What's new

RSS
Date Content
29/11/2019 Periodic safety update single assessment: Triamcinolone (intraocular formulations): List of nationally authorised medicinal products - PSUSA/00010292/201903
29/11/2019 Other: PDCO meeting dates for 2019, 2020 and 2021
29/11/2019 Human medicines European public assessment report (EPAR): Tysabri, natalizumab, Multiple Sclerosis, 27/06/2006, Additional monitoring, 28, Authorised
29/11/2019 Human medicines European public assessment report (EPAR): Udenyca, pegfilgrastim, Neutropenia, 21/09/2018, Additional monitoring, Biosimilar, 3, Authorised
29/11/2019 Human medicines European public assessment report (EPAR): Kanjinti, trastuzumab, Stomach Neoplasms, Breast Neoplasms, 16/05/2018, Additional monitoring, Biosimilar, 6, Authorised
29/11/2019 Human medicines European public assessment report (EPAR): Senstend, lidocaine, prilocaine, Premature Ejaculation, 14/11/2019, Authorised
29/11/2019 Leaflet: World AIDS Day – Communities make the difference
29/11/2019 Other: Timetable: Periodic safety update report (PSUR) and PSUR single assessment (PSUSA)
29/11/2019 Other: Timetable: Periodic safety update report (PSUR) and PSUR single assessment (PSUSA) - Advanced therapy medicinal products (ATMPs)
29/11/2019 News and press releases: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 25-28 November 2019
29/11/2019 Paediatric Committee (PDCO): 25-28 June 2019 , European Medicines Agency, Amsterdam, The Netherlands, from 25/06/2019 to 28/06/2019
29/11/2019 Minutes: Minutes - PDCO minutes of the 25-28 June 2019 meeting
29/11/2019 Minutes: Minutes - PDCO minutes of the 27-29 May 2019 meeting
29/11/2019 Veterinary Medicines
29/11/2019 Other: Organisation chart: Veterinary Medicines
29/11/2019 Human medicines European public assessment report (EPAR): Neulasta, pegfilgrastim, Neutropenia, Cancer, 22/08/2002, 34, Authorised
29/11/2019 Committee meeting report: CAT monthly report of application procedures, guidelines and related documents on advanced therapies: November 2019
28/11/2019 Paediatric Committee (PDCO): 9-11 December 2019 , European Medicines Agency, Amsterdam, The Netherlands, from 09/12/2019 to 11/12/2019
28/11/2019 Human medicines European public assessment report (EPAR): Pelgraz, pegfilgrastim, Neutropenia, 21/09/2018, Additional monitoring, Biosimilar, 4, Authorised
28/11/2019 News and press releases: ‘Regulatory science to 2025’: live broadcast of post-consultation workshop on veterinary medicines
28/11/2019 Agenda: Agenda - Multi-stakeholder workshop on draft 'Regulatory Science to 2025' strategy (stakeholders for veterinary medicines)
28/11/2019 Leaflet: EMA Regulatory Science to 2025 - Four goals for veterinary medicines regulation
28/11/2019 Periodic safety update single assessment: Cabergoline: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00000477/20190
28/11/2019 Periodic safety update single assessment: Cabergoline: List of nationally authorised medicinal products - PSUSA/00000477/201903
28/11/2019 Human medicines European public assessment report (EPAR): Fotivda, tivozanib, Carcinoma, Renal Cell, 24/08/2017, Additional monitoring, 4, Authorised
28/11/2019 Human medicines European public assessment report (EPAR): Zeffix, lamivudine, Hepatitis B, Chronic, 28/07/1999, 24, Authorised
28/11/2019 Human medicines European public assessment report (EPAR): Toviaz, fesoterodine fumarate, Urinary Bladder, Overactive, 20/04/2007, 23, Authorised
28/11/2019 Human medicines European public assessment report (EPAR): Rixathon, rituximab, Lymphoma, Non-Hodgkin, Arthritis, Rheumatoid, Leukemia, Lymphocytic, Chronic, B-Cell, Wegener Granulomatosis, Microscopic Polyangiitis, Pemphigus, 15/06/2017, Additional monitoring, Biosimilar, 3, Authorised
28/11/2019 Human medicines European public assessment report (EPAR): Somavert, Pegvisomant, Acromegaly, 12/11/2002, 21, Authorised
28/11/2019 Human medicines European public assessment report (EPAR): Dynastat, parecoxib sodium, Pain, Postoperative, 22/03/2002, 29, Authorised
27/11/2019 Human medicines European public assessment report (EPAR): Champix, varenicline, Tobacco Use Cessation, 25/09/2006, 36, Authorised
27/11/2019 Orphan designation: trabectedin for the: Treatment of ovarian cancer, 17/10/2003, Expired
