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22/11/2019 Regulatory awareness session on medical devices (Webinar) , European Medicines Agency, Amsterdam, the Netherlands, from 02/12/2019 to 02/12/2019
22/11/2019 Ebola (updated)
22/11/2019 Human medicines European public assessment report (EPAR): Ivozall, clofarabine, Precursor Cell Lymphoblastic Leukemia-Lymphoma, 14/11/2019, Additional monitoring, Generic, Authorised
22/11/2019 Human medicines European public assessment report (EPAR): Silodyx, silodosin, Prostatic Hyperplasia, 29/01/2010, 13, Authorised (updated)
22/11/2019 Minutes: Minutes of the CAT meeting 17-19 July 2019
22/11/2019 Other: EMA tracking tool: relocation to Amsterdam - Main milestones (updated)
22/11/2019 Human medicines European public assessment report (EPAR): Trevicta (previously Paliperidone Janssen), paliperidone palmitate, Schizophrenia, 05/12/2014, 9, Authorised (updated)
22/11/2019 Human medicines European public assessment report (EPAR): Inlyta, axitinib, Carcinoma, Renal Cell, 03/09/2012, 12, Authorised (updated)
22/11/2019 Ethanol (updated)
22/11/2019 Annex to the European Commission guideline on 'Excipients in the labelling and package leaflet of medicinal products for human use' (updated)
22/11/2019 Scientific guideline: Annex to the European Commission guideline on ‘Excipients in the labelling and package leaflet of medicinal products for human use’ (SANTE-2017-11668) - Revision 1
22/11/2019 Scientific guideline: Information for the package leaflet regarding ethanol used as an excipient in medicinal products for human use
21/11/2019 Minor uses / minor species and limited markets (updated)
21/11/2019 Scientific guideline: Concept paper for the revision of scientific guidelines on limited market for veterinary medicinal products
21/11/2019 Concept paper for the revision of scientific guidelines on limited market for veterinary medicinal products
21/11/2019 Report: Decision on amending budget No 1-2019
21/11/2019 Human medicines European public assessment report (EPAR): Instanyl, Fentanyl citrate, Pain, Cancer, 20/07/2009, 22, Authorised (updated)
21/11/2019 Human medicines European public assessment report (EPAR): Edistride, dapagliflozin propanediol monohydrate, Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1, 09/11/2015, 11, Authorised (updated)
21/11/2019 Human medicines European public assessment report (EPAR): Erelzi, etanercept, Arthritis, Psoriatic, Psoriasis, Arthritis, Juvenile Rheumatoid, Arthritis, Rheumatoid, Spondylitis, Ankylosing, 23/06/2017, Additional monitoring, Biosimilar, 5, Authorised (updated)
21/11/2019 Human medicines European public assessment report (EPAR): Fulphila, pegfilgrastim, Neutropenia, 20/11/2018, Additional monitoring, Biosimilar, 2, Authorised (updated)
21/11/2019 Periodic safety update single assessment: Acetylsalicylic acid: List of nationally authorised medicinal products - PSUSA/00000039/201902
21/11/2019 Periodic safety update single assessment: Acetylsalicylic acid: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00000039/201902
21/11/2019 Other: From laboratory to patient: the journey of a centrally authorised medicine (updated)
21/11/2019 Report: Recommendations on eligibility to PRIME scheme - Adopted at the CHMP meeting of 11-14 November 2019
21/11/2019 Report: List of products granted eligibility to PRIME (updated)
21/11/2019 Human medicines European public assessment report (EPAR): Otezla, apremilast, Arthritis, Psoriatic, Psoriasis, 15/01/2015, 11, Authorised (updated)
21/11/2019 Regulatory and procedural guideline: Procedural advice for orphan medicinal product designation: Guidance for sponsors (updated)
21/11/2019 Other: Procedural advice for post-orphan medicinal product designation activities: Guidance for sponsors (updated)
21/11/2019 Human medicines European public assessment report (EPAR): NovoSeven, eptacog alfa (activated), Hemophilia B, Thrombasthenia, Factor VII Deficiency, Hemophilia A, 23/02/1996, 33, Authorised (updated)
21/11/2019 Medicines under additional monitoring (updated)
21/11/2019 Report: European Medicines Agency and Member States joint report to the European Commission on the experience with the list of products subject to additional monitoring
20/11/2019 Opinion/decision on a Paediatric investigation plan (PIP): Human chorionic gonadotrophin, W: decision granting a waiver in all age groups for all conditions/indications, P/0283/2019
20/11/2019 Opinion/decision on a Paediatric investigation plan (PIP): Istradefylline, W: decision granting a waiver in all age groups for all conditions/indications, P/0270/2019
20/11/2019 Opinion/decision on a Paediatric investigation plan (PIP): Botulinum toxin type A, W: decision granting a waiver in all age groups for all conditions/indications, P/0281/2019
20/11/2019 Opinion/decision on a Paediatric investigation plan (PIP): eteplirsen, PM: decision on the application for modification of an agreed PIP, P/0286/2019 (updated)
20/11/2019 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/0287/2019 (updated)
20/11/2019 Opinion/decision on a Paediatric investigation plan (PIP): Vyxeos liposomal (previously known as Vyxeos), daunorubicin,cytarabine, PM: decision on the application for modification of an agreed PIP, P/0292/2019 (updated)
