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31/03/2021 Human medicines European public assessment report (EPAR): Ivozall, clofarabine, Precursor Cell Lymphoblastic Leukemia-Lymphoma, 14/11/2019, Generic, 2, Authorised
31/03/2021 Human medicines European public assessment report (EPAR): Alli (previously Orlistat GSK), orlistat, Obesity, 22/07/2007, 17, Authorised
31/03/2021 Annex to CHMP highlights: Recommendations on eligibility to PRIME scheme - Adopted at the CHMP meeting of 22-25 March 2021
31/03/2021 Template or form: Presubmission request form for a EMA procedure prior to the submission of a marketing authorisation application or Article 58 Application
31/03/2021 News and press releases: AstraZeneca COVID-19 vaccine: review of very rare cases of unusual blood clots continues
31/03/2021 Human medicines European public assessment report (EPAR): Levetiracetam Teva, levetiracetam, Epilepsy, 25/08/2011, Generic, 17, Authorised
31/03/2021 PRAC recommendation on signal: Signal assessment report on embolic and thrombotic events (SMQ) with COVID-19 Vaccine (ChAdOx1-S [recombinant]) – COVID-19 Vaccine AstraZeneca (Other viral vaccines)
31/03/2021 Human medicines European public assessment report (EPAR): Amyvid, florbetapir (18F), Radionuclide Imaging, 14/01/2013, 14, Authorised
31/03/2021 Veterinary Medicines Regulation
31/03/2021 Human medicines European public assessment report (EPAR): Matever, levetiracetam, Epilepsy, 03/10/2011, Generic, 22, Authorised
31/03/2021 Newsletter: Veterinary Medicines Regulation highlights - Issue 4
31/03/2021 Human medicines European public assessment report (EPAR): Pioglitazone Teva Pharma, pioglitazone hydrochloride, Diabetes Mellitus, Type 2, 26/03/2012, Generic, 12, Authorised
31/03/2021 Human medicines European public assessment report (EPAR): Lenalidomide Mylan, lenalidomide, Multiple Myeloma, 18/12/2020, Generic, 1, Authorised
31/03/2021 Human medicines European public assessment report (EPAR): Zelboraf, vemurafenib, Melanoma, 17/02/2012, 20, Authorised
31/03/2021 Human medicines European public assessment report (EPAR): Epclusa, Sofosbuvir, velpatasvir, Hepatitis C, Chronic, 06/07/2016, Accelerated assessment, Additional monitoring, 14, Authorised
31/03/2021 Supply shortage: Respreeza (human alpha1-proteinase inhibitor) supply shortage
31/03/2021 Herbal - Call for data: Call for scientific data for the periodic review of the monograph on Urticae radix - Revision 1
31/03/2021 Herbal - Call for data: Call for scientific data for the periodic review of the monograph on Liquiritiae radix - Revision 1
31/03/2021 Herbal - Call for data: Call for scientific data for use in HMPC assessment work on Cetraria islandica (L.) Acharius s.l. - Revision 1
31/03/2021 Herbal - Call for data: Call for scientific data for the periodic review of the monograph on Origani dictamni herba - Revision 1
31/03/2021 Herbal - Call for data: Call for scientific data for the periodic review of the monograph on Paulliniae semen - Revision 1
31/03/2021 Herbal - Call for data: Call for scientific data for the periodic review of the monograph on Rhodiolae roseae rhizoma et radix - Revision 1
31/03/2021 Herbal - Call for data: Call for scientific data for the periodic review of the monograph on Tiliae flos - Revision 1
31/03/2021 Human medicines European public assessment report (EPAR): Xaluprine (previously Mercaptopurine Nova Laboratories), 6-mercaptopurine monohydrate, Leukemia, Lymphoid, 09/03/2012, Orphan, 12, Authorised
31/03/2021 Human medicines European public assessment report (EPAR): Amglidia, glibenclamide, Diabetes Mellitus, 24/05/2018, Orphan, 4, Authorised
30/03/2021 Consultation procedure for ancillary medicinal substances in medical devices
30/03/2021 Template or form: Application form for consultation by a notified body on an ancillary medicinal substance/ancillary human blood or plasma derivative used in a medical device 
30/03/2021 Template or form: Application form for a post-consultation procedure on an ancillary medicinal substance in a medical device
30/03/2021 Other: Questions and answers on the consultation procedure to the European Medicines Agency by notified bodies on an ancillary medicinal substance or an ancillary human blood derivative incorporated in a medical device
30/03/2021 Veterinary medicines European public assessment report (EPAR): Palladia, toceranib, 23/09/2009, 10, Authorised
30/03/2021 Periodic safety update single assessment: Azithromycin: List of nationally authorised medicinal products - PSUSA/00010492/202004
30/03/2021 News and press releases: EU recommendations for 2021-2022 seasonal flu vaccine composition
30/03/2021 Regulatory and procedural guideline: Biologics Working Party (BWP) Ad hoc Influenza Working Group - Amended European Union recommendations for the seasonal influenza vaccine composition for the season 2021/2022