27/11/2019 Human medicines European public assessment report (EPAR): Repatha, Evolocumab, Dyslipidemias, Hypercholesterolemia, 17/07/2015, Additional monitoring, 12, Authorised
27/11/2019 Human medicines European public assessment report (EPAR): Vaborem, meropenem trihydrate, vaborbactam, Urinary Tract Infections, Bacteremia, Bacterial Infections, Respiratory Tract Infections, Pneumonia, Pneumonia, Ventilator-Associated, 20/11/2018, Additional monitoring, 3, Authorised
27/11/2019 Report: Dashboard created for visual representation of the scoring of the included data sources
27/11/2019 Report: Inventory of registries
27/11/2019 Report: Bioanalytical Omics - Subgroup report
27/11/2019 Report: Clinical Trial and Imaging - Subgroup report
27/11/2019 Report: Data Analytics - Subgroup report
27/11/2019 Report: Genomics, Genetics, Transcriptomics and Epigenetics - Subgroup report
27/11/2019 Report: Observational data (Real World Data) - Subgroup report
27/11/2019 Report: Spontaneous Adverse Drug Reactions - Subgroup report
27/11/2019 Human medicines European public assessment report (EPAR): Ifirmasta (previously Irbesartan Krka), irbesartan hydrochloride, Hypertension, 01/12/2008, Generic, 11, Authorised
27/11/2019 Maximum Residue Limits - Report: Toltrazuril: Summary Report (1) – Committee for Veterinary Medicinal Products
27/11/2019 Veterinary medicines European public assessment report (EPAR): Suvaxyn CSF Marker, live Recombinant E2 gene deleted Bovine Viral Diarrhoea Virus containing Classical Swine Fever E2 (CP7_E2alf), 10/02/2015, 3, Authorised
27/11/2019 Veterinary medicines European public assessment report (EPAR): Bovela, modified live bovine viral diarrhoea virus type 1, non-cytopathic parent strain KE-9 and modified live bovine viral diarrhoea virus type 2, non-cytopathic parent strain NY-93, 22/12/2014, 4, Authorised
27/11/2019 Leaflet: Ebola vaccine development 2014-2019
27/11/2019 Human medicines European public assessment report (EPAR): Elaprase, idursulfase, Mucopolysaccharidosis II, 08/01/2007, Additional monitoring, Exceptional circumstances, 19, Authorised
27/11/2019 Template or form: EudraVigilance user declaration for qualified person for pharmacovigilance/responsible person for EudraVigilance and trusted deputy
27/11/2019 Annex to CHMP highlights: Scientific advice and protocol assistance adopted during the CHMP meeting 11-14 November 2019
27/11/2019 Human medicines European public assessment report (EPAR): Revatio, sildenafil, Hypertension, Pulmonary, 28/10/2005, 38, Authorised
27/11/2019 Human medicines European public assessment report (EPAR): Sutent, sunitinib, Gastrointestinal Stromal Tumors, Carcinoma, Renal Cell, Neuroendocrine Tumors, 19/07/2006, 38, Authorised
27/11/2019 Medicines under additional monitoring: Annex XII - List of Dexamed and associated names (dexamfetamine sulphate-containing medicinal products) in the European Union
27/11/2019 Medicines under additional monitoring: Annex VII - List of Targocid and associated names (teicoplanin-containing medicinal products in the EU)
27/11/2019 Medicines under additional monitoring: Annex XII - List of Dexamed and associated names (dexamfetamine sulphate-containing medicinal products) in the European Union
27/11/2019 Medicines under additional monitoring: Annex VII - List of Targocid and associated names (teicoplanin-containing medicinal products in the EU)
26/11/2019 Human medicines European public assessment report (EPAR): Oprymea, pramipexole dihydrochloride monohydrate, Parkinson Disease, 12/09/2008, Generic, 19, Authorised
26/11/2019 Periodic safety update single assessment: Levothyroxine : List of nationally authorised medicinal products - PSUSA/00001860/201901
26/11/2019 Periodic safety update single assessment: Levothyroxine : CMDh Scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00001860/201901
26/11/2019 Human medicines European public assessment report (EPAR): Enbrel, etanercept, Spondylitis, Ankylosing, Arthritis, Juvenile Rheumatoid, Arthritis, Psoriatic, Psoriasis, Arthritis, Rheumatoid, 02/02/2000, 60, Authorised
26/11/2019 Human medicines European public assessment report (EPAR): Capecitabine Medac, capecitabine, Colorectal Neoplasms, 19/11/2012, Generic, 9, Authorised
26/11/2019 Human medicines European public assessment report (EPAR): Tandemact, pioglitazone, glimepiride, Diabetes Mellitus, Type 2, 08/01/2007, 17, Authorised
