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31/01/2019 Opinion/decision on a Paediatric investigation plan (PIP): Emapalumab, PM: decision on the application for modification of an agreed PIP, P/0306/2018
31/01/2019 Opinion/decision on a Paediatric investigation plan (PIP): Fc- and CDR-modified humanized monoclonal antibody against C5, PM: decision on the application for modification of an agreed PIP, P/0261/2018
31/01/2019 Opinion/decision on a Paediatric investigation plan (PIP): Human fibrinogen concentrate (BT524), PM: decision on the application for modification of an agreed PIP, P/0285/2018
31/01/2019 Opinion/decision on a Paediatric investigation plan (PIP): Balovaptan, PM: decision on the application for modification of an agreed PIP, P/0259/2018
31/01/2019 Opinion/decision on a Paediatric investigation plan (PIP): andexanet alfa, PM: decision on the application for modification of an agreed PIP, P/0243/2018
31/01/2019 Opinion/decision on a Paediatric investigation plan (PIP): Foclivia, Pandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted), PM: decision on the application for modification of an agreed PIP, P/0260/2018
31/01/2019 Opinion/decision on a Paediatric investigation plan (PIP): Recombinant human alpha-galactosidase A (PRX 102), PM: decision on the application for modification of an agreed PIP, P/0286/2018
31/01/2019 Opinion/decision on a Paediatric investigation plan (PIP): Symtuza, darunavir,cobicistat,emtricitabine,tenofovir alafenamide, PM: decision on the application for modification of an agreed PIP, P/0310/2018
31/01/2019 Opinion/decision on a Paediatric investigation plan (PIP): Vamorolone, PM: decision on the application for modification of an agreed PIP, P/0288/2018
31/01/2019 Regulatory and procedural guideline: Electronic product information for human medicines in the European Union – draft key principles
31/01/2019 News and press releases: Public consultation on key principles for the electronic product information of EU medicines
31/01/2019 Electronic product information for human medicines in the European Union – draft key principles
31/01/2019 Product-information requirements
31/01/2019 Opinion/decision on a Paediatric investigation plan (PIP): Macrogol 3350,sodium sulfate,sodium chloride,sodium ascorbate,potassium chloride (NER1006),Ascorbic acid, PM: decision on the application for modification of an agreed PIP, P/0315/2018
31/01/2019 European Medicines Agency (EMA) / Heads of Medicines Agencies (HMA) / European Commission (EC) workshop on electronic product information (ePI) , European Medicines Agency, London, UK, from 28/11/2018 to 28/11/2018
31/01/2019 Opinion/decision on a Paediatric investigation plan (PIP): Olipudase alfa, PM: decision on the application for modification of an agreed PIP, P/0258/2018
31/01/2019 Opinion/decision on a Paediatric investigation plan (PIP): Ciprofloxacin (hydrochloride), PM: decision on the application for modification of an agreed PIP, P/0253/2018
31/01/2019 Opinion/decision on a Paediatric investigation plan (PIP): Cariprazine (hydrochloride), PM: decision on the application for modification of an agreed PIP, P/0301/2018
31/01/2019 Opinion/decision on a Paediatric investigation plan (PIP): Roxadustat, PM: decision on the application for modification of an agreed PIP, P/0146/2019
30/01/2019 Opinion/decision on a Paediatric investigation plan (PIP): Trobalt, retigabine, W: decision granting a waiver in all age groups for all conditions/indications, P/0299/2018
30/01/2019 Opinion/decision on a Paediatric investigation plan (PIP): Osilodrostat, PM: decision on the application for modification of an agreed PIP, P/0252/2018
30/01/2019 Scientific guideline: Procedure on management of proposals submitted by Interested Parties for European Union List Entries or European Union herbal monographs - Revision 2
30/01/2019 Procurement: Guidebook for Tenderers (revised January 2019)
30/01/2019 Human medicines European public assessment report (EPAR): Kisqali, ribociclib succinate, Breast Neoplasms, 22/08/2017, Additional monitoring, 1, Authorised
29/01/2019 Opinion/decision on a Paediatric investigation plan (PIP): Mepolizumab, PM: decision on the application for modification of an agreed PIP, P/0300/2018
29/01/2019 Committee meeting report: COMP meeting report on the review of applications for orphan designation: January 2019
29/01/2019 Opinion/decision on a Paediatric investigation plan (PIP): atorvastatin (calcium trihydrate),Perindopril (arginine),indapamide, W: decision granting a waiver in all age groups for all conditions/indications, P/0333/2018
29/01/2019 Opinion/decision on a Paediatric investigation plan (PIP): Synthetic ribonucleic acid oligonucleotide directed against superoxide dismutase 1 (SOD1) messenger ribonucleic acid, W: decision granting a waiver in all age groups for all conditions/indications, P/0337/2018
29/01/2019 Agenda: Agenda - PDCO agenda of the 29 January - 1 February 2019 meeting
29/01/2019 Periodic safety update single assessment: Praziquantel : List of nationally authorised medicinal products - PSUSA/00002503/201804
