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16/08/2019 Human medicines European public assessment report (EPAR): Dafiro, amlodipine, valsartan, Hypertension, 15/01/2007, 25, Authorised (updated)
16/08/2019 Human medicines European public assessment report (EPAR): Envarsus, tacrolimus, Graft Rejection, 18/07/2014, 6, Authorised (updated)
16/08/2019 Human medicines European public assessment report (EPAR): NovoMix, insulin aspart, Diabetes Mellitus, 01/08/2000, 27, Authorised (updated)
16/08/2019 Human medicines European public assessment report (EPAR): Xolair, omalizumab, Asthma, Urticaria, 25/10/2005, 38, Authorised (updated)
16/08/2019 Human medicines European public assessment report (EPAR): Skilarence, dimethyl fumarate, Psoriasis, 23/06/2017, 2, Authorised (updated)
16/08/2019 Human medicines European public assessment report (EPAR): Mysildecard, sildenafil citrate, Hypertension, Pulmonary, 15/09/2016, Generic, 1, Authorised (updated)
16/08/2019 Human medicines European public assessment report (EPAR): Exforge HCT, Amlodipine besylate, valsartan, hydrochlorothiazide, Hypertension, 15/10/2009, 16, Authorised (updated)
16/08/2019 Human medicines European public assessment report (EPAR): Copalia HCT, amlodipine, valsartan, hydrochlorothiazide, Hypertension, 03/11/2009, 15, Authorised (updated)
16/08/2019 Human medicines European public assessment report (EPAR): Humira, adalimumab, Spondylitis, Ankylosing, Arthritis, Juvenile Rheumatoid, Uveitis, Colitis, Ulcerative, Psoriasis, Arthritis, Psoriatic, Crohn Disease, Arthritis, Rheumatoid, 08/09/2003, 74, Authorised (updated)
16/08/2019 Human medicines European public assessment report (EPAR): Vantobra (previously Tobramycin PARI), Tobramycin, Respiratory Tract Infections, Cystic Fibrosis, 18/02/2019, 1, Authorised (updated)
16/08/2019 Human medicines European public assessment report (EPAR): Exforge, amlodipine (as besylate), valsartan, Hypertension, 16/01/2007, 24, Authorised (updated)
16/08/2019 Scientific publications (updated)
16/08/2019 Human medicines European public assessment report (EPAR): Sevelamer carbonate Winthrop (previously Sevelamer carbonate Zentiva), sevelamer carbonate, Hyperphosphatemia, Renal Dialysis, 15/01/2015, 14, Authorised (updated)
16/08/2019 News and press releases: EMA/FDA analysis shows high degree of alignment in marketing application decisions between EU and US
16/08/2019 Human medicines European public assessment report (EPAR): Afstyla, lonoctocog alfa, Hemophilia A, 04/01/2017, Additional monitoring, 5, Authorised (updated)
16/08/2019 Other: EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) organisations (updated)
16/08/2019 Other: EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) substances (updated)
16/08/2019 Report: Medicinal products for human use: monthly figures - July 2019 (updated)
16/08/2019 Human medicines European public assessment report (EPAR): Rezolsta, darunavir, cobicistat, HIV Infections, 19/11/2014, Additional monitoring, 8, Authorised (updated)
16/08/2019 Human medicines European public assessment report (EPAR): Helicobacter Test INFAI, 13C-urea, Breath Tests, Helicobacter Infections, 14/08/1997, 16, Authorised (updated)
16/08/2019 Template or form: Appendix V - Adverse-drug-reaction reporting details (updated)