30/03/2021 COVID-19 vaccine safety update: COVID-19 vaccine safety update for Comirnaty: 29 March 2021
30/03/2021 COVID-19 vaccine safety update: COVID-19 vaccine safety update for Vaxzevria (previously COVID-19 Vaccine AstraZeneca): 29 March 2021
30/03/2021 COVID-19 vaccine safety update: COVID-19 vaccine safety update for COVID-19 Vaccine Moderna: 29 March 2021
30/03/2021 News and press releases: EMA working on COVID-19 over holiday period
29/03/2021 Veterinary product information templates
29/03/2021 Template or form: Draft QRD veterinary annotated product information template v.9
29/03/2021 Other: EMA initiatives for acceleration of development support and evaluation procedures for COVID-19 treatments and vaccines
29/03/2021 Other: GB ICSRs reported to EV 15-31 December 2020 - Including the active substances in the suspect / interacting drugs
29/03/2021 Human medicines European public assessment report (EPAR): Epivir, lamivudine, HIV Infections, 08/08/1996, 46, Authorised
29/03/2021 Veterinary medicines European public assessment report (EPAR): Aivlosin, tylvalosin, 09/09/2004, 33, Authorised
29/03/2021 Human medicines European public assessment report (EPAR): Slenyto, melatonin, Sleep Initiation and Maintenance Disorders, Autistic Disorder, 20/09/2018, 7, Authorised
29/03/2021 Human medicines European public assessment report (EPAR): Norvir, ritonavir, HIV Infections, 25/08/1996, 66, Authorised
29/03/2021 Human medicines European public assessment report (EPAR): Bonviva, ibandronic acid, Osteoporosis, Postmenopausal, 23/02/2004, 28, Authorised
29/03/2021 Veterinary medicines European public assessment report (EPAR): SevoFlo, sevoflurane, 11/12/2002, 18, Authorised
29/03/2021 Certification procedures for micro-, small- and medium-sized enterprises (SMEs)
26/03/2021 Human medicines European public assessment report (EPAR): Luminity, perflutren, Echocardiography, 20/09/2006, 15, Authorised
26/03/2021 Other: Committee for Orphan Medicinal Products (COMP) meetings 2022, 2023 and 2024
26/03/2021 Minutes: Minutes of the CVMP meeting of 16-17 February 2021
26/03/2021 News and press releases: Increase in vaccine manufacturing capacity and supply for COVID-19 vaccines from AstraZeneca, BioNTech/Pfizer and Moderna
26/03/2021 News and press releases: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 March 2021
26/03/2021 Summary of opinion: Saxenda, liraglutide, 25/03/2021, Positive
26/03/2021 Summary of opinion: Tecentriq, atezolizumab, 25/03/2021, Positive
26/03/2021 News and press releases: EMA issues advice on use of regdanvimab for treating COVID-19
26/03/2021 Summary of opinion: Kalydeco, ivacaftor, 25/03/2021, Positive
26/03/2021 Summary of opinion: Benlysta, belimumab, 25/03/2021, Positive
26/03/2021 Annex to CHMP highlights: Start of Union reviews - CHMP meeting of 22-25 March 2021
26/03/2021 Annex to CHMP highlights: Scientific advice and protocol assistance adopted during the CHMP meeting 22-25 March 2021
26/03/2021 Annex to CHMP highlights: Overview of (invented) names reviewed in February 2021 by the Name Review Group (NRG) adopted at the CHMP meeting of 22-25 March 2021
26/03/2021 Human medicines European public assessment report (EPAR): Tandemact, pioglitazone, glimepiride, Diabetes Mellitus, Type 2, 08/01/2007, 19, Authorised
26/03/2021 Human medicines European public assessment report (EPAR): Xeloda, capecitabine, Colonic Neoplasms, Breast Neoplasms, Colorectal Neoplasms, Stomach Neoplasms, 02/02/2001, Patient safety, 26, Authorised
26/03/2021 Other: Reply to open letter concerning vaccines for COVID-19
26/03/2021 Direct healthcare professional communication (DHPC): Respreeza (human alpha-1-proteinase inhibitor): Sterility issue with the infusion device co-packed with Respreeza 4.000 mg and 5.000 mg, Active substance: Human alpha1-proteinase inhibitor, DHPC type: Medicine shortage, Last updated: 26/03/2021
25/03/2021 Agenda: Agenda - Webinar on reporting suspected side effects following administration of veterinary medicines
25/03/2021 Human medicines European public assessment report (EPAR): Combivir, lamivudine, zidovudine, HIV Infections, 18/03/1998, 32, Authorised
25/03/2021 Human medicines European public assessment report (EPAR): Zonegran, zonisamide, Epilepsies, Partial, 10/03/2005, 33, Authorised
25/03/2021 Human medicines European public assessment report (EPAR): Glubrava, metformin hydrochloride, pioglitazone hydrochloride, Diabetes Mellitus, Type 2, 11/12/2007, 18, Authorised
25/03/2021 Human medicines European public assessment report (EPAR): Staquis, Crisaborole, Dermatitis, Atopic, 27/03/2020, Additional monitoring, 3, Authorised
25/03/2021 Maximum Residue Limits - Opinion: Opinion of the CVMP on the establishment of maximum residue limits: Lidocaine (porcine)
