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12/04/2019 Periodic safety update single assessment: Pseudoephedrine, acetylsalicylic acid / pseudoephedrine: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010667/201806
12/04/2019 Periodic safety update single assessment: Pseudoephedrine, acetylsalicylic acid / pseudoephedrine: List of nationally authorised medicinal products - PSUSA/00010667/201806
12/04/2019 Other: European Medicines Agency breach of trust procedure on declarations of competing interests for Management Board members
12/04/2019 Opinion/decision on a Paediatric investigation plan (PIP): Pretomanid, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0058/2019
12/04/2019 Opinion/decision on a Paediatric investigation plan (PIP): Givosiran, W: decision granting a waiver in all age groups for all conditions/indications, P/0038/2019
12/04/2019 Opinion/decision on a Paediatric investigation plan (PIP): Pexidartinib, W: decision granting a waiver in all age groups for all conditions/indications, P/0044/2019
12/04/2019 News and press releases: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 8-11 April 2019
12/04/2019 Referral: Estradiol-containing (0.01% w/w) medicinal products for topical use ,  estradiol , Linoladiol,Linoladiol N,Linoladiol Estradiol,Estradiol Wolff,Montadiol, Article 31 referrals, Under evaluation
12/04/2019 Opinion/decision on a Paediatric investigation plan (PIP): Ozanimod, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0050/2019
12/04/2019 Opinion/decision on a Paediatric investigation plan (PIP): filgotinib, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0045/2019
12/04/2019 Opinion/decision on a Paediatric investigation plan (PIP): Dienogest,ethinyl estradiol (LPRI-424), PM: decision on the application for modification of an agreed PIP, P/0053/2019
12/04/2019 Opinion/decision on a Paediatric investigation plan (PIP): Crizanlizumab, PM: decision on the application for modification of an agreed PIP, P/0060/2019
12/04/2019 News and press releases: Use of multiple sclerosis medicine Lemtrada restricted while EMA review is ongoing
12/04/2019 Human medicines European public assessment report (EPAR): Yentreve, duloxetine hydrochloride, Urinary Incontinence, Stress, 11/08/2004, 24, Authorised
12/04/2019 News and press releases: Update of EU recommendations for 2019/2020 seasonal flu vaccine composition
12/04/2019 Human medicines European public assessment report (EPAR): Integrilin, eptifibatide, Angina, Unstable, Myocardial Infarction, 01/07/1999, 23, Authorised
12/04/2019 Periodic safety update single assessment: Tianeptine: CMDh scientific conclusions, amendments to product information and implementation timetable - PSUSA/00002943/201806
12/04/2019 Periodic safety update single assessment: Tianeptine: List of nationally authorised medicinal products - PSUSA/00002943/201806
12/04/2019 Human medicines European public assessment report (EPAR): Holoclar, ex vivo expanded autologous human corneal epithelial cells containing stem cells, Stem Cell Transplantation, Corneal Diseases, 17/02/2015, Orphan, Additional monitoring, Conditional approval, 5, Authorised
12/04/2019 Veterinary medicines European public assessment report (EPAR): SevoFlo, sevoflurane, 11/12/2002, 16, Authorised
11/04/2019 Human medicines European public assessment report (EPAR): Vidaza, azacitidine, Myelodysplastic Syndromes, 17/12/2008, 18, Authorised
11/04/2019 Human medicines European public assessment report (EPAR): Genvoya, elvitegravir, cobicistat, emtricitabine, tenofovir alafenamide, HIV Infections, 19/11/2015, Additional monitoring, 19, Authorised