16/08/2019 Human medicines European public assessment report (EPAR): Odefsey, emtricitabine, rilpivirine hydrochloride, tenofovir alafenamide, HIV Infections, 21/06/2016, Additional monitoring, 14, Authorised (updated)
16/08/2019 Human medicines European public assessment report (EPAR): Dukoral, recombinant cholera toxin B subunit, vibrio cholerae 01, Cholera, Immunization, 28/04/2004, 13, Authorised (updated)
16/08/2019 Human medicines European public assessment report (EPAR): Abasaglar (previously Abasria), insulin glargine, Diabetes Mellitus, 09/09/2014, Additional monitoring, Biosimilar, 7, Authorised (updated)
14/08/2019 Human medicines European public assessment report (EPAR): ReFacto AF, moroctocog alfa, Hemophilia A, 13/04/1999, 36, Authorised (updated)
14/08/2019 Human medicines European public assessment report (EPAR): Naglazyme, galsulfase, Mucopolysaccharidosis VI, 23/01/2006, Orphan, Additional monitoring, Exceptional circumstances, 14, Authorised (updated)
14/08/2019 Other: Article 57 product data (updated)
14/08/2019 Withdrawn application: Radicava, edaravone, Date of withdrawal: 24/05/2019, Initial authorisation (updated)
14/08/2019 Human medicines European public assessment report (EPAR): Bonviva, ibandronic acid, Osteoporosis, Postmenopausal, 23/02/2004, 25, Authorised (updated)
14/08/2019 Human medicines European public assessment report (EPAR): Herzuma, trastuzumab, Stomach Neoplasms, Breast Neoplasms, 08/02/2018, Additional monitoring, Biosimilar, 6, Authorised (updated)
14/08/2019 Human medicines European public assessment report (EPAR): Rotarix, human rotavirus, live attenuated, Immunization, Rotavirus Infections, 21/02/2006, 31, Authorised (updated)
14/08/2019 Human medicines European public assessment report (EPAR): Mysimba, bupropion hydrochloride, naltrexone hydrochloride, Obesity, Overweight, 26/03/2015, Additional monitoring, 12, Authorised (updated)
14/08/2019 Committee meeting report: Monthly report on application procedures, guidelines and related documents for veterinary medicines: June 2019
14/08/2019 Committee for Medicinal Products for Veterinary Use (CVMP): 18-20 June 2019 , European Medicines Agency, Amsterdam, the Netherlands, from 18/06/2019 to 20/06/2019 (updated)
14/08/2019 Procurement (updated)
14/08/2019 Human medicines European public assessment report (EPAR): Xarelto, rivaroxaban, Arthroplasty, Replacement, Venous Thromboembolism, 30/09/2008, Additional monitoring, 29, Authorised (updated)
14/08/2019 Referral: Leuprorelin-containing depot medicinal products , leuprorelin , Daronda,Depo-Eligard,Eligard,Eligard Depot,Eligard Mensua,Eligard Semestral,Elityran 1 Month Depot (Dps),Elityran 3 Month Depot (Dps),Enanton Depot Dual,Enanton Depot Set,Enantone,Enantone L.P,Enantone Lp,Enantone Monats-Depot,Enantone-Gyn Monats-Depot,Ginecrin Depot,Klebrocid 3-Monats-Depot,Klebrocid Depot Zweikammerspritze,Leptoprol,Lerin,Leugon,Leuprex 3,Leuprol,Leuprolin Ratiopharm,Leuprone 1-Monatsdepot,Leuprone 3-Monatsdepot,Leuprorelin 1-Month Depot Gp-Pharm,Leupro-Sandoz 3-Monats-Depot,Leuprostin,Lucrin,Lucrin Depot,Lucrin Pds Depot,Lucrin Pds Depot 1 Maand,Lucrin Pds Depot 3 Maanden,Lucrin Pds Depot 6 Maanden,Lupron Depo,Lutrate 1 Month Depot,Lutrate 3 Month Depot,Lutrate Depo,Lutrate Depot,Lutrate Depot Trimestral,Politrate,Politrate Politrate Depot,Procren Depot,Procren Depot Pds,Procrin Mensual,Procrin Semestral,Procrin Trimestral,Prostap 3 Dcs,Prostap 6 Dcs,Prostap Sr Dcs,Prostaplant,Sixantone,Trenantone,Trenantone-Gyn,Zeulide,Елигард,Лутрат Депо, Article 31 referrals, Procedure started, 14/08/2019 (updated)