25/03/2021 Human medicines European public assessment report (EPAR): MabThera, rituximab, Lymphoma, Non-Hodgkin, Arthritis, Rheumatoid, Leukemia, Lymphocytic, Chronic, B-Cell, 02/06/1998, 53, Authorised
25/03/2021 European network of paediatric research at the European Medicines Agency (Enpr-EMA) Coordinating Group and networks meeting , Virtual meeting, from 02/03/2021 to 02/03/2021
25/03/2021 Human medicines European public assessment report (EPAR): Telmisartan Teva, telmisartan, Hypertension, 25/01/2010, Generic, 11, Authorised
25/03/2021 News and press releases: COVID-19 Vaccine AstraZeneca – Update on ongoing evaluation of blood clot cases
25/03/2021 Human medicines European public assessment report (EPAR): Cosentyx, Secukinumab, Arthritis, Psoriatic, Psoriasis, Spondylitis, Ankylosing, 14/01/2015, 20, Authorised
25/03/2021 Human medicines European public assessment report (EPAR): Zoledronic Acid Hospira, zoledronic acid monohydrate, Hypercalcemia, 19/11/2012, Generic, 17, Authorised
25/03/2021 Human medicines European public assessment report (EPAR): Strensiq, asfotase alfa, Hypophosphatasia, 28/08/2015, Orphan, Additional monitoring, Exceptional circumstances, 14, Authorised
25/03/2021 Human medicines European public assessment report (EPAR): Enbrel, etanercept, Spondylitis, Ankylosing, Arthritis, Juvenile Rheumatoid, Arthritis, Psoriatic, Psoriasis, Arthritis, Rheumatoid, 02/02/2000, 65, Authorised
25/03/2021 Veterinary medicines European public assessment report (EPAR): Nobivac Myxo-RHD, live myxoma-vectored rabbit-haemorrhagic-disease virus strain 009, 07/09/2011, 4, Authorised
25/03/2021 Human medicines European public assessment report (EPAR): Lenvima, lenvatinib mesilate, Thyroid Neoplasms, 28/05/2015, Accelerated assessment, Additional monitoring, 15, Authorised
25/03/2021 Procurement: Guidebook for tenderers (revised March 2021)
25/03/2021 Direct healthcare professional communication (DHPC): Tecentriq (atezolizumab): Risk of Severe Cutaneous Adverse Reactions (SCARs), Active substance: atezolizumab, DHPC type: Adverse event, Last updated: 25/03/2021
25/03/2021 Classification of changes: questions and answers
25/03/2021 Human medicines European public assessment report (EPAR): Hexyon, filamentous haemagglutinin, Haemophilus influenzae type B polysaccharide (polyribosylribitol phosphate), hepatitis B surface antigen, pertussis toxoid, poliovirus (inactivated) type 1 (Mahoney strain) produced on Vero cells, poliovirus (inactivated) type 2 (MEF-1 strain) produced on Vero cells, poliovirus (inactivated) type 3 (Saukett strain) produced on Vero cells, tetanus protein, tetanus toxoid adsorbed on aluminium hydroxide, hydrated, Diphtheria toxoid, Hepatitis B, Tetanus, Immunization, Meningitis, Haemophilus, Whooping Cough, Poliomyelitis, Diphtheria, 17/04/2013, 22/02/2013, 24, Authorised
25/03/2021 Human medicines European public assessment report (EPAR): Deferiprone Lipomed, Deferiprone, Iron Overload, beta-Thalassemia, 19/09/2018, Generic, 3, Authorised
25/03/2021 Veterinary medicines European public assessment report (EPAR): Nobilis Influenza H5N2, inactivated whole avian influenza virus antigen of H5N2 subtype (strain A/duck/Potsdam/1402/86), 01/09/2006, Accelerated assessment, 8, Authorised
25/03/2021 Eligible patients and consumers organisations
25/03/2021 Human medicines European public assessment report (EPAR): Hexacima, hepatitis B surface antigen, Diphtheria toxoid, tetanus toxoid, Bordetella pertussis antigens Pertussis Toxoid Filamentous Haemagglutinin, poliovirus (inactivated) type 1 (Mahoney) type 2 (MEF-1) type 3 (Saukett), Haemophilus influenzae type b polysaccharide (Polyribosylribitol Phosphate) conjugated to Tetanus protein, Hepatitis B, Tetanus, Immunization, Meningitis, Haemophilus, Whooping Cough, Poliomyelitis, Diphtheria, 17/04/2013, 22/02/2013, 23, Authorised
24/03/2021 Human medicines European public assessment report (EPAR): Ziagen, abacavir, HIV Infections, 08/07/1999, 43, Authorised
24/03/2021 Referrals document: Eli Lilly and Company Limited antibody combination (bamlanivimab / etesevimab - COVID19 - Article-5(3) procedure: Assessment report
24/03/2021 Other: PDCO meetings in 2021, 2022, 2023 and 2024
24/03/2021 Human medicines European public assessment report (EPAR): Bortezomib Fresenius Kabi, bortezomib, Multiple Myeloma, 14/11/2019, Generic, 4, Authorised
24/03/2021 Other: Inclusion and exclusion criteria for the important medical events list (MedDRA)
24/03/2021 Other: Important medical event terms list version (MedDRA) - version 24.0
24/03/2021 Agenda: Agenda - Public stakeholder meeting: approval, safety monitoring and impact of COVID-19 vaccines in the EU
24/03/2021 Referrals document: REGN-COV2 antibody combination (casirivimab / imdevimab) - COVID19 - Article-5(3) procedure: Conditions of use, conditions for distribution and patients targeted and conditions for safety monitoring