11/04/2019 Human medicines European public assessment report (EPAR): Prasugrel Mylan, prasugrel besilate, Myocardial Infarction, Acute Coronary Syndrome, Angina, Unstable, 15/05/2018, Generic, 3, Authorised
11/04/2019 Opinion/decision on a Paediatric investigation plan (PIP): Braftovi, Encorafenib, W: decision granting a waiver in all age groups for all conditions/indications, P/0049/2019
11/04/2019 Opinion/decision on a Paediatric investigation plan (PIP): Tremfya, guselkumab, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0025/2019
11/04/2019 Opinion/decision on a Paediatric investigation plan (PIP): Mektovi, binimetinib, W: decision granting a waiver in all age groups for all conditions/indications, P/0037/2019
11/04/2019 Opinion/decision on a Paediatric investigation plan (PIP): Imbruvica, Ibrutinib, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0021/2019
11/04/2019 Opinion/decision on a Paediatric investigation plan (PIP): semaglutide, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0007/2019
11/04/2019 Opinion/decision on a Paediatric investigation plan (PIP): Turoctocog alfa pegol, W: decision granting a waiver in all age groups for all conditions/indications, P/0046/2019
11/04/2019 Opinion/decision on a Paediatric investigation plan (PIP): Bilastine, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0009/2019
11/04/2019 Opinion/decision on a Paediatric investigation plan (PIP): Edurant, rilpivirine, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0039/2019
11/04/2019 News and press releases: The role of regulators in establishing added benefit of novel therapies
11/04/2019 Classification of changes: questions and answers
11/04/2019 Pre-authorisation guidance
11/04/2019 Post-authorisation measures: questions and answers
11/04/2019 Extensions of marketing authorisations: questions and answers
11/04/2019 Opinion/decision on a Paediatric investigation plan (PIP): Ozempic, semaglutide, PM: decision on the application for modification of an agreed PIP, P/0036/2019
11/04/2019 Regulatory and procedural guideline: European Medicines Agency procedural advice for users of the centralised procedure for generic / hybrid applications
11/04/2019 Regulatory and procedural guideline: European Medicines Agency procedural advice for users of the centralised procedure for generic / hybrid applications (track changes)
11/04/2019 Regulatory and procedural guideline: European Medicines Agency procedural advice for users of the centralised procedure for similar biological medicinal product applications (track changes)
11/04/2019 Regulatory and procedural guideline: European Medicines Agency procedural advice for users of the centralised procedure for similar biological medicinal product applications
11/04/2019 Opinion/decision on a Paediatric investigation plan (PIP): Triumeq, dolutegravir,abacavir,lamivudine, PM: decision on the application for modification of an agreed PIP, P/0018/2019
11/04/2019 Opinion/decision on a Paediatric investigation plan (PIP): Rezolsta, darunavir,cobicistat, PM: decision on the application for modification of an agreed PIP, P/0006/2019
11/04/2019 Regulatory and procedural guideline: European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure
11/04/2019 Regulatory and procedural guideline: European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure: document with tracked changes
11/04/2019 Opinion/decision on a Paediatric investigation plan (PIP): Moventig, Naloxegol, PM: decision on the application for modification of an agreed PIP, P/0056/2019
11/04/2019 Human medicines European public assessment report (EPAR): Luminity, perflutren, Echocardiography, 20/09/2006, 12, Authorised
11/04/2019 Opinion/decision on a Paediatric investigation plan (PIP): Sodium sulphate,potassium sulphate,magnesium sulphate heptahydrate (BLI800), PM: decision on the application for modification of an agreed PIP, P/0035/2019