20/11/2019 Opinion/decision on a Paediatric investigation plan (PIP): Axumin, Fluciclovine (18F), PM: decision on the application for modification of an agreed PIP, P/0285/2019 (updated)
20/11/2019 Opinion/decision on a Paediatric investigation plan (PIP): lasmiditan, PM: decision on the application for modification of an agreed PIP, P/0291/2019 (updated)
20/11/2019 Opinion/decision on a Paediatric investigation plan (PIP): Selumetinib, PM: decision on the application for modification of an agreed PIP, P/0279/2019 (updated)
20/11/2019 Orphan designation: 4-hydroxy-6-{2-[4-(trifluoromethyl)phenyl]ethyl}pyridazin-3(2H)-one for the: Treatment of Friedreich’s ataxia, 01/04/2019, Withdrawn (updated)
20/11/2019 Opinion/decision on a Paediatric investigation plan (PIP): Octenidine (dihydrochloride), PM: decision on the application for modification of an agreed PIP, P/0269/2019 (updated)
20/11/2019 Opinion/decision on a Paediatric investigation plan (PIP): Tafasitamab, W: decision granting a waiver in all age groups for all conditions/indications, P/0294/2019
20/11/2019 Opinion/decision on a Paediatric investigation plan (PIP): Bempegaldesleukin, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0298/2019
20/11/2019 Opinion/decision on a Paediatric investigation plan (PIP): ciclosporin, W: decision granting a waiver in all age groups for all conditions/indications, P/0293/2019
20/11/2019 Opinion/decision on a Paediatric investigation plan (PIP): Human immunoglobulin (Ig) G4-variant monoclonal antibody that binds and neutralizes soluble human, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0275/2019
20/11/2019 Opinion/decision on a Paediatric investigation plan (PIP): Gallium 68-labelled Prostate-Specific Membrane Antigen-11 (68Ga-PSMA-11), W: decision granting a waiver in all age groups for all conditions/indications, P/0290/2019
20/11/2019 Human medicines European public assessment report (EPAR): Tamiflu, oseltamivir, Influenza, Human, 20/06/2002, 37, Authorised (updated)
20/11/2019 Opinion/decision on a Paediatric investigation plan (PIP): Deltyba, Delamanid, PM: decision on the application for modification of an agreed PIP, P/0271/2019 (updated)
20/11/2019 Opinion/decision on a Paediatric investigation plan (PIP): Zebinix, Eslicarbazepine (acetate), PM: decision on the application for modification of an agreed PIP, P/0272/2019 (updated)
20/11/2019 Opinion/decision on a Paediatric investigation plan (PIP): Bosulif, Bosutinib, PM: decision on the application for modification of an agreed PIP, P/0282/2019 (updated)
20/11/2019 Opinion/decision on a Paediatric investigation plan (PIP): Taltz, ixekizumab, PM: decision on the application for modification of an agreed PIP, P/0280/2019 (updated)
20/11/2019 Opinion/decision on a Paediatric investigation plan (PIP): Briviact (in Italy: Nubriveo), Brivaracetam, PM: decision on the application for modification of an agreed PIP, P/0297/2019 (updated)
20/11/2019 Opinion/decision on a Paediatric investigation plan (PIP): EGFR-cMET bispecific antibody, W: decision granting a waiver in all age groups for all conditions/indications, P/0289/2019
20/11/2019 Opinion/decision on a Paediatric investigation plan (PIP): Onglyza, Saxagliptin, PM: decision on the application for modification of an agreed PIP, P/0277/2019 (updated)
20/11/2019 Orphan designation: 5,7-dichloro-2-dimethylaminomethyl-8-hydroxyquinoline hydrochloride for the: Treatment of Huntington’s disease, 21/05/2015, Withdrawn (updated)
20/11/2019 Opinion/decision on a Paediatric investigation plan (PIP): Anti-neonatal Fc receptor human monoclonal antibody, W: decision granting a waiver in all age groups for all conditions/indications, P/0288/2019
20/11/2019 Opinion/decision on a Paediatric investigation plan (PIP): Relugolix,estradiol,norethisterone acetate, RP: decision refers to a refusal on a proposed Paediatric Investigation Plan, P/0278/2019
20/11/2019 Opinion/decision on a Paediatric investigation plan (PIP): Prepandrix, Purified antigen fractions of inactivated split virion Influenza A/Vietnam/1194/2004 (H5N1) like strain used (NIBRG-14),Purified antigen fractions of inactivated split virion Influenza A/Indonesia/05/2005 (H5N1) like strain used (PR8-IBCDC-RG2), PM: decision on the application for modification of an agreed PIP, P/0299/2019 (updated)
20/11/2019 Referral: Veterinary medicinal products containing paromomycin to be administered parenterally to pigs , Paromomycin , Parofor,Gabbrovet,Gabbrocol, Article 35, European Commission final decision, 18/07/2019, 11/10/2019
20/11/2019 Orphan designation: Halofuginone hydrobromide for the: Treatment of systemic sclerosis, 11/12/2001, Withdrawn (updated)
20/11/2019 Veterinary medicines European public assessment report (EPAR): Vectormune ND, cell-associated live recombinant turkey herpes virus (rHVT/ND) expressing the fusion protein of Newcastle diseases virus D-26 lentogenic strain, 08/09/2015, 4, Authorised (updated)
20/11/2019 Other: List of European Union reference dates and frequency of submission of periodic safety update reports (updated)
20/11/2019 Human medicines European public assessment report (EPAR): Rixubis, nonacog gamma, Hemophilia B, 19/12/2014, Additional monitoring, 7, Authorised (updated)