24/03/2021 Human medicines European public assessment report (EPAR): Lumigan, bimatoprost, Glaucoma, Open-Angle, Ocular Hypertension, 08/03/2002, 33, Authorised
24/03/2021 Other: Speakers - European Medicines Agency / AnimalhealthEurope veterinary medicines info day 2021
24/03/2021 Human medicines European public assessment report (EPAR): Bondronat, ibandronic acid, Hypercalcemia, Breast Neoplasms, Neoplasm Metastasis, Fractures, Bone, 25/06/1996, 31, Authorised
24/03/2021 Human medicines European public assessment report (EPAR): Rizmoic, Naldemedine tosilate, Constipation, 18/02/2019, Additional monitoring, 5, Authorised
24/03/2021 Human medicines European public assessment report (EPAR): Bortezomib Accord, bortezomib, Multiple Myeloma, 20/07/2015, Generic, 9, Authorised
24/03/2021 Periodic safety update single assessment: Tramadol: List of nationally authorised medicinal products - PSUSA/00003002/202005
24/03/2021 Periodic safety update single assessment: Tramadol: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00003002/202005
24/03/2021 Veterinary medicines European public assessment report (EPAR): Acticam, meloxicam, 09/12/2008, Generic, 9, Withdrawn
24/03/2021 Human medicines European public assessment report (EPAR): NeuroBloc, botulinum toxin type B, Torticollis, 22/01/2001, 33, Authorised
24/03/2021 Periodic safety update single assessment: Lidocaine hydrochloride/methylprednisolone acetate: List of nationally authorised medicinal products - PSUSA/00001879/202008
24/03/2021 Direct healthcare professional communication (DHPC): Xeljanz (tofacitinib): Initial clinical trial results of increased risk of major adverse cardiovascular events and malignancies (excluding NMSC) with use of tofacitinib relative to TNF— alpha inhibitors, Active substance: tofacitinib citrate, DHPC type: Safety signal, Last updated: 24/03/2021
24/03/2021 EPAR - Scientific Discussion: Acticam : EPAR - Scientific discussion
24/03/2021 Veterinary medicines European public assessment report (EPAR): Innovax-ND-IBD, Cell-associated live recombinant turkey herpesvirus (strain HVP360), expressing the fusion protein of ND virus and the VP2 protein of IBD virus, 22/08/2017, 4, Authorised
24/03/2021 Veterinary medicines European public assessment report (EPAR): Innovax-ILT, Cell-associated live recombinant turkey herpesvirus (strain HVT/ILT-138), expressing the glycoproteins gD and gI of infectious laryngotracheitis virus, 03/07/2015, 4, Authorised
24/03/2021 Orphan designation: Sparsentan for the: Treatment of primary IgA nephropathy, 19/10/2020, Positive
24/03/2021 Orphan designation: 4'-[(2-butyl-4-oxo-1,3-diazaspiro[4.4]non-1-en-3-yl)methyl]-N-(4,5-dimethyl-3-isoxazolyl)-2'-(ethoxymethyl)-[1,1'-biphenyl]-2-sulfonamide for the: Treatment of focal segmental glomerulosclerosis, 11/11/2015, Positive
24/03/2021 Veterinary medicines European public assessment report (EPAR): Innovax-ND-ILT, Cell-associated live recombinant turkey herpesvirus (strain HVT/NDV/ILT) expressing the fusion protein of newcastle disease virus and the glycoproteins gD and gI of infectious laryngotracheitis virus, 16/09/2020, 1, Authorised
24/03/2021 Human medicines European public assessment report (EPAR): Aranesp, darbepoetin alfa, Anemia, Cancer, Kidney Failure, Chronic, 08/06/2001, 43, Authorised
24/03/2021 Direct healthcare professional communication (DHPC): Vaxzevria (previously COVID-19 Vaccine AstraZeneca): Risk of thrombocytopenia and coagulation disorders, Active substance: Chimpanzee Adenovirus encoding the SARS CoV 2 Spike glycoprotein (ChAdOx1-S), DHPC type: Safety signal, Last updated: 24/03/2021
24/03/2021 Veterinary medicines European public assessment report (EPAR): Kriptazen, halofuginone, 08/02/2019, Generic, 1, Authorised
24/03/2021 Committee meeting report: COMP meeting report on the review of applications for orphan designation: March 2021
24/03/2021 EPAR - Procedural steps taken before authorisation: Acticam : EPAR - Procedural steps taken before authorisation
23/03/2021 Human medicines European public assessment report (EPAR): Relvar Ellipta, fluticasone furoate, vilanterol, Pulmonary Disease, Chronic Obstructive, 13/11/2013, 19, Authorised
23/03/2021 Human medicines European public assessment report (EPAR): Giapreza, Angiotensin II acetate, Hypotension, Shock, 23/08/2019, Additional monitoring, 1, Authorised
23/03/2021 Human medicines European public assessment report (EPAR): Ambrisentan Mylan, ambrisentan, Hypertension, Pulmonary, 20/06/2019, Generic, 2, Authorised
23/03/2021 Human medicines European public assessment report (EPAR): Uptravi, Selexipag, Hypertension, Pulmonary, 12/05/2016, 12, Authorised
23/03/2021 Human medicines European public assessment report (EPAR): Leflunomide Zentiva (previously Leflunomide Winthrop), leflunomide, Arthritis, Rheumatoid, Arthritis, Psoriatic, 08/01/2010, 16, Authorised