11/04/2019 Human medicines European public assessment report (EPAR): Suboxone, buprenorphine, naloxone, Opioid-Related Disorders, 26/09/2006, 15, Authorised
11/04/2019 Opinion/decision on a Paediatric investigation plan (PIP): Birch pollen extract, PM: decision on the application for modification of an agreed PIP, P/0029/2019
11/04/2019 Human medicines European public assessment report (EPAR): Xydalba, dalbavancin hcl, Soft Tissue Infections, Skin Diseases, Bacterial, 19/02/2015, Additional monitoring, 8, Authorised
11/04/2019 Human medicines European public assessment report (EPAR): Trulicity, dulaglutide, Diabetes Mellitus, Type 2, 21/11/2014, Additional monitoring, 10, Authorised
11/04/2019 Human medicines European public assessment report (EPAR): Vargatef, nintedanib, Carcinoma, Non-Small-Cell Lung, 21/11/2014, Additional monitoring, 10, Authorised
11/04/2019 Human medicines European public assessment report (EPAR): Siklos, hydroxycarbamide, Anemia, Sickle Cell, 29/06/2007, Orphan, 16, Authorised
10/04/2019 Human medicines European public assessment report (EPAR): Mepact, mifamurtide, Osteosarcoma, 06/03/2009, Orphan, 14, Authorised
10/04/2019 Human medicines European public assessment report (EPAR): Pregabalin Mylan Pharma, pregabalin, Anxiety Disorders, Neuralgia, Epilepsy, 25/06/2015, Generic, 5, Authorised
10/04/2019 Human medicines European public assessment report (EPAR): Bortezomib Accord, bortezomib, Multiple Myeloma, 20/07/2015, Generic, 6, Authorised
10/04/2019 Human medicines European public assessment report (EPAR): Resolor, Prucalopride succinate, Constipation, 14/10/2009, 22, Authorised
10/04/2019 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, 31, Authorised
10/04/2019 Human medicines European public assessment report (EPAR): Febuxostat Mylan, febuxostat, Hyperuricemia, Arthritis, Gouty, Gout, 15/06/2017, Generic, 2, Authorised
10/04/2019 Human medicines European public assessment report (EPAR): Glyxambi, empagliflozin, linagliptin, Diabetes Mellitus, Type 2, 11/11/2016, Additional monitoring, 5, Authorised
10/04/2019 Human medicines European public assessment report (EPAR): Alimta, pemetrexed, Mesothelioma, Carcinoma, Non-Small-Cell Lung, 20/09/2004, 23, Authorised
10/04/2019 Human medicines European public assessment report (EPAR): Caspofungin Accord, caspofungin acetate, Candidiasis, Aspergillosis, 11/02/2016, Generic, 4, Authorised
10/04/2019 Periodic safety update single assessment: Ibuprofen / pseudoephedrine: List of nationally authorised medicinal products - PSUSA/00001711/201807
10/04/2019 Periodic safety update single assessment: Ibuprofen / pseudoephedrine: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001711/201807
10/04/2019 Human medicines European public assessment report (EPAR): Caprelsa, Vandetanib, Thyroid Neoplasms, 16/02/2012, Additional monitoring, Conditional approval, 15, Authorised
10/04/2019 Human medicines European public assessment report (EPAR): Panretin, alitretinoin, Sarcoma, Kaposi, 11/10/2000, 17, Authorised
10/04/2019 Human medicines European public assessment report (EPAR): Pemetrexed Lilly, pemetrexed, Carcinoma, Non-Small-Cell Lung, Mesothelioma, 14/09/2015, Generic, 4, Authorised
10/04/2019 Human medicines European public assessment report (EPAR): Nyxoid, Naloxone hydrochloride dihydrate, Opioid-Related Disorders, 09/11/2017, 3, Authorised
10/04/2019 Human medicines European public assessment report (EPAR): Alprolix, eftrenonacog alfa, Hemophilia B, 12/05/2016, Orphan, Additional monitoring, 4, Authorised
10/04/2019 Human medicines European public assessment report (EPAR): Cometriq, cabozantinib, Thyroid Neoplasms, 21/03/2014, Orphan, Additional monitoring, Conditional approval, 13, Authorised
