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30/04/2019 Human medicines European public assessment report (EPAR): Hemangiol, propranolol hydrochloride, Hemangioma, 23/04/2014, 4, Authorised (updated)
30/04/2019 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, 39, Authorised (updated)
30/04/2019 Human medicines European public assessment report (EPAR): Kineret, anakinra, Arthritis, Rheumatoid, 08/03/2002, 24, Authorised (updated)
30/04/2019 Herbal medicinal product: Gentianae radix, Gentianae radix, F: Assessment finalised (updated)
30/04/2019 Human medicines European public assessment report (EPAR): Eptifibatide Accord, eptifibatide, Myocardial Infarction, 11/01/2016, Generic, 2, Authorised (updated)
30/04/2019 Human medicines European public assessment report (EPAR): Hefiya, adalimumab, Hidradenitis Suppurativa, Spondylitis, Ankylosing, Psoriasis, Arthritis, Juvenile Rheumatoid, Uveitis, 26/07/2018, Additional monitoring, Biosimilar, 3, Authorised (updated)
30/04/2019 Human medicines European public assessment report (EPAR): Invokana, canagliflozin, Diabetes Mellitus, Type 2, 15/11/2013, 13, Authorised (updated)
30/04/2019 Mutual recognition agreements (MRA) (updated)
30/04/2019 Other: Questions and answers on the impact of mutual recognition agreement between the European Union and the United States as of 30 April 2019 (updated)
30/04/2019 News and press releases: Two additional countries to benefit from EU-US mutual recognition agreement for inspections
30/04/2019 Veterinary medicines European public assessment report (EPAR): Aivlosin, tylvalosin, 09/09/2004, 29, Authorised (updated)
30/04/2019 Human medicines European public assessment report (EPAR): Menveo, meningococcal group A, C, W-135 and Y conjugate vaccine, Immunization, Meningitis, Meningococcal, 15/03/2010, 17/12/2009, 26, Authorised (updated)
30/04/2019 Human medicines European public assessment report (EPAR): Entecavir Mylan, entecavir monohydrate, Hepatitis B, 18/09/2017, Generic, 1, Authorised (updated)
30/04/2019 Human medicines European public assessment report (EPAR): Darunavir Krka, darunavir, HIV Infections, 26/01/2018, Generic, 3, Authorised (updated)
30/04/2019 Report: Recommendations on eligibility to PRIME scheme - Adopted at the CHMP meeting of 23-26 April 2019
30/04/2019 Report: List of products granted eligibility to PRIME (updated)
30/04/2019 Human medicines European public assessment report (EPAR): Orfadin, nitisinone, Tyrosinemias, 20/02/2005, Orphan, 16, Authorised (updated)
30/04/2019 Periodic safety update single assessment: Daunorubicin: CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/0000936/201806
30/04/2019 Periodic safety update single assessment: Daunorubicin: List of nationally authorised medicinal products - PSUSA/0000936/201806
30/04/2019 Report: Questions and answers on the European Medicines Agency policy on publication of clinical data for medicinal products for human use (updated)
30/04/2019 Other: List of European Union reference dates and frequency of submission of periodic safety update reports (updated)
30/04/2019 Human medicines European public assessment report (EPAR): Stribild, elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil fumarate, HIV Infections, 24/05/2013, 21, Authorised (updated)
30/04/2019 Other: European Medicines Agency policy on publication of clinical data for medicinal products for human use (updated)
29/04/2019 Human medicines European public assessment report (EPAR): RoActemra, tocilizumab, Arthritis, Rheumatoid, Arthritis, Juvenile Rheumatoid, 15/01/2009, 27, Authorised (updated)
29/04/2019 Human medicines European public assessment report (EPAR): Xermelo, telotristat etiprate, Carcinoid Tumor, Neuroendocrine Tumors, 17/09/2017, Orphan, Additional monitoring, 4, Authorised (updated)
29/04/2019 Human medicines European public assessment report (EPAR): Ongentys, opicapone, Parkinson Disease, 24/06/2016, Additional monitoring, 2, Authorised (updated)
29/04/2019 Orphan designation: Eflornithine for the: Treatment of neuroblastoma, 27/09/2011, Positive (updated)
29/04/2019 Orphan designation: Eflornithine for the: Treatment of familial adenomatous polyposis, 20/09/2010, Positive (updated)
29/04/2019 Orphan designation: Eflornithine for the: Treatment of familial adenomatous polyposis, 24/01/2013, Positive (updated)
29/04/2019 Orphan designation: Humanised IgG4 monoclonal antibody against extracellular tau for the: Treatment of progressive supranuclear palsy, 28/07/2015, Positive (updated)
29/04/2019 Human medicines European public assessment report (EPAR): Amlodipine / Valsartan Mylan , Amlodipine besilate, valsartan, Hypertension, 22/03/2016, Generic, 3, Authorised (updated)
29/04/2019 Human medicines European public assessment report (EPAR): Parsabiv, etelcalcetide hydrochloride, Hyperparathyroidism, Secondary, 11/11/2016, Additional monitoring, 6, Authorised (updated)
29/04/2019 Human medicines European public assessment report (EPAR): Vosevi, Sofosbuvir, velpatasvir, voxilaprevi, Hepatitis C, Chronic, 26/07/2017, Additional monitoring, 4, Authorised (updated)
