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30/06/2020 Human medicines European public assessment report (EPAR): Velphoro, mixture of polynuclear iron(III)-oxyhydroxide, sucrose and starches, Hyperphosphatemia, Renal Dialysis, 26/08/2014, 7, Authorised
30/06/2020 Procurement activities 2019
30/06/2020 Other: Annual list of contract modifications 2019
30/06/2020 Other: Annual list of contractors 2019 - contract values Euro 15,000 - 143,999
30/06/2020 Other: Annual list of specific contracts based on framework contracts - 2019
30/06/2020 News and press releases: EMA and Korean Ministry of Food and Drug Safety to share confidential COVID-19 information
30/06/2020 Regulatory and procedural guideline: Procedural advice for orphan medicinal product designation: Guidance for sponsors
30/06/2020 Committee meeting report: CAT monthly report of application procedures, guidelines and related documents on advanced therapies: June 2020
29/06/2020 Human medicines European public assessment report (EPAR): Akynzeo, netupitant, palonosetron hydrochloride, Vomiting, Cancer, Nausea, 27/05/2015, 8, Authorised
29/06/2020 Human medicines European public assessment report (EPAR): Nplate, romiplostim, Purpura, Thrombocytopenic, Idiopathic, 04/02/2009, 23, Authorised
29/06/2020 Other: Mandate, objectives and rules of procedure for the CVMP Immunologicals Working Party (IWP)
29/06/2020 Human medicines European public assessment report (EPAR): Telzir, fosamprenavir calcium, HIV Infections, 12/07/2004, 44, Authorised
29/06/2020 Other: Mandate, objectives and rules of procedure of the Scientific Advice Working Party (SAWP)
29/06/2020 Implications of coronavirus disease (COVID-19) on methodological aspects of ongoing clinical trials
29/06/2020 Human medicines European public assessment report (EPAR): Spherox, spheroids of human autologous matrix-associated chondrocytes, Cartilage Diseases, 10/07/2017, Additional monitoring, 4, Authorised
29/06/2020 Minutes: Minutes of the CAT meeting 18-20 May 2020
29/06/2020 Veterinary medicines European public assessment report (EPAR): Stronghold Plus, selamectin, sarolaner, 08/02/2017, 3, Authorised
29/06/2020 Human medicines European public assessment report (EPAR): Idelvion, albutrepenonacog alfa, Hemophilia B, 11/05/2016, Orphan, Additional monitoring, 7, Authorised
26/06/2020 Human medicines European public assessment report (EPAR): Kineret, anakinra, Arthritis, Rheumatoid, 08/03/2002, 27, Authorised
26/06/2020 Human medicines European public assessment report (EPAR): Eviplera, emtricitabine, rilpivirine hydrochloride / tenofovir disoproxil fumarate, HIV Infections, 27/11/2011, 23, Authorised
26/06/2020 Human medicines European public assessment report (EPAR): Xermelo, telotristat etiprate, Carcinoid Tumor, Neuroendocrine Tumors, 17/09/2017, Orphan, Additional monitoring, 10, Authorised
26/06/2020 Human medicines European public assessment report (EPAR): Symkevi, tezacaftor, ivacaftor, Cystic Fibrosis, 31/10/2018, Orphan, Additional monitoring, 6, Authorised
26/06/2020 Human medicines European public assessment report (EPAR): Pradaxa, Dabigatran etexilate mesilate, Arthroplasty, Replacement, Venous Thromboembolism, 17/03/2008, Patient safety, 31, Authorised
26/06/2020 Other: Questions and answers on management of extraneous agents in immunological veterinary medicinal products (IVMPs)
26/06/2020 Questions and answers on management of extraneous agents in immunological veterinary medicinal products (IVMPs)
26/06/2020 Human medicines European public assessment report (EPAR): Epivir, lamivudine, HIV Infections, 08/08/1996, 45, Authorised
26/06/2020 News and press releases: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 June 2020
26/06/2020 Summary of opinion: Zavicefta, ceftazidime / avibactam, 25/06/2020, Positive
