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30/04/2019 Human medicines European public assessment report (EPAR): Hemangiol, propranolol hydrochloride, Hemangioma, 23/04/2014, 4, Authorised
30/04/2019 Human medicines European public assessment report (EPAR): Kineret, anakinra, Arthritis, Rheumatoid, 08/03/2002, 24, Authorised
30/04/2019 Human medicines European public assessment report (EPAR): Eptifibatide Accord, eptifibatide, Myocardial Infarction, 11/01/2016, Generic, 2, Authorised
30/04/2019 Human medicines European public assessment report (EPAR): Invokana, canagliflozin, Diabetes Mellitus, Type 2, 15/11/2013, 13, Authorised
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
30/04/2019 Human medicines European public assessment report (EPAR): Entecavir Mylan, entecavir monohydrate, Hepatitis B, 18/09/2017, Generic, 1, Authorised
30/04/2019 Human medicines European public assessment report (EPAR): Darunavir Krka, darunavir, HIV Infections, 26/01/2018, Generic, 3, Authorised
30/04/2019 Report: Recommendations on eligibility to PRIME scheme - Adopted at the CHMP meeting of 23-26 April 2019
30/04/2019 Human medicines European public assessment report (EPAR): Orfadin, nitisinone, Tyrosinemias, 20/02/2005, Orphan, 16, Authorised
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
30/04/2019 Human medicines European public assessment report (EPAR): Stribild, elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil fumarate, HIV Infections, 24/05/2013, 21, Authorised
30/04/2019 Other: European Medicines Agency policy on publication of clinical data for medicinal products for human use
29/04/2019 Human medicines European public assessment report (EPAR): Ongentys, opicapone, Parkinson Disease, 24/06/2016, Additional monitoring, 2, Authorised
29/04/2019 Orphan designation: Eflornithine for the: Treatment of neuroblastoma, 27/09/2011, Positive
29/04/2019 Orphan designation: Eflornithine for the: Treatment of familial adenomatous polyposis (FAP), 20/09/2010, Positive
29/04/2019 Orphan designation: Eflornithine for the: Treatment of familial adenomatous polyposis (FAP), 24/01/2013, Positive
29/04/2019 Orphan designation: Humanised IgG4 monoclonal antibody against extracellular tau for the: Treatment of progressive supranuclear palsy, 28/07/2015, Positive
29/04/2019 Human medicines European public assessment report (EPAR): Adempas, riociguat, Hypertension, Pulmonary, 27/03/2014, Orphan, 10, Authorised
29/04/2019 Other: European authorities working to avoid shortages of medicines due to Brexit – Questions and answers
29/04/2019 Human medicines European public assessment report (EPAR): Revestive, teduglutide, Malabsorption Syndromes, 30/08/2012, Orphan, Additional monitoring, 13, Authorised
29/04/2019 Human medicines European public assessment report (EPAR): Galafold, migalastat hydrochloride, Fabry Disease, 25/05/2016, Orphan, Additional monitoring, 9, Authorised
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
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
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
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
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
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
29/04/2019 Human medicines European public assessment report (EPAR): Omidria, ketorolac, phenylephrine, Lens Implantation, Intraocular, Pain, Postoperative, 28/07/2015, 3, Authorised
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
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
26/04/2019 Human medicines European public assessment report (EPAR): Lumigan, bimatoprost, Glaucoma, Open-Angle, Ocular Hypertension, 08/03/2002, 31, Authorised
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
26/04/2019 Summary of opinion: Xromi, hydroxycarbamide, 26/04/2019, Positive
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 News and press releases: New long-lasting implant to treat opioid dependence
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