29/04/2019 Human medicines European public assessment report (EPAR): Docetaxel Kabi, docetaxel, Head and Neck Neoplasms, Carcinoma, Non-Small-Cell Lung, Adenocarcinoma, Prostatic Neoplasms, Breast Neoplasms, 22/05/2012, Generic, 11, Authorised (updated)
29/04/2019 Herbal medicinal product: Leonuri cardiacae herba, Leonuri cardiacae herba, F: Assessment finalised (updated)
29/04/2019 Scientific publications (updated)
29/04/2019 Human medicines European public assessment report (EPAR): Adempas, riociguat, Hypertension, Pulmonary, 27/03/2014, Orphan, 10, Authorised (updated)
29/04/2019 Other: European authorities working to avoid shortages of medicines due to Brexit – Questions and answers (updated)
29/04/2019 Human medicines European public assessment report (EPAR): Revestive, teduglutide, Malabsorption Syndromes, 30/08/2012, Orphan, Additional monitoring, 13, Authorised (updated)
29/04/2019 Human medicines European public assessment report (EPAR): Galafold, migalastat hydrochloride, Fabry Disease, 25/05/2016, Orphan, Additional monitoring, 9, Authorised (updated)
29/04/2019 Opinion/decision on a Paediatric investigation plan (PIP): 2-hydroxypropyl-ß-cyclodextrin (HP-ß-CD), PM: decision on the application for modification of an agreed PIP, P/0027/2019 (updated)
29/04/2019 Opinion/decision on a Paediatric investigation plan (PIP): Autologous peripheral blood T cells CD4 and CD8 selected and CD3 and CD28 activated transduced with retroviral vector expressing anti CD19 CD28/CD3-zeta chimeric antigen receptor and cultured (KTE-X19), PM: decision on the application for modification of an agreed PIP, P/0002/2019 (updated)
29/04/2019 Regulatory and procedural guideline: European Medicines Agency post-authorisation procedural advice for users of the centralised procedure (updated)
29/04/2019 Opinion/decision on a Paediatric investigation plan (PIP): Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain A (H3N2),Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain B (Yamagata lineage),Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain B (Victoria lineage),Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain A (H1N1), PM: decision on the application for modification of an agreed PIP, P/0057/2019 (updated)
29/04/2019 Risk management plan (RMP): questions and answers (updated)
29/04/2019 Opinion/decision on a Paediatric investigation plan (PIP): fostemsavir (tromethamine), PM: decision on the application for modification of an agreed PIP, P/0040/2019 (updated)
29/04/2019 Opinion/decision on a Paediatric investigation plan (PIP): Bivalent anti-human myostatin adnectin recombinant human IgG1-Fc fusion protein (RO7239361), PM: decision on the application for modification of an agreed PIP, P/0043/2019 (updated)
29/04/2019 Opinion/decision on a Paediatric investigation plan (PIP): Juluca, rilpivirine,dolutegravir, PM: decision on the application for modification of an agreed PIP, P/0054/2019 (updated)
29/04/2019 Opinion/decision on a Paediatric investigation plan (PIP): Fevipiprant, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0124/2018 (updated)
29/04/2019 Human medicines European public assessment report (EPAR): Omidria, ketorolac, phenylephrine, Lens Implantation, Intraocular, Pain, Postoperative, 28/07/2015, 3, Authorised (updated)
29/04/2019 Regulatory and procedural guideline: European Medicines Agency post-authorisation procedural advice for users of the centralised procedure - track changes (updated)
29/04/2019 News and press releases: European Medicines Agency closed 1 May 2019
29/04/2019 Opinion/decision on a Paediatric investigation plan (PIP): Burosumab, PM: decision on the application for modification of an agreed PIP, P/0007/2018 (updated)
29/04/2019 Scientific guideline: Guideline on equivalence studies for the demonstration of therapeutic equivalence for locally applied, locally acting products in the gastrointestinal tract - Revision 1 (updated)
29/04/2019 Summary of opinion: Dovato, dolutegravir, lamivudine, 26/04/2019, Positive
26/04/2019 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, 3, Authorised (updated)
26/04/2019 Human medicines European public assessment report (EPAR): Lumigan, bimatoprost, Glaucoma, Open-Angle, Ocular Hypertension, 08/03/2002, 31, Authorised (updated)
26/04/2019 Summary of opinion: Cabazitaxel Teva, cabazitaxel, 26/04/2019, Negative
26/04/2019 Opinion/decision on a Paediatric investigation plan (PIP): Kymriah, tisagenlecleucel, PM: decision on the application for modification of an agreed PIP, P/0008/2019 (updated)
26/04/2019 Human medicines European public assessment report (EPAR): Pelgraz, pegfilgrastim, Neutropenia, 21/09/2018, Additional monitoring, Biosimilar, 2, Authorised (updated)
26/04/2019 Summary of opinion: Xromi, hydroxycarbamide, 26/04/2019, Positive
26/04/2019 Summary of opinion: Striascan, ioflupane (123i), 26/04/2019, Positive