26/11/2019 Human medicines European public assessment report (EPAR): Arsenic trioxide Accord, Arsenic trioxide, Leukemia, Promyelocytic, Acute, 14/11/2019, Generic, Authorised
26/11/2019 Human medicines European public assessment report (EPAR): Nyxoid, Naloxone hydrochloride dihydrate, Opioid-Related Disorders, 09/11/2017, 4, Authorised
26/11/2019 Human medicines European public assessment report (EPAR): Segluromet, ertugliflozin l-pyroglutamic acid / metformin hydrochloride, Diabetes Mellitus, Type 2, 23/03/2018, Additional monitoring, 3, Authorised
26/11/2019 Human medicines European public assessment report (EPAR): Trisenox, Arsenic trioxide, Leukemia, Promyelocytic, Acute, 05/03/2002, 27, Authorised
26/11/2019 Human medicines European public assessment report (EPAR): Ozurdex, dexamethasone, Macular Edema, Uveitis, 26/07/2010, 13, Authorised
26/11/2019 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
26/11/2019 Agenda: Agenda - Annual Patients and Consumers Working Party (PCWP) and Healthcare Professionals Working Party (HCPWP) meeting with all eligible organisations
26/11/2019 Other: European Medicines Agency second response to European Ombudsman regarding pre-submission activities
26/11/2019 Other: List of participants - Annual Patients and Consumers Working Party (PCWP) and Healthcare Professionals Working Party (HCPWP) meeting with all eligible organisations
26/11/2019 Human medicines European public assessment report (EPAR): Elonva, corifollitropin alfa, Reproductive Techniques, Assisted, Ovulation Induction, 25/01/2010, 15, Authorised
25/11/2019 Veterinary medicines European public assessment report (EPAR): Cepedex, dexmedetomidine hydrochloride, 13/12/2016, 3, Authorised
25/11/2019 Orphan designation: (S)-3-(1-(9H-purin-6-ylamino)ethyl)-8-chloro-2-phenylisoquinolin-1(2H)-one for the: Treatment of follicular lymphoma, 17/07/2013, Positive
25/11/2019 Orphan designation: (S)-3-(1-(9H-purin-6-ylamino)ethyl)-8-chloro-2-phenylisoquinolin-1(2H)-one (duvelisib) for the: Treatment of chronic lymphocytic leukaemia / small lymphocytic lymphoma, 26/04/2013, Positive
25/11/2019 Human medicines European public assessment report (EPAR): Pifeltro, Doravirine, HIV Infections, 22/11/2018, Additional monitoring, 3, Authorised
25/11/2019 Agenda: Agenda - PRAC draft agenda of meeting 25-28 November 2019
25/11/2019 Human medicines European public assessment report (EPAR): Steglatro, ertugliflozin l-pyroglutamic acid, Diabetes Mellitus, Type 2, 21/03/2018, Additional monitoring, 5, Authorised
25/11/2019 Human medicines European public assessment report (EPAR): Exjade, deferasirox, beta-Thalassemia, Iron Overload, 28/08/2006, Additional monitoring, 43, Authorised
25/11/2019 Human medicines European public assessment report (EPAR): Ifirmacombi, irbesartan, hydrochlorothiazide, Hypertension, 04/03/2011, Generic, 10, Authorised
25/11/2019 Human medicines European public assessment report (EPAR): Steglujan, ertugliflozin l-pyroglutamic acid, sitagliptin phosphate monohydrate, Diabetes Mellitus, Type 2, 23/03/2018, Additional monitoring, 6, Authorised
25/11/2019 Human medicines European public assessment report (EPAR): Pemetrexed Krka, pemetrexed disodium, Carcinoma, Non-Small-Cell Lung, Mesothelioma, 22/05/2018, Generic, 2, Authorised
25/11/2019 Human medicines European public assessment report (EPAR): Bortezomib Fresenius Kabi, bortezomib, Multiple Myeloma, 14/11/2019, Generic, Authorised
25/11/2019 Periodic safety update single assessment: Dorzolamide: List of nationally authorised medicinal products - PSUSA/00003168/201902
25/11/2019 Periodic safety update single assessment: Dorzolamide: CMDh Scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00003168/201902
25/11/2019 Regulatory and procedural guideline: Advice on implementing measures under Article 37(4) of Regulation (EU) 2019/6 on veterinary medicinal products – Criteria for the designation of antimicrobials to be reserved for treatment of certain infections in humans
25/11/2019 PRAC recommendation on signal: PRAC recommendations on signals adopted at the 28-31 October 2019 PRAC meeting
25/11/2019 Other: New product information wording: extracts from PRAC recommendations on signals adopted at the 28-31 October 2019 PRAC
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