20/11/2019 Human medicines European public assessment report (EPAR): Keytruda, Pembrolizumab, Melanoma, Hodgkin Disease, Carcinoma, Non-Small-Cell Lung, 17/07/2015, Additional monitoring, 23, Authorised (updated)
20/11/2019 Opinion/decision on a Paediatric investigation plan (PIP): Humanized anti-CD19, Fc engineered, monoclonal antibody (XmAb5871), P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0274/2019
20/11/2019 Orphan designation: Recombinant human tissue non-specific alkaline phosphatase - Fc - deca-aspartate fusion protein for the: Treatment of hypophosphatasia, 04/12/2008, Positive (updated)
20/11/2019 Orphan designation: Choline tetrathiomolybdate for the: Treatment of Wilson's disease, 24/01/2013, Positive (updated)
20/11/2019 Orphan designation: Recombinant human lysosomal acid lipase for the: Treatment of lysosomal acid lipase deficiency, 17/12/2010, Positive (updated)
20/11/2019 Orphan designation: Eculizumab for the: Treatment myasthenia gravis, 29/07/2014, Positive (updated)
20/11/2019 Orphan designation: Eculizumab for the: Treatment of neuromyelitis optica spectrum disorders, 05/08/2013, Positive (updated)
20/11/2019 Orphan designation: Eculizumab for the: Treatment of paroxysmal nocturnal haemoglobinuria, 17/10/2003, Expired (updated)
20/11/2019 Orphan designation: Eculizumab for the: Treatment of atypical haemolytic uraemic syndrome (aHUS), 24/07/2009, Positive (updated)
20/11/2019 Human medicines European public assessment report (EPAR): Pelmeg, pegfilgrastim, Neutropenia, 20/11/2018, Additional monitoring, Biosimilar, 2, Authorised (updated)
20/11/2019 Opinion/decision on a Paediatric investigation plan (PIP): Bulevirtide, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0296/2019
20/11/2019 Opinion/decision on a Paediatric investigation plan (PIP): mifepristone, W: decision granting a waiver in all age groups for all conditions/indications, P/0295/2019
20/11/2019 Human medicines European public assessment report (EPAR): Cinacalcet Mylan, cinacalcet hydrochloride, Hyperparathyroidism, Secondary, Hypercalcemia, 19/11/2015, Generic, 4, Authorised (updated)
20/11/2019 Opinion/decision on a Paediatric investigation plan (PIP): Entyvio, vedolizumab, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0276/2019
20/11/2019 Human medicines European public assessment report (EPAR): Mulpleo (previously Lusutrombopag Shionogi), Lusutrombopag, Thrombocytopenia, 18/02/2019, Additional monitoring, 3, Authorised (updated)
20/11/2019 Opinion/decision on a Paediatric investigation plan (PIP): Oxalobacter formigenes strain HC-1, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0273/2019
19/11/2019 Orphan designation: Autologous collagen type II-specific regulatory T cells for the: Treatment of non-infectious uveitis, 16/12/2014, Withdrawn (updated)
19/11/2019 Periodic safety update single assessment: Germanium (68Ge) chloride / gallium (68Ga) chloride : List of nationally authorised medicinal products - PSUSA/00010364/201903
19/11/2019 Periodic safety update single assessment: Glipizide : List of nationally authorised medicinal products - PSUSA/00001535/201901
19/11/2019 Veterinary medicines European public assessment report (EPAR): Bravecto, fluralaner, 11/02/2014, 9, Authorised (updated)
19/11/2019 Human medicines European public assessment report (EPAR): Lucentis, ranibizumab, Wet Macular Degeneration, Macular Edema, Myopia, Degenerative, Diabetes Complications, 22/01/2007, 35, Authorised (updated)
19/11/2019 Human medicines European public assessment report (EPAR): Olanzapine Teva, olanzapine, Schizophrenia, Bipolar Disorder, 12/12/2007, Generic, 26, Authorised (updated)
19/11/2019 Veterinary medicines European public assessment report (EPAR): Vectra Felis, pyriproxyfen, dinotefuran, 06/06/2014, 3, Authorised (updated)
19/11/2019 Committee for Medicinal Products for Human Use (CHMP): 16-19 September 2019 , European Medicines Agency, Amsterdam, the Netherlands, from 16/09/2019 to 19/09/2019 (updated)
19/11/2019 International Coalition of Medicines Regulatory Authorities (ICMRA) (updated)
19/11/2019 Minutes: Minutes of the CHMP meeting 16-19 September 2019
19/11/2019 Referral: Veterinary medicinal products containing tylosin presented as solution for injection to be administered to sheep , tylosin , See annex I, Article 35, European Commission final decision, 20/06/2019, 20/09/2019
19/11/2019 Orphan designation: Multilamellar microvesicle comprising phosphatidylcholine, sphingomyelin, phosphatidylethanolamine, phosphatidylserine, phosphatidylinositol and cholesterol for the: Treatment of cystic fibrosis, 30/08/2011, Positive (updated)
19/11/2019 Orphan designation: Encapsulated human retinal pigment epithelial cell line transfected with plasmid vector expressing human ciliary neurotropic factor for the: Treatment of macular telangiectasia type 2, 08/11/2012, Positive (updated)
19/11/2019 Human medicines European public assessment report (EPAR): Benepali, etanercept, Arthritis, Psoriatic, Arthritis, Rheumatoid, Psoriasis, 13/01/2016, Additional monitoring, Biosimilar, 10, Authorised (updated)
19/11/2019 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, 22, Authorised (updated)