26/04/2019 Referral: Lartruvo , olaratumab , Article 20 procedures, Opinion provided by Committee for Medicinal Products for Human Use, 31/01/2019, 26/04/2019 (updated)
26/04/2019 News and press releases: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 April 2019
26/04/2019 Summary of opinion: Sixmo, buprenorphine, 26/04/2019, Positive
26/04/2019 Summary of opinion: Temybric Ellipta, fluticasone furoate, umeclidinium, vilanterol, 26/04/2019, Positive
26/04/2019 Summary of opinion: Esperoct, turoctocog alfa pegol, 26/04/2019, Positive
26/04/2019 Summary of opinion: Doptelet, avatrombopag, 26/04/2019, Positive
26/04/2019 Summary of opinion: Ultomiris, ravulizumab, 26/04/2019, Positive
26/04/2019 News and press releases: New long-lasting implant to treat opioid dependence
26/04/2019 Summary of opinion: Libtayo, cemiplimab, 26/04/2019, Positive
26/04/2019 Summary of opinion: Nuceiva, botulinum toxin type a, 26/04/2019, Positive
26/04/2019 Summary of opinion: Talzenna, talazoparib, 26/04/2019, Positive
26/04/2019 Summary of opinion: Ambrisentan Mylan, ambrisentan, 26/04/2019, Positive
26/04/2019 Human medicines European public assessment report (EPAR): Kromeya, adalimumab, Arthritis, Rheumatoid, Arthritis, Juvenile Rheumatoid, Psoriasis, Arthritis, Psoriatic, Spondylitis, Ankylosing, Uveitis, Colitis, Ulcerative, Crohn Disease, 02/04/2019, Additional monitoring, Biosimilar, Authorised
26/04/2019 Orphan designation: N-[2,6-bis(1-methylethyl)phenyl]-N'-[[1-[4-(dimethylamino)phenyl]cyclopentyl]methyl]urea, hydrochloride salt for the: Treatment of congenital adrenal hyperplasia, 17/01/2018, Positive (updated)
26/04/2019 Orphan designation: 5,7-dichloro-2-dimethylaminomethyl-8-hydroxyquinoline hydrochloride for the: Treatment of Huntington's disease, 21/05/2015, Positive (updated)
26/04/2019 Opinion/decision on a Paediatric investigation plan (PIP): Human ciliary neurotrophic factor, W: decision granting a waiver in all age groups for all conditions/indications, P/0051/2019
26/04/2019 Opinion/decision on a Paediatric investigation plan (PIP): Fibroblast activation protein alpha-targeted interleukin 2 variant immunocytokine, W: decision granting a waiver in all age groups for all conditions/indications, P/0032/2019
26/04/2019 Opinion/decision on a Paediatric investigation plan (PIP): Telmisartan / indapamide, W: decision granting a waiver in all age groups for all conditions/indications, P/0024/2019
26/04/2019 Human medicines European public assessment report (EPAR): Aripiprazole Mylan Pharma (previously Aripiprazole Pharmathen), aripiprazole, Schizophrenia, Bipolar Disorder, 30/06/2015, Generic, 7, Authorised (updated)
26/04/2019 Opinion/decision on a Paediatric investigation plan (PIP): Amantadine (hydrochloride), W: decision granting a waiver in all age groups for all conditions/indications, P/0033/2019
26/04/2019 Opinion/decision on a Paediatric investigation plan (PIP): Rifamycin, W: decision granting a waiver in all age groups for all conditions/indications, P/0047/2019
26/04/2019 Opinion/decision on a Paediatric investigation plan (PIP): Technetium (99mTc) trofolastat chloride, W: decision granting a waiver in all age groups for all conditions/indications, P/0052/2019
26/04/2019 News and press releases: EMA recommends withdrawal of marketing authorisation for cancer medicine Lartruvo
26/04/2019 List of medicines under additional monitoring (updated)
26/04/2019 Medicine for use outside EU: List of medicinal products under additional monitoring (updated)
26/04/2019 Medicines under additional monitoring: List of medicinal products under additional monitoring (updated)
26/04/2019 Summary of opinion: Lynparza, olaparib, 26/04/2019, Positive
26/04/2019 Summary of opinion: Grasustek, pegfilgrastim, 26/04/2019, Positive
25/04/2019 Veterinary medicines European public assessment report (EPAR): Vepured, recombinant Verotoxin 2e of E. coli, 17/08/2017, 1, Authorised (updated)
25/04/2019 Human medicines European public assessment report (EPAR): Vokanamet, canagliflozin, metformin hydrochloride, Diabetes Mellitus, Type 2, 23/04/2014, 13, Authorised (updated)
25/04/2019 News and press releases: EMA regrets to learn of the passing of Dr Eric Abadie, former CHMP Chair
25/04/2019 Periodic safety update single assessment: Finasteride: List of nationally authorised medicinal products - PSUSA/00001392/201808
25/04/2019 Human medicines European public assessment report (EPAR): Ogivri, trastuzumab, Stomach Neoplasms, Breast Neoplasms, 12/12/2018, Additional monitoring, Biosimilar, 1, Authorised (updated)
25/04/2019 Human medicines European public assessment report (EPAR): Fulphila, pegfilgrastim, Neutropenia, 20/11/2018, Biosimilar, 1, Authorised (updated)
25/04/2019 Human medicines European public assessment report (EPAR): Myalepta, Metreleptin, Lipodystrophy, Familial Partial, 29/07/2018, Orphan, Additional monitoring, Exceptional circumstances, 2, Authorised (updated)
25/04/2019 Periodic safety update single assessment: Dexamfetamine: List of nationally authorised medicinal products - PSUSA/00000986/201809