26/06/2020 Withdrawn application: Zemdri, plazomicin, Date of withdrawal: 16/06/2020, Initial authorisation
26/06/2020 Summary of opinion: Epclusa, sofosbuvir / velpatasvir, 25/06/2020, Positive
26/06/2020 Summary of opinion: Turalio, pexidartinib, 25/06/2020, Negative
26/06/2020 Annex to CHMP highlights: Start of Union reviews - CHMP meeting of 22-25 June 2020
26/06/2020 Annex to CHMP highlights: Scientific advice and protocol assistance adopted during the CHMP meeting 22-25 June 2020
26/06/2020 Summary of opinion: Livogiva, teriparatide, 25/06/2020, Positive
26/06/2020 Summary of opinion: Qutavina, teriparatide, 25/06/2020, Positive
26/06/2020 News and press releases: New medicine for cystic fibrosis patients
26/06/2020 News and press releases: New treatment to enable kidney transplant in highly sensitised patients
26/06/2020 Veterinary medicines European public assessment report (EPAR): Tulaven, tulathromycin, 24/04/2020, Generic, Authorised
26/06/2020 Orphan designation: Ciprofloxacin (liposomal) for the: Treatment of cystic fibrosis, 24/07/2009, Positive
26/06/2020 Human medicines European public assessment report (EPAR): Januvia, sitagliptin, Diabetes Mellitus, Type 2, 20/03/2007, 27, Authorised
26/06/2020 Human medicines European public assessment report (EPAR): Yescarta, axicabtagene ciloleucel, Lymphoma, Follicular, Lymphoma, Large B-Cell, Diffuse, 23/08/2018, Orphan, Additional monitoring, 6, Authorised
26/06/2020 Veterinary medicines European public assessment report (EPAR): Loxicom, meloxicam, 10/02/2009, Generic, 15, Authorised
26/06/2020 Other: Emerging safety issues (ESI) contact points at the national competent authority (NCA) level
26/06/2020 Veterinary medicines European public assessment report (EPAR): Porcilis ColiClos, Clostridium perfringens type C / Escherichia coli F4ab / E. coli F4ac / E. coli F5 / E. coli F6 / E. coli LT, 14/06/2012, 5, Authorised
26/06/2020 Committee for Medicinal Products for Veterinary Use (CVMP): 18-20 May 2020 , European Medicines Agency, Amsterdam, the Netherlands, from 18/05/2020 to 20/05/2020
26/06/2020 Minutes: Minutes of the CVMP meeting of 18-20 May 2020
25/06/2020 News and press releases: First COVID-19 treatment recommended for EU authorisation
25/06/2020 Veterinary medicines European public assessment report (EPAR): Felisecto Plus, selamectin, sarolaner, 26/04/2019, 1, Authorised
25/06/2020 News and press releases: Emer Cooke nominated as new EMA Executive Director
25/06/2020 How to prepare and review a summary of product characteristics
25/06/2020 Presentation: Presentation - Section 4.8: Undesirable effects
25/06/2020 Other: Scientific guidelines with summary-of-product-characteristics recommendations
25/06/2020 Committee meeting report: CAT monthly report of application procedures, guidelines and related documents on advanced therapies: March 2020
25/06/2020 Agenda: Agenda - Extraordinary Management Board meeting to nominate a new EMA Executive Director: 25 June 2020
25/06/2020 Minutes: Minutes of the COMP meeting 18-20 May 2020
25/06/2020 eXtended EudraVigilance Medicinal Product Dictionary training course , Online, from 21/10/2020 to 23/10/2020
25/06/2020 eXtended EudraVigilance Medicinal Product Dictionary training course , Online, from 14/12/2020 to 16/12/2020
25/06/2020 Supply shortage: Cinryze (C1 inhibitor, human) supply shortage
25/06/2020 Other: List of eligible industry stakeholder organisations
25/06/2020 Business hours and holidays
24/06/2020 Agenda: Agenda - PDCO agenda of the 23-26 June 2020 meeting
24/06/2020 Withdrawn application: Rituximab Mabion, rituximab, Date of withdrawal: 16/03/2020, Initial authorisation
24/06/2020 Withdrawn application: Rituximab Mabion, rituximab, Date of withdrawal: 16/03/2020, Initial authorisation