23/03/2021 Human medicines European public assessment report (EPAR): Vidaza, azacitidine, Myelodysplastic Syndromes, 17/12/2008, Accelerated assessment, 21, Authorised
23/03/2021 Template or form: Template - Active substance-master-file procedure
23/03/2021 Human medicines European public assessment report (EPAR): Tadalafil Lilly, tadalafil, Erectile Dysfunction, 22/03/2017, 4, Authorised
23/03/2021 Herbal medicinal product: Species amarae, Combination: Species amarae, F: Assessment finalised
23/03/2021 Human medicines European public assessment report (EPAR): Gamifant, Emapalumab, Immune System Diseases, 07/01/2021, Orphan, Refused
23/03/2021 Human medicines European public assessment report (EPAR): Olanzapine Mylan, olanzapine, Schizophrenia, Bipolar Disorder, 06/10/2008, Generic, 16, Authorised
23/03/2021 Human medicines European public assessment report (EPAR): Cialis, tadalafil, Erectile Dysfunction, 12/11/2002, 29, Authorised
23/03/2021 Human medicines European public assessment report (EPAR): Briviact (in Italy: Nubriveo), Brivaracetam, Epilepsy, 13/01/2016, 11, Authorised
23/03/2021 Human medicines European public assessment report (EPAR): Conbriza, bazedoxifene, Osteoporosis, Postmenopausal, 17/04/2009, 15, Authorised
23/03/2021 Human medicines European public assessment report (EPAR): Dectova, Zanamivir, Influenza, Human, 26/04/2019, Additional monitoring, 3, Authorised
23/03/2021 Veterinary medicines European public assessment report (EPAR): Fortekor Plus, benazepril hydrochloride, pimobendan, 08/09/2015, 4, Authorised
23/03/2021 Human medicines European public assessment report (EPAR): Zyclara, imiquimod, Keratosis, Keratosis, Actinic, 23/08/2012, 11, Authorised
23/03/2021 Periodic safety update single assessment: Lidocaine tetracaine: List of nationally authorised medicinal products - PSUSA/00001868/202006
22/03/2021 Human medicines European public assessment report (EPAR): NutropinAq, somatropin, Turner Syndrome, Dwarfism, Pituitary, 15/02/2001, 18, Authorised
22/03/2021 Agenda: Agenda - PDCO agenda of the 23-26 March 2021 meeting
22/03/2021 Other: Ms Enrica Alteri - Assessment outcome of occupational activities after leaving the service
22/03/2021 Other: Mr Hans Georg Eichler - Assessment outcome of occupational activities after leaving the service (March 2021)
22/03/2021 Human medicines European public assessment report (EPAR): Abasaglar (previously Abasria), insulin glargine, Diabetes Mellitus, 09/09/2014, Biosimilar, 11, Authorised
22/03/2021 News and press releases: EMA advises against use of ivermectin for the prevention or treatment of COVID-19 outside randomised clinical trials
22/03/2021 Direct healthcare professional communication (DHPC): Strimvelis® (autologous CD34+ enriched cell fraction that contains CD34+ cells transduced with retroviral vector that encodes for the human adenosine deaminase [ADA] cDNA sequence): first case of lymphoid T cell leukaemia after insertional oncogenesis, Active substance: autologous CD34+ enriched cell fraction that contains CD34+ cells transduced with retroviral vector that encodes for the human adenosine deaminase (ADA) cDNA sequence from human haematopoietic stem/progenitor (CD34+) cells, DHPC type: Adverse event, Last updated: 22/03/2021
22/03/2021 Veterinary medicines European public assessment report (EPAR): Rheumocam, meloxicam, 10/01/2008, Generic, 16, Authorised
22/03/2021 Maximum Residue Limits - Report: Lidocaine (porcine species): European Public MRL Assessment Report (EPMAR) - CVMP
22/03/2021 Human medicines European public assessment report (EPAR): Trepulmix, Treprostinil sodium, Hypertension, Pulmonary, 03/04/2020, Orphan, 1, Authorised
22/03/2021 Human medicines European public assessment report (EPAR): Komboglyze, metformin hydrochloride, saxagliptin hydrochloride, Diabetes Mellitus, Type 2, 24/11/2011, 17, Authorised
22/03/2021 Agenda: Agenda - CHMP agenda of the 22-25 March 2021 meeting
22/03/2021 Orphan designation: Terguride for the: Treatment of systemic sclerosis, 24/01/2013, Withdrawn
22/03/2021 Orphan designation: Salmonella typhi Ty21a strain transfected with a plasmid vector encoding the human vascular endothelial growth factor receptor 2 for the: Treatment of glioma, 23/08/2017, Positive
22/03/2021 Orphan designation: Pirfenidone for the: Treatment of idiopathic pulmonary fibrosis, 16/11/2004, Expired
22/03/2021 Human medicines European public assessment report (EPAR): Zinforo, Ceftaroline fosamil, Community-Acquired Infections, Skin Diseases, Infectious, Pneumonia, 22/08/2012, 25, Authorised
22/03/2021 Orphan designation: milciclib maleate for the: Treatment of malignant thymoma, 08/11/2012, Withdrawn
22/03/2021 Veterinary medicines European public assessment report (EPAR): Equioxx, firocoxib, 25/06/2008, 10, Authorised