25/04/2019 Opinion/decision on a Paediatric investigation plan (PIP): Synthetic double-stranded siRNA oligonucleotide targeted against transthyretin mRNA, with six phosphorothioate linkages in the backbone, and nine 2’-fluoro and thirty-five 2’-O-methyl nucleoside residues in the sequence, which is covalently linked via a phosphodiester group to a ligand containing three N-acetylgalactosamine residues (ALN-65492), W: decision granting a waiver in all age groups for all conditions/indications, P/0015/2019
25/04/2019 Human medicines European public assessment report (EPAR): Anagrelide Mylan, Anagrelide hydrochloride, Thrombocythemia, Essential, 15/02/2018, Generic, 1, Authorised (updated)
25/04/2019 Human medicines European public assessment report (EPAR): Verkazia, ciclosporin, Conjunctivitis, Keratitis, 06/07/2018, Orphan, 1, Authorised (updated)
25/04/2019 Human medicines European public assessment report (EPAR): Amgevita, adalimumab, Arthritis, Psoriatic, Colitis, Ulcerative, Arthritis, Juvenile Rheumatoid, Spondylitis, Ankylosing, Psoriasis, Crohn Disease, Arthritis, Rheumatoid, 21/03/2017, Additional monitoring, Biosimilar, 5, Authorised (updated)
25/04/2019 Human medicines European public assessment report (EPAR): Kalydeco, ivacaftor, Cystic Fibrosis, 22/07/2012, Orphan, 17, Authorised (updated)
25/04/2019 Human medicines European public assessment report (EPAR): Pantoloc Control, pantoprazole, Gastroesophageal Reflux, 11/06/2009, 15, Authorised (updated)
25/04/2019 Orphan designation: Alpha-1 antitrypsin (inhalation use) for the: Treatment of cystic fibrosis, 16/11/2004, Positive (updated)
25/04/2019 Orphan designation: Poly(oxy-1,2-ethanediyl),.alpha.-hydro-.omega.-hydroxy-,15,15'-diester with N-acetyl-L-isoleucyl-L-cysteinyl-L-valyl-1-methyl-L-tryptophyl-L-glutaminyl-L-.alpha.-aspartyl-L-tryptophylglycyl-L-alanyl-L-histidyl-L-arginyl-L-cysteinyl-L-threonyl-2-[2-(2-aminoethoxy)ethoxy]acetyl-N6-carboxy-L-lysinamide cyclic (2.fwdarw.12)-(disulfide); where two identical synthetic peptide domains are covalently linked at the ends of the polyethylene glycol chain for the: Treatment of paroxysmal nocturnal haemoglobinuria, 22/05/2017, Positive (updated)
25/04/2019 Orphan designation: Recombinant human type I pancreatic elastase for the prevention of arteriovenous access dysfunction in haemodialysis patients (vonapanitase) for the: Prevention of arteriovenous access dysfunction in haemodialysis patients, 16/01/2014, Positive (updated)
25/04/2019 Regulatory and procedural guideline: List of substances and products subject to worksharing for signal management (updated)
25/04/2019 Recruitment: European Medicines Agency's privacy statement for selection and recruitment
25/04/2019 Orphan designation: Acetylleucine for the: Treatment of spinocerebellar ataxia, 22/11/2018, Positive (updated)
25/04/2019 Orphan designation: Acetylleucine for the: Treatment of ataxia telangiectasia, 11/01/2019, Positive (updated)
25/04/2019 Orphan designation: Acetylleucine for the: Treatment of Niemann-Pick disease, 20/03/2017, Positive (updated)
25/04/2019 Orphan designation: Ursodeoxycholic acid for the: Treatment of Niemann-Pick disease, 22/05/2017, Positive (updated)
25/04/2019 Medicines under additional monitoring: Annex III - List of intravenous iron-containing medicinal products in the European Union (updated)
25/04/2019 Medicines under additional monitoring: Annex III - List of intravenous iron-containing medicinal products in the European Union (updated)
25/04/2019 Orphan designation: Acetylleucine for the: Treatment of GM2 gangliosidosis, 12/12/2017, Positive (updated)
25/04/2019 Medicines under additional monitoring: Annex XIV – retinoid containing medicinal products and related substances (acitretin, alitretinoin, isotretinoin) (updated)
25/04/2019 Medicines under additional monitoring: Annex XIV – retinoid containing medicinal products and related substances (acitretin, alitretinoin, isotretinoin) (updated)
25/04/2019 Opinion/decision on a Paediatric investigation plan (PIP): levodopa,carbidopa monohydrate,entacapone, W: decision granting a waiver in all age groups for all conditions/indications, P/0011/2019
25/04/2019 Opinion/decision on a Paediatric investigation plan (PIP): Anti-VEGF and anti-DLL4 dual variable domain immunoglobulin (ABT-165), W: decision granting a waiver in all age groups for all conditions/indications, P/0012/2019
25/04/2019 Opinion/decision on a Paediatric investigation plan (PIP): Ramipril,Atorvastatin,amlodipine, W: decision granting a waiver in all age groups for all conditions/indications, P/0048/2019
24/04/2019 News and press releases: European Immunization Week 2019: statement by Executive Director Guido Rasi
24/04/2019 Human medicines European public assessment report (EPAR): Senshio, ospemifene, Postmenopause, 14/01/2015, Additional monitoring, 7, Authorised (updated)
24/04/2019 Human medicines European public assessment report (EPAR): Zyprexa Velotab, olanzapine, Schizophrenia, Bipolar Disorder, 03/02/2000, 28, Authorised (updated)