26/04/2019 Orphan designation: 5,7-dichloro-2-dimethylaminomethyl-8-hydroxyquinoline hydrochloride for the: Treatment of Huntington’s disease, 21/05/2015, Positive
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 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 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, 2, Authorised
25/04/2019 Human medicines European public assessment report (EPAR): Vokanamet, canagliflozin, metformin hydrochloride, Diabetes Mellitus, Type 2, 23/04/2014, 13, Authorised
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): Fulphila, pegfilgrastim, Neutropenia, 20/11/2018, Additional monitoring, Biosimilar, 1, Authorised
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
25/04/2019 Periodic safety update single assessment: Dexamfetamine: List of nationally authorised medicinal products - PSUSA/00000986/201809
25/04/2019 Human medicines European public assessment report (EPAR): Anagrelide Mylan, Anagrelide hydrochloride, Thrombocythemia, Essential, 15/02/2018, Generic, 1, Authorised
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 Orphan designation: Alpha-1 antitrypsin (inhalation use) for the: Treatment of cystic fibrosis, 16/11/2004, Positive
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
25/04/2019 Regulatory and procedural guideline: List of substances and products subject to worksharing for signal management
25/04/2019 Orphan designation: Acetylleucine for the: Treatment of spinocerebellar ataxia, 22/11/2018, Positive
25/04/2019 Orphan designation: Acetylleucine for the: Treatment of ataxia telangiectasia, 11/01/2019, Positive
25/04/2019 Orphan designation: Acetylleucine for the: Treatment of Niemann-Pick disease, 20/03/2017, Positive
25/04/2019 Orphan designation: Ursodeoxycholic acid for the: Treatment of Niemann-Pick disease, 22/05/2017, Positive
25/04/2019 Orphan designation: Acetylleucine for the: Treatment of GM2 gangliosidosis, 12/12/2017, Positive
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): Zyprexa Velotab, olanzapine, Schizophrenia, Bipolar Disorder, 03/02/2000, 28, Authorised
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): 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 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 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
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
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
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
24/04/2019 Herbal - HMPC assessment report: Addendum to Assessment report on Phaseolus vulgaris L., fructus sine semine - First review
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
24/04/2019 Human medicines European public assessment report (EPAR): Januvia, sitagliptin, Diabetes Mellitus, Type 2, 20/03/2007, 25, Authorised
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
24/04/2019 Herbal - HMPC assessment report: Addendum to Assessment report on Potentialla erecta (L.) Raeusch., rhizoma - First review
24/04/2019 Orphan designation: Ralinepag for the: Treatment of pulmonary arterial hypertension, 11/01/2019, Positive
24/04/2019 Human medicines European public assessment report (EPAR): Tarceva, erlotinib, Carcinoma, Non-Small-Cell Lung, Pancreatic Neoplasms, 19/09/2005, 29, Authorised
23/04/2019 Recommendation on medication errors: Lynparza: warning that new tablets are used at different doses to the capsules
23/04/2019 Agenda: Agenda - PDCO agenda of the 23-26 April 2019 meeting
23/04/2019 Veterinary medicines European public assessment report (EPAR): Zycortal, desoxycortone pivalate, 06/11/2015, 3, Authorised
23/04/2019 Herbal medicinal product: Malvae folium, Malvae folium, F: Assessment finalised
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
23/04/2019 Orphan designation: Ofranergene obadenovec for the: Treatment of ovarian cancer, 16/10/2017, Positive
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
23/04/2019 Herbal medicinal product: Echinaceae angustifoliae radix, Echinaceae angustifoliae radix, F: Assessment finalised
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