29/01/2019 Human medicines European public assessment report (EPAR): Viekirax, Ombitasvir, paritaprevir, ritonavir, Hepatitis C, Chronic, 14/01/2015, Additional monitoring, 17, Authorised
29/01/2019 Human medicines European public assessment report (EPAR): Ravicti,  glycerol phenylbutyrate, Urea Cycle Disorders, Inborn, 26/11/2015, Orphan, Additional monitoring, 10, Authorised
29/01/2019 Periodic safety update single assessment: Chlorphenoxamine hydrochloride : List of nationally authorised medicinal products - PSUSA/00010361/201805
29/01/2019 Opinion/decision on a Paediatric investigation plan (PIP): dupilumab, PM: decision on the application for modification of an agreed PIP, P/0304/2018
29/01/2019 Opinion/decision on a Paediatric investigation plan (PIP): Halaven, Eribulin, PM: decision on the application for modification of an agreed PIP, P/0264/2018
29/01/2019 Opinion/decision on a Paediatric investigation plan (PIP): autologous haematopoietic stem cells transduced with lentiviral vector Lenti-D encoding the human ATP-binding cassette, sub-family D (ALD), member 1 (ABCD1) from cDNA, PM: decision on the application for modification of an agreed PIP, P/0290/2018
28/01/2019 Opinion/decision on a Paediatric investigation plan (PIP): Mirikizumab, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0283/2018
28/01/2019 Opinion/decision on a Paediatric investigation plan (PIP): Glasdegib, W: decision granting a waiver in all age groups for all conditions/indications, P/0239/2018
28/01/2019 Opinion/decision on a Paediatric investigation plan (PIP): Human donor haematopoietic stem and progenitor cells (HSPC) that have been treated ex vivo with the protein transduction domain of the HIV-1 transactivation protein fused to MYC transcription factor (TBX-1400), P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0284/2018
28/01/2019 Opinion/decision on a Paediatric investigation plan (PIP): Setrusumab, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0241/2018
28/01/2019 Opinion/decision on a Paediatric investigation plan (PIP): Serotype 26 adenovirus encoding mosaic 1 HIV-1 group-specific antigen and polymerase proteins (Ad26.Mos1.Gag-Pol) / serotype 26 adenovirus encoding mosaic 2 HIV-1 group-specific antigen and polymerase proteins (Ad26.Mos2.Gag-Pol) / serotype 26 adenovirus encoding mosaic 1 HIV-1 envelope protein (Ad26.Mos1.Env) / serotype 26 adenovirus encoding mosaic 2S HIV-1 envelope protein (Ad26.Mos2S.Env) [Ad26.Mos4.HIV], P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0238/2018
28/01/2019 Opinion/decision on a Paediatric investigation plan (PIP): Sodium thiosulfate, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0312/2018
28/01/2019 Opinion/decision on a Paediatric investigation plan (PIP): Monovalent, recombinant, replication-incompetent human adenovirus serotype 26-vectored vaccine encoding the pre-fusion conformation-stabilised F protein derived from the RSV A2 strain, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0318/2018
28/01/2019 Opinion/decision on a Paediatric investigation plan (PIP): Sarizotan (hydrochloride), P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0287/2018
28/01/2019 Opinion/decision on a Paediatric investigation plan (PIP): Trimeric, recombinant HIV-1 envelope glycoprotein 140 of Clade C / trimeric, recombinant HIV-1 envelope glycoprotein 140 containing motifs of multiple HIV-1 variants, adjuvanted with aluminium phosphate [Clade C gp140/ Mosaic gp140], P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0237/2018
28/01/2019 Opinion/decision on a Paediatric investigation plan (PIP): Risankizumab, PM: decision on the application for modification of an agreed PIP, P/0231/2018
28/01/2019 Opinion/decision on a Paediatric investigation plan (PIP): Cefiderocol, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0266/2018
28/01/2019 Opinion/decision on a Paediatric investigation plan (PIP): Alicaforsen, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0265/2018
28/01/2019 Opinion/decision on a Paediatric investigation plan (PIP): Fasinumab, W: decision granting a waiver in all age groups for all conditions/indications, P/0302/2018
28/01/2019 Opinion/decision on a Paediatric investigation plan (PIP): Risankizumab, PM: decision on the application for modification of an agreed PIP, P/0230/2018
28/01/2019 Periodic safety update single assessment: Benzyl nicotinate / camphor / dimethyl sulfoxide / nonivamide / turpentine oil: List of nationally authorised medicinal products - PSUSA/00010584/20180
28/01/2019 Periodic safety update single assessment: Tenoxicam: List of nationally authorised medicinal products - PSUSA/00002893/201802
28/01/2019 Opinion/decision on a Paediatric investigation plan (PIP): arimoclomol citrate, W: decision granting a waiver in all age groups for all conditions/indications, P/0317/2018
28/01/2019 Periodic safety update single assessment: Allergen for therapy: Dermatophagoides pteronyssinus / Dermatophagoides farina: List of nationally authorised medicinal products - PSUSA/00010582/201803
28/01/2019 Periodic safety update single assessment: Ondansetron: List of nationally authorised medicinal products - PSUSA/00002217/201802