19/11/2019 Human medicines European public assessment report (EPAR): Defitelio, defibrotide, Hepatic Veno-Occlusive Disease, 18/10/2013, Orphan, Additional monitoring, Exceptional circumstances, 10, Authorised (updated)
19/11/2019 Opinion/decision on a Paediatric investigation plan (PIP): pneumococcal polysaccharide serotype 1- diphtheria CRM197 conjugate,pneumococcal polysaccharide serotype 3 - diphtheria CRM197 conjugate,pneumococcal polysaccharide serotype 4 - diphtheria CRM197 conjugate,pneumococcal polysaccharide serotype 5 - diphtheria CRM197 conjugate,pneumococcal polysaccharide serotype 6A- diphtheria CRM197 conjugate,pneumococcal polysaccharide serotype 6B - diphtheria CRM197 conjugate,pneumococcal polysaccharide serotype 7F - diphtheria CRM197 conjugate,pneumococcal polysaccharide serotype 9V - diphtheria CRM197 conjugate,pneumococcal polysaccharide serotype 14 - diphtheria CRM197 conjugate,pneumococcal polysaccharide serotype 18C - diphtheria CRM197 conjugate,pneumococcal polysaccharide serotype 19A - diphtheria CRM197 conjugate,pneumococcal polysaccharide serotype 19F - diphtheria CRM197 conjugate,pneumococcal polysaccharide serotype 22F - diphtheria CRM197 conjugate,pneumococcal polysaccharide serotype 23F - diphtheria CRM197 conjugate,pneumococcal polysaccharide serotype 33F – diphtheria CRM197 conjugate (15-valent pneumococcal polysaccharide conjugate vaccine [V114]), PM: decision on the application for modification of an agreed PIP, P/0244/2019 (updated)
19/11/2019 Opinion/decision on a Paediatric investigation plan (PIP): Tremelimumab, PM: decision on the application for modification of an agreed PIP, P/0245/2019 (updated)
19/11/2019 Opinion/decision on a Paediatric investigation plan (PIP): Imfinzi, durvalumab, PM: decision on the application for modification of an agreed PIP, P/0256/2019 (updated)
19/11/2019 Human medicines European public assessment report (EPAR): Sevelamer carbonate Winthrop (previously Sevelamer carbonate Zentiva), sevelamer carbonate, Hyperphosphatemia, Renal Dialysis, 15/01/2015, 16, Authorised (updated)
19/11/2019 Agenda: Agenda - HMPC agenda of the 18-20 November 2019 meeting
19/11/2019 Human medicines European public assessment report (EPAR): Clopidogrel ratiopharm, clopidogrel hydrogen sulphate, Myocardial Infarction, Acute Coronary Syndrome, Peripheral Vascular Diseases, Stroke, 18/02/2015, Generic, 8, Authorised (updated)
18/11/2019 Opinion/decision on a Paediatric investigation plan (PIP): Venclyxto, Venetoclax, PM: decision on the application for modification of an agreed PIP, P/0246/2019 (updated)
18/11/2019 Opinion/decision on a Paediatric investigation plan (PIP): Balovaptan, PM: decision on the application for modification of an agreed PIP, P/0247/2019 (updated)
18/11/2019 Opinion/decision on a Paediatric investigation plan (PIP): Takhzyro, Lanadelumab (DX-2930), PM: decision on the application for modification of an agreed PIP, P/0265/2019 (updated)
18/11/2019 Human medicines European public assessment report (EPAR): Zirabev, bevacizumab, Colorectal Neoplasms, Breast Neoplasms, Carcinoma, Non-Small-Cell Lung, Carcinoma, Renal Cell, Uterine Cervical Neoplasms, 14/02/2019, Additional monitoring, Biosimilar, 2, Authorised (updated)
18/11/2019 Opinion/decision on a Paediatric investigation plan (PIP): Emgality, Galcanezumab, PM: decision on the application for modification of an agreed PIP, P/0248/2019 (updated)
18/11/2019 Human medicines European public assessment report (EPAR): Onivyde pegylated liposomal (previously known as Onivyde), irinotecan hydrochloride trihydrate, Pancreatic Neoplasms, 14/10/2016, Orphan, 4, Authorised (updated)
18/11/2019 Human medicines European public assessment report (EPAR): Matever, levetiracetam, Epilepsy, 03/10/2011, Generic, 19, Authorised (updated)
18/11/2019 Human medicines European public assessment report (EPAR): Alkindi, hydrocortisone, Adrenal Insufficiency, 09/02/2018, 5, Authorised (updated)
18/11/2019 Opinion/decision on a Paediatric investigation plan (PIP): Human normal immunoglobulin, PM: decision on the application for modification of an agreed PIP, P/0264/2019 (updated)
18/11/2019 Committee for Orphan Medicinal Products (COMP): 5-7 November 2019 , European Medicines Agency, Amsterdam, the Netherlands, from 05/11/2019 to 07/11/2019 (updated)
18/11/2019 Standard Operating Procedure - SOP: Standard operating procedure for handling of requests for information (updated)
18/11/2019 Human medicines European public assessment report (EPAR): Nucala, Mepolizumab, Asthma, 01/12/2015, Additional monitoring, 13, Authorised (updated)
18/11/2019 Opinion/decision on a Paediatric investigation plan (PIP): Symkevi, 1-(2,2-difluoro-1,3-benzodioxol-5-yl)-N-{1-[(2R)-2,3-dihydroxypropyl]-6-fluoro-2-(1-hydroxy-2-methylpropan-2-yl)-1H-indol-5-yl}cyclopropanecarboxamide (VX-661),ivacaftor, PM: decision on the application for modification of an agreed PIP, P/0250/2019 (updated)
18/11/2019 Opinion/decision on a Paediatric investigation plan (PIP): tezepelumab, PM: decision on the application for modification of an agreed PIP, P/0263/2019 (updated)
18/11/2019 Opinion/decision on a Paediatric investigation plan (PIP): Giotrif, afatinib, PM: decision on the application for modification of an agreed PIP, P/0235/2019 (updated)