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
23/04/2019 Orphan designation: Cannabidivarin for the: Treatment of fragile X syndrome, 22/02/2018, Positive
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
23/04/2019 Orphan designation: Cannabidiol for the: Treatment of tuberous sclerosis, 17/01/2018, Positive
23/04/2019 Orphan designation: Cannabidiol for the: Treatment of West syndrome, 16/10/2017, Positive
23/04/2019 Orphan designation: Cannabidivarin for the: Treatment of Rett syndrome, 16/10/2017, Positive
23/04/2019 Orphan designation: Delta-9-tetrahydrocannabinol and cannabidiol from extracts of the Cannabis sativa L. plant for the: Treatment of glioma, 17/02/2016, Positive
23/04/2019 Minutes: Minutes of the HMPC 26-27 March 2018 meeting
23/04/2019 Orphan designation: 1,2:5,6-Dianhydrogalactitol for the: Treatment of glioma, 24/01/2013, Positive
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
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
23/04/2019 Orphan designation: Raxibacumab for the: Treatment of inhalation anthrax disease, 15/10/2014, Positive
23/04/2019 Other: Nominations to the European Union Telematics governance bodies
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 ICH guideline S11 on nonclinical safety testing in support of development of paediatric medicines - Step 2b
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)
18/04/2019 Human medicines European public assessment report (EPAR): Cystagon, mercaptamine bitartrate, Cystinosis, 23/06/1997, 16, Authorised
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 Periodic safety update single assessment: Aztreonam: List of nationally authorised medicinal products - PSUSA/00010178/201808
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): 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): 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 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): 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): Esbriet, Pirfenidone, Idiopathic Pulmonary Fibrosis, 27/02/2011, Orphan, 23, 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
12/04/2019 Orphan designation: Adeno-associated viral vector serotype 2 containing the human REP1 gene for the: Treatment of choroideraemia, 04/07/2014, Positive
12/04/2019 Orphan designation: Tyr-Met-Phe-Pro-Asn-Ala-Pro-Tyr-Leu, Ser-Gly-Gln-Ala-Tyr-Met-Phe-Pro-Asn-Ala-Pro-Tyr-Leu-Pro-Ser-Cys-Leu-Glu-Ser, Arg-Ser-Asp-Glu-Leu-Val-Arg-His-His-Asn-Met-His-Gln-Arg-Asn-Met-Thr-Lys-Leu and Pro-Gly-Cys-Asn-Lys-Arg-Tyr-Phe-Lys-Leu-Ser-His-Leu-Gln-Met-His-Ser-Arg-Lys-His-Thr-Gly for the: Treatment of acute myeloid leukaemia, 28/04/2016, Positive
12/04/2019 Orphan designation: Tyr-Met-Phe-Pro-Asn-Ala-Pro-Tyr-Leu, Ser-Gly-Gln-Ala-Tyr-Met-Phe-Pro-Asn-Ala-Pro-Tyr-Leu-Pro-Ser-Cys-Leu-Glu-Ser, Arg-Ser-Asp-Glu-Leu-Val-Arg-His-His-Asn-Met-His-Gln-Arg-Asn-Met-Thr-Lys-Leu and Pro-Gly-Cys-Asn-Lys-Arg-Tyr-Phe-Lys-Leu-Ser-His-Leu-Gln-Met-His-Ser-Arg-Lys-His-Thr-Gly for the: Treatment of malignant mesothelioma, 28/04/2016, Positive
12/04/2019 Orphan designation: Entinostat for the: Treatment of Hodgkin's lymphoma, 10/06/2010, Positive
12/04/2019 Orphan designation: N-Hydroxy-4-(3-methyl-2-(S)-phenyl-butyrylamino) benzamide for the: Treatment of meningioma, 06/06/2012, Positive
12/04/2019 Orphan designation: Recombinant human monoclonal antibody to insulin receptor for the: Treatment of congenital hyperinsulinism, 14/07/2016, Positive
12/04/2019 Orphan designation: N-Hydroxy-4-(3-methyl-2-(S)-phenyl-butyrylamino) benzamide for the: Treatment of neurofibromatosis type 2, 26/04/2012, Positive
12/04/2019 Orphan designation: N-Hydroxy-4-(3-methyl-2-(S)-phenyl-butyrylamino) benzamide for the: Treatment of schwannoma, 06/06/2012, Positive
12/04/2019 Orphan designation: Glycyl-L-2-methylprolyl-L-glutamic acid for the: Treatment of fragile X syndrome, 28/07/2015, Positive
12/04/2019 Orphan designation: Glycyl-L-2-methylprolyl-L-glutamic acid for the: Treatment of Rett syndrome, 10/08/2015, Positive