14/08/2019 Human medicines European public assessment report (EPAR): Azacitidine Celgene, azacitidine, Myelodysplastic Syndromes, Leukemia, Myelomonocytic, Chronic, Leukemia, Myeloid, Acute, 02/08/2019, Authorised
13/08/2019 Paediatric Committee (PDCO): 26 February-1 March 2019 , European Medicines Agency, from 26/02/2019 to 01/03/2019 (updated)
13/08/2019 Minutes: Minutes - PDCO minutes of the 26 February-01 March 2019 meeting
13/08/2019 News and press releases: EMA closed 15 August 2019
13/08/2019 Newsletter: Human medicines highlights - August 2019
13/08/2019 Report: Applications for new human medicines under evaluation by the CHMP: August 2019
13/08/2019 Human medicines European public assessment report (EPAR): Glustin, pioglitazone hydrochloride, Diabetes Mellitus, Type 2, 11/10/2000, 25, Authorised (updated)
13/08/2019 Human medicines European public assessment report (EPAR): Renagel, sevelamer, Renal Dialysis, Hyperphosphatemia, 28/01/2000, 30, Authorised (updated)
13/08/2019 Human medicines European public assessment report (EPAR): Praluent, Alirocumab, Dyslipidemias, 23/09/2015, Additional monitoring, 11, Authorised (updated)
13/08/2019 Veterinary medicines European public assessment report (EPAR): Bovalto Ibraxion, inactivated IBR virus, 09/03/2000, 10, Withdrawn (updated)
13/08/2019 Human medicines European public assessment report (EPAR): Strensiq, asfotase alfa, Hypophosphatasia, 28/08/2015, Orphan, Additional monitoring, Exceptional circumstances, 9, Authorised (updated)
13/08/2019 Ebola (updated)
12/08/2019 Human medicines European public assessment report (EPAR): Ecansya (previously Capecitabine Krka), capecitabine, Colonic Neoplasms, Breast Neoplasms, Colorectal Neoplasms, Stomach Neoplasms, 20/04/2012, Generic, 10, Authorised (updated)
12/08/2019 Human medicines European public assessment report (EPAR): Stocrin, efavirenz, HIV Infections, 28/05/1999, 41, Authorised (updated)
12/08/2019 Human medicines European public assessment report (EPAR): Entyvio, vedolizumab, Colitis, Ulcerative, Crohn Disease, 22/05/2014, 13, Authorised (updated)
12/08/2019 Human medicines European public assessment report (EPAR): Constella, linaclotide, Irritable Bowel Syndrome, 26/11/2012, 18, Authorised (updated)
12/08/2019 Orphan designation: Zanubrutinib for the: Treatment of lymphoplasmacytic lymphoma, 29/05/2019, Positive
12/08/2019 Orphan designation: Sodium benzoate, sodium phenylacetate for the: Treatment of carbamoyl-phosphate synthase-1 deficiency, 29/05/2019, Positive
12/08/2019 Orphan designation: Sodium benzoate, sodium phenylacetate for the: Treatment of citrullinaemia type 1, 29/05/2019, Positive
12/08/2019 Human medicines European public assessment report (EPAR): Glubrava, metformin hydrochloride, pioglitazone hydrochloride, Diabetes Mellitus, Type 2, 11/12/2007, 16, Authorised (updated)
12/08/2019 Minutes: CHMP ORGAM minutes for the meeting on 15 April 2019
12/08/2019 Agenda: CHMP ORGAM agenda for the meeting on 15 April 2019
12/08/2019 Human medicines European public assessment report (EPAR): Tamiflu, oseltamivir, Influenza, Human, 20/06/2002, 36, Authorised (updated)
09/08/2019 Human medicines European public assessment report (EPAR): Olanzapine Glenmark Europe, olanzapine, Schizophrenia, Bipolar Disorder, 03/12/2009, Generic, 11, Authorised (updated)