22/03/2021 Orphan designation: Allogeneic umbilical cord blood CD34+ cells cultured ex vivo with Notch ligand Delta1 (dilanubicel) for the: Treatment in haematopoietic stem cell transplantation, 17/01/2018, Withdrawn
22/03/2021 Veterinary pre-submission Q&A: 1-20
22/03/2021 Template or form: Pre-submission request form to the European Medicines Agency for veterinary medicinal product in accordance with Regulation (EU) 2019/6
22/03/2021 Orphan designation: (E)-2,4,6-trimethoxystyryl-3-carboxymethylamino-4-methoxybenzyl-sulfone sodium salt for the: Treatment of myelodysplastic syndromes, 26/04/2012, Positive
19/03/2021 Withdrawn application: Dexamethasone Taw, dexamethasone phosphate, Date of withdrawal: 20/01/2021, Initial authorisation
19/03/2021 Press briefing on the conclusion of the investigation of COVID-19 Vaccine AstraZeneca and thromboembolic events by the Pharmacovigilance Risk Assessment Committee (PRAC) , Virtual meeting, from 18/03/2021 to 18/03/2021
19/03/2021 Referral: Adjusol trimethoprim sulfa liquide and its associated names , Article 34, European Commission final decision, 10/12/2020, 25/02/2021
19/03/2021 Committee meeting report: HMPC meeting report on European Union herbal monographs, guidelines and other activities - 1-3 March 2021
19/03/2021 Orphan designation: Genetically modified serotype 5/3 adenovirus coding for granulocyte macrophage colony-stimulating factor for the: Treatment of malignant mesothelioma, 16/12/2014, Positive
19/03/2021 Orphan designation: Genetically modified serotype 5/3 adenovirus coding for granulocyte macrophage colony-stimulating factor for the treatment of ovarian cancer for the: Treatment of ovarian cancer, 29/04/2014, Positive
19/03/2021 Orphan designation: genetically modified serotype 5/3 adenovirus coding for granulocyte-macrophage colony-stimulating factor for the: Treatment of soft tissue sarcoma, 19/06/2013, Positive
19/03/2021 Veterinary medicines European public assessment report (EPAR): Inflacam, meloxicam, 09/12/2011, Generic, 12, Authorised
19/03/2021 Human medicines European public assessment report (EPAR): Glustin, pioglitazone hydrochloride, Diabetes Mellitus, Type 2, 11/10/2000, 27, Authorised
19/03/2021 Minutes: Minutes of the CAT meeting 20-22 January 2021
19/03/2021 ICH M4 Common technical document (CTD) for the registration of pharmaceuticals for human use - organisation of CTD
19/03/2021 Human medicines European public assessment report (EPAR): Darunavir Krka d.d., darunavir, HIV Infections, 18/01/2018, Generic, 6, Authorised
19/03/2021 Other: EMA medical terms simplifier
19/03/2021 News and press releases: Meeting highlights from the Committee for Medicinal Products for Veterinary Use (CVMP) 16-18 March 2021
19/03/2021 Summary of opinion: Cortavance, hydrocortisone, 18/03/2021, Positive
19/03/2021 Maximum Residue Limits - Summary of opinion: Bambermycin (poultry) - Summary opinion of the CVMP on the establishment of maximum residue limits
19/03/2021 News and press releases: COVID-19 Vaccine AstraZeneca: benefits still outweigh the risks despite possible link to rare blood clots with low blood platelets
19/03/2021 Template or form: Letter of recommendations - Template
19/03/2021 Orphan designation: Levosimendan for the: Treatment of amyotrophic lateral sclerosis, 22/02/2018, Withdrawn
19/03/2021 Orphan designation: Humanised single-chain monoclonal antibody against CD37 (otlertuzumab) for the: Treatment chronic lymphocytic leukaemia, 06/12/2012, Withdrawn
19/03/2021 Orphan designation: Adeno-associated viral vector serotype 8 containing the human UGT1A1 gene (volrubigene ralaparvovec) for the: Treatment of Crigler-Najjar syndrome, 22/08/2014, Withdrawn
19/03/2021 Orphan designation: Nimorazole maleate for the: Treatment of squamous-cell carcinoma of the head and neck in patients undergoing radiotherapy, 09/02/2012, Withdrawn
19/03/2021 Orphan designation: Three chimeric human/murine monoclonal antibodies against the Ebola (Zaire) surface glycoprotein (porgaviximab) for the: Treatment for Ebola virus disease, 09/10/2015, Withdrawn
19/03/2021 Human medicines European public assessment report (EPAR): Aripiprazole Zentiva, aripiprazole, Schizophrenia, Bipolar Disorder, 25/06/2015, Generic, 8, Authorised
19/03/2021 Referral: Angiotensin-II-receptor antagonists (sartans) containing a tetrazole group , valsartan, candesartan, irbesartan, losartan, olmesartan, Article 31 referrals, European Commission final decision, 12/11/2020, 19/02/2021, 19/03/2021
19/03/2021 Human medicines European public assessment report (EPAR): Revinty Ellipta, fluticasone furoate, vilanterol trifenatate, Asthma, 02/05/2014, 18, Authorised
19/03/2021 Template or form: Submission of day +25 /235 final product information annexes (human and veterinary) - QRD Form 2 and checklist
19/03/2021 Template or form: QRD Appendix V - Adverse-drug-reaction reporting details