24/04/2019 Human medicines European public assessment report (EPAR): Remsima, infliximab, Arthritis, Psoriatic, Spondylitis, Ankylosing, Colitis, Ulcerative, Psoriasis, Crohn Disease, Arthritis, Rheumatoid, 10/09/2013, Biosimilar, 15, Authorised (updated)
24/04/2019 Opinion/decision on a Paediatric investigation plan (PIP): Split influenza virus, inactivated containing antigens equivalent to the A/H1N1-like strain, A/H3N2-like strain, B-like strain (Victoria lineage) and B-like strain (Yamagata lineage), P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0023/2019
24/04/2019 Opinion/decision on a Paediatric investigation plan (PIP): Bruton’s tyrosine kinase inhibitor, W: decision granting a waiver in all age groups for all conditions/indications, P/0020/2019
24/04/2019 Opinion/decision on a Paediatric investigation plan (PIP): Tremfya, avapritinib, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0026/2019
24/04/2019 Opinion/decision on a Paediatric investigation plan (PIP): Germanium (68Ge) chloride / Gallium (68Ga) chloride, W: decision granting a waiver in all age groups for all conditions/indications, P/0019/2019
24/04/2019 Human medicines European public assessment report (EPAR): Otezla, apremilast, Arthritis, Psoriatic, Psoriasis, 15/01/2015, Additional monitoring, 8, Authorised (updated)
24/04/2019 Opinion/decision on a Paediatric investigation plan (PIP): Ianalumab, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0041/2019
24/04/2019 Human medicines European public assessment report (EPAR): Maviret, glecaprevir / pibrentasvir, Hepatitis C, Chronic, 26/07/2017, Additional monitoring, 5, Authorised (updated)
24/04/2019 Human medicines European public assessment report (EPAR): Ebilfumin, oseltamivir, Influenza, Human, 22/05/2014, Generic, 10, Authorised (updated)
24/04/2019 Opinion/decision on a Paediatric investigation plan (PIP): Rezafungin acetate, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0014/2019
24/04/2019 Orphan designation: Autologous CD34+ cells transfected with lentiviral vector containing the Wiskott-Aldrich syndrome protein gene for the: Treatment of Wiskott-Aldrich syndrome, 06/06/2012, Positive (updated)
24/04/2019 Orphan designation: Adeno-associated viral vector serotype 2 containing the human CHM gene encoding human Rab escort protein 1 for the: Treatment of choroideraemia, 04/06/2014, Positive (updated)
24/04/2019 Orphan designation: Recombinant adeno-associated viral vector containing a bioengineered capsid and a codon-optimised expression cassette to drive the expression of the SQ form of a B-domain deleted human coagulation factor VIII for the: Treatment of haemophilia A, 26/10/2018, Positive (updated)
24/04/2019 Orphan designation: Radio-iodinated (131I) anti-CD45 murine monoclonal antibody for the: Treatment in haematopoietic stem cell transplantation, 14/10/2016, Positive (updated)
24/04/2019 Herbal medicinal product: Phaseoli fructus (sine semine), Phaseoli fructus (sine semine), F: Assessment finalised (updated)
24/04/2019 Herbal - HMPC assessment report: Addendum to Assessment report on Phaseolus vulgaris L., fructus sine semine - First review
24/04/2019 Herbal medicinal product: Bursae pastoris herba, Bursae pastoris herba, F: Assessment finalised (updated)
24/04/2019 Herbal - HMPC assessment report: Addendum to Assessment report on Capsella bursa-pastoris (L.) Medikus, herba - First review
24/04/2019 Herbal medicinal product: Millefolii herba, Millefolii herba, F: Assessment finalised (updated)
24/04/2019 Human medicines European public assessment report (EPAR): Januvia, sitagliptin, Diabetes Mellitus, Type 2, 20/03/2007, 25, Authorised (updated)
24/04/2019 Herbal - HMPC assessment report: Addendum to Assessment report on Achillea millefolium L., flos - First review
24/04/2019 Herbal medicinal product: Tormentillae rhizoma, Tormentillae rhizoma, C: ongoing call for scientific data (updated)
24/04/2019 Herbal - HMPC assessment report: Addendum to Assessment report on Potentialla erecta (L.) Raeusch., rhizoma - First review
24/04/2019 Human medicines European public assessment report (EPAR): Kiovig, human normal immunoglobulin (IVIg), Purpura, Thrombocytopenic, Idiopathic, Bone Marrow Transplantation, Immunologic Deficiency Syndromes, Guillain-Barre Syndrome, Mucocutaneous Lymph Node Syndrome, 18/01/2006, 21, Authorised (updated)
24/04/2019 Orphan designation: Ralinepag for the: Treatment of pulmonary arterial hypertension, 11/01/2019, Positive (updated)
24/04/2019 Human medicines European public assessment report (EPAR): Tarceva, erlotinib, Carcinoma, Non-Small-Cell Lung, Pancreatic Neoplasms, 19/09/2005, 29, Authorised (updated)
24/04/2019 Stakeholder workshop on support to quality development in early access approaches, such as PRIME and Breakthrough Therapies , European Medicines Agency, London, UK, from 26/11/2018 to 26/11/2018 (updated)
23/04/2019 Recommendation on medication errors: Lynparza: warning that new tablets are used at different doses to the capsules