28/01/2019 Opinion/decision on a Paediatric investigation plan (PIP): Venglustat, W: decision granting a waiver in all age groups for all conditions/indications, P/0248/2018
28/01/2019 Opinion/decision on a Paediatric investigation plan (PIP): Palovarotene, PM: decision on the application for modification of an agreed PIP, P/0289/2018
28/01/2019 Opinion/decision on a Paediatric investigation plan (PIP): Giotrif, afatinib, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0320/2018
28/01/2019 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/0347/2018
28/01/2019 Orphan designation: Pegylated B-domain-deleted sequence-modified recombinant human factor VIII (damoctocog alfa pegol) for the: Treatment of haemophilia A, 23/02/2011, Positive
28/01/2019 Human medicines European public assessment report (EPAR): Jivi, Damoctocog alfa pegol, Hemophilia A, 22/11/2018, Additional monitoring, Authorised
28/01/2019 Opinion/decision on a Paediatric investigation plan (PIP): Amikacin (sulfate), PM: decision on the application for modification of an agreed PIP, P/0346/2018
28/01/2019 Opinion/decision on a Paediatric investigation plan (PIP): Zydelig, Idelalisib, W: decision granting a waiver in all age groups for all conditions/indications, P/0345/2018
28/01/2019 Minutes: CHMP ORGAM minutes for the meeting on 4 December 2018
28/01/2019 Opinion/decision on a Paediatric investigation plan (PIP): Akynzeo, Fosnetupitant,Palonosetron, PM: decision on the application for modification of an agreed PIP, P/0344/2018
28/01/2019 Human medicines European public assessment report (EPAR): Poteligeo, Mogamulizumab, Sezary Syndrome, Mycosis Fungoides, 22/11/2018, Orphan, Additional monitoring, Authorised
28/01/2019 Orphan designation: Mogamulizumab for the: Treatment of cutaneous T-cell lymphoma, 14/10/2016, Positive
28/01/2019 Opinion/decision on a Paediatric investigation plan (PIP): Ruconest, Conestat alfa, PM: decision on the application for modification of an agreed PIP, P/0343/2018
28/01/2019 Opinion/decision on a Paediatric investigation plan (PIP): Peanut allergen extract, PM: decision on the application for modification of an agreed PIP, P/0342/2018
28/01/2019 Opinion/decision on a Paediatric investigation plan (PIP): Zavicefta, Ceftazidime,avibactam, PM: decision on the application for modification of an agreed PIP, P/0340/2018
25/01/2019 Human medicines European public assessment report (EPAR): Xtandi, enzalutamide, Prostatic Neoplasms, 21/06/2013, 26/04/2013, 14, Authorised
25/01/2019 News and press releases: Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 22-24 January 2019
25/01/2019 Periodic safety update single assessment: Olodaterol / tiotropium: List of nationally authorised medicinal products - PSUSA/00010489/201805
25/01/2019 Periodic safety update single assessment: Oxaliplatin: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002229/201804
25/01/2019 Periodic safety update single assessment: Oxaliplatin: List of nationally authorised medicinal products - PSUSA/00002229/201804
25/01/2019 Agenda: Agenda - Industry stakeholder meeting on Brexit and operation of the centralised procedure for human and veterinary medicine products
25/01/2019 Periodic safety update single assessment: Ranitidine: List of nationally authorised medicinal products - PSUSA/00002610/201805
25/01/2019 Human medicines European public assessment report (EPAR): Tyverb, lapatinib, Breast Neoplasms, 10/06/2008, 29, Authorised
25/01/2019 Orphan designation: Glucagon for the: Treatment of congenital hyperinsulinism, 08/10/2009, Positive
25/01/2019 Orphan designation: Mannitolum for the: Treatment of cystic fibrosis, 07/11/2005, Positive
25/01/2019 Orphan designation: Triamcinolone acetonide for the: Treatment of non-infectious uveitis, 21/05/2015, Positive
25/01/2019 Orphan designation: Sirolimus for the: Prevention of arteriovenous access dysfunction..., 13/11/2013, Positive
25/01/2019 Orphan designation: Sulfonated monophosphorylated mannose oligosaccharide for the: Treatment of hepatocellular carcinoma, 21/06/2011, Positive
24/01/2019 Periodic safety update single assessment: Patent blue V sodium: List of nationally authorised medicinal products - PSUSA/00002320/201804
24/01/2019 Human medicines European public assessment report (EPAR): Brineura, cerliponase alfa, Neuronal Ceroid-Lipofuscinoses, 30/05/2017, Orphan, Additional monitoring, Exceptional circumstances, 2, Authorised
24/01/2019 Veterinary medicines European public assessment report (EPAR): Kexxtone, monensin (as monensin sodium), 28/01/2013, 6, Authorised
24/01/2019 Agenda: Agenda - CAT agenda of the 23-25 January 2019 meeting
24/01/2019 Human medicines European public assessment report (EPAR): NovoEight, turoctocog alfa, Hemophilia A, 13/11/2013, 7, Authorised
24/01/2019 Human medicines European public assessment report (EPAR): Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan, efavirenz, emtricitabine, tenofovir disoproxil maleate, HIV Infections, 05/09/2017, Generic, 3, Authorised
24/01/2019 Human medicines European public assessment report (EPAR): Cabometyx , cabozantinib s-malate, Carcinoma, Renal Cell, 09/09/2016, Additional monitoring, 4, Authorised