10/04/2019 Human medicines European public assessment report (EPAR): Tacforius, tacrolimus monohydrate, Liver Transplantation, Kidney Transplantation, 08/12/2017, Generic, 1, Authorised
09/04/2019 Human medicines European public assessment report (EPAR): Betmiga, Mirabegron, Urinary Bladder, Overactive, 20/12/2012, 11, Authorised
09/04/2019 Human medicines European public assessment report (EPAR): Afinitor, everolimus, Carcinoma, Renal Cell, Breast Neoplasms, Pancreatic Neoplasms, 02/08/2009, 23, Authorised
09/04/2019 Orphan designation: Allogeneic cultured postnatal thymus-derived tissue for the: Treatment of severe combined immunodeficiency due to FOXN1 deficiency, 26/02/2019, Positive
09/04/2019 Orphan designation: Allogeneic cultured postnatal thymus-derived tissue for the: Treatment of CHARGE syndrome, 26/02/2019, Positive
09/04/2019 Orphan designation: Allogeneic cultured postnatal thymus-derived tissue for the: Treatment of DiGeorge syndrome, 26/02/2019, Positive
09/04/2019 Orphan designation: Poly(N-acetyl, N-arginyl)glucosamine for the: Treatment of cystic fibrosis, 26/02/2019, Positive
09/04/2019 Orphan designation: losartan for the: Treatment of epidermolysis bullosa, 26/02/2019, Positive
09/04/2019 Orphan designation: Lentiviral vector encoding human coagulation factor IX for the: Treatment of haemophilia B, 26/02/2019, Positive
09/04/2019 Opinion/decision on a Paediatric investigation plan (PIP): Entrectinib, PM: decision on the application for modification of an agreed PIP, P/0010/2019
09/04/2019 Opinion/decision on a Paediatric investigation plan (PIP): Venclyxto, Venetoclax, PM: decision on the application for modification of an agreed PIP, P/0001/2019
09/04/2019 Template or form: Template letter of intent for request of scientific advice or protocol assistance
09/04/2019 Human medicines European public assessment report (EPAR): Gilenya, fingolimod hydrochloride , Multiple Sclerosis, 17/03/2011, Additional monitoring, 22, Authorised
09/04/2019 Human medicines European public assessment report (EPAR): Cimzia, Certolizumab pegol, Arthritis, Rheumatoid, 01/10/2009, 24, Authorised
09/04/2019 Human medicines European public assessment report (EPAR): Epivir, lamivudine, HIV Infections, 08/08/1996, 42, Authorised
09/04/2019 Human medicines European public assessment report (EPAR): Ibandronic acid Accord, ibandronic acid, Wounds and Injuries, Breast Diseases, Neoplastic Processes, Calcium Metabolism Disorders, Neoplasms by Site, Water-Electrolyte Imbalance, 18/11/2012, Generic, 9, Authorised
09/04/2019 Human medicines European public assessment report (EPAR): Raloxifene Teva, raloxifene hydrochloride, Osteoporosis, Postmenopausal, 29/04/2010, Generic, 8, Authorised
09/04/2019 European Directorate for the Quality of Medicines and HealthCare (EDQM) of the Council of Europe
09/04/2019 Other: Acceptance of working arrangement between EMA-EC and EDQM
09/04/2019 Orphan designation: 9-cis, 12-cis-11,11-D2-linoleic acid ethyl ester for the: Treatment of infantile neuroaxonal dystrophy, 26/02/2019, Positive
09/04/2019 Paediatric investigation plans: questions and answers
09/04/2019 Orphan designation: Risdiplam for the: Treatment of spinal muscular atrophy, 26/02/2019, Positive
09/04/2019 Template or form: Notification of discontinuation of an agreed PIP decision
09/04/2019 Orphan designation: Humanised IGg1 monoclonal antibody targeting human transferrin receptor conjugated to human iduronate-2-sulfatase for the: Treatment of mucopolysaccharidosis type II (Hunter’s syndrome), 26/02/2019, Positive
09/04/2019 Other: Information Technology Directors Group - List of nominated members (alphabetically by country)