22/11/2019 Human medicines European public assessment report (EPAR): Silodyx, silodosin, Prostatic Hyperplasia, 29/01/2010, 13, Authorised
22/11/2019 Minutes: Minutes of the CAT meeting 17-19 July 2019
22/11/2019 Human medicines European public assessment report (EPAR): Trevicta (previously Paliperidone Janssen), paliperidone palmitate, Schizophrenia, 05/12/2014, 9, Authorised
22/11/2019 Human medicines European public assessment report (EPAR): Inlyta, axitinib, Carcinoma, Renal Cell, 03/09/2012, 12, Authorised
22/11/2019 Ethanol
22/11/2019 Annex to the European Commission guideline on 'Excipients in the labelling and package leaflet of medicinal products for human use'
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 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 2-2019
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
21/11/2019 Human medicines European public assessment report (EPAR): Fulphila, pegfilgrastim, Neutropenia, 20/11/2018, Additional monitoring, Biosimilar, 2, Authorised
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 Report: Recommendations on eligibility to PRIME scheme - Adopted at the CHMP meeting of 11-14 November 2019
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
21/11/2019 Human medicines European public assessment report (EPAR): Urorec, silodosin, Prostatic Hyperplasia, 29/01/2010, 15, Authorised
21/11/2019 Medicines under additional monitoring
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
20/11/2019 Orphan designation: 5,7-dichloro-2-dimethylaminomethyl-8-hydroxyquinoline hydrochloride for the: Treatment of Huntington’s disease, 21/05/2015, Withdrawn
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
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
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
20/11/2019 Orphan designation: Choline tetrathiomolybdate for the: Treatment of Wilson's disease, 24/01/2013, Positive
20/11/2019 Orphan designation: Recombinant human lysosomal acid lipase for the: Treatment of lysosomal acid lipase deficiency, 17/12/2010, Positive
20/11/2019 Orphan designation: Eculizumab for the: Treatment myasthenia gravis, 29/07/2014, Positive
20/11/2019 Orphan designation: Eculizumab for the: Treatment of neuromyelitis optica spectrum disorders, 05/08/2013, Positive
20/11/2019 Orphan designation: Eculizumab for the: Treatment of paroxysmal nocturnal haemoglobinuria, 17/10/2003, Expired
20/11/2019 Orphan designation: Eculizumab for the: Treatment of atypical haemolytic uraemic syndrome (aHUS), 24/07/2009, Positive
20/11/2019 Human medicines European public assessment report (EPAR): Pelmeg, pegfilgrastim, Neutropenia, 20/11/2018, Additional monitoring, Biosimilar, 2, Authorised
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 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
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
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 Human medicines European public assessment report (EPAR): Olanzapine Teva, olanzapine, Schizophrenia, Bipolar Disorder, 12/12/2007, Generic, 26, Authorised
19/11/2019 Veterinary medicines European public assessment report (EPAR): Vectra Felis, pyriproxyfen, dinotefuran, 06/06/2014, 3, Authorised
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
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
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
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
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
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
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
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
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
19/11/2019 Agenda: Agenda - HMPC agenda of the 18-20 November 2019 meeting
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
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
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
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
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
18/11/2019 Human medicines European public assessment report (EPAR): Matever, levetiracetam, Epilepsy, 03/10/2011, Generic, 19, Authorised
18/11/2019 Human medicines European public assessment report (EPAR): Alkindi, hydrocortisone, Adrenal Insufficiency, 09/02/2018, 5, Authorised