23/04/2019 Paediatric Committee (PDCO): 23-26 April 2019 , European Medicines Agency, Amsterdam, The Netherlands, from 23/04/2019 to 26/04/2019 (updated)
23/04/2019 Agenda: Agenda - PDCO agenda of the 23-26 April 2019 meeting
23/04/2019 Regulatory and procedural guideline: Member states contact points for translations review (updated)
23/04/2019 Veterinary medicines European public assessment report (EPAR): Zycortal, desoxycortone pivalate, 06/11/2015, 3, Authorised (updated)
23/04/2019 Herbal medicinal product: Malvae folium, Malvae folium, F: Assessment finalised (updated)
23/04/2019 Orphan designation: Asp-Arg-Val-Tyr-Ile-His-Pro (Angiotensin 1-7) for the: Treatment of epidermolysis bullosa, 20/06/2017, Positive (updated)
23/04/2019 Orphan designation: Ofranergene obadenovec for the: Treatment of ovarian cancer, 16/10/2017, Positive (updated)
23/04/2019 Orphan designation: (5R,5aR,8aR,9S)-9-[[4,6-O-[(R)-Ethylidene]-β-D-glucopyranosyl]-oxy]-5-(4-({[(2,2-dimethyl-1,3-dioxolan-4-yl)methoxy]carbonyl}oxy)-3,5-dimethoxyphenyl)-5,8,8a,9-tetrahydroisobenzofuro[5,6-f][1,3]benzodioxol-6(5aH)-one (etoposide toniribate) for the: Treatment of biliary tract cancer, 04/06/2014, Positive (updated)
23/04/2019 Herbal medicinal product: Echinaceae angustifoliae radix, Echinaceae angustifoliae radix, F: Assessment finalised (updated)
23/04/2019 Orphan designation: Asp-Arg-Val-Tyr-Ile-His-Pro (Angiotensin 1-7) for the: Treatment of Duchenne muscular dystrophy, 19/02/2014, Positive (updated)
23/04/2019 Herbal - HMPC assessment report: Addendum to Assessment report on Echinacea angustifolia, radix - First review
23/04/2019 Orphan designation: Adenovirus-associated vector containing human Fas-c gene (ofranergene obadenovec) for the: Treatment of glioma, 06/06/2012, Positive (updated)
23/04/2019 Orphan designation: Cannabidivarin for the: Treatment of fragile X syndrome, 22/02/2018, Positive (updated)
23/04/2019 Orphan designation: Adeno-associated viral vector serotype 8 containing the human MTM1 gene for the: Treatment of X-linked myotubular myopathy, 10/08/2015, Positive (updated)
23/04/2019 Human medicines European public assessment report (EPAR): Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva, efavirenz, emtricitabine, tenofovir disoproxil, phosphate, HIV Infections, 17/07/2017, Additional monitoring, Generic, 4, Authorised (updated)
23/04/2019 Orphan designation: Cannabidiol for the: Treatment of tuberous sclerosis, 17/01/2018, Positive (updated)
23/04/2019 Orphan designation: Cannabidiol for the: Treatment of Lennox-Gastaut syndrome, 20/03/2017, Positive (updated)
23/04/2019 Orphan designation: Cannabidiol for the: Treatment of West syndrome, 16/10/2017, Positive (updated)
23/04/2019 Orphan designation: Cannabidivarin for the: Treatment of Rett syndrome, 16/10/2017, Positive (updated)
23/04/2019 Orphan designation: Delta-9-tetrahydrocannabinol and cannabidiol from extracts of the Cannabis sativa L. plant for the: Treatment glioma, 17/02/2016, Positive (updated)
23/04/2019 Orphan designation: Cannabidiol for the: Treatment of Dravet syndrome, 15/10/2014, Positive (updated)
23/04/2019 Human medicines European public assessment report (EPAR): Xigduo, metformin hydrochloride, dapagliflozin propanediol monohydrate, Diabetes Mellitus, Type 2, 16/01/2014, 12, Authorised (updated)
23/04/2019 Minutes: Minutes of the HMPC 26-27 March 2018 meeting (updated)
23/04/2019 Orphan designation: 1,2:5,6-Dianhydrogalactitol for the: Treatment of glioma, 24/01/2013, Positive (updated)
23/04/2019 Periodic safety update single assessment: Fluocinolone acetonide (intravitreal implant in applicator): List of nationally authorised medicinal products - PSUSA/00010224/201808
23/04/2019 Orphan designation: R-1-[2,3-dihydro-2-oxo-1-pivaloylmethyl-5-(2-pyridyl)-1 H-1,4-benzodiazepin-3-yl]-3-(3-methylaminophenyl)urea (netazepide) for the: Treatment of gastric carcinoid, 14/06/2007, Positive (updated)
23/04/2019 Orphan designation: (R)-1-[1-(4-acetoxy-3,3-dimethyl-2-oxo-butyl)-2-oxo-5-(pyridin-2-yl)-2,3-dihydro-1H-benzo[e][1,4]diazepin-3-yl]-3-(3-methylamino-phenyl)-urea (ceclazepide) for the: Treatment of gastro-entero-pancreatic neuroendocrine tumours, 14/12/2015, Positive (updated)
23/04/2019 Orphan designation: Raxibacumab for the: Treatment of inhalation anthrax disease, 15/10/2014, Positive (updated)
23/04/2019 Other: Nominations to the European Union Telematics governance bodies (updated)
23/04/2019 Periodic safety update single assessment: Paracetamol (IV formulation): CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00002311/201805
23/04/2019 Periodic safety update single assessment: Paracetamol (IV formulation): List of nationally authorised medicinal products - PSUSA/00002311/201805
23/04/2019 News and press releases: Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 15-16 April 2019
23/04/2019 Summary of opinion: Suvaxyn PRRS MLV, Porcine respiratory and reproductive syndrome virus vaccine (live), 16/04/2019, Positive