09/04/2019 Orphan designation: Autologous adult live cultured osteoblasts for the: Treatment of non-traumatic osteonecrosis, 26/02/2019, Positive
09/04/2019 Other: Privacy Statement on the processing of personal data in the context of public procurement procedures
09/04/2019 Committee meeting report: PDCO monthly report of opinions on paediatric investigation plans and other activities 29 January - 1 February 2019
09/04/2019 Orphan designation: Lurbinectedin for the: Treatment of small cell lung cancer, 26/02/2019, Positive
09/04/2019 Submitting annual reports on medicine development
08/04/2019 Human medicines European public assessment report (EPAR): Coagadex, Human coagulation factor X, Factor X Deficiency, 16/03/2016, Orphan, Additional monitoring, 3, Authorised
08/04/2019 Orphan designation: N-[(1R)-1-phenylethyl]-6-{1H-pyrazolo[3,4-d]pyrimidin-4-yl}quinazolin-2-amine for the: Treatment of fragile X syndrome, 20/04/2017, Positive
08/04/2019 Orphan designation: Recombinant human club cell 10 KDa protein for the: Treatment of bronchiolitis obliterans syndrome, 27/02/2017, Positive
08/04/2019 Orphan designation: Autologous stromal vascular cell fraction from adipose tissue for the: Treatment of systemic sclerosis, 28/04/2016, Positive
08/04/2019 Orphan designation: Sirolimus for the: Treatment of tuberous sclerosis, 23/08/2017, Positive
08/04/2019 Agenda: Agenda - PRAC draft agenda of meeting 8-11 April 2019
08/04/2019 Human medicines European public assessment report (EPAR): Privigen, human normal immunoglobulin (IVIg), Purpura, Thrombocytopenic, Idiopathic, Bone Marrow Transplantation, Immunologic Deficiency Syndromes, Guillain-Barre Syndrome, Mucocutaneous Lymph Node Syndrome, 24/04/2008, 23, Authorised
08/04/2019 Human medicines European public assessment report (EPAR): Edistride, dapagliflozin propanediol monohydrate, Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1, 09/11/2015, 9, Authorised
08/04/2019 Human medicines European public assessment report (EPAR): Fortacin, lidocaine, prilocaine, Sexual Dysfunction, Physiological, 15/11/2013, 8, Authorised
08/04/2019 Opinion/decision on a Paediatric investigation plan (PIP): axicabtagene ciloleucel, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0004/2019
08/04/2019 Opinion/decision on a Paediatric investigation plan (PIP): Pimodivir, PM: decision on the application for modification of an agreed PIP, P/0003/2019
08/04/2019 Opinion/decision on a Paediatric investigation plan (PIP): Gadopiclenol, PM: decision on the application for modification of an agreed PIP, P/0055/2019
08/04/2019 Human medicines European public assessment report (EPAR): Mekinist, trametinib, Melanoma, 30/06/2014, 16, Authorised
08/04/2019 PRAC recommendation on signal: PRAC recommendations on signals adopted at the 12-15 March 2019 PRAC meeting
08/04/2019 Other: New product information wording: extracts from PRAC recommendations on signals adopted at the 12-15 March 2019 PRAC
08/04/2019 Human medicines European public assessment report (EPAR): Forxiga, dapagliflozin propanediol monohydrate, Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1, 11/11/2012, 14, Authorised
05/04/2019 Human medicines European public assessment report (EPAR): Deltyba, Delamanid, Tuberculosis, Multidrug-Resistant, 27/04/2014, 25/07/2013, Orphan, Additional monitoring, Conditional approval, 11, Authorised
05/04/2019 Periodic safety update single assessment: Paracetamol/pseudoephedrine: List of nationally authorised medicinal products - PSUSA/00002307/201806
05/04/2019 Veterinary medicines European public assessment report (EPAR): Activyl Tick Plus, indoxacarb / permethrin, 09/01/2012, 7, Authorised
05/04/2019 Veterinary medicines European public assessment report (EPAR): Activyl, indoxacarb, 18/02/2011, 8, Authorised
