved products
18/08/2023	Newsletter: CTIS newsflash – 18 August 2023
18/08/2023	Withdrawn application: Lutholaz, Date of withdrawal: 19/07/2023, Initial authorisation
18/08/2023	10 years of the Healthcare Professionals' Working Party
17/08/2023	Human medicines European public assessment report (EPAR): Nexpovio, Selinexor, Multiple Myeloma, 26/03/2021, , 8, Authorised
17/08/2023	Signal management (veterinary medicines)
17/08/2023	Pharmacovigilance (veterinary medicines)
17/08/2023	Human medicines European public assessment report (EPAR): Jalra, vildagliptin, Diabetes Mellitus, Type 2, 19/11/2008, 24, Authorised
17/08/2023	Human medicines European public assessment report (EPAR): Galvus, vildagliptin, Diabetes Mellitus, Type 2, 25/09/2007, 23, Authorised
17/08/2023	Human medicines European public assessment report (EPAR): Xiliarx, vildagliptin, Diabetes Mellitus, Type 2, 19/11/2008, 23, Authorised
17/08/2023	Human medicines European public assessment report (EPAR): Dupixent, dupilumab, Dermatitis, Atopic; Prurigo; Esophageal Diseases; Asthma; Sinusitis, 26/09/2017, 29, Authorised
17/08/2023	Development of a reflection paper on modern manufacturing techniques used for herbal preparations - Scientific guideline
17/08/2023	Direct healthcare professional communication (DHPC): Potential missing package leaflet in folding boxes of RoActemra (tocilizumab), Hemlibra (emicizumab), Herceptin (trastuzumab), Kadcyla (trastuzumab emtansine), MabThera (rituximab), Phesgo (pertuzumab / trastuzumab) and Tecentriq (atezolizumab), Active substance: tocilizumab, Emicizumab, trastuzumab, trastuzumab emtansine, rituximab, pertuzumab, trastuzumab, atezolizumab, DHPC type: Quality defect, Last updated: 17/08/2023
17/08/2023	Human medicines European public assessment report (EPAR): Nemdatine, memantine, Alzheimer Disease, 22/04/2013, 22/02/2013, , 13, Authorised
17/08/2023	Medical Device Shortages Single Point of Contact (SPOC) Working Party
17/08/2023	Other: Mandate, objectives and rules of procedure for the Medical Device Shortages SPOC Working Party
17/08/2023	Human medicines European public assessment report (EPAR): Amlodipine / Valsartan Mylan , Amlodipine besilate, valsartan, Hypertension, 22/03/2016, , 11, Authorised
16/08/2023	Human medicines European public assessment report (EPAR): Tobi Podhaler, Tobramycin, Cystic Fibrosis; Respiratory Tract Infections, 20/07/2011, 21, Authorised
16/08/2023	Human medicines European public assessment report (EPAR): Competact, pioglitazone, metformin hydrochloride, Diabetes Mellitus, Type 2, 28/07/2006, 21, Authorised
16/08/2023	Human medicines European public assessment report (EPAR): Lacosamide Accord, lacosamide, Epilepsy, 18/09/2017, , 12, Authorised
16/08/2023	Human medicines European public assessment report (EPAR): Caprelsa, Vandetanib, Thyroid Neoplasms, 16/02/2012, , 52, Authorised
16/08/2023	Human medicines European public assessment report (EPAR): Takhzyro, lanadelumab, Angioedemas, Hereditary, 22/11/2018, , , 11, Authorised
16/08/2023	News and press releases: EMA review of data on paternal exposure to valproate
16/08/2023	Human medicines European public assessment report (EPAR): Colobreathe, Colistimethate sodium, Cystic Fibrosis, 13/02/2012, 15, Authorised
16/08/2023	Human medicines European public assessment report (EPAR): Buvidal, buprenorphine, Opioid-Related Disorders, 20/11/2018, 8, Authorised
14/08/2023	Human medicines European public assessment report (EPAR): Tivicay, dolutegravir, HIV Infections, 16/01/2014, 34, Authorised
14/08/2023	Human medicines European public assessment report (EPAR): Aimovig, erenumab, Migraine Disorders, 26/07/2018, , 11, Authorised
14/08/2023	Human medicines European public assessment report (EPAR): Deltyba, Delamanid, Tuberculosis, Multidrug-Resistant, 27/04/2014, 25/07/2013, , , , 25, Authorised