24/01/2019 Human medicines European public assessment report (EPAR): Olanzapine Glenmark, olanzapine, Schizophrenia, Bipolar Disorder, 03/12/2009, Generic, 12, Authorised
24/01/2019 Periodic safety update single assessment: Nadroparin: CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00002104/201803
24/01/2019 Periodic safety update single assessment: Nadroparin: List of nationally authorised medicinal products - PSUSA/00002104/201803
24/01/2019 Periodic safety update single assessment: Treprostinil: List of nationally authorised medicinal products - PSUSA/00003013/201805
23/01/2019 Agenda: Agenda - CVMP agenda of the 22-24 January 2019 meeting
23/01/2019 Periodic safety update single assessment: Ozenoxacin: List of nationally authorised medicinal products - PSUSA/00010651/201805
23/01/2019 Committee for Medicinal Products for Veterinary Use (CVMP): 22-24 January 2019 , European Medicines Agency, London, UK, from 22/01/2019 to 24/01/2019
23/01/2019 Report: Medicinal products for human use: monthly figures - December 2018
23/01/2019 Human medicines European public assessment report (EPAR): NovoSeven, eptacog alfa (activated), Hemophilia B, Thrombasthenia, Factor VII Deficiency, Hemophilia A, 23/02/1996, 32, Authorised
23/01/2019 Report: PDCO monthly report of opinions on paediatric investigation plans and other activities 11-14 December 2018
23/01/2019 Orphan designation: Allogeneic ex-vivo-expanded umbilical cord blood-derived haematopoietic CD34+ progenitor cells and allogeneic non-expanded umbilical cord blood-derived haematopoietic mature myeloid and lymphoid cells for the: Treatment in haematopoietic stem cell transplantation, 20/03/2017, Positive
23/01/2019 Human medicines European public assessment report (EPAR): Esmya, ulipristal acetate, Leiomyoma, 22/02/2012, Patient safety, 15, Authorised
23/01/2019 Orphan designation: Octreotide acetate (oral use) for the: Treatment of acromegaly, 05/08/2013, Positive
23/01/2019 Orphan designation: 3-(5-Amino-2-methyl-4-oxoquinazolin-3(4H)-yl)piperidine-2,6-dione hydrochloride- for the: Treatment of diffuse large B-cell lymphoma, 27/06/2016, Positive
23/01/2019 Human medicines European public assessment report (EPAR): Mylotarg, gemtuzumab ozogamicin, Leukemia, Myeloid, Acute, 19/04/2018, Orphan, Additional monitoring, 3, Authorised
23/01/2019 Orphan designation: Humanised anti-IL-6 receptor monoclonal antibody for the: Treatment of neuromyelitis optica spectrum disorders, 27/06/2016, Positive
23/01/2019 Human medicines European public assessment report (EPAR): Kengrexal, cangrelor, Acute Coronary Syndrome, Vascular Surgical Procedures, 23/03/2015, Additional monitoring, 7, Authorised
23/01/2019 Human medicines European public assessment report (EPAR): Flebogamma DIF (previously Flebogammadif), Human normal immunoglobulin, Mucocutaneous Lymph Node Syndrome, Guillain-Barre Syndrome, Bone Marrow Transplantation, Purpura, Thrombocytopenic, Idiopathic, Immunologic Deficiency Syndromes, 23/07/2007, 16, Authorised
23/01/2019 Human medicines European public assessment report (EPAR): Reyataz, atazanavir sulphate, HIV Infections, 01/03/2004, 48, Authorised
23/01/2019 News and press releases: EMA relocation updates
23/01/2019 Press Release: EMA relocation updates
23/01/2019 Human medicines European public assessment report (EPAR): Fareston, toremifene, Breast Neoplasms, 14/02/1996, 22, Authorised
23/01/2019 News and press releases: No new patients should start treatment with Lartruvo after study shows cancer medicine does not prolong life
23/01/2019 Periodic safety update single assessment: 5 fluorouracil / salicylic acid: List of nationally authorised medicinal products - PSUSA/00000008/201805
23/01/2019 Periodic safety update single assessment: Human hemin: List of nationally authorised medicinal products - PSUSA/00001629/201805
23/01/2019 Withdrawn application: Graspa, asparaginase, Date of withdrawal: 22/06/2018, Initial authorisation
23/01/2019 Periodic safety update single assessment: Terlipressin: List of nationally authorised medicinal products - PSUSA/00002905/201804
23/01/2019 Periodic safety update single assessment: Deoxycholic acid: List of nationally authorised medicinal products - PSUSA/00010525/201804
23/01/2019 Periodic safety update single assessment: Acipimox: List of nationally authorised medicinal products - PSUSA/00000050/201805
23/01/2019 Human medicines European public assessment report (EPAR): Lokelma, sodium zirconium cyclosilicate, Hyperkalemia, 22/03/2018, Additional monitoring, 2, Authorised
23/01/2019 Classifications as minor-use-minor-species and limited-market
23/01/2019 Periodic safety update single assessment: Thiamphenicol: List of nationally authorised medicinal products - PSUSA/00002925/201805
23/01/2019 Periodic safety update single assessment: Cidofovir: List of nationally authorised medicinal products - PSUSA/00010558/201806
23/01/2019 Human medicines European public assessment report (EPAR): Exviera, dasabuvir sodium, Hepatitis C, Chronic, 14/01/2015, Additional monitoring, 15, Authorised