12/04/2019 Orphan designation: Recombinant human minibody against complement component C5 fused with RGD-motif for the: Prevention of ischaemia/reperfusion injury associated with solid organ transplantation, 20/01/2009, Withdrawn
12/04/2019 Orphan designation: Recombinant human minibody against complement component C5 for the: Treatment of primary membranoproliferative glomerulonephritis, 27/10/2011, Withdrawn
12/04/2019 Orphan designation: Recombinant human minibody against complement component C5 for the: Treatment of atypical haemolytic uraemic syndrome (aHUS), 22/09/2008, Withdrawn
12/04/2019 Orphan designation: cholest-4-en-3-one, oxime for the: Treatment of 5q spinal muscular atrophy, 10/03/2005, Withdrawn
12/04/2019 Human medicines European public assessment report (EPAR): M-M-RVaxPro, measles virus Enders’ Edmonston strain (live, attenuated), mumps virus Jeryl Lynn (level B) strain (live, attenuated), rubella virus Wistar RA 27/3 strain (live, attenuated), Rubella, Mumps, Immunization, Measles, 05/05/2006, 21, Authorised
12/04/2019 Regulatory and procedural guideline: Practical guidance for procedures related to Brexit for medicinal products for human and veterinary use within the framework of the centralised procedure
12/04/2019 Orphan designation: Fusion proteins composed by a genetically modified cholera toxin subunit A1, peptides from the acetylcholine receptor alpha chain and a dimer of the D fragment from Staphylococcus aureus protein A for the: Treatment of myasthenia gravis, 21/05/2015, Withdrawn
12/04/2019 Orphan designation: Venetoclax for the: Treatment of acute myeloid leukaemia, 17/02/2016, Withdrawn
12/04/2019 Orphan designation: Nitric oxide for the: Treatment of cystic fibrosis, 24/04/2015, Withdrawn
12/04/2019 Other: Information package for certificates of medicinal products issued by the European Medicines Agency
12/04/2019 Opinion/decision on a Paediatric investigation plan (PIP): Etripamil, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0042/2019
12/04/2019 Opinion/decision on a Paediatric investigation plan (PIP): bupivacaine,meloxicam (HTX-011), P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0013/2019
12/04/2019 Opinion/decision on a Paediatric investigation plan (PIP): Ibrance, palbociclib, W: decision granting a waiver in all age groups for all conditions/indications, P/0005/2019
12/04/2019 Newsletter: Human medicines highlights - April 2019
12/04/2019 Periodic safety update single assessment: Pseudoephedrine, acetylsalicylic acid / pseudoephedrine: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010667/201806
12/04/2019 Periodic safety update single assessment: Pseudoephedrine, acetylsalicylic acid / pseudoephedrine: List of nationally authorised medicinal products - PSUSA/00010667/201806
12/04/2019 Other: European Medicines Agency breach of trust procedure on declarations of competing interests for Management Board members
12/04/2019 Opinion/decision on a Paediatric investigation plan (PIP): Pretomanid, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0058/2019
12/04/2019 Opinion/decision on a Paediatric investigation plan (PIP): Givosiran, W: decision granting a waiver in all age groups for all conditions/indications, P/0038/2019
12/04/2019 Opinion/decision on a Paediatric investigation plan (PIP): Pexidartinib, W: decision granting a waiver in all age groups for all conditions/indications, P/0044/2019
12/04/2019 News and press releases: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 8-11 April 2019
12/04/2019 Opinion/decision on a Paediatric investigation plan (PIP): Ozanimod, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0050/2019
12/04/2019 Opinion/decision on a Paediatric investigation plan (PIP): filgotinib, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0045/2019
12/04/2019 Opinion/decision on a Paediatric investigation plan (PIP): Dienogest,ethinyl estradiol (LPRI-424), PM: decision on the application for modification of an agreed PIP, P/0053/2019