09/08/2019 Fingolimod product-specific bioequivalence guidance (updated)
09/08/2019 Scientific guideline: Fingolimod capsules 0.25 and 0.5 mg product-specific bioequivalence guidance (updated)
09/08/2019 Newsletter: What’s new in pharmacovigilance - QPPV Update - Issue 1 - 2019
09/08/2019 Orphan designation: Relacorilant for the: Treatment of Cushing's syndrome, 29/05/2019, Positive
09/08/2019 Orphan designation: N-(trans-3-(5-((R)-1-hydroxyethyl)-1,3,4-oxadiazol-2-yl)cyclobutyl)-3-phenylisoxazole-5-carboxamide for the: Treatment of cystic fibrosis, 29/05/2019, Positive
09/08/2019 Orphan designation: Emixustat hydrochloride for the: Treatment of Stargardt’s disease, 29/05/2019, Positive
09/08/2019 Orphan designation: Diacerein for the: Treatment of epidermolysis bullosa, 29/05/2019, Positive
09/08/2019 Orphan designation: Allogeneic skin-derived ABCB5-positive mesenchymal stem cells for the: Treatment of epidermolysis bullosa, 29/05/2019, Positive
09/08/2019 Orphan designation: (S)-5-(1-(6-chloro-2-oxo-1,2-dihydroquinolin-3-yl)ethylamino-1-methyl-6-oxo-1,6-dihydropyridine-2-carbonitrile for the: Treatment of acute myeloid leukaemia, 29/05/2019, Positive
09/08/2019 Orphan designation: (S)-3-((3-(1-((6-(3,4-dimethoxyphenyl)pryazin-2-yl)amino)ethyl)phenyl)carbamoyl)-5-methylpridin-1-ium for the: Treatment of pulmonary arterial hypertension, 29/05/2019, Positive
09/08/2019 Human medicines European public assessment report (EPAR): Mozobil, Plerixafor, Multiple Myeloma, Hematopoietic Stem Cell Transplantation, Lymphoma, 30/07/2009, Orphan, 16, Authorised (updated)
09/08/2019 Human medicines European public assessment report (EPAR): Myozyme, alglucosidase alfa, Glycogen Storage Disease Type II, 28/03/2006, Orphan, 15, Authorised (updated)
08/08/2019 Periodic safety update single assessment: Dextromethorphan: Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001009/201811
08/08/2019 Other: Coordinating group of the European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA) (updated)
08/08/2019 Periodic safety update single assessment: Dextromethorphan: List of nationally authorised medicinal products - PSUSA/00001009/201811
08/08/2019 Committee for Medicinal Products for Human Use (CHMP): 27-29 May 2019 , European Medicines Agency, Amsterdam, the Netherlands, from 27/05/2019 to 29/05/2019 (updated)
08/08/2019 Committee for Medicinal Products for Human Use (CHMP): 24-27 June 2019 , European Medicines Agency, Amsterdam, the Netherlands, from 24/06/2019 to 27/06/2019 (updated)
08/08/2019 Committee for Medicinal Products for Human Use (CHMP): 22-25 July 2019 , European Medicines Agency, Amsterdam, the Netherlands, from 22/07/2019 to 25/07/2019 (updated)
08/08/2019 Human medicines European public assessment report (EPAR): Ultomiris, ravulizumab, Hemoglobinuria, Paroxysmal, 02/07/2019, Additional monitoring, 1, Authorised (updated)
08/08/2019 Human medicines European public assessment report (EPAR): Aclasta, zoledronic acid, Osteoporosis, Osteitis Deformans, Osteoporosis, Postmenopausal, 15/04/2005, 26, Authorised (updated)
08/08/2019 Minutes: CHMP ORGAM minutes for the meeting on 15 July 2019
08/08/2019 Minutes: CHMP ORGAM minutes for the meeting on 20 May 2019
08/08/2019 Agenda: CHMP ORGAM agenda for the meeting on 15 July 2019
08/08/2019 Agenda: CHMP ORGAM agenda for the meeting on 17 June 2019