05/04/2019 Human medicines European public assessment report (EPAR): Lumark, lutetium, isotope of mass 177, Radionuclide Imaging, 18/06/2015, Additional monitoring, 6, Authorised
05/04/2019 Human medicines European public assessment report (EPAR): Rotarix, human rotavirus, live attenuated, Immunization, Rotavirus Infections, 21/02/2006, 30, Authorised
05/04/2019 Human medicines European public assessment report (EPAR): Bronchitol, mannitol, Cystic Fibrosis, 13/04/2012, Orphan, 13, Authorised
05/04/2019 Withdrawn application: Efgratin, pegfilgrastim, Date of withdrawal: 20/12/2018, Initial authorisation
05/04/2019 Referral: Fluorouracil and fluorouracil related substances (capecitabine, tegafur and flucytosine) containing medicinal products , capecitabine, fluorouracil, tegafur, flucytosine , Article 31 referrals, Procedure started, 05/04/2019
05/04/2019 Human medicines European public assessment report (EPAR): Capecitabine Accord, capecitabine, Colonic Neoplasms, Breast Neoplasms, Colorectal Neoplasms, Stomach Neoplasms, 20/04/2012, Generic, 9, Authorised
05/04/2019 Withdrawn application: Cavoley, pegfilgrastim, Date of withdrawal: 20/12/2018, Initial authorisation
05/04/2019 Human medicines European public assessment report (EPAR): EndolucinBeta, lutetium (177 Lu) chloride, Radionuclide Imaging, 06/07/2016, Additional monitoring, 4, Authorised
05/04/2019 Periodic safety update single assessment: Metyrapone: CMDh scientific conclusions, amendments to product information and implementation timetable - PSUSA/00002046/201806
05/04/2019 Periodic safety update single assessment: Metyrapone: List of nationally authorised medicinal products - PSUSA/00002046/201806
04/04/2019 Regulatory and procedural guideline: EudraVigilance registration manual
04/04/2019 Report: Recommendations on eligibility to PRIME scheme - Adopted at the CHMP meeting of 25-28 March 2019
03/04/2019 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, 26, Authorised
03/04/2019 Human medicines European public assessment report (EPAR): Xalkori, crizotinib, Carcinoma, Non-Small-Cell Lung, 23/10/2012, 25, Authorised
03/04/2019 Human medicines European public assessment report (EPAR): Spinraza, nusinersen sodium, Muscular Atrophy, Spinal, 30/05/2017, Orphan, Additional monitoring, 6, Authorised
03/04/2019 Paediatric Committee (PDCO): 26 February-1 March 2019 , European Medicines Agency, from 26/02/2019 to 01/03/2019
03/04/2019 Human medicines European public assessment report (EPAR): Cancidas (previously Caspofungin MSD), caspofungin, Candidiasis, Aspergillosis, 23/10/2001, 25, Authorised
03/04/2019 Human medicines European public assessment report (EPAR): Neulasta, pegfilgrastim, Neutropenia, Cancer, 22/08/2002, 33, Authorised
03/04/2019 Minutes: Minutes - PDCO minutes of the 11-14 December 2018 meeting
03/04/2019 VICH GL36 Studies to evaluate the safety of residues of veterinary drugs in human food: General approach to establish a microbiological ADI
03/04/2019 Scientific guideline: VICH GL36(R2): Studies to evaluate the safety of residues of veterinary drugs in human food: general approach to establish a microbiological ADI - Revision 2
03/04/2019 VICH GL57 on studies to evaluate the metabolism and residue kinetics of veterinary drugs in food-producing species: marker residue depletion studies to establish product withdrawal periods in aquatic species
03/04/2019 Scientific guideline: VICH GL57 on Studies to evaluate the metabolism and residue kinetics of veterinary drugs in food-producing species: marker residue depletion studies to establish product withdrawal periods in aquatic species