24/06/2020 Human medicines European public assessment report (EPAR): Avastin, bevacizumab, Carcinoma, Non-Small-Cell Lung, Breast Neoplasms, Ovarian Neoplasms, Colorectal Neoplasms, Carcinoma, Renal Cell, 12/01/2005, 55, Authorised
24/06/2020 Committee for Medicinal Products for Human Use (CHMP): 28-30 April 2020 , European Medicines Agency, Amsterdam, the Netherlands, from 28/04/2020 to 30/04/2020
24/06/2020 Human medicines European public assessment report (EPAR): Bemrist Breezhaler, indacaterol, Mometasone furoate, Asthma, 30/05/2020, Authorised
24/06/2020 Minutes: Minutes of the CHMP meeting 28-30 April 2020
24/06/2020 Human medicines European public assessment report (EPAR): Elaprase, idursulfase, Mucopolysaccharidosis II, 08/01/2007, Additional monitoring, Exceptional circumstances, 20, Authorised
24/06/2020 Human medicines European public assessment report (EPAR): Lamivudine Teva, lamivudine, Hepatitis B, Chronic, 23/10/2009, Generic, 9, Authorised
24/06/2020 Human medicines European public assessment report (EPAR): Deferasirox Mylan, deferasirox, Iron Overload, beta-Thalassemia, 26/09/2019, Generic, Authorised
24/06/2020 Recommendations on medication errors
24/06/2020 Human medicines European public assessment report (EPAR): Galafold, migalastat hydrochloride, Fabry Disease, 25/05/2016, Orphan, Additional monitoring, 10, Authorised
24/06/2020 News and press releases: Global regulators discuss data requirements for phase 3 trials of COVID-19 vaccines
24/06/2020 Human medicines European public assessment report (EPAR): Circadin, melatonin, Sleep Initiation and Maintenance Disorders, 29/06/2007, 31, Authorised
24/06/2020 Human medicines European public assessment report (EPAR): Pazenir, paclitaxel, Breast Neoplasms, 06/05/2019, Generic, 5, Authorised
24/06/2020 Human medicines European public assessment report (EPAR): Zoledronic acid medac, zoledronic acid monohydrate, Fractures, Bone, Cancer, 03/08/2012, Generic, 12, Authorised
24/06/2020 Human medicines European public assessment report (EPAR): Velmetia, sitagliptin, metformin hydrochloride, Diabetes Mellitus, Type 2, 16/07/2008, 27, Authorised
24/06/2020 Human medicines European public assessment report (EPAR): Aripiprazole Mylan Pharma (previously Aripiprazole Pharmathen), aripiprazole, Schizophrenia, Bipolar Disorder, 30/06/2015, Generic, 10, Authorised
23/06/2020 Human medicines European public assessment report (EPAR): Cervarix, human papillomavirus1 type 16 L1 protein, human papillomavirus type 18 L1 protein, Papillomavirus Infections, Uterine Cervical Dysplasia, Immunization, 20/09/2007, 33, Authorised
23/06/2020 Orphan designation: Ex-vivo-expanded autologous human corneal epithelium-containing stem cells for the: Corneal lesions, with associated corneal (limbal) stem cell deficiency, due to ocular burns, 07/11/2008, Positive
23/06/2020 Orphan designation: 2'-O-methyl phosphorothioate RNA oligonucleotide, 5'-m5CUGm5CUGm5CUGm5CUGm5CUGm5CUGm5CUG-3' for the: Treatment of Huntington’s disease, 12/02/2015, Positive
23/06/2020 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, 8, Authorised
23/06/2020 Veterinary medicines European public assessment report (EPAR): Comfortis, spinosad, 11/02/2011, 8, Authorised
23/06/2020 Scientific guideline: Guideline on good pharmacovigilance practices (GVP): Module VIII Addendum I - Requirements and recommendations for the submission of information on non-interventional post-authorisation safety studies (Rev. 3)
23/06/2020 Regulatory and procedural guideline: Guidelines on good pharmacovigilance practices (GVP): Introductory cover note, last updated with revision 3 of Addendum I of Module VIII on requirements and recommendations for the submission of information on non-interventional post-authorisation safety
23/06/2020 News and press releases: European regulators make recommendations drawing on lessons learnt from presence of nitrosamines in sartan medicines