08/08/2019 Agenda: CHMP ORGAM agenda for the meeting on 20 May 2019
08/08/2019 Other: List of European Union reference dates and frequency of submission of periodic safety update reports (updated)
08/08/2019 Minutes: Minutes - European network of paediatric research at the European Medicines Agency (Enpr-EMA) Coordinating Group and networks meeting
08/08/2019 Agenda: Agenda - European network of paediatric research at the European Medicines Agency (Enpr-EMA) Coordinating Group and networks meeting
08/08/2019 European network of paediatric research at the European Medicines Agency (Enpr-EMA) Coordinating Group and networks meeting , European Medicines Agency, Amsterdam, the Netherlands, from 04/07/2019 to 04/07/2019
08/08/2019 Human medicines European public assessment report (EPAR): Deltyba, Delamanid, Tuberculosis, Multidrug-Resistant, 27/04/2014, 25/07/2013, Orphan, Additional monitoring, Conditional approval, 12, Authorised (updated)
08/08/2019 Human medicines European public assessment report (EPAR): Hepsera, adefovir dipivoxil, Hepatitis B, Chronic, 06/03/2003, 26, Authorised (updated)
08/08/2019 Human medicines European public assessment report (EPAR): Soliris, Eculizumab, Hemoglobinuria, Paroxysmal, 20/06/2007, Orphan, 25, Authorised (updated)
07/08/2019 Opinion/decision on a Paediatric investigation plan (PIP): Humanised chimeric antibody with a humanised H chain and a chimeric (mouse V-domain, human C-domain) L chain against epidermal growth factor receptor conjugated to maleimidocaproyl monomethylauristatin F (ABT-414)L chain against epidermal growth factor receptor conjugated to maleimidocaproylmonomethylauristatin F (ABT-414), P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0298/2016 (updated)
07/08/2019 Scientific guideline: Draft guideline on clinical investigation of medicinal products for the treatment of gout (updated)
07/08/2019 Human medicines European public assessment report (EPAR): Bosulif, bosutinib (as monohydrate), Leukemia, Myeloid, 26/03/2013, Additional monitoring, Conditional approval, 18, Authorised (updated)
07/08/2019 Human medicines European public assessment report (EPAR): Kanuma, sebelipase alfa, Lipid Metabolism, Inborn Errors, 28/08/2015, Orphan, Accelerated assessment, Additional monitoring, 3, Authorised (updated)
06/08/2019 Referral: Cyproterone-containing medicinal products , cyproterone , Article 31 referrals, Procedure started, 06/08/2019 (updated)
06/08/2019 Periodic safety update single assessment: Danaparoid: List of nationally authorised medicinal products - PSUSA/00000923/201812
06/08/2019 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
06/08/2019 Periodic safety update single assessment: Methylphenidate: List of nationally authorised medicinal products - PSUSA/00002024/201810
06/08/2019 Human medicines European public assessment report (EPAR): Adenuric, febuxostat, Gout, 21/04/2008, 19, Authorised (updated)
06/08/2019 Minutes: Minutes of the COMP meeting 15-17 April 2019
06/08/2019 Other: List of signals discussed at PRAC since September 2012 (updated)
06/08/2019 PRAC recommendation on signal: PRAC recommendations on signals adopted at the 8-11 July 2019 PRAC meeting
06/08/2019 Other: New product information wording: extracts from PRAC recommendations on signals adopted at the 8-11 July 2019 PRAC