23/01/2019 Periodic safety update single assessment: Tafluprost: List of nationally authorised medicinal products - PSUSA/00002843/201804
23/01/2019 Periodic safety update single assessment: Methoxyflurane: List of nationally authorised medicinal products - PSUSA/00010484/201805
22/01/2019 Periodic safety update single assessment: Flunarizine: List of nationally authorised medicinal products - PSUSA/00001416/201805
22/01/2019 Human medicines European public assessment report (EPAR): Stelara, Ustekinumab, Psoriasis, Arthritis, Psoriatic, Crohn Disease, 15/01/2009, 27, Authorised
22/01/2019 Human medicines European public assessment report (EPAR): Adenuric, febuxostat, Gout, 21/04/2008, 18, Authorised
22/01/2019 Periodic safety update single assessment: Acemetacin: List of nationally authorised medicinal products - PSUSA/00000026/201805
22/01/2019 Orphan designation: 17α,21-Dihydroxy-16α-methyl-pregna-1,4,9(11)-triene-3,20-dione for the: Treatment of Duchenne muscular dystrophy, 22/08/2014, Positive
22/01/2019 Human medicines European public assessment report (EPAR): Kentera (previously Oxybutynin Nicobrand), oxybutynin, Urinary Incontinence, Urge, 15/06/2004, 16, Authorised
22/01/2019 Human medicines European public assessment report (EPAR): Zostavax, varicella-zoster virus (live, attenuated), Herpes Zoster, Immunization, 19/05/2006, 27, Authorised
22/01/2019 Orphan designation: Moxetumomab pasudotox for the: Treatment of B-lymphoblastic leukaemia / lymphoma, 17/07/2013, Positive
22/01/2019 Human medicines European public assessment report (EPAR): Xenical, orlistat, Obesity, 29/07/1998, 23, Authorised
22/01/2019 Periodic safety update single assessment: Fenspiride: CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00001368/201804
22/01/2019 Periodic safety update single assessment: Fenspiride: List of nationally authorised medicinal products - PSUSA/00001368/201804
22/01/2019 Orphan designation: Doxorubicin hydrochloride (in heat-sensitive liposomes) for the: Treatment of hepatocellular carcinoma, 23/02/2011, Positive
22/01/2019 Periodic safety update single assessment: Isotretinoin (oral formulations): CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00010488/201805
22/01/2019 Periodic safety update single assessment: Isotretinoin (oral formulations): List of nationally authorised medicinal products - PSUSA/00010488/201805
22/01/2019 Orphan designation: Chimeric monoclonal antibody against GD2 for the: Treatment of neuroblastoma, 08/11/2012, Positive
22/01/2019 Orphan designation: Humanised IgG4 monoclonal antibody against total complement component 1, subcomponent s for the: Treatment of autoimmune haemolytic anaemia, 17/02/2016, Positive
22/01/2019 Human medicines European public assessment report (EPAR): Twinrix Paediatric, hepatitis-A virus (inactivated), hepatitis-B surface antigen, Immunization, Hepatitis B, Hepatitis A, 10/02/1997, 20, Authorised
22/01/2019 Fexinidazole Winthrop H-W-2320
22/01/2019 Human medicines European public assessment report (EPAR): Lusduna, insulin glargine, Diabetes Mellitus, 03/01/2017, Biosimilar, 2, Withdrawn
22/01/2019 Human medicines European public assessment report (EPAR): Sivextro, tedizolid phosphate, Soft Tissue Infections, Skin Diseases, Bacterial, 23/03/2015, Additional monitoring, 10, Authorised
22/01/2019 Human medicines European public assessment report (EPAR): Trumenba, Neisseria meningitidis serogroup B fHbp (recombinant lipidated fHbp (factor H binding protein)) subfamily A; Neisseria meningitidis serogroup B fHbp (recombinant lipidated fHbp (factor H binding protein)) subfamily B, Meningitis, Meningococcal, 24/05/2017, Additional monitoring, 5, Authorised
22/01/2019 Human medicines European public assessment report (EPAR): Silodosin Recordati, silodosin, Prostatic Hyperplasia, 07/01/2019, Generic, Authorised
22/01/2019 Human medicines European public assessment report (EPAR): Olazax, olanzapine, Schizophrenia, Bipolar Disorder, 11/12/2009, Generic, 10, Authorised
22/01/2019 Human medicines European public assessment report (EPAR): Pemetrexed Pfizer (previously known as Pemetrexed Hospira UK Limited), pemetrexed ditromethamine, Carcinoma, Non-Small-Cell Lung, Mesothelioma, 24/04/2017, Generic, 5, Authorised
22/01/2019 Human medicines European public assessment report (EPAR): Olanzapine Glenmark Europe, olanzapine, Schizophrenia, Bipolar Disorder, 03/12/2009, Generic, 10, Authorised
22/01/2019 Agenda: Agenda - HMPC agenda of the 14-16 January 2019 meeting
22/01/2019 Human medicines European public assessment report (EPAR): Efavirenz Teva, efavirenz, HIV Infections, 09/01/2012, Generic, 8, Authorised
22/01/2019 Agenda: Agenda - COMP agenda of the 22-24 January 2019 meeting
22/01/2019 Human medicines European public assessment report (EPAR): Vepacel, Influenza virus (whole virion, inactivated), containing antigen of: A/Vietnam/1203/2004 (H5N1), Influenza, Human, Immunization, Disease Outbreaks, 17/02/2012, Additional monitoring, 9, Authorised
22/01/2019 Human medicines European public assessment report (EPAR): Binocrit, epoetin alfa, Anemia, Kidney Failure, Chronic, 28/08/2007, Biosimilar, 19, Authorised