18/11/2019 Opinion/decision on a Paediatric investigation plan (PIP): Xerava, eravacycline, PM: decision on the application for modification of an agreed PIP, P/0251/2019 (updated)
18/11/2019 Human medicines European public assessment report (EPAR): Nexavar, sorafenib, Carcinoma, Hepatocellular, Carcinoma, Renal Cell, 19/07/2006, Orphan, 28, Authorised (updated)
18/11/2019 Committee meeting report: COMP meeting report on the review of applications for orphan designation: November 2019
18/11/2019 Periodic safety update single assessment: Methylphenidate: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002024/201810
18/11/2019 Human medicines European public assessment report (EPAR): Slenyto, melatonin, Sleep Initiation and Maintenance Disorders, Autistic Disorder, 20/09/2018, 5, Authorised (updated)
18/11/2019 Human medicines European public assessment report (EPAR): Abraxane, paclitaxel, Breast Neoplasms, Pancreatic Neoplasms, Carcinoma, Non-Small-Cell Lung, 10/01/2008, 25, Authorised (updated)
18/11/2019 Procurement (updated)
18/11/2019 Procurement: Ex ante publicity of a negotiated procedure: EMA/2019/40/LD – Legal advice in relation to procurement matters and contracts under EU procurement and Dutch law
18/11/2019 Human medicines European public assessment report (EPAR): Verzenios, abemaciclib, Breast Neoplasms, 26/09/2018, Additional monitoring, 3, Authorised (updated)
18/11/2019 Scientific guideline: Draft VICH GL59 Harmonisation of criteria to waive laboratory animal batch safety testing for vaccines for veterinary use
18/11/2019 VICH GL59 Harmonisation of criteria to waive laboratory animal batch safety testing for vaccines for veterinary use
18/11/2019 Human medicines European public assessment report (EPAR): Vyxeos liposomal (previously known as Vyxeos), daunorubicin hydrochloride / cytarabine, Leukemia, Myeloid, Acute, 23/08/2018, Orphan, 2, Authorised (updated)
18/11/2019 Antimicrobial resistance (updated)
18/11/2019 Leaflet: Responsible use of antibiotics: what’s your role?
18/11/2019 Human medicines European public assessment report (EPAR): Myocet liposomal (previously Myocet), doxorubicin hydrochloride, Breast Neoplasms, 13/07/2000, 21, Authorised (updated)
15/11/2019 Periodic safety update single assessment: 5 fluorouracil (topical application) : List of nationally authorised medicinal products - PSUSA/00010000/201901
15/11/2019 Periodic safety update single assessment: 5 fluorouracil (topical application) : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010000/201901
15/11/2019 Report: Medicinal products for human use: monthly figures - October 2019
15/11/2019 Multi-stakeholder workshop on draft 'Regulatory Science to 2025' strategy (stakeholders for human medicines) , European Medicines Agency, Amsterdam, the Netherlands, from 18/11/2019 to 19/11/2019 (updated)
15/11/2019 Annual Patients and Consumers Working Party (PCWP) and Healthcare Professionals Working Party (HCPWP) meeting with all eligible organisations , European Medicines Agency, Amsterdam, the Netherlands, from 20/11/2019 to 20/11/2019 (updated)
15/11/2019 Agenda: Agenda - Annual Patients and Consumers Working Party (PCWP) and Healthcare Professionals Working Party (HCPWP) meeting with all eligible organisations (updated)
15/11/2019 News and press releases: Dutch authorities hand over final building to EMA in Amsterdam
15/11/2019 Relocation to Amsterdam (updated)
15/11/2019 Human medicines European public assessment report (EPAR): Picato, Ingenol mebutate, Keratosis, Actinic, 15/11/2012, Additional monitoring, 9, Authorised (updated)
15/11/2019 News and press releases: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 11-14 November 2019 (updated)
15/11/2019 News and press releases: EMA confirms Xeljanz to be used with caution in patients at high risk of blood clots
15/11/2019 Summary of opinion: Clopidogrel / Acetylsalicylic acid Mylan, clopidogrel / acetylsalicylic acid, 14/11/2019, Positive
15/11/2019 Withdrawn application: Linhaliq, ciprofloxacin, Date of withdrawal: 29/10/2019, Initial authorisation
15/11/2019 Summary of opinion: Tavlesse, fostamatinib, 14/11/2019, Positive
15/11/2019 Withdrawn application: Luxceptar, viable T-cells, Date of withdrawal: 06/11/2019, Initial authorisation
15/11/2019 Withdrawn application: Opsumit, macitentan, Date of withdrawal: 08/11/2019, Post-authorisation
15/11/2019 Summary of opinion: Isturisa, osilodrostat, 14/11/2019, Positive
15/11/2019 Summary of opinion: Mayzent, siponimod, 14/11/2019, Positive
15/11/2019 Summary of opinion: Sunosi, solriamfetol, 14/11/2019, Positive
15/11/2019 Summary of opinion: Deferasirox Accord, deferasirox, 14/11/2019, Positive
15/11/2019 News and press releases: Measures to minimise risk of serious side effects of multiple sclerosis medicine Lemtrada
15/11/2019 Summary of opinion: Revlimid, lenalidomide, 14/11/2019, Positive
15/11/2019 Summary of opinion: Kadcyla, trastuzumab emtansine, 14/11/2019, Positive
15/11/2019 Summary of opinion: Polivy, polatuzumab vedotin, 14/11/2019, Positive
15/11/2019 Referral: Lemtrada ,  alemtuzumab , Article 20 procedures, Opinion provided by Committee for Medicinal Products for Human Use, 14/11/2019, 15/11/2019 (updated)
15/11/2019 Referral: Xeljanz , tofacitinib , Article 20 procedures, Opinion provided by Committee for Medicinal Products for Human Use, 14/11/2019, 15/11/2019 (updated)