23/04/2019 ICH guideline S11 on nonclinical safety testing in support of development of paediatric medicines - Step 2b (updated)
23/04/2019 Overview of comments: Overview of comments received on draft ICH guideline S11 on nonclinical safety testing in support of development of paediatric medicines (EMA/CHMP/ICH/616110/2018)
17/04/2019 Medicine evaluation figures
17/04/2019 Report: Medicinal products for human use: monthly figures - March 2019
17/04/2019 Minutes: Minutes of the CHMP meeting 25-28 February 2019
17/04/2019 Human medicines European public assessment report (EPAR): Ajovy, fremanezumab, Migraine Disorders, 28/03/2019, Additional monitoring, Authorised
17/04/2019 Human medicines European public assessment report (EPAR): Cystagon, mercaptamine bitartrate, Cystinosis, 23/06/1997, 15, Authorised
17/04/2019 Human medicines European public assessment report (EPAR): Ammonaps, Sodium phenylbutyrate, Ornithine Carbamoyltransferase Deficiency Disease, Citrullinemia, Carbamoyl-Phosphate Synthase I Deficiency Disease, 07/12/1999, 18, Authorised
17/04/2019 Human medicines European public assessment report (EPAR): Tobramycin PARI, Tobramycin, Respiratory Tract Infections, Cystic Fibrosis, 18/02/2019, Authorised
17/04/2019 Human medicines European public assessment report (EPAR): Idacio, adalimumab, Arthritis, Rheumatoid, Arthritis, Juvenile Rheumatoid, Psoriasis, Arthritis, Psoriatic, Spondylitis, Ankylosing, Uveitis, Hidradenitis Suppurativa, Colitis, Ulcerative, Crohn Disease, 02/04/2019, Additional monitoring, Biosimilar, Authorised
17/04/2019 Periodic safety update single assessment: Aztreonam: List of nationally authorised medicinal products - PSUSA/00010178/201808
17/04/2019 Human medicines European public assessment report (EPAR): Glivec, imatinib, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Gastrointestinal Stromal Tumors, Dermatofibrosarcoma, Myelodysplastic-Myeloproliferative Diseases, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Hypereosinophilic Syndrome, 07/11/2001, Additional monitoring, 34, Authorised
17/04/2019 Periodic safety update single assessment: Ciclesonide: List of nationally authorised medicinal products - PSUSA-00000742-201808
17/04/2019 Periodic safety update single assessment: Rilmenidine: List of nationally authorised medicinal products - PSUSA-00002643-201808
17/04/2019 Periodic safety update single assessment: Paracetamol / pseudoephedrine: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002307/201806
17/04/2019 Committee meeting report: CAT monthly report of application procedures, guidelines and related documents on advanced therapies: March 2019
17/04/2019 Committee for Advanced Therapies (CAT): 23-25 January 2019 , European Medicines Agency, London, UK, from 23/01/2019 to 25/01/2019
17/04/2019 Committee for Advanced Therapies (CAT): 20-22 March 2019 , European Medicines Agency, from 20/03/2019 to 22/03/2019
17/04/2019 Committee for Advanced Therapies (CAT): 16-17 April 2019 , European Medicines Agency, Amsterdam, the Netherlands, from 16/04/2019 to 17/04/2019
17/04/2019 Minutes: Minutes of the CAT meeting 23-25 January 2019
17/04/2019 Agenda: Agenda - CAT agenda of the 16-17 April 2019 meeting
17/04/2019 Minutes: Minutes of the COMP meeting 22-24 January 2019
16/04/2019 Human medicines European public assessment report (EPAR): Sprycel, dasatinib, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, 20/11/2006, 32, Authorised
16/04/2019 Human medicines European public assessment report (EPAR): Somavert, Pegvisomant, Acromegaly, 12/11/2002, Orphan, 20, Authorised
16/04/2019 Human medicines European public assessment report (EPAR): Entecavir Accord, Entecavir, Hepatitis B, Chronic, 25/09/2017, Generic, 2, Authorised
16/04/2019 Human medicines European public assessment report (EPAR): Ilumetri, tildrakizumab, Psoriasis, 17/09/2018, Additional monitoring, 1, Authorised
16/04/2019 Human medicines European public assessment report (EPAR): Neofordex, dexamethasone, Multiple Myeloma, 16/03/2016, 4, Authorised
16/04/2019 Human medicines European public assessment report (EPAR): Olanzapine Mylan, olanzapine, Schizophrenia, Bipolar Disorder, 06/10/2008, Generic, 14, Authorised
16/04/2019 Regulatory and procedural guideline: IRIS quick guide to the portal for orphan industry users
16/04/2019 Regulatory and procedural guideline: Procedure for orphan medicinal product designation: Guidance for sponsors submitting an application via IRIS secure online portal
16/04/2019 Human medicines European public assessment report (EPAR): Cinacalcet Mylan, cinacalcet hydrochloride, Hyperparathyroidism, Secondary, Hypercalcemia, 19/11/2015, Generic, 3, Authorised
16/04/2019 Opinion/decision on a Paediatric investigation plan (PIP): Humenza, Split influenza virus, inactivated containing antigen equivalent to A/California/7/2009 (H1N1)-like strain (A/California/7/2009 (NYMC X-179A)), adjuvanted, PM: decision on the application for modification of an agreed PIP, P/0022/2019
16/04/2019 Opinion/decision on a Paediatric investigation plan (PIP): Rapiscan, regadenoson, PM: decision on the application for modification of an agreed PIP, P/0030/2019