03/04/2019 Human medicines European public assessment report (EPAR): Jylamvo, Methotrexate, Arthritis, Psoriatic, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Psoriasis, Arthritis, Rheumatoid, Arthritis, 29/03/2017, 2, Authorised
02/04/2019 Referral: Fosfomycin-containing medicinal products , fosfomycin calcium, fosfomycin disodium, fosfomycin sodium, fosfomycin trometamol , Article 31 referrals, Under evaluation, 13/12/2018, 02/04/2019
02/04/2019 Referrals document: Fosfomycin Article-31 referral - Timetable for the procedure
02/04/2019 Human medicines European public assessment report (EPAR): Plegridy, peginterferon beta-1a, Multiple Sclerosis, 17/07/2014, 16, Authorised
02/04/2019 Human medicines European public assessment report (EPAR): Slenyto, melatonin, Sleep Initiation and Maintenance Disorders, Autistic Disorder, 20/09/2018, 2, Authorised
02/04/2019 Other: EMA tracking tool: relocation to Amsterdam - Main milestones
02/04/2019 Online training: How to submit a 'safety update and update of the status' for parallel distribution via IRIS , European Medicines Agency, Amsterdam, the Netherlands, from 15/02/2019 to 15/02/2019
02/04/2019 Human medicines European public assessment report (EPAR): Lutathera, lutetium (177Lu) oxodotreotide, Neuroendocrine Tumors, 26/09/2017, Orphan, Additional monitoring, 2, Authorised
02/04/2019 Minutes: Minutes of the CVMP meeting of 19-21 February 2019
02/04/2019 Veterinary medicines European public assessment report (EPAR): Equisolon, Prednisolone, 12/03/2014, 4, Authorised
02/04/2019 Human medicines European public assessment report (EPAR): Silgard, human papillomavirus type 11 L1 protein / human papillomavirus type 16 L1 protein / human papillomavirus type 18 L1 protein / human papillomavirus type 6 L1 protein, Papillomavirus Infections, Uterine Cervical Dysplasia, Condylomata Acuminata, Immunization, 19/09/2006, 33, Withdrawn
02/04/2019 Other: List of eligible industry stakeholder organisations
02/04/2019 EPAR - Assessment report - Variation: Silgard-H-C-732-II-18 : EPAR - Assessment Report - Variation
02/04/2019 EPAR - Assessment report - Variation: Silgard-H-C-732-II-06 : EPAR - Assessment Report - Variation
02/04/2019 EPAR - Assessment report - Variation: Silgard-H-C-732-II-12 : EPAR - Assessment Report - Variation
01/04/2019 Withdrawn application: Equitend, polycarboxymethyl glucose sulfate acetate, Date of withdrawal: 05/11/2018, Initial authorisation
01/04/2019 Minutes: Minutes of the CHMP meeting 28-31 January 2019
01/04/2019 Other: Decision of the Executive Director on rules governing the secondment of national experts to the European Medicines Agency
01/04/2019 Human medicines European public assessment report (EPAR): Entyvio, vedolizumab, Colitis, Ulcerative, Crohn Disease, 22/05/2014, 12, Authorised
01/04/2019 Agenda: CHMP ORGAM agenda for the meeting on 18 February 2019
01/04/2019 News and press releases: EU recommendations for 2019/2020 seasonal flu vaccine composition
01/04/2019 Human medicines European public assessment report (EPAR): Velphoro, mixture of polynuclear iron(III)-oxyhydroxide, sucrose and starches, Hyperphosphatemia, Renal Dialysis, 26/08/2014, 6, Authorised
01/04/2019 Regulatory and procedural guideline: Explanatory note on general fees payable to the European Medicines Agency as of 1 April 2019
01/04/2019 Regulatory and procedural guideline: Commission Regulation (EU) 2019/480 of 22 March 2019 amending Council Regulation (EC) No 297/95 as regards the adjustment of the fees of the European Medicines Agency to the inflation rate with effect from 1 April 2019
01/04/2019 News and press releases: Regulatory information – 1.7% increase of fees from 1 April 2019
01/04/2019 Other: Organisation chart: Veterinary Medicines
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