12/04/2019 Opinion/decision on a Paediatric investigation plan (PIP): Crizanlizumab, PM: decision on the application for modification of an agreed PIP, P/0060/2019
12/04/2019 News and press releases: Use of multiple sclerosis medicine Lemtrada restricted while EMA review is ongoing
12/04/2019 News and press releases: Update of EU recommendations for 2019/2020 seasonal flu vaccine composition
12/04/2019 Human medicines European public assessment report (EPAR): Integrilin, eptifibatide, Angina, Unstable, Myocardial Infarction, 01/07/1999, 23, Authorised
12/04/2019 Periodic safety update single assessment: Tianeptine: CMDh scientific conclusions, amendments to product information and implementation timetable - PSUSA/00002943/201806
12/04/2019 Periodic safety update single assessment: Tianeptine: List of nationally authorised medicinal products - PSUSA/00002943/201806
12/04/2019 Human medicines European public assessment report (EPAR): Holoclar, ex vivo expanded autologous human corneal epithelial cells containing stem cells, Stem Cell Transplantation, Corneal Diseases, 17/02/2015, Orphan, Additional monitoring, Conditional approval, 5, Authorised
12/04/2019 Veterinary medicines European public assessment report (EPAR): SevoFlo, sevoflurane, 11/12/2002, 16, Authorised
11/04/2019 Human medicines European public assessment report (EPAR): Vidaza, azacitidine, Myelodysplastic Syndromes, 17/12/2008, Accelerated assessment, 18, Authorised
11/04/2019 Opinion/decision on a Paediatric investigation plan (PIP): Braftovi, Encorafenib, W: decision granting a waiver in all age groups for all conditions/indications, P/0049/2019
11/04/2019 Opinion/decision on a Paediatric investigation plan (PIP): Tremfya, guselkumab, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0025/2019
11/04/2019 Opinion/decision on a Paediatric investigation plan (PIP): Mektovi, binimetinib, W: decision granting a waiver in all age groups for all conditions/indications, P/0037/2019
11/04/2019 Opinion/decision on a Paediatric investigation plan (PIP): Imbruvica, Ibrutinib, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0021/2019
11/04/2019 Opinion/decision on a Paediatric investigation plan (PIP): semaglutide, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0007/2019
11/04/2019 Opinion/decision on a Paediatric investigation plan (PIP): Turoctocog alfa pegol, W: decision granting a waiver in all age groups for all conditions/indications, P/0046/2019
11/04/2019 Opinion/decision on a Paediatric investigation plan (PIP): Bilastine, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0009/2019
11/04/2019 Opinion/decision on a Paediatric investigation plan (PIP): Edurant, rilpivirine, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0039/2019
11/04/2019 News and press releases: The role of regulators in establishing added benefit of novel therapies
11/04/2019 Classification of changes: questions and answers
11/04/2019 Post-authorisation measures: questions and answers
11/04/2019 Opinion/decision on a Paediatric investigation plan (PIP): Ozempic, semaglutide, PM: decision on the application for modification of an agreed PIP, P/0036/2019
11/04/2019 Opinion/decision on a Paediatric investigation plan (PIP): Triumeq, dolutegravir,abacavir,lamivudine, PM: decision on the application for modification of an agreed PIP, P/0018/2019
11/04/2019 Opinion/decision on a Paediatric investigation plan (PIP): Rezolsta, darunavir,cobicistat, PM: decision on the application for modification of an agreed PIP, P/0006/2019
11/04/2019 Opinion/decision on a Paediatric investigation plan (PIP): Moventig, Naloxegol, PM: decision on the application for modification of an agreed PIP, P/0056/2019
11/04/2019 Opinion/decision on a Paediatric investigation plan (PIP): Jardiance, empagliflozin, PM: decision on the application for modification of an agreed PIP, P/0031/2019
11/04/2019 Opinion/decision on a Paediatric investigation plan (PIP): Sodium sulphate,potassium sulphate,magnesium sulphate heptahydrate (BLI800), PM: decision on the application for modification of an agreed PIP, P/0035/2019