18/03/2021 Work programme: CHMP work plan 2021
18/03/2021 Periodic safety update single assessment: Naproxen: List of nationally authorised medicinal products - PSUSA/00002125/202008
18/03/2021 Periodic safety update single assessment: Clotiazepam: List of nationally authorised medicinal products - PSUSA/00000827/202005
18/03/2021 Periodic safety update single assessment: Clotiazepam: CMDh Scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00000827/202005
18/03/2021 Human medicines European public assessment report (EPAR): Ultibro Breezhaler, indacaterol, glycopyrronium bromide, Pulmonary Disease, Chronic Obstructive, 19/09/2013, 12, Authorised
18/03/2021 Human medicines European public assessment report (EPAR): Cerdelga, eliglustat, Gaucher Disease, 19/01/2015, Orphan, Additional monitoring, 12, Authorised
18/03/2021 Human medicines European public assessment report (EPAR): Irbesartan Zentiva (previously Irbesartan Winthrop), irbesartan, Hypertension, 19/01/2007, 24, Authorised
18/03/2021 Periodic safety update single assessment: Oxymetazoline: List of nationally authorised medicinal products - PSUSA/00002258/202008
18/03/2021 Direct healthcare professional communication (DHPC): Zolgensma (onasemnogene abeparvovec): risk for thrombotic microangiopathy, Active substance: onasemnogene abeparvovec, DHPC type: Type II variation, Last updated: 18/03/2021
18/03/2021 Periodic safety update single assessment: Ziprasidone: List of nationally authorised medicinal products - PSUSA/00003146/202007
18/03/2021 Human medicines European public assessment report (EPAR): Sialanar, glycopyrronium bromide, Sialorrhea, 15/09/2016, 6, Authorised
18/03/2021 Newsletter: Human medicines highlights - March 2021
18/03/2021 Human medicines European public assessment report (EPAR): Forsteo, teriparatide, Osteoporosis, Osteoporosis, Postmenopausal, 10/06/2003, 23, Authorised
18/03/2021 Human medicines European public assessment report (EPAR): Inlyta, axitinib, Carcinoma, Renal Cell, 03/09/2012, 13, Authorised
18/03/2021 Human medicines European public assessment report (EPAR): Thyrogen, thyrotropin alfa, Thyroid Neoplasms, 09/03/2000, 27, Authorised
18/03/2021 Human medicines European public assessment report (EPAR): Daxas, roflumilast, Pulmonary Disease, Chronic Obstructive, 05/07/2010, Additional monitoring, 16, Authorised
18/03/2021 Report: Medicinal products for human use: monthly figures - February 2021
18/03/2021 Human medicines European public assessment report (EPAR): Nevirapine Teva, nevirapine, HIV Infections, 30/11/2009, Generic, 10, Authorised
18/03/2021 Veterinary medicines European public assessment report (EPAR): Comfortis, spinosad, 11/02/2011, 9, Authorised
18/03/2021 EU big data stakeholder virtual forum , Virtual meeting, from 15/12/2020 to 15/12/2020
18/03/2021 Veterinary medicines European public assessment report (EPAR): Zolvix, monepantel, 04/11/2009, 14, Authorised
17/03/2021 Regulatory and procedural guideline: Guidance on parallel consultation
17/03/2021 Union Product Database: release notes
17/03/2021 Other: Production API and registration process (01.02)
17/03/2021 Other: Substance, Product, Organisation, Referentials (SPOR) API v2 Specification (01.02)
17/03/2021 Other: UPD Production release notes for version 01.02 March 2021
17/03/2021 Other: UPD example files (01.02)
17/03/2021 Other: UPD use cases (01.02)
17/03/2021 Human medicines European public assessment report (EPAR): Trumenba, Neisseria meningitidis serogroup B fHbp (recombinant lipidated fHbp (factor H binding protein)) subfamily A; Neisseria meningitidis serogroup B fHbp (recombinant lipidated fHbp (factor H binding protein)) subfamily B, Meningitis, Meningococcal, 24/05/2017, Additional monitoring, 9, Authorised
17/03/2021 Minutes: Minutes - PDCO minutes of the 26-29 January 2021 meeting
17/03/2021 Human medicines European public assessment report (EPAR): Pregabalin Zentiva k.s., pregabalin, Anxiety Disorders, Neuralgia, Epilepsy, 27/02/2017, Generic, 7, Authorised
17/03/2021 Agenda: CHMP ORGAM agenda for the meeting on 30 November 2020
17/03/2021 Minutes: CHMP ORGAM minutes for the meeting on 7 September 2020
17/03/2021 Human medicines European public assessment report (EPAR): Ribavirin Teva Pharma B.V., Ribavirin, Hepatitis C, Chronic, 01/07/2009, Generic, 14, Authorised
17/03/2021 Human medicines European public assessment report (EPAR): Blenrep, belantamab mafodotin, Multiple Myeloma, 25/08/2020, Orphan, Additional monitoring, Conditional approval, 2, Authorised
17/03/2021 Human medicines European public assessment report (EPAR): Pravafenix, fenofibrate, Pravastatin, Dyslipidemias, 14/04/2011, 6, Authorised
17/03/2021 Human medicines European public assessment report (EPAR): Naglazyme, galsulfase, Mucopolysaccharidosis VI, 23/01/2006, Additional monitoring, Exceptional circumstances, 18, Authorised