21/01/2019 Human medicines European public assessment report (EPAR): Dificlir, fidaxomicin, Clostridium Infections, 05/12/2011, 11, Authorised
21/01/2019 Human medicines European public assessment report (EPAR): Respreeza, alpha1-proteinase inhibitor (human), Genetic Diseases, Inborn, Lung Diseases, 20/08/2015, Additional monitoring, 5, Authorised
21/01/2019 Referral: Perlinring and associated names , etonogestrel, ethinylestradiol , Article 29(4) referrals, European Commission final decision, 18/10/2018, 18/12/2018, 21/01/2019
21/01/2019 Veterinary medicines European public assessment report (EPAR): Bovilis Blue-8, bluetongue virus vaccine, serotype 8 (inactivated), 21/11/2017, 2, Authorised
21/01/2019 Human medicines European public assessment report (EPAR): Verzenios, abemaciclib, Breast Neoplasms, 26/09/2018, Additional monitoring, 2, Authorised
21/01/2019 Human medicines European public assessment report (EPAR): Peyona (previously Nymusa), Caffeine citrate, Apnea, 02/07/2009, 9, Authorised
21/01/2019 Human medicines European public assessment report (EPAR): Nexium Control, esomeprazole, Gastroesophageal Reflux, 26/08/2013, 12, Authorised
21/01/2019 Human medicines European public assessment report (EPAR): Tractocile, atosiban acetate, Premature Birth, 20/01/2000, 22, Authorised
21/01/2019 Human medicines European public assessment report (EPAR): Zypadhera, olanzapine pamoate, Schizophrenia, 19/11/2008, 18, Authorised
21/01/2019 Referral: Paclitaxel Hetero and associated names , paclitaxel , Article 29(4) referrals, European Commission final decision, 18/10/2018, 11/01/2019, 21/01/2019
21/01/2019 Other: EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) units of measurement
21/01/2019 Human medicines European public assessment report (EPAR): NutropinAq, somatropin, Turner Syndrome, Dwarfism, Pituitary, 15/02/2001, 16, Authorised
21/01/2019 Human medicines European public assessment report (EPAR): Inovelon, Rufinamide, Epilepsy, 16/01/2007, 18, Authorised
21/01/2019 Human medicines European public assessment report (EPAR): Opsumit, Macitentan, Hypertension, Pulmonary, 20/12/2013, Orphan, 13, Authorised
21/01/2019 Human medicines European public assessment report (EPAR): Rasilez, aliskiren, Hypertension, 22/08/2007, 24, Authorised
21/01/2019 Human medicines European public assessment report (EPAR): Rasilez HCT, aliskiren, hydrochlorothiazide, Hypertension, 16/01/2009, 16, Authorised
21/01/2019 Human medicines European public assessment report (EPAR): Targretin, bexarotene, Lymphoma, T-Cell, Cutaneous, 29/03/2001, 19, Authorised
21/01/2019 Human medicines European public assessment report (EPAR): Epoetin Alfa Hexal, epoetin alfa, Anemia, Kidney Failure, Chronic, Cancer, 27/08/2007, Biosimilar, 20, Authorised
21/01/2019 Periodic safety update single assessment: Nitrofurantoin, nifurtoinol: List of nationally authorised medicinal products - PSUSA/00002174/201802
21/01/2019 Periodic safety update single assessment: Nitrofurantoin, nifurtoinol: CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00002174/201802
21/01/2019 Periodic safety update single assessment: Ciprofloxacin (systemic use): List of nationally authorised medicinal products - PSUSA/00000775/201801
21/01/2019 Periodic safety update single assessment: Ciprofloxacin (systemic use): CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00000775/201801
18/01/2019 Human medicines European public assessment report (EPAR): Elonva, corifollitropin alfa, Reproductive Techniques, Assisted, Ovulation Induction, 25/01/2010, 14, Authorised
18/01/2019 ICH Q12 Technical and regulatory considerations for pharmaceutical product lifecycle management
18/01/2019 Overview of comments: Overview of comments received on ICH guideline Q12 on technical and regulatory considerations for pharmaceutical product lifecycle management
18/01/2019 Human medicines European public assessment report (EPAR): Rapamune, Sirolimus, Graft Rejection, Kidney Transplantation, 13/03/2001, 38, Authorised
18/01/2019 Veterinary medicines European public assessment report (EPAR): Galliprant, grapiprant, 09/01/2018, 2, Authorised
18/01/2019 Human medicines European public assessment report (EPAR): Fycompa, perampanel, Epilepsies, Partial, 23/07/2012, 15, Authorised
18/01/2019 Human medicines European public assessment report (EPAR): Actelsar HCT, telmisartan, hydrochlorothiazide, 13/03/2013, Generic, 9, Authorised
18/01/2019 Human medicines European public assessment report (EPAR): BeneFIX, Nonacog alfa, Hemophilia B, 27/08/1997, 38, Authorised
18/01/2019 Human medicines European public assessment report (EPAR): Aldara, imiquimod, Condylomata Acuminata, Keratosis, Keratosis, Actinic, Carcinoma, Basal Cell, 18/09/1998, 25, Authorised
18/01/2019 Human medicines European public assessment report (EPAR): Cyanokit, hydroxocobalamin, Poisoning, 23/11/2007, 10, Authorised
18/01/2019 Regulatory and procedural guideline: European Medicines Agency practical guidance on the application form for centralised type IA and IB variations for veterinary medicinal products
18/01/2019 Regulatory and procedural guideline: Checklist for the submission of Type IA and Type IB (without linguistic review) product information annexes and Annex A (if applicable) - veterinary