14/08/2023	Human medicines European public assessment report (EPAR): Mayzent, Siponimod fumaric acid, Multiple Sclerosis, Relapsing-Remitting, 13/01/2020, , 10, Authorised
14/08/2023	Human medicines European public assessment report (EPAR): Evenity, Romosozumab, Osteoporosis, 09/12/2019, , 4, Authorised
14/08/2023	Human medicines European public assessment report (EPAR): Refixia, Nonacog beta pegol, Hemophilia B, 02/06/2017, , 4, Authorised
14/08/2023	Human medicines European public assessment report (EPAR): Zabdeno, Recombinant Adenovirus type 26 (Ad26) encoding the glycoprotein (GP) of the Ebola virus Zaire (ZEBOV) Mayinga strain, Hemorrhagic Fever, Ebola, 01/07/2020, , , 4, Authorised
14/08/2023	Transparency: exceptional measures for COVID-19 medicines
14/08/2023	Safety of COVID-19 vaccines
14/08/2023	COVID-19 vaccine safety update: Comirnaty : Periodic safety update report assessment: 19 December 2021 to 18 June 2022
14/08/2023	Human medicines European public assessment report (EPAR): Mvabea, Recombinant Modified Vaccinia Ankara Bavarian Nordic Virus encoding the: Ebola virus Zaire (ZEBOV) Mayinga strain glycoprotein (GP); Ebola virus Sudan Gulu strain GP; Ebola virus Taï Forest strain nucleoprotein and the Marburg virus Musoke strain GP, Hemorrhagic Fever, Ebola, 01/07/2020, , , 3, Authorised
14/08/2023	Human medicines European public assessment report (EPAR): Tolvaptan Accord, Tolvaptan, Inappropriate ADH Syndrome, , Authorised
14/08/2023	Direct healthcare professional communication (DHPC): Replacement BAXJECT II / BAXJECT II Hi-Flow Reconstitution Devices co-packaged with Advate/Feiba/Rixubis, Active substance: octocog alfa, Factor VIII Inhibitor Bypassing Activity, nonacog gamma, DHPC type: Quality defect, Last updated: 14/08/2023
14/08/2023	News and press releases: EMA mourns passing of Noël Wathion
11/08/2023	Human medicines European public assessment report (EPAR): Tagrisso, osimertinib mesilate, Carcinoma, Non-Small-Cell Lung, 01/02/2016, , 18, Authorised
11/08/2023	Orphan designation: 4-Amino-(6R,S)-5,6,7,8-tetrahydro-L-biopterin dihydrochloride (ronopterin) for the: Treatment of moderate and severe traumatic brain injury, 28/08/2006, Positive
11/08/2023	Human medicines European public assessment report (EPAR): Mircera, Methoxy polyethylene glycol-epoetin beta, Anemia; Kidney Failure, Chronic, 20/07/2007, 29, Authorised
11/08/2023	Human medicines European public assessment report (EPAR): Bonviva, ibandronic acid, Osteoporosis, Postmenopausal, 23/02/2004, 29, Authorised
11/08/2023	Human medicines European public assessment report (EPAR): Trodelvy, Sacituzumab govitecan, Breast Neoplasms; Triple Negative Breast Neoplasms, 22/11/2021, , 3, Authorised
11/08/2023	News and press releases: EMA business hours over Assumption Day, 15 August
10/08/2023	Direct healthcare professional communication (DHPC): Simponi (golimumab) 50 mg and 100 mg: important changes to the injection instructions for the SmartJect Pre-filled Pen, Active substance: Golimumab, DHPC type: Quality defect, Last updated: 10/08/2023
10/08/2023	Other: EMA's response to the COVID-19 pandemic: Putting people's health first
10/08/2023	Human medicines European public assessment report (EPAR): Prevenar 13, Pneumococcal polysaccharide serotype 1, Pneumococcal polysaccharide serotype 3, Pneumococcal polysaccharide serotype 4, Pneumococcal polysaccharide serotype 5, Pneumococcal polysaccharide serotype 6A, Pneumococcal polysaccharide serotype 6B, Pneumococcal polysaccharide serotype 7F, Pneumococcal polysaccharide serotype 9V, Pneumococcal polysaccharide serotype 14, Pneumococcal polysaccharide serotype 18C, Pneumococcal polysaccharide serotype 19A, Pneumococcal polysaccharide serotype 19F, Pneumococcal polysaccharide serotype 23F, Pneumococcal Infections; Immunization, 09/12/2009, 44, Authorised