15/11/2019 Summary of opinion: Hopveus, sodium oxybate, 17/10/2019, Negative (updated)
15/11/2019 Report: European Medicines Agency mid-year report 2019 from the Executive Director
15/11/2019 Human medicines European public assessment report (EPAR): Cyramza, Ramucirumab, Stomach Neoplasms, 19/12/2014, 9, Authorised (updated)
15/11/2019 Human medicines European public assessment report (EPAR): Eliquis, Apixaban, Arthroplasty, Venous Thromboembolism, 18/05/2011, 18, Authorised (updated)
15/11/2019 Human medicines European public assessment report (EPAR): Esbriet, Pirfenidone, Idiopathic Pulmonary Fibrosis, 27/02/2011, Orphan, 24, Authorised (updated)
15/11/2019 Human medicines European public assessment report (EPAR): Lenvima, lenvatinib mesylate, Thyroid Neoplasms, 28/05/2015, Accelerated assessment, Additional monitoring, 10, Authorised (updated)
15/11/2019 Regulatory and procedural guideline: IRIS guide to the industry portal (updated)
14/11/2019 News and press releases: First vaccine to protect against Ebola (updated)
14/11/2019 Human medicines European public assessment report (EPAR): Erivedge, vismodegib, Carcinoma, Basal Cell, 12/07/2013, 26/04/2013, 12, Authorised (updated)
14/11/2019 Human medicines European public assessment report (EPAR): Nimenrix, Neisseria meningitidis serogroup A polysaccharide conjugated to tetanus toxoid, Neisseria meningitidis serogroup C polysaccharide conjugated to tetanus toxoid / Neisseria meningitidis serogroup W-135 polysaccharide conjugated to tetanus toxoid, Neisseria meningitidis serogroup Y polysaccharide conjugated to tetanus toxoid, Meningitis, Meningococcal, 20/04/2012, 28, Authorised (updated)
14/11/2019 Human medicines European public assessment report (EPAR): Tysabri, natalizumab, Multiple Sclerosis, 27/06/2006, Additional monitoring, 28, Authorised (updated)
14/11/2019 Opinion/decision on a Paediatric investigation plan (PIP): Testosterone, PM: decision on the application for modification of an agreed PIP, P/0236/2019 (updated)
14/11/2019 Opinion/decision on a Paediatric investigation plan (PIP): Fentanyl (hydrochloride), PM: decision on the application for modification of an agreed PIP, P/0237/2019 (updated)
14/11/2019 Opinion/decision on a Paediatric investigation plan (PIP): Esketamine (hydrochloride), PM: decision on the application for modification of an agreed PIP, P/0238/2019 (updated)
14/11/2019 Opinion/decision on a Paediatric investigation plan (PIP): Ninlaro, Ixazomib, PM: decision on the application for modification of an agreed PIP, P/0261/2019 (updated)
14/11/2019 Regulatory and procedural guideline: IRIS guide to registration (updated)
14/11/2019 Agenda: Agenda - Multi-stakeholder workshop on draft 'Regulatory Science to 2025' strategy (stakeholders for human medicines) (updated)
14/11/2019 Leaflet: EMA Regulatory Science to 2025 - Five goals (updated)
14/11/2019 Opinion/decision on a Paediatric investigation plan (PIP): Sivextro, Tedizolid (phosphate), PM: decision on the application for modification of an agreed PIP, P/0226/2019 (updated)
14/11/2019 Opinion/decision on a Paediatric investigation plan (PIP): Olumiant, baricitinib, PM: decision on the application for modification of an agreed PIP, P/0239/2019 (updated)
14/11/2019 Opinion/decision on a Paediatric investigation plan (PIP): Akynzeo, Fosnetupitant,Palonosetron, PM: decision on the application for modification of an agreed PIP, P/0267/2019 (updated)
14/11/2019 Opinion/decision on a Paediatric investigation plan (PIP): Soliris, Eculizumab, PM: decision on the application for modification of an agreed PIP, P/0252/2019 (updated)
14/11/2019 Opinion/decision on a Paediatric investigation plan (PIP): Dermatophagoides pteronyssinus and Dermatophagoides farinae extracts 50% / 50%, PM: decision on the application for modification of an agreed PIP, P/225/2019 (updated)
14/11/2019 Human medicines European public assessment report (EPAR): Duavive, oestrogens conjugated, bazedoxifene, Osteoporosis, 16/12/2014, 9, Authorised (updated)
14/11/2019 Human medicines European public assessment report (EPAR): Empliciti, Elotuzumab, Multiple Myeloma, 11/05/2016, Accelerated assessment, Additional monitoring, 6, Authorised (updated)
14/11/2019 Human medicines European public assessment report (EPAR): Exviera, dasabuvir sodium, Hepatitis C, Chronic, 14/01/2015, Accelerated assessment, Additional monitoring, 17, Authorised (updated)
14/11/2019 Opinion/decision on a Paediatric investigation plan (PIP): Birch, hazel and alder pollen extracts, PM: decision on the application for modification of an agreed PIP, P/224/2019 (updated)
14/11/2019 Human medicines European public assessment report (EPAR): Symkevi, tezacaftor, ivacaftor, Cystic Fibrosis, 31/10/2018, Orphan, Additional monitoring, 3, Authorised (updated)
14/11/2019 Human medicines European public assessment report (EPAR): Kalydeco, ivacaftor, Cystic Fibrosis, 22/07/2012, Orphan, Accelerated assessment, 20, Authorised (updated)
14/11/2019 Human medicines European public assessment report (EPAR): RoActemra, tocilizumab, Arthritis, Rheumatoid, Arthritis, Juvenile Rheumatoid, 15/01/2009, 29, Authorised (updated)