06/08/2019 Human medicines European public assessment report (EPAR): Flucelvax Tetra, Influenza virus surface antigens (haemagglutinin and neuraminidase)* , inactivated, of the following strains: A/xxxxx (H3N2)-like strain (reassortant used)/ A/xxxxx H1N1- like strain (reassortant used)/ B/xxxxx (Yamagata Lineage) – like strain (reassortant used)/ B/xxxxx (Victoria Lineage) – like strain (reassortant used), Influenza, Human, 12/12/2018, Additional monitoring, 2, Authorised (updated)
06/08/2019 Human medicines European public assessment report (EPAR): Blitzima, rituximab, Lymphoma, Non-Hodgkin, Leukemia, Lymphocytic, Chronic, B-Cell, 13/07/2017, Additional monitoring, Biosimilar, 7, Authorised (updated)
05/08/2019 Human medicines European public assessment report (EPAR): Biktarvy, bictegravir, emtricitabine, tenofovir alafenamide, fumarate, HIV Infections, 21/06/2018, Additional monitoring, 3, Authorised (updated)
05/08/2019 Human medicines European public assessment report (EPAR): Docetaxel Teva, docetaxel, Head and Neck Neoplasms, Carcinoma, Non-Small-Cell Lung, Adenocarcinoma, Prostatic Neoplasms, Stomach Neoplasms, Breast Neoplasms, 26/01/2010, Generic, 17, Authorised (updated)
05/08/2019 Human medicines European public assessment report (EPAR): Ogivri, trastuzumab, Stomach Neoplasms, Breast Neoplasms, 12/12/2018, Additional monitoring, Biosimilar, 2, Authorised (updated)
05/08/2019 Human medicines European public assessment report (EPAR): Gardasil, human papillomavirus type 6 L1 protein, human papillomavirus type 11 L1 protein, human papillomavirus type 16 L1 protein, human papillomavirus type 18 L1 protein, Papillomavirus Infections, Uterine Cervical Dysplasia, Condylomata Acuminata, Immunization, 20/09/2006, 41, Authorised (updated)
05/08/2019 Human medicines European public assessment report (EPAR): Harvoni, ledipasvir 90 mg, sofosbuvir 400 mg, Hepatitis C, Chronic, 17/11/2014, Accelerated assessment, Additional monitoring, 17, Authorised (updated)
05/08/2019 Human medicines European public assessment report (EPAR): Aflunov, influenza virus surface antigens (haemagglutinin and neuraminidase) of strain: A/turkey/Turkey/1/05 (H5N1)-like strain (NIBRG-23), Influenza, Human, Immunization, Disease Outbreaks, 28/11/2010, 11, Authorised (updated)
05/08/2019 Human medicines European public assessment report (EPAR): Feraccru, ferric maltol, Anemia, Iron-Deficiency, 18/02/2016, 8, Authorised (updated)
05/08/2019 Human medicines European public assessment report (EPAR): Xgeva, denosumab, Fractures, Bone, Neoplasm Metastasis, 13/07/2011, 18, Authorised (updated)
05/08/2019 Human medicines European public assessment report (EPAR): Keytruda, Pembrolizumab, Melanoma, Hodgkin Disease, Carcinoma, Non-Small-Cell Lung, 17/07/2015, Additional monitoring, 19, Authorised (updated)
05/08/2019 Human medicines European public assessment report (EPAR): Genvoya, elvitegravir, cobicistat, emtricitabine, tenofovir alafenamide, HIV Infections, 19/11/2015, Additional monitoring, 20, Authorised (updated)
05/08/2019 Human medicines European public assessment report (EPAR): Natpar, parathyroid hormone, Hypoparathyroidism, 24/04/2017, Orphan, Additional monitoring, Conditional approval, 6, Authorised (updated)
05/08/2019 Human medicines European public assessment report (EPAR): Kanjinti, trastuzumab, Stomach Neoplasms, Breast Neoplasms, 16/05/2018, Additional monitoring, Biosimilar, 5, Authorised (updated)
05/08/2019 Quality of medicines questions and answers: Part 1 (updated)