23/06/2020 Overview of comments: Overview of comments received on recommendations in report on lessons learnt from presence of N-nitrosamine impurities in sartan medicines
23/06/2020 Scientific guideline: Guideline on good pharmacovigilance practices (GVP) - Module VIII Addendum I – Requirements and recommendations for the submission of information on non-interventional post-authorisation safety studies (Rev. 2)
23/06/2020 Committee meeting report: Monthly report on application procedures, guidelines and related documents for veterinary medicines: May 2020
23/06/2020 Report: Medicinal products for human use: monthly figures - May 2020
23/06/2020 Human medicines European public assessment report (EPAR): Fertavid, follitropin beta, Infertility, Hypogonadism, 19/03/2009, 12, Withdrawn
23/06/2020 Public Statement: Public statement on Fertavid: Withdrawal of the marketing authorisation in the European Union
23/06/2020 News and press releases: Academia developing medicines for rare diseases to receive free EMA scientific advice
23/06/2020 Other: Decision of the Executive Director on fee reductions for designated orphan medicinal products
23/06/2020 Academia
23/06/2020 Human medicines European public assessment report (EPAR): Atectura Breezhaler, indacaterol acetate, Mometasone furoate, Asthma, 30/05/2020, Authorised
23/06/2020 Medical devices
23/06/2020 Other: Policy 44: European Medicines Agency policy on the handling of competing interests of scientific committees’ members and experts
22/06/2020 Human medicines European public assessment report (EPAR): Irbesartan Zentiva (previously Irbesartan Winthrop), irbesartan, Hypertension, 19/01/2007, 22, Authorised
22/06/2020 News and press releases: European Commission, EMA and FDA agree new priorities to strengthen their collaboration on medicines
22/06/2020 Agenda: Agenda - CHMP agenda of the 22-25 June 2020 meeting
22/06/2020 Human medicines European public assessment report (EPAR): Maviret, glecaprevir / pibrentasvir, Hepatitis C, Chronic, 26/07/2017, Accelerated assessment, Additional monitoring, 10, Authorised
22/06/2020 Human medicines European public assessment report (EPAR): Cablivi, Caplacizumab, Purpura, Thrombotic Thrombocytopenic, 30/08/2018, Orphan, Additional monitoring, 3, Authorised
22/06/2020 Human medicines European public assessment report (EPAR): Vaxchora, vibrio cholerae, strain cvd 103-hgr, live, Cholera, 01/04/2020, Additional monitoring, 1, Authorised
19/06/2020 Human medicines European public assessment report (EPAR): Vizamyl, flutemetamol (18F), Radionuclide Imaging, Alzheimer Disease, 22/08/2014, 11, Authorised
19/06/2020 Human medicines European public assessment report (EPAR): Lamivudine Teva Pharma B.V., lamivudine, HIV Infections, 10/12/2009, Generic, 15, Authorised
19/06/2020 News and press releases: Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 16-18 June 2020
19/06/2020 Summary of opinion: Bluevac BTV8, 18/06/2020, Positive
19/06/2020 Human medicines European public assessment report (EPAR): Elebrato Ellipta, fluticasone furoate, umeclidinium bromide, vilanterol trifenatate, Pulmonary Disease, Chronic Obstructive, 15/11/2017, Additional monitoring, 6, Authorised
19/06/2020 Human medicines European public assessment report (EPAR): Alecensa, alectinib hydrochloride, Carcinoma, Non-Small-Cell Lung, 16/02/2017, Additional monitoring, 8, Authorised
19/06/2020 EPAR - All authorised presentations: Lamivudine Teva Pharma B.V. : EPAR - All Authorised presentations
18/06/2020 Other: Record of data processing activity relating to managed print and ancillary services (public)
18/06/2020 Human medicines European public assessment report (EPAR): Praluent, Alirocumab, Dyslipidemias, 23/09/2015, Additional monitoring, 14, Authorised