14/11/2019 Human medicines European public assessment report (EPAR): Viekirax, Ombitasvir, paritaprevir, ritonavir, Hepatitis C, Chronic, 14/01/2015, Accelerated assessment, Additional monitoring, 19, Authorised (updated)
14/11/2019 Scientific guideline: Guideline on clinical investigation of medicinal products for the treatment of gout - First version
14/11/2019 Clinical investigation of medicinal products for the treatment of gout (updated)
14/11/2019 Veterinary medicines European public assessment report (EPAR): Novaquin, meloxicam, 08/09/2015, 2, Authorised (updated)
14/11/2019 Human medicines European public assessment report (EPAR): Brinavess, Vernakalant hydrochloride, Atrial Fibrillation, 01/09/2010, 13, Authorised (updated)
14/11/2019 Orphan designation: drotrecogin alfa (activated) for the: Treatment of acute respiratory distress syndrome (ARDS), 22/09/2008, Positive (updated)
14/11/2019 Orphan designation: eptacog alfa (activated) for the: Treatment of diffuse alveolar haemorrhage, 14/12/2005, Positive (updated)
14/11/2019 Human medicines European public assessment report (EPAR): Zynteglo, Autologous CD34+ cell enriched population that contains hematopoietic stem cells transduced with lentiglobin BB305 lentiviral vector encoding the beta-A-T87Q-globin gene, beta-Thalassemia, 29/05/2019, Orphan, Accelerated assessment, Additional monitoring, Conditional approval, Authorised (updated)
13/11/2019 Veterinary medicines European public assessment report (EPAR): Meloxidolor, meloxicam, 22/04/2013, Generic, 7, Authorised (updated)
13/11/2019 Opinion/decision on a Paediatric investigation plan (PIP): RoActemra, tocilizumab, PM: decision on the application for modification of an agreed PIP, P/0253/2019 (updated)
13/11/2019 Opinion/decision on a Paediatric investigation plan (PIP): Nulojix, belatacept, PM: decision on the application for modification of an agreed PIP, P/0260/2019 (updated)
13/11/2019 Opinion/decision on a Paediatric investigation plan (PIP): NexoBrid, Concentrate of proteolytic enzymes in bromelain, PM: decision on the application for modification of an agreed PIP, P/0240/2019 (updated)
13/11/2019 Human medicines European public assessment report (EPAR): Yervoy, Ipilimumab, Melanoma, 12/07/2011, 29, Authorised (updated)
13/11/2019 Opinion/decision on a Paediatric investigation plan (PIP): Bisoprolol fumarate,Ramipril, W: decision granting a waiver in all age groups for all conditions/indications, P/0254/2019
13/11/2019 Opinion/decision on a Paediatric investigation plan (PIP): BLU-667, W: decision granting a waiver in all age groups for all conditions/indications, P/0266/2019
13/11/2019 Human medicines European public assessment report (EPAR): Vosevi, Sofosbuvir, velpatasvir, voxilaprevi, Hepatitis C, Chronic, 26/07/2017, Accelerated assessment, Additional monitoring, 6, Authorised (updated)
13/11/2019 Opinion/decision on a Paediatric investigation plan (PIP): brimonidine, RP: decision refers to a refusal on a proposed Paediatric Investigation Plan, P/0255/2019
13/11/2019 Opinion/decision on a Paediatric investigation plan (PIP): Heparin (sodium), W: decision granting a waiver in all age groups for all conditions/indications, P/0257/2019
13/11/2019 Opinion/decision on a Paediatric investigation plan (PIP): Rosuvastatin (calcium),Ezetimibe, W: decision granting a waiver in all age groups for all conditions/indications, P/0259/2019
13/11/2019 Opinion/decision on a Paediatric investigation plan (PIP): Moxetumomab pasudotox, W: decision granting a waiver in all age groups for all conditions/indications, P/0228/2019
13/11/2019 Human medicines European public assessment report (EPAR): Kyntheum, brodalumab, Psoriasis, 17/07/2017, Additional monitoring, 3, Authorised (updated)
13/11/2019 Opinion/decision on a Paediatric investigation plan (PIP): Lonafarnib, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0258/2019
13/11/2019 Opinion/decision on a Paediatric investigation plan (PIP): genetically modified replication-incompetent herpes simplex virus-1 expressing collagen VII, RP: decision refers to a refusal on a proposed Paediatric Investigation Plan, P/0227/2019
13/11/2019 Opinion/decision on a Paediatric investigation plan (PIP): Tropifexor, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0229/2019
13/11/2019 Human medicines European public assessment report (EPAR): IntronA, interferon alfa-2b, Carcinoid Tumor, Leukemia, Hairy Cell, Lymphoma, Follicular, Hepatitis B, Chronic, Hepatitis C, Chronic, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Melanoma, Multiple Myeloma, 09/03/2000, 32, Authorised (updated)
13/11/2019 Opinion/decision on a Paediatric investigation plan (PIP): Emricasan, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0230/2019
13/11/2019 Opinion/decision on a Paediatric investigation plan (PIP): Bemarituzumab, W: decision granting a waiver in all age groups for all conditions/indications, P/0241/2019
13/11/2019 Human medicines European public assessment report (EPAR): Praluent, Alirocumab, Dyslipidemias, 23/09/2015, Additional monitoring, 12, Authorised (updated)
13/11/2019 Opinion/decision on a Paediatric investigation plan (PIP): Dexamethasone (sodium phosphate),levofloxacin, RP: decision refers to a refusal on a proposed Paediatric Investigation Plan, P/0242/2019