16/04/2019 Opinion/decision on a Paediatric investigation plan (PIP): Vimpat, lacosamide, PM: decision on the application for modification of an agreed PIP, P/0059/2019
16/04/2019 Opinion/decision on a Paediatric investigation plan (PIP): Tivicay, dolutegravir, PM: decision on the application for modification of an agreed PIP, P/0017/2019
16/04/2019 Opinion/decision on a Paediatric investigation plan (PIP): Revatio, sildenafil, PM: decision on the application for modification of an agreed PIP, P/0016/2019
16/04/2019 Opinion/decision on a Paediatric investigation plan (PIP): ocrelizumab, PM: decision on the application for modification of an agreed PIP, P/0028/2019
16/04/2019 News and press releases: EMA closed 18-22 April 2019
16/04/2019 Opinion/decision on a Paediatric investigation plan (PIP): Edarbi, Azilsartan medoxomil, PM: decision on the application for modification of an agreed PIP, P/0034/2019
15/04/2019 Periodic safety update single assessment: Cefuroxime sodium (for intracameral use): CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010206/201805
15/04/2019 Periodic safety update single assessment: Cefuroxime sodium (for intracameral use): List of nationally authorised medicinal products - PSUSA/00010206/201805
15/04/2019 Human medicines European public assessment report (EPAR): Tybost, cobicistat on silicon dioxide, HIV Infections, 19/09/2013, 12, Authorised
15/04/2019 Human medicines European public assessment report (EPAR): Vaniqa, Eflornithine, Hirsutism, 19/03/2001, 22, Authorised
15/04/2019 Human medicines European public assessment report (EPAR): Fulvestrant Mylan, fulvestrant, Breast Neoplasms, 08/01/2018, Generic, 1, Authorised
15/04/2019 Periodic safety update single assessment: Ceftriaxone: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00000613/201805
15/04/2019 Periodic safety update single assessment: Ceftriaxone: List of nationally authorised medicinal products - PSUSA/00000613/201805
15/04/2019 Human medicines European public assessment report (EPAR): Zoledronic Acid Accord, zoledronic acid monohydrate, Hypercalcemia, Fractures, Bone, Cancer, 16/01/2014, Generic, 6, Authorised
15/04/2019 Human medicines European public assessment report (EPAR): Sialanar, Glycopyrronium bromide, Sialorrhea, 15/09/2016, 3, Authorised
15/04/2019 Standard Operating Procedure - SOP: Standard operating procedure for conducting checks for conflicts of interest of the European Medicines Agency employees assigned duties relating to medicinal products for human or veterinary use
15/04/2019 Human medicines European public assessment report (EPAR): Luxturna, voretigene neparvovec, Leber Congenital Amaurosis, Retinitis Pigmentosa, 22/11/2018, Orphan, Additional monitoring, 1, Authorised
15/04/2019 Report: Applications for new human medicines under evaluation by the CHMP: April 2019
15/04/2019 Veterinary medicines European public assessment report (EPAR): Parvoduk, live attenuated Muscovy duck parvovirus, 11/04/2014, 2, Withdrawn
15/04/2019 Human medicines European public assessment report (EPAR): HBVaxPro, hepatitis B, recombinant surface antigen, Hepatitis B, Immunization, 27/04/2001, 25, Authorised
15/04/2019 Human medicines European public assessment report (EPAR): Lenalidomide Accord, lenalidomide, Multiple Myeloma, 20/09/2018, Additional monitoring, Generic, 1, Authorised
15/04/2019 Human medicines European public assessment report (EPAR): Ganfort, bimatoprost, timolol, Glaucoma, Open-Angle, Ocular Hypertension, 19/05/2006, 17, Authorised
15/04/2019 Human medicines European public assessment report (EPAR): Fasenra, benralizumab, Asthma, 08/01/2018, Additional monitoring, 3, Authorised
15/04/2019 Human medicines European public assessment report (EPAR): Perjeta, pertuzumab, Breast Neoplasms, 04/03/2013, 17, Authorised
15/04/2019 Human medicines European public assessment report (EPAR): Atazanavir Mylan, atazanavir sulfate, HIV Infections, 22/08/2016, Generic, 6, Authorised
15/04/2019 Human medicines European public assessment report (EPAR): Advagraf, tacrolimus, Graft Rejection, 23/04/2007, 18, Authorised
15/04/2019 Human medicines European public assessment report (EPAR): Esbriet, Pirfenidone, Idiopathic Pulmonary Fibrosis, 27/02/2011, Orphan, 23, Authorised
15/04/2019 Orphan designation: Sodium nitrite for the: Treatment of aneurysmal subarachnoid haemorrhage, 16/01/2014, Positive
15/04/2019 Orphan designation: Sodium thiosulfate for the: Treatment for calciphylaxis, 15/01/2015, Positive
12/04/2019 Human medicines European public assessment report (EPAR): Hemlibra, Emicizumab, Hemophilia A, 23/02/2018, Additional monitoring, 4, Authorised
12/04/2019 Orphan designation: Chimeric monoclonal antibody to shiga toxin 1 and 2 for the: Treatment of shiga-toxin-producing bacterial infection, 26/08/2005, Positive
12/04/2019 Orphan designation: 4-[3-(Methylsulfonyl)phenyl]-1-propylpiperidine x HC1 for the: Treatment of Huntington's disease, 20/06/2005, Positive