18/06/2020 Veterinary medicines European public assessment report (EPAR): Bravecto Plus, fluralaner, moxidectin, 08/05/2018, 4, Authorised
18/06/2020 Veterinary medicines European public assessment report (EPAR): Bravecto, fluralaner, 11/02/2014, 12, Authorised
18/06/2020 Veterinary medicines European public assessment report (EPAR): Porcilis PCV M Hyo, Porcine circovirus type 2 (PCV2) ORF2 subunit antigen, Mycoplasma hyopneumoniae J strain inactivated, 06/11/2014, 7, Authorised
18/06/2020 Periodic safety update single assessment: Methoxyflurane: List of nationally authorised medicinal products - PSUSA/00010484/201905
18/06/2020 Direct healthcare professional communication (DHPC): Myalepta (metreleptin): inconsistencies in the package leaflet , Active substance: Metreleptin, DHPC type: Quality defect, Last updated: 18/06/2020
18/06/2020 Direct healthcare professional communication (DHPC): Suboxone sublingual tablets (buprenorphine / naloxone): inaccurate Braille information on the carton for HU/CZ/SK pack, Active substance: Buprenorphine | Naloxone, DHPC type: Quality defect, Last updated: 18/06/2020
18/06/2020 News and press releases: International regulators stress value of safe and effective vaccines
17/06/2020 Withdrawn application: Fingolimod Mylan, fingolimod, Date of withdrawal: 08/05/2020, Initial authorisation
17/06/2020 Application withdrawal assessment report: Withdrawal assessment report for Fingolimod Mylan
17/06/2020 Veterinary medicines European public assessment report (EPAR): Novem, meloxicam, 02/03/2004, 12, Authorised
17/06/2020 Veterinary medicines European public assessment report (EPAR): Metacam, meloxicam, 07/01/1998, 26, Authorised
17/06/2020 Periodic safety update single assessment: Isoflurane: List of nationally authorised medicinal products - PSUSA/00001786/201910
17/06/2020 Committee for Medicinal Products for Human Use (CHMP): 23-26 March 2020 , European Medicines Agency, Amsterdam, the Netherlands, from 23/03/2020 to 26/03/2020
17/06/2020 Minutes: Minutes of the CHMP meeting 23-26 March 2020
17/06/2020 Human medicines European public assessment report (EPAR): Multaq, dronedarone, Atrial Fibrillation, 25/11/2009, 14, Authorised
17/06/2020 Agenda: Agenda - CAT agenda of the 17-19 June 2020 meeting
17/06/2020 Human medicines European public assessment report (EPAR): Refixia, Nonacog beta pegol, Hemophilia B, 02/06/2017, Additional monitoring, 1, Authorised
17/06/2020 Direct healthcare professional communication (DHPC): Ondexxya (andexanet alfa): Commercial anti-FXa activity assays are unsuitable for measuring anti-FXa activity following administration of andexanet alfa , Active substance: andexanet alfa, DHPC type: Safety signal, Last updated: 17/06/2020
17/06/2020 Human medicines European public assessment report (EPAR): Mepact, mifamurtide, Osteosarcoma, 06/03/2009, 16, Authorised
17/06/2020 Periodic safety update single assessment: Isoniazid: List of nationally authorised medicinal products - PSUSA/00001789/201911
17/06/2020 Periodic safety update single assessment: Tixocortol, chlorhexidine gluconate / tixocortol pivalate: List of nationally authorised medicinal products - PSUSA/00010333/201911
17/06/2020 Periodic safety update single assessment: Ozenoxacin: List of nationally authorised medicinal products - PSUSA/00010651/201911
17/06/2020 Human medicines European public assessment report (EPAR): Aripiprazole Zentiva, aripiprazole, Schizophrenia, Bipolar Disorder, 25/06/2015, Generic, 7, Authorised
17/06/2020 Human medicines European public assessment report (EPAR): Icandra (previously Vildagliptin / metformin hydrochloride Novartis), vildagliptin, metformin hydrochloride, Diabetes Mellitus, Type 2, 30/11/2008, 21, Authorised