13/11/2019 Human medicines European public assessment report (EPAR): Capecitabine Accord, capecitabine, Colonic Neoplasms, Breast Neoplasms, Colorectal Neoplasms, Stomach Neoplasms, 20/04/2012, Generic, 11, Authorised (updated)
13/11/2019 Referrals document: Nitrosamines EMEA-H-A5(3)-1490 - Questions and answers on 'Information on nitrosamines for marketing authorisation holders' (updated)
13/11/2019 Human medicines European public assessment report (EPAR): Clopidogrel/Acetylsalicylic acid Zentiva (previously DuoCover), clopidogrel, acetylsalicylic acid, Acute Coronary Syndrome, Myocardial Infarction, 14/03/2010, 22, Authorised (updated)
13/11/2019 Regulatory and procedural guideline: EudraVigilance registration manual (updated)
13/11/2019 Other: New Organization First User QPPV/RP or Change of EU QPPV/RP (updated)
13/11/2019 Regulatory and procedural guideline: EudraVigilance registration documents for Production (updated)
13/11/2019 Pharmacovigilance Risk Assessment Committee (PRAC): 11-14 June 2019 , European Medicines Agency, Amsterdam, the Netherlands, from 11/06/2019 to 14/06/2019 (updated)
13/11/2019 Opinion/decision on a Paediatric investigation plan (PIP): 6-cyclopropaneamido-4-{[2-methoxy-3-(1-methyl-1H-1,2,4 triazol-3-yl)phenyl]amino}-N-(2H3)methylpyridazine-3-carboxamide (BMS-986165), P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0262/2019
13/11/2019 Opinion/decision on a Paediatric investigation plan (PIP): Diphtheria toxoid,tetanus toxoid,pertussis toxoid,pertussis filamentous haemagglutinin,pertactin, RP: decision refers to a refusal on a proposed Paediatric Investigation Plan, P/0231/2019
13/11/2019 Minutes: Minutes of the PRAC meeting 11-14 June 2019
13/11/2019 Opinion/decision on a Paediatric investigation plan (PIP): (2S,4R)-1-(2-(3-acetyl-5-(2-methylpyrimidin-5-yl)-1H-indazol-1-yl)acetyl)-N-(6-bromopyridin-2-yl)-4- fluoropyrrolidine-2-carboxamide (ACH-0144471), P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0243/2019
13/11/2019 Human medicines European public assessment report (EPAR): Buccolam, midazolam, Epilepsy, 04/09/2011, Patient safety, 9, Authorised (updated)
13/11/2019 Other: Article 57 product data (updated)
12/11/2019 Opinion/decision on a Paediatric investigation plan (PIP): Bempedoic acid,Ezetimibe, W: decision granting a waiver in all age groups for all conditions/indications, P/0232/2019
12/11/2019 Human medicines European public assessment report (EPAR): Avastin, bevacizumab, Carcinoma, Non-Small-Cell Lung, Breast Neoplasms, Ovarian Neoplasms, Colorectal Neoplasms, Carcinoma, Renal Cell, 12/01/2005, 52, Authorised (updated)
12/11/2019 Opinion/decision on a Paediatric investigation plan (PIP): Hydrogen Peroxide (45%), RP: decision refers to a refusal on a proposed Paediatric Investigation Plan, P/0268/2019
12/11/2019 Human medicines European public assessment report (EPAR): Kisplyx, lenvatinib mesilate, Carcinoma, Renal Cell, 25/08/2016, Accelerated assessment, Additional monitoring, 10, Authorised (updated)
12/11/2019 Opinion/decision on a Paediatric investigation plan (PIP): Bempedoic acid, W: decision granting a waiver in all age groups for all conditions/indications, P/0233/2019
12/11/2019 Human medicines European public assessment report (EPAR): Zebinix, eslicarbazepine acetate, Epilepsy, 21/04/2009, 26, Authorised (updated)
12/11/2019 Human medicines European public assessment report (EPAR): Zaltrap, aflibercept, Colorectal Neoplasms, 01/02/2013, 8, Authorised (updated)
12/11/2019 Report: Annual Activity Report 2018
12/11/2019 Human medicines European public assessment report (EPAR): Rebetol, Ribavirin, Hepatitis C, Chronic, 06/05/1999, 36, Authorised (updated)
12/11/2019 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, Additional monitoring, Biosimilar, 5, Authorised (updated)
12/11/2019 News and press releases: Regulators’ advice can make a difference for faster patient access to highly innovative therapies
12/11/2019 Human medicines European public assessment report (EPAR): Lynparza, Olaparib, Ovarian Neoplasms, 16/12/2014, 8, Authorised (updated)
12/11/2019 Referral: Cyproterone-containing medicinal products , cyproterone , Article 31 referrals, Under evaluation, 12/11/2019 (updated)
12/11/2019 Scientific publications (updated)
12/11/2019 Human medicines European public assessment report (EPAR): Imbruvica, Ibrutinib, Lymphoma, Mantle-Cell, Leukemia, Lymphocytic, Chronic, B-Cell, 21/10/2014, Orphan, 15, Authorised (updated)
12/11/2019 Standard Operating Procedure - SOP: Standard operating procedure for review of orphan designation at the time of granting/varying a marketing authorisation (updated)
12/11/2019 Agenda: Agenda - PDCO agenda of the 12-15 November 2019 meeting
12/11/2019 Human medicines European public assessment report (EPAR): Wakix, pitolisant, Narcolepsy, 31/03/2016, Orphan, Additional monitoring, 7, Authorised (updated)
12/11/2019 Human medicines European public assessment report (EPAR): Duloxetine Mylan, duloxetine, Neuralgia, Diabetic Neuropathies, Anxiety Disorders, Depressive Disorder, Major, 19/06/2015, Generic, 10, Authorised (updated)
11/11/2019 Human medicines European public assessment report (EPAR): Temozolomide Teva, temozolomide, Glioma, Glioblastoma, 28/01/2010, Generic, 18, Authorised (updated)