18/01/2019 Veterinary medicines European public assessment report (EPAR): Pirsue, pirlimycin, 29/01/2001, 14, Authorised
18/01/2019 Human medicines European public assessment report (EPAR): Daptomycin Hospira, daptomycin, Soft Tissue Infections, Skin Diseases, Bacterial, 22/03/2017, Generic, 4, Authorised
18/01/2019 Opinion/decision on a Paediatric investigation plan (PIP): Cell-free solution of lysed Escherichia coli culture, strain Laves, W: decision granting a waiver in all age groups for all conditions/indications, P/0328/2018
18/01/2019 Human medicines European public assessment report (EPAR): Pandemic Influenza Vaccine H5N1 Baxter AG, influenza vaccine (whole virion, inactivated) containing antigen of: A/Vietnam/1203/2004 (H5N1), Influenza, Human, Immunization, Disease Outbreaks, 16/10/2009, Exceptional circumstances, 6, Authorised
18/01/2019 Opinion/decision on a Paediatric investigation plan (PIP): Pamiparib, W: decision granting a waiver in all age groups for all conditions/indications, P/0329/2018
18/01/2019 Opinion/decision on a Paediatric investigation plan (PIP): Eflapegrastim, PM: decision on the application for modification of an agreed PIP, P/0336/2018
18/01/2019 Opinion/decision on a Paediatric investigation plan (PIP): Omega-3-acid ethyl esters 90 / rosuvastatin (calcium), W: decision granting a waiver in all age groups for all conditions/indications, P/0309/2018
18/01/2019 News and press releases: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 14-17 January 2019
18/01/2019 Opinion/decision on a Paediatric investigation plan (PIP): Autologous dendritic cells pulsed with allogeneic tumour cell lysate, W: decision granting a waiver in all age groups for all conditions/indications, P/0334/2018
18/01/2019 Opinion/decision on a Paediatric investigation plan (PIP): Empliciti, Elotuzumab, W: decision granting a waiver in all age groups for all conditions/indications, P/0267/2018
18/01/2019 Opinion/decision on a Paediatric investigation plan (PIP): Nadofaragene firadenovec, W: decision granting a waiver in all age groups for all conditions/indications, P/0276/2018
18/01/2019 Opinion/decision on a Paediatric investigation plan (PIP): Anti-alpha synuclein monoclonal antibody (BIIB054), W: decision granting a waiver in all age groups for all conditions/indications, P/0278/2018
18/01/2019 Opinion/decision on a Paediatric investigation plan (PIP): Acetylsalicylic acid / rosuvastatin (calcium) / perindopril (tert-butylamine) / indapamide (hemihydrate), W: decision granting a waiver in all age groups for all conditions/indications, P/0311/2018
18/01/2019 Periodic safety update single assessment: Ivabradine / metoprolol: List of nationally authorised medicinal products - PSUSA/00010381/201804
18/01/2019 Human medicines European public assessment report (EPAR): Lamivudine Teva Pharma B.V., lamivudine, HIV Infections, 10/12/2009, Generic, 13, Authorised
18/01/2019 Human medicines European public assessment report (EPAR): Efient, prasugrel, Acute Coronary Syndrome, Angina, Unstable, Myocardial Infarction, 24/02/2009, 16, Authorised
18/01/2019 Other: Timetable: Type II variation and worksharing application alternative monthly assessment
18/01/2019 EPAR - All authorised presentations: Foclivia : EPAR - All Authorised presentations
17/01/2019 Opinion/decision on a Paediatric investigation plan (PIP): 3-(3-(3,5-Dimethyl-1H-pyrazol-4-yl)propoxy)-4-fluorobenzoic acid, W: decision granting a waiver in all age groups for all conditions/indications, P/0330/2018
17/01/2019 Opinion/decision on a Paediatric investigation plan (PIP): Telisotuzumab vedotin, W: decision granting a waiver in all age groups for all conditions/indications, P/0331/2018
17/01/2019 Opinion/decision on a Paediatric investigation plan (PIP): Irbesartan / amlodipine, W: decision granting a waiver in all age groups for all conditions/indications, P/0245/2018
17/01/2019 Human medicines European public assessment report (EPAR): Palonosetron Hospira, palonosetron hydrochloride, Nausea, Vomiting, Cancer, 08/04/2016, Generic, 4, Authorised
17/01/2019 Opinion/decision on a Paediatric investigation plan (PIP): Tepotinib, W: decision granting a waiver in all age groups for all conditions/indications, P/0279/2018
17/01/2019 Opinion/decision on a Paediatric investigation plan (PIP): Ianalumab, W: decision granting a waiver in all age groups for all conditions/indications, P/0332/2018
17/01/2019 Opinion/decision on a Paediatric investigation plan (PIP): Autologous T cells transduced with retroviral vector encoding an anti-CD19 CD28/CD3- zeta chimeric antigen receptor, W: decision granting a waiver in all age groups for all conditions/indications, P/0232/2018
17/01/2019 Opinion/decision on a Paediatric investigation plan (PIP): Ibalizumab, PM: decision on the application for modification of an agreed PIP, P/0271/2018
17/01/2019 Opinion/decision on a Paediatric investigation plan (PIP): His-Ser-Gln-Gly-Thr-Phe-Thr-Ser-Asp-Lys(γ-Glu-palmitoyl)-Ser-Glu-Tyr-Leu-Asp-Ser-Glu-Arg-Ala-Arg-Asp-Phe-Val-Ala-Trp-Leu-Glu-Ala-Gly-Gly-OH (MEDI0382), P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0235/2018