17/06/2020 Referral: Methocarbamol / paracetamol-containing medicinal products , methocarbamol/paracetamol , Robaxisal compuesto, Article 31 referrals, European Commission final decision, 26/03/2020, 09/06/2020, 17/06/2020
17/06/2020 Human medicines European public assessment report (EPAR): Xelevia, sitagliptin, Diabetes Mellitus, Type 2, 21/03/2007, 29, Authorised
17/06/2020 Human medicines European public assessment report (EPAR): Miglustat Gen.Orph, miglustat, Gaucher Disease, 09/11/2017, Generic, 6, Authorised
16/06/2020 Human medicines European public assessment report (EPAR): Herzuma, trastuzumab, Stomach Neoplasms, Breast Neoplasms, 08/02/2018, Additional monitoring, Biosimilar, 8, Authorised
16/06/2020 Human medicines European public assessment report (EPAR): Mulpleo (previously Lusutrombopag Shionogi), Lusutrombopag, Thrombocytopenia, 18/02/2019, Additional monitoring, 4, Authorised
16/06/2020 Human medicines European public assessment report (EPAR): Karvea, irbesartan, Hypertension, 26/08/1997, 39, Authorised
16/06/2020 Human medicines European public assessment report (EPAR): Descovy, emtricitabine, tenofovir alafenamide, HIV Infections, 21/04/2016, Additional monitoring, 16, Authorised
16/06/2020 Periodic safety update single assessment: Felbamate: List of nationally authorised medicinal products - PSUSA/00010155/201909
16/06/2020 Human medicines European public assessment report (EPAR): Farydak, panobinostat lactate anhydrous, Multiple Myeloma, 28/08/2015, Orphan, 9, Authorised
16/06/2020 Veterinary medicines European public assessment report (EPAR): BTVPUR, bluetongue-virus serotype-1 antigen / bluetongue-virus serotype-8 antigen , 17/12/2010, 11, Authorised
16/06/2020 Human medicines European public assessment report (EPAR): Pemetrexed Lilly, pemetrexed, Carcinoma, Non-Small-Cell Lung, Mesothelioma, 14/09/2015, Generic, 5, Authorised
16/06/2020 Human medicines European public assessment report (EPAR): Isturisa, Osilodrostat phosphate, Cushing Syndrome, 09/01/2020, Orphan, Additional monitoring, 2, Authorised
16/06/2020 Human medicines European public assessment report (EPAR): Defitelio, defibrotide, Hepatic Veno-Occlusive Disease, 18/10/2013, Orphan, Additional monitoring, Exceptional circumstances, 11, Authorised
16/06/2020 Veterinary medicines European public assessment report (EPAR): Neocolipor, E. coli F6 / E. coli field strain ag f41 / Recombinant e.coli ag k88 (or f4) (ab, ac, ad) / Recombinant e.coli ag k99 (or f5), 14/04/1998, 13, Authorised
16/06/2020 Veterinary medicines European public assessment report (EPAR): Porcilis PCV ID, porcine circovirus type 2 ORF2 subunit antigen, 28/08/2015, 2, Authorised
16/06/2020 Veterinary medicines European public assessment report (EPAR): Galliprant, grapiprant, 09/01/2018, 4, Authorised
16/06/2020 EPAR - Risk-management-plan summary: Actraphane : EPAR - Risk-management-plan summary
16/06/2020 EPAR - Risk-management-plan summary: Actrapid : EPAR - Risk-management-plan summary
16/06/2020 Other: Designated Medical Event (DME) list
16/06/2020 Human medicines European public assessment report (EPAR): Olazax Disperzi, olanzapine, Schizophrenia, Bipolar Disorder, 10/12/2009, Generic, 12, Authorised
16/06/2020 Human medicines European public assessment report (EPAR): Braftovi, Encorafenib, Melanoma, 19/09/2018, Additional monitoring, 4, Authorised
16/06/2020 Human medicines European public assessment report (EPAR): Ikervis, ciclosporin, Corneal Diseases, 19/03/2015, 7, Authorised
16/06/2020 Human medicines European public assessment report (EPAR): Vimpat, lacosamide, Epilepsy, 29/08/2008, 32, Authorised
16/06/2020 Periodic safety update single assessment: Calcium salts / colecalciferol: List of nationally authorised medicinal products - PSUSA/00010386/201910
16/06/2020 Periodic safety update single assessment: Fluticasone / salmeterol: List of nationally authorised medicinal products - PSUSA/00001455/201910