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
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
18/11/2019 Standard Operating Procedure - SOP: Standard operating procedure for handling of requests for information
18/11/2019 Human medicines European public assessment report (EPAR): Nucala, Mepolizumab, Asthma, 01/12/2015, Additional monitoring, 13, Authorised
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
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
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
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
18/11/2019 Human medicines European public assessment report (EPAR): Nexavar, sorafenib, Carcinoma, Hepatocellular, Carcinoma, Renal Cell, 19/07/2006, Orphan, 28, Authorised
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
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 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 Leaflet: Responsible use of antibiotics: what’s your role?
18/11/2019 Antimicrobial resistance
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 News and press releases: Dutch authorities hand over final building to EMA in Amsterdam
15/11/2019 Relocation to Amsterdam
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 News and press releases: Measures to minimise risk of serious side effects of multiple sclerosis medicine Lemtrada
15/11/2019 Summary of opinion: Hopveus, sodium oxybate, 17/10/2019, Negative
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): Lenvima, lenvatinib mesylate, Thyroid Neoplasms, 28/05/2015, Accelerated assessment, Additional monitoring, 10, Authorised
14/11/2019 News and press releases: First vaccine to protect against Ebola
14/11/2019 Human medicines European public assessment report (EPAR): Erivedge, vismodegib, Carcinoma, Basal Cell, 12/07/2013, 26/04/2013, 12, Authorised
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
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
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
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
14/11/2019 Agenda: Agenda - Multi-stakeholder workshop on draft 'Regulatory Science to 2025' strategy (stakeholders for human medicines)
14/11/2019 Leaflet: EMA Regulatory Science to 2025 - Five goals
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
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
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
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
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
14/11/2019 Human medicines European public assessment report (EPAR): Duavive, oestrogens conjugated, bazedoxifene, Postmenopause, 16/12/2014, 9, Authorised
14/11/2019 Human medicines European public assessment report (EPAR): Empliciti, Elotuzumab, Multiple Myeloma, 11/05/2016, Accelerated assessment, Additional monitoring, 6, Authorised
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
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
14/11/2019 Human medicines European public assessment report (EPAR): RoActemra, tocilizumab, Arthritis, Rheumatoid, Arthritis, Juvenile Rheumatoid, 15/01/2009, 29, Authorised
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
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
14/11/2019 Veterinary medicines European public assessment report (EPAR): Novaquin, meloxicam, 08/09/2015, 2, Authorised
14/11/2019 Orphan designation: drotrecogin alfa (activated) for the: Treatment of acute respiratory distress syndrome (ARDS), 22/09/2008, Positive
14/11/2019 Orphan designation: eptacog alfa (activated) for the: Treatment of diffuse alveolar haemorrhage, 14/12/2005, Positive
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, 1, Authorised
13/11/2019 Veterinary medicines European public assessment report (EPAR): Meloxidolor, meloxicam, 22/04/2013, Generic, 7, Authorised
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
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
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
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 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
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 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 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
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