10/08/2023	Other: Release notes - production release version 1.6.30 July 2023 - Veterinary Medicinal Products Regulation: Union Product Database
10/08/2023	Human medicines European public assessment report (EPAR): Ilumetri, tildrakizumab, Psoriasis, 17/09/2018, 10, Authorised
09/08/2023	Non-Clinical and New Approach Methodologies European Specialised Expert Community
09/08/2023	Other: Mandate, objective and rules of procedure for the Non-Clinical and New Approach Methodologies European Specialised Expert Community
09/08/2023	News and press releases: Revocation of authorisation for sickle cell disease medicine Adakveo
09/08/2023	Human medicines European public assessment report (EPAR): Lantus, insulin glargine, Diabetes Mellitus, 09/06/2000, 40, Authorised
09/08/2023	Withdrawn application: Lagevrio, molnupiravir, Date of withdrawal: 21/06/2023, Initial authorisation
09/08/2023	Supply shortage: Methotrexate supply shortage
09/08/2023	Human medicines European public assessment report (EPAR): Toujeo (previously Optisulin), insulin glargine, Diabetes Mellitus, 26/06/2000, 33, Authorised
09/08/2023	Other: Informed consent for paediatric clinical trials in Europe 2015
08/08/2023	Other: List of eligible industry stakeholder organisations
08/08/2023	Human medicines European public assessment report (EPAR): Trecondi, Treosulfan, Hematopoietic Stem Cell Transplantation, 20/06/2019, 4, Authorised
08/08/2023	Periodic safety update single assessment: Morphine / cyclizine : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010549/202210
08/08/2023	Periodic safety update single assessment: morphine / cyclizine : List of nationally authorised medicinal products - PSUSA/00010549/202210
08/08/2023	Human medicines European public assessment report (EPAR): Vpriv, velaglucerase alfa, Gaucher Disease, 26/08/2010, , 20, Authorised
08/08/2023	Orphan designation: Adeno-associated virus serotype HSC 15 expressing human iduronate 2-sulfatase (Bevufenogene nofeparvovec) for the: Treatment of mucopolysaccharidosis type II (Hunter Syndrome), 16/03/2022, Withdrawn
08/08/2023	Orphan designation: Adeno-associated virus serotype HSC15 expressing human phenylalanine hydroxylase for the: Treatment of phenylalanine hydroxylase deficiency, 14/12/2018, Withdrawn
08/08/2023	Orphan designation: Human telomerase reverse transcriptase peptide (611-626) (tertomotide) for the: Treatment of pancreatic cancer, 25/07/2006, Withdrawn
08/08/2023	Withdrawn application: Lumevoq, lenadogene nolparvovec, Date of withdrawal: 20/04/2023, Initial authorisation
08/08/2023	Regulatory and procedural guideline: Guidance to applicants/marketing authorisation holders on oral explanations at European Medicines Agency
07/08/2023	Human medicines European public assessment report (EPAR): Plerixafor Accord, Plerixafor, Multiple Myeloma; Hematopoietic Stem Cell Transplantation, 16/12/2022, , , 1, Authorised
07/08/2023	Human medicines European public assessment report (EPAR): Fluenz Tetra, A/Darwin/9/2021 (H3N2) - like strain (A/Norway/16606/2021, MEDI 355293) / A/Victoria/2570/2019 (H1N1)pdm09 - like strain (A/Victoria/1/2020, MEDI 340505) / B/Austria/1359417/2021 - like strain (B/Austria/1359417/2021, MEDI 355292) / B/Phuket/3073/2013 - like strain (B/Phuket/3073/2013, MEDI 306444), Influenza, Human, 04/12/2013, 24, Authorised
07/08/2023	Human medicines European public assessment report (EPAR): Camzyos, Mavacamten, Cardiomyopathy, Hypertrophic, 26/06/2023, , 1, Authorised
07/08/2023	Other: Declaration of interets: Elias Pean