05/08/2019 Human medicines European public assessment report (EPAR): Intelence, Etravirine, HIV Infections, 28/08/2008, 24, Authorised (updated)
05/08/2019 Human medicines European public assessment report (EPAR): Cometriq, cabozantinib, Thyroid Neoplasms, 21/03/2014, Orphan, Additional monitoring, Conditional approval, 14, Authorised (updated)
05/08/2019 Human medicines European public assessment report (EPAR): Neofordex, dexamethasone, Multiple Myeloma, 16/03/2016, 5, Authorised (updated)
05/08/2019 Human medicines European public assessment report (EPAR): Fabrazyme, agalsidase beta, Fabry Disease, 03/08/2001, Orphan, 26, Authorised (updated)
05/08/2019 Human medicines European public assessment report (EPAR): Inflectra, infliximab, Arthritis, Psoriatic, Spondylitis, Ankylosing, Colitis, Ulcerative, Psoriasis, Crohn Disease, Arthritis, Rheumatoid, 09/09/2013, Biosimilar, 22, Authorised (updated)
05/08/2019 Template or form: Template to report an allegation concerning an impropriety in an area of EMA’s responsibility (authorisation, supervision and maintenance of human and veterinary medicinal products) (updated)
02/08/2019 Human medicines European public assessment report (EPAR): Tadalafil Mylan, tadalafil, Erectile Dysfunction, 21/11/2014, Generic, 9, Authorised (updated)
02/08/2019 Human medicines European public assessment report (EPAR): Zinforo, Ceftaroline fosamil, Community-Acquired Infections, Skin Diseases, Infectious, Pneumonia, 22/08/2012, 20, Authorised (updated)
02/08/2019 Periodic safety update single assessment: Acitretin: List of nationally authorised medicinal products - PSUSA/00000051/201810
02/08/2019 Periodic safety update single assessment: Acitretin: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00000051/201810
02/08/2019 Human medicines European public assessment report (EPAR): Vizamyl, flutemetamol (18F), Radionuclide Imaging, Alzheimer Disease, 22/08/2014, Additional monitoring, 9, Authorised (updated)
02/08/2019 Human medicines European public assessment report (EPAR): Rivastigmine Hexal, rivastigmine, Dementia, Alzheimer Disease, Parkinson Disease, 11/12/2009, 10, Authorised (updated)
02/08/2019 Annex to the European Commission guideline on 'Excipients in the labelling and package leaflet of medicinal products for human use' (updated)
02/08/2019 Referral: Xeljanz , tofacitinib , Article 20 procedures, Under evaluation, 02/08/2019 (updated)
02/08/2019 Human medicines European public assessment report (EPAR): Lynparza, Olaparib, Ovarian Neoplasms, 16/12/2014, Additional monitoring, 7, Authorised (updated)
02/08/2019 Human medicines European public assessment report (EPAR): Somac Control, pantoprazole, Gastroesophageal Reflux, 12/06/2009, 12, Authorised (updated)
02/08/2019 Human medicines European public assessment report (EPAR): Striascan, ioflupane (123i), Radionuclide Imaging, Dementia, Movement Disorders, 25/06/2019, Generic
02/08/2019 Human medicines European public assessment report (EPAR): Pantozol Control, pantoprazole, Gastroesophageal Reflux, 11/06/2009, 13, Authorised (updated)
02/08/2019 Human medicines European public assessment report (EPAR): Suliqua, insulin glargine, lixisenatide, Diabetes Mellitus, Type 2, 11/01/2017, Additional monitoring, 3, Authorised (updated)
02/08/2019 Human medicines European public assessment report (EPAR): Uptravi, Selexipag, Hypertension, Pulmonary, 12/05/2016, Additional monitoring, 8, Authorised (updated)