17/03/2021 Shortages catalogue
17/03/2021 Opinion/decision on a Paediatric investigation plan (PIP): Factor VIII Fc - von Willebrand factor - XTEN fusion protein (rFVIIIFc-VWF-XTEN), P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0238/2020
17/03/2021 Opinion/decision on a Paediatric investigation plan (PIP): peginesatide, PM: decision on the application for modification of an agreed PIP, P/0251/2012
17/03/2021 Agenda: Agenda - CAT agenda of the 17-18 March 2021 meeting
17/03/2021 Opinion/decision on a Paediatric investigation plan (PIP): eptinezumab, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0209/2020
17/03/2021 Opinion/decision on a Paediatric investigation plan (PIP): lucerastat, PM: decision on the application for modification of an agreed PIP, P/0221/2020
17/03/2021 Human medicines European public assessment report (EPAR): Pradaxa, Dabigatran etexilate mesilate, Arthroplasty, Replacement, Venous Thromboembolism, 17/03/2008, Patient safety, 33, Authorised
17/03/2021 Opinion/decision on a Paediatric investigation plan (PIP): Autologous CD34+ cells transduced with lentiviral vector encoding the human beta-globin gene, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0236/2020
17/03/2021 Opinion/decision on a Paediatric investigation plan (PIP): Human fibrinogen concentrate (BT524), PM: decision on the application for modification of an agreed PIP, P/0232/2020
17/03/2021 Human medicines European public assessment report (EPAR): Alprolix, eftrenonacog alfa, Hemophilia B, 12/05/2016, Orphan, Additional monitoring, 7, Authorised
17/03/2021 Opinion/decision on a Paediatric investigation plan (PIP): ligelizumab, PM: decision on the application for modification of an agreed PIP, P/0208/2020
17/03/2021 Opinion/decision on a Paediatric investigation plan (PIP): Rinvoq, upadacitinib, PM: decision on the application for modification of an agreed PIP, P/0214/2020
17/03/2021 Opinion/decision on a Paediatric investigation plan (PIP): Aimovig, erenumab, PM: decision on the application for modification of an agreed PIP, P/0107/2019
17/03/2021 Opinion/decision on a Paediatric investigation plan (PIP): Alofisel, darvadstrocel, PM: decision on the application for modification of an agreed PIP, P/0207/2020
17/03/2021 Opinion/decision on a Paediatric investigation plan (PIP): satralizumab, PM: decision on the application for modification of an agreed PIP, P/0204/2020
17/03/2021 Opinion/decision on a Paediatric investigation plan (PIP): anifrolumab, PM: decision on the application for modification of an agreed PIP, P/0239/2020
17/03/2021 Other: Decision of the Executive Director on fee reductions for scientific advice requests on products for the prevention and/or treatment of COVID-19
17/03/2021 Opinion/decision on a Paediatric investigation plan (PIP): outer membrane vesicles (OMV) from n. meningitidis strain NZ 98/254,recombinant neisseria meningitis group B Protein 936-741,meningococcal group W-135 oligosaccharides conjugated to corynebacterium diphtheriae CRM197 protein,meningococcal group A oligosaccharides conjugated to corynebacterium diphtheriae CRM197 protein,meningococcal group C oligosaccharides conjugated to corynebacterium diphtheriae CRM197 protein,recombinant neisseria meningitis group B Protein 287-953,recombinant neisseria meningitis group B Protein 961c,meningococcal group Y oligosaccharides conjugated to corynebacterium diphtheriae CRM197 protein (MenABCWY), PM: decision on the application for modification of an agreed PIP, P/0231/2020
17/03/2021 Agenda: Programme - European Medicines Agency / AnimalhealthEurope veterinary medicines info day 2021
17/03/2021 Opinion/decision on a Paediatric investigation plan (PIP): Adcetris, Brentuximab vedotin, PM: decision on the application for modification of an agreed PIP, P/0243/2020
17/03/2021 Human medicines European public assessment report (EPAR): Emend, Aprepitant, Vomiting, Postoperative Nausea and Vomiting, Cancer, 11/11/2003, 26, Authorised
17/03/2021 Opinion/decision on a Paediatric investigation plan (PIP): Xeljanz, Tofacitinib, PM: decision on the application for modification of an agreed PIP, P/0227/2020
17/03/2021 Opinion/decision on a Paediatric investigation plan (PIP): Brilique, ticagrelor, PM: decision on the application for modification of an agreed PIP, P/0217/2020
17/03/2021 Human medicines European public assessment report (EPAR): Capecitabine Teva, capecitabine, Colonic Neoplasms, Breast Neoplasms, Colorectal Neoplasms, Stomach Neoplasms, 20/04/2012, Patient safety, Generic, 14, Authorised
17/03/2021 Periodic safety update single assessment: Indium (111In) pentetreotide: List of nationally authorised medicinal products - PSUSA/00009192/202007
17/03/2021 Scientific guideline: CHMP Safety Working Party’s response to CMDh questions on chlorobutanol