07/08/2023	Human medicines European public assessment report (EPAR): Flucelvax Tetra, A/Darwin/6/2021(H3N2)-like strain (A/Darwin/11/2021, wild type) / A/Wisconsin/67/2022 (H1N1)pdm09-like strain (A/Georgia/12/2022 CVR-167) / B/Austria/1359417/2021-like strain (B/Singapore/WUH4618/2021) / B/Phuket/3073/2013-like virus (B/Singapore/INFTT-16-0610/2016, wild type), Influenza, Human, 12/12/2018, , 14, Authorised
07/08/2023	Human medicines European public assessment report (EPAR): Renagel, sevelamer, Renal Dialysis; Hyperphosphatemia, 28/01/2000, 36, Authorised
07/08/2023	Other: PRAC meetings in 2025 and 2026
07/08/2023	Human medicines European public assessment report (EPAR): Ruconest, Recombinant human C1-inhibitor, Angioedemas, Hereditary, 28/10/2010, 12, Authorised
04/08/2023	Newsletter: CTIS newsflash - 4 August 2023
04/08/2023	Agenda: Agenda - Strengthening life-sciences innovation across Europe: EU-Innovation Network conference
04/08/2023	Strengthening life-sciences innovation across Europe: EU-Innovation Network conference , Dublin and online (hybrid), from 21/11/2023 to 21/11/2023
04/08/2023	Other: Declaration of interests: Karen Quigley
04/08/2023	Human medicines European public assessment report (EPAR): Erelzi, etanercept, Arthritis, Psoriatic; Psoriasis; Arthritis, Juvenile Rheumatoid; Arthritis, Rheumatoid; Spondylitis, Ankylosing, 23/06/2017, , 13, Authorised
04/08/2023	Human medicines European public assessment report (EPAR): Busilvex, busulfan, Hematopoietic Stem Cell Transplantation, 09/07/2003, 19, Withdrawn
04/08/2023	Human medicines European public assessment report (EPAR): Arikayce liposomal, Amikacin sulfate, Respiratory Tract Infections, 27/10/2020, , 2, Authorised
04/08/2023	Human medicines European public assessment report (EPAR): Pifeltro, doravirine, HIV Infections, 22/11/2018, 9, Authorised
04/08/2023	Report: EMA communication perception survey report 2022
04/08/2023	Human medicines European public assessment report (EPAR): Delstrigo, doravirine, lamivudine, tenofovir disoproxil fumarate, HIV Infections, 22/11/2018, 11, Authorised
04/08/2023	Human medicines European public assessment report (EPAR): Ristfor, sitagliptin, metformin hydrochloride, Diabetes Mellitus, Type 2, 15/03/2010, 27, Authorised
04/08/2023	Human medicines European public assessment report (EPAR): Efficib, sitagliptin, metformin hydrochloride, Diabetes Mellitus, Type 2, 15/07/2008, 33, Authorised
04/08/2023	Human medicines European public assessment report (EPAR): Janumet, sitagliptin, metformin hydrochloride, Diabetes Mellitus, Type 2, 16/07/2008, 18/02/2009, 30, Authorised
04/08/2023	Human medicines European public assessment report (EPAR): Fluad Tetra, A/Darwin/9/2021 (H3N2) - like strain (A/Darwin/6/2021, IVR-227) / A/Victoria/4897/2022 (H1N1) pdm09-like strain (A/Victoria/4897/2022, IVR-238) / B/Phuket/3073/2013-like strain (B/Phuket/3073/2013, BVR-1B) / Influenza virus B/Austria/1359417/2021-like strain (B/Austria/1359417/2021, BVR-26), Influenza, Human, 20/05/2020, , 7, Authorised
03/08/2023	Other: Declaration of interests: Patrice Verpillat
03/08/2023	Orphan designation: Recombinant human factor IX protein modified with three point mutations (dalcinonacog alfa) for the: Treatment of haemophilia B, 20/06/2017, Positive
03/08/2023	Orphan designation: Marzeptacog alfa (activated) for the: Treatment of haemophilia B, 01/04/2019, Positive
03/08/2023	Supply shortage: Victoza (liraglutide) supply shortage
03/08/2023	Human medicines European public assessment report (EPAR): Brilique, Ticagrelor, Peripheral Vascular Diseases; Acute Coronary Syndrome, 03/12/2010, 21, Authorised
03/08/2023	Recruitment: Traineeship - Frequently asked questions (FAQs)
03/08/2023	Human medicines European public assessment report (EPAR): Ebymect, dapagliflozin propanediol monohydrate, metformin hydrochloride, Diabetes Mellitus, Type 2, 15/11/2015, 20, Authorised