11/04/2019 Human medicines European public assessment report (EPAR): Suboxone, buprenorphine, naloxone, Opioid-Related Disorders, 26/09/2006, 15, Authorised
11/04/2019 Opinion/decision on a Paediatric investigation plan (PIP): Birch pollen extract, PM: decision on the application for modification of an agreed PIP, P/0029/2019
11/04/2019 Human medicines European public assessment report (EPAR): Xydalba, dalbavancin hcl, Soft Tissue Infections, Skin Diseases, Bacterial, 19/02/2015, Additional monitoring, 8, Authorised
10/04/2019 Human medicines European public assessment report (EPAR): Mepact, mifamurtide, Osteosarcoma, 06/03/2009, 14, Authorised
10/04/2019 Human medicines European public assessment report (EPAR): Pregabalin Mylan Pharma, pregabalin, Anxiety Disorders, Neuralgia, Epilepsy, 25/06/2015, Generic, 5, Authorised
10/04/2019 Human medicines European public assessment report (EPAR): Bortezomib Accord, bortezomib, Multiple Myeloma, 20/07/2015, Generic, 6, Authorised
10/04/2019 Human medicines European public assessment report (EPAR): Resolor, Prucalopride succinate, Constipation, 14/10/2009, 22, Authorised
10/04/2019 Human medicines European public assessment report (EPAR): IntronA, interferon alfa-2b, Carcinoid Tumor, Leukemia, Hairy Cell, Lymphoma, Follicular, Hepatitis B, Chronic, Hepatitis C, Chronic, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Melanoma, Multiple Myeloma, 09/03/2000, 31, Authorised
10/04/2019 Human medicines European public assessment report (EPAR): Febuxostat Mylan, febuxostat, Hyperuricemia, Arthritis, Gouty, Gout, 15/06/2017, Generic, 2, Authorised
10/04/2019 Human medicines European public assessment report (EPAR): Alimta, pemetrexed, Mesothelioma, Carcinoma, Non-Small-Cell Lung, 20/09/2004, 23, Authorised
10/04/2019 Periodic safety update single assessment: Ibuprofen / pseudoephedrine: List of nationally authorised medicinal products - PSUSA/00001711/201807
10/04/2019 Periodic safety update single assessment: Ibuprofen / pseudoephedrine: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001711/201807
10/04/2019 Human medicines European public assessment report (EPAR): Panretin, alitretinoin, Sarcoma, Kaposi, 11/10/2000, 17, Authorised
10/04/2019 Human medicines European public assessment report (EPAR): Pemetrexed Lilly, pemetrexed, Carcinoma, Non-Small-Cell Lung, Mesothelioma, 14/09/2015, Generic, 4, Authorised
10/04/2019 Human medicines European public assessment report (EPAR): Nyxoid, Naloxone hydrochloride dihydrate, Opioid-Related Disorders, 09/11/2017, 3, Authorised
10/04/2019 Human medicines European public assessment report (EPAR): Alprolix, eftrenonacog alfa, Hemophilia B, 12/05/2016, Orphan, Additional monitoring, 4, Authorised
09/04/2019 Human medicines European public assessment report (EPAR): Betmiga, Mirabegron, Urinary Bladder, Overactive, 20/12/2012, 11, Authorised
09/04/2019 Human medicines European public assessment report (EPAR): Afinitor, everolimus, Carcinoma, Renal Cell, Breast Neoplasms, Pancreatic Neoplasms, 02/08/2009, 23, Authorised
09/04/2019 Orphan designation: Allogeneic cultured postnatal thymus-derived tissue for the: Treatment of severe combined immunodeficiency due to FOXN1 deficiency, 26/02/2019, Positive
09/04/2019 Orphan designation: Allogeneic cultured postnatal thymus-derived tissue for the: Treatment of CHARGE syndrome, 26/02/2019, Positive
09/04/2019 Orphan designation: Allogeneic cultured postnatal thymus-derived tissue for the: Treatment of DiGeorge syndrome, 26/02/2019, Positive
09/04/2019 Orphan designation: Poly(N-acetyl, N-arginyl)glucosamine for the: Treatment of cystic fibrosis, 26/02/2019, Positive
09/04/2019 Orphan designation: losartan for the: Treatment of epidermolysis bullosa, 26/02/2019, Positive
09/04/2019 Orphan designation: Lentiviral vector encoding human coagulation factor IX for the: Treatment of haemophilia B, 26/02/2019, Positive
09/04/2019 Opinion/decision on a Paediatric investigation plan (PIP): Entrectinib, PM: decision on the application for modification of an agreed PIP, P/0010/2019