02/08/2019 Human medicines European public assessment report (EPAR): Xoterna Breezhaler, indacaterol, Glycopyrronium bromide, Pulmonary Disease, Chronic Obstructive, 18/09/2013, Additional monitoring, 13, Authorised (updated)
02/08/2019 Human medicines European public assessment report (EPAR): Controloc Control, pantoprazole, Gastroesophageal Reflux, 11/06/2009, 11, Authorised (updated)
01/08/2019 Human medicines European public assessment report (EPAR): Zyclara, imiquimod, Keratosis, Keratosis, Actinic, 23/08/2012, 8, Authorised (updated)
01/08/2019 Human medicines European public assessment report (EPAR): Hizentra, human normal immunoglobulin (SCIg), Immunologic Deficiency Syndromes, 14/04/2011, 18, Authorised (updated)
01/08/2019 Human medicines European public assessment report (EPAR): Halimatoz, adalimumab, Hidradenitis Suppurativa, Psoriasis, Arthritis, Juvenile Rheumatoid, Uveitis, Arthritis, Rheumatoid, Spondylitis, Ankylosing, Arthritis, Psoriatic, 26/07/2018, Additional monitoring, Biosimilar, 4, Authorised (updated)
01/08/2019 Human medicines European public assessment report (EPAR): Cholestagel, colesevelam, Hypercholesterolemia, 09/03/2004, 20, Authorised (updated)
01/08/2019 Human medicines European public assessment report (EPAR): Kisplyx, lenvatinib mesilate, Carcinoma, Renal Cell, 25/08/2016, Accelerated assessment, Additional monitoring, 9, Authorised (updated)
01/08/2019 Tritanrix HB H-W-3838 (updated)
01/08/2019 Medicine for use outside EU: Tritanrix HB: Public statement on the withdrawal of the scientific opinion under Article 58
01/08/2019 Human medicines European public assessment report (EPAR): Methylthioninium chloride Proveblue, methylthioninium chloride, Methemoglobinemia, 06/05/2011, 20, Authorised (updated)
01/08/2019 Human medicines European public assessment report (EPAR): Opdivo, nivolumab, Melanoma, Hodgkin Disease, Carcinoma, Renal Cell, Carcinoma, Non-Small-Cell Lung, 19/06/2015, Additional monitoring, 27, Authorised (updated)
01/08/2019 Veterinary medicines European public assessment report (EPAR): Evicto, selamectin, 19/07/2019, Generic, Authorised
01/08/2019 Human medicines European public assessment report (EPAR): Thyrogen, thyrotropin alfa, Thyroid Neoplasms, 09/03/2000, 24, Authorised (updated)
01/08/2019 Other: New Organization First User QPPV/RP or Change of EU QPPV/RP (updated)
01/08/2019 European Union (EU) International Organisation for Standardization (ISO) for identification of medical products (IDMP)/Substance, Product, Organisation and Referential (SPOR) data Task Force meeting , European Medicines Agency, Amsterdam, the Netherlands, from 24/05/2019 to 24/05/2019
01/08/2019 Human medicines European public assessment report (EPAR): Ryzodeg, insulin aspart, insulin degludec, Diabetes Mellitus, 21/01/2013, 11, Authorised (updated)
01/08/2019 Human medicines European public assessment report (EPAR): Xelevia, sitagliptin, Diabetes Mellitus, Type 2, 21/03/2007, 27, Authorised (updated)
01/08/2019 Human medicines European public assessment report (EPAR): Glyxambi, empagliflozin, linagliptin, Diabetes Mellitus, Type 2, 11/11/2016, Additional monitoring, 6, Authorised (updated)
01/08/2019 Human medicines European public assessment report (EPAR): Jentadueto, linagliptin, metformin, Diabetes Mellitus, Type 2, 19/07/2012, 15, Authorised (updated)