17/01/2019 Opinion/decision on a Paediatric investigation plan (PIP): Recombinant human acid ceramidase (RVT-801), P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0319/2018
17/01/2019 Opinion/decision on a Paediatric investigation plan (PIP): Ferric pyrophosphate citrate, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0263/2018
17/01/2019 Opinion/decision on a Paediatric investigation plan (PIP): Ivosidenib, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0280/2018
17/01/2019 Human medicines European public assessment report (EPAR): Tracleer, bosentan monohydrate, Scleroderma, Systemic, Hypertension, Pulmonary, 14/05/2002, 34, Authorised
17/01/2019 Opinion/decision on a Paediatric investigation plan (PIP): diphtheria toxin interleukin-3 Fusion Protein, W: decision granting a waiver in all age groups for all conditions/indications, P/0326/2018
17/01/2019 Opinion/decision on a Paediatric investigation plan (PIP): interferon beta-1a, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0305/2018
17/01/2019 Opinion/decision on a Paediatric investigation plan (PIP): Trimeric, recombinant HIV-1 envelope glycoprotein 140 of Clade C, adjuvanted with aluminium phosphate [Clade C gp140], P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0236/2018
17/01/2019 Opinion/decision on a Paediatric investigation plan (PIP): Anti-mucosal addressin cell adhesion molecule antibody (SHP647), P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0281/2018
17/01/2019 Opinion/decision on a Paediatric investigation plan (PIP): Autologous cartilage derived cultured chondrocytes, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0282/2018
17/01/2019 Opinion/decision on a Paediatric investigation plan (PIP): Inclisiran sodium, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0321/2018
17/01/2019 Opinion/decision on a Paediatric investigation plan (PIP): Lynparza, Olaparib, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0262/2018
16/01/2019 Human medicines European public assessment report (EPAR): Ziextenzo, pegfilgrastim, Neutropenia, 22/11/2018, Additional monitoring, Biosimilar, Authorised
16/01/2019 Human medicines European public assessment report (EPAR): Idelvion, albutrepenonacog alfa, Hemophilia B, 11/05/2016, Orphan, Additional monitoring, 4, Authorised
16/01/2019 Human medicines European public assessment report (EPAR): Exforge HCT, Amlodipine besylate, valsartan, hydrochlorothiazide, Hypertension, 15/10/2009, 15, Authorised
15/01/2019 Human medicines European public assessment report (EPAR): Zavesca, miglustat, Gaucher Disease, Niemann-Pick Diseases, 20/11/2002, 16/06/2009, 29, Authorised
15/01/2019 Minutes: Minutes of the CAT meeting 7-8 November 2018
15/01/2019 Committee for Advanced Therapies (CAT): 7-9 November 2018 , European Medicines Agency, London, UK, from 07/11/2018 to 08/11/2018
15/01/2019 Human medicines European public assessment report (EPAR): Vihuma, simoctocog alfa, Hemophilia A, 13/02/2017, Additional monitoring, 1, Authorised
15/01/2019 Human medicines European public assessment report (EPAR): Ritonavir Mylan, ritonavir, HIV Infections, 09/11/2017, Generic, 3, Authorised
15/01/2019 Veterinary medicines European public assessment report (EPAR): Stronghold, selamectin, 25/11/1999, 23, Authorised
14/01/2019 Agenda: Agenda - PRAC draft agenda of meeting 14-17 January 2019
14/01/2019 Regulatory and procedural guideline: Answer to the request from the European Commission for updating the scientific advice on the impact on public health and animal health of the use of antibiotics in animals - Preliminary risk profiling for new antimicrobials
14/01/2019 Newsletter: Human medicines highlights - January 2019
14/01/2019 Other: Questions and answers on signal management
14/01/2019 Human medicines European public assessment report (EPAR): Wakix, pitolisant, Narcolepsy, 31/03/2016, Orphan, Additional monitoring, 6, Authorised
14/01/2019 Scientific guideline: Concept paper on the revision of the guideline on the evaluation of anticancer medicinal products in man
14/01/2019 Veterinary medicines European public assessment report (EPAR): Semintra, telmisartan, 13/02/2013, 6, Authorised
14/01/2019 Human medicines European public assessment report (EPAR): Granupas (previously Para-aminosalicylic acid Lucane), Para-aminosalicylic acid, Tuberculosis, 07/04/2014, Orphan, 6, Authorised
14/01/2019 Human medicines European public assessment report (EPAR): Riluzole Zentiva, Riluzole, Amyotrophic Lateral Sclerosis, 07/05/2012, 10, Authorised
14/01/2019 Human medicines European public assessment report (EPAR): Adrovance, alendronate sodium trihydrate, colecalciferol, Osteoporosis, Postmenopausal, 04/01/2007, 19, Authorised
14/01/2019 Scientific guideline: Draft guideline on the evaluation of medicinal products indicated for treatment of bacterial infections - Revision 3
14/01/2019 News and press releases: Revised guideline aims to strengthen global approach to development of new antibacterial medicines
14/01/2019 Evaluation of medicinal products indicated for treatment of bacterial infections