03/08/2023	Periodic safety update single assessment: Inactivated leptospire vaccine : List of nationally authorised medicinal products - PSUSA/00010813/202211
03/08/2023	Periodic safety update single assessment: Yellow fever vaccine (live) : List of nationally authorised medicinal products - PSUSA/00003135/202212
03/08/2023	Other: Declaration of interests: Silvy da Rocha Dias
03/08/2023	Human medicines European public assessment report (EPAR): Capecitabine Accord, capecitabine, Colonic Neoplasms; Breast Neoplasms; Colorectal Neoplasms; Stomach Neoplasms, 20/04/2012, , 16, Authorised
03/08/2023	Opinion/decision on a Paediatric investigation plan (PIP): Adalimumab conjugated with (4S)-4-[2-(2-bromoacetamido)acetamido]-5-{3-[(4-{(4aR,4bS,5S,6aS,6bS,8R,9aR,10aS,10bS)-5-hydroxy-4a,6a-dimethyl-2-oxo-6b-[(phosphonooxy)acetyl]-4a,4b,5,6,6a,6b,9a,10,10a,10b,11,12-dodecahydro-2H,8H-naphtho[2',1':4,5]indeno[1,2-d][1,3]dioxol-8-yl}phenyl)methyl] anilino}-5-oxopentanoic acid; (ABBV-154), P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0454/2021
02/08/2023	Human medicines European public assessment report (EPAR): Brintellix, Vortioxetine, Depressive Disorder, Major, 18/12/2013, 22, Authorised
02/08/2023	Herbal medicinal product: Rhodiolae roseae rhizoma et radix, Rhodiolae roseae rhizoma et radix, F: Assessment finalised
02/08/2023	Human medicines European public assessment report (EPAR): Neoclarityn, desloratadine, Rhinitis, Allergic, Perennial; Urticaria; Rhinitis, Allergic, Seasonal, 15/01/2001, 46, Authorised
02/08/2023	Human medicines European public assessment report (EPAR): Aerius, desloratadine, Rhinitis, Allergic, Perennial; Urticaria; Rhinitis, Allergic, Seasonal, 15/01/2001, 50, Authorised
02/08/2023	Herbal medicinal product: Origani majoranae herba, Origani majoranae herba, F: Assessment finalised
02/08/2023	Human medicines European public assessment report (EPAR): Azomyr, desloratadine, Rhinitis, Allergic, Perennial; Urticaria; Rhinitis, Allergic, Seasonal, 15/01/2001, 52, Authorised
02/08/2023	Report: HMPC meeting report on European Union herbal monographs, guidelines and other activities - 17-19 July 2023
02/08/2023	Twelfth Paediatric Oncology Strategy Forum for Medicinal Product Development of CDK4/6, CDK7 and CDK9 Inhibitors in children and adolescents , Hybrid, from 26/10/2023 to 27/10/2023
02/08/2023	Herbal medicinal product: Melaleucae aetheroleum, Melaleucae aetheroleum, F: Assessment finalised
02/08/2023	Human medicines European public assessment report (EPAR): Xarelto, rivaroxaban, Arthroplasty, Replacement; Venous Thromboembolism, 30/09/2008, 40, Authorised
01/08/2023	Stakeholders and Communication
01/08/2023	Other: Organisation chart: Stakeholders and Communication
01/08/2023	Veterinary Medicines
01/08/2023	Other: Organisation chart: Veterinary Medicines
01/08/2023	Regulatory and procedural guideline: Questions and answers (Q&As) on the external guidance of Policy 0070 on clinical data publication (CDP)
01/08/2023	Opinion/decision on a Paediatric investigation plan (PIP): Rimegepant, W: decision granting a waiver in all age groups for all conditions or indications, P/0285/2020
01/08/2023	Human medicines European public assessment report (EPAR): Idefirix, Imlifidase, Desensitization, Immunologic; Kidney Transplantation, 25/08/2020, , , , 4, Authorised
01/08/2023	Human medicines European public assessment report (EPAR): Xydalba, dalbavancin hydrochloride, Soft Tissue Infections; Skin Diseases, Bacterial, 19/02/2015, 15, Authorised
01/08/2023	Human medicines European public assessment report (EPAR): Ofev, nintedanib, Idiopathic Pulmonary Fibrosis, 14/01/2015, , 24, Authorised
01/08/2023	Human medicines European public assessment report (EPAR): Bydureon, exenatide, Diabetes Mellitus, Type 2, 17/06/2011, 25, Authorised