16/06/2020 Periodic safety update single assessment: 1-propanol / 2-propanol / orthophenylphenol: List of nationally authorised medicinal products - PSUSA/00010406/201910
16/06/2020 Frequently asked questions
16/06/2020 Periodic safety update single assessment: Corticorelin: List of nationally authorised medicinal products - PSUSA/00000876/201910
16/06/2020 Human medicines European public assessment report (EPAR): Janumet, sitagliptin, metformin hydrochloride, Diabetes Mellitus, Type 2, 16/07/2008, 18/02/2009, 25, Authorised
16/06/2020 EPAR - Risk-management-plan summary: Protaphane : EPAR - Risk-management-plan summary
16/06/2020 EPAR - Risk-management-plan summary: Mixtard : EPAR - Risk-management-plan summary
16/06/2020 EPAR - Risk-management-plan summary: Insulatard : EPAR - Risk-management-plan summary
16/06/2020 Human medicines European public assessment report (EPAR): Yellox, bromfenac sodium sesquihydrate, Pain, Postoperative, Ophthalmologic Surgical Procedures, 18/05/2011, 9, Authorised
16/06/2020 Other: Working arrangement between EMA, Directorate-General Health and Food Safety (DG SANTE) and Department of Health Canada (Health Canada)
16/06/2020 Human medicines European public assessment report (EPAR): Ivemend, fosaprepitant, Vomiting, Cancer, 11/01/2008, 22, Authorised
16/06/2020 Human medicines European public assessment report (EPAR): Oncaspar, pegaspargase, Precursor Cell Lymphoblastic Leukemia-Lymphoma, 14/01/2016, Additional monitoring, 11, Authorised
16/06/2020 Human medicines European public assessment report (EPAR): Sancuso, granisetron, Vomiting, Cancer, 20/04/2012, 13, Authorised
16/06/2020 Canada
16/06/2020 Opinion/decision on a Paediatric investigation plan (PIP): Simponi, Golimumab, PM: decision on the application for modification of an agreed PIP, P/0065/2018
16/06/2020 Template or form: CHMP and Rapporteurs' assessment report template on Similarity rev. 06.20
16/06/2020 Periodic safety update single assessment: Timolol (systemic use): List of nationally authorised medicinal products - PSUSA/00010432/201910
16/06/2020 Management Board meeting: 11 June 2020 , European Medicines Agency, Amsterdam, the Netherlands, from 11/06/2020 to 11/06/2020
16/06/2020 Report: Summary of transfers of appropriations in budget 2020 - Issues for consideration - Management Board meeting of 11 June 2020
16/06/2020 Other: Outcome of written procedures finalised during the period from 21 February 2020 to 26 May 2020
16/06/2020 Agenda: Agenda - CVMP agenda of the 16-18 June 2020 meeting
15/06/2020 News and press releases: Global regulators work towards alignment on policy approaches and regulatory flexibility during COVID-19 – update #4
15/06/2020 Regulatory and procedural guideline: Rules for the implementation of Council Regulation (EC) No 297/95 on fees payable to the European Medicines Agency and other measures - Revised implementing rules to the Fee Regulation as of 12 June 2020
15/06/2020 Abiraterone product-specific bioequivalence guidance
15/06/2020 Scientific guideline: Draft abiraterone tablets 250 mg and 500 mg product-specific bioequivalence guidance
15/06/2020 News and press releases: Annual report 2019 published
15/06/2020 Annual reports and work programmes
15/06/2020 Annual Report: 2019 annual report of the European Medicines Agency
15/06/2020 Annual Report: Annexes - 2019 annual report of the European Medicines Agency
15/06/2020 Annual Report: Annex 10 – 2019 annual report of the European Medicines Agency – CHMP opinions on initial evaluations and extensions of therapeutic indication
15/06/2020 Human medicines European public assessment report (EPAR): Fiasp, insulin aspart, Diabetes Mellitus, 09/01/2017, Additional monitoring, 6, Authorised
15/06/2020 Scientific guideline: Levothyroxine tablets 12.5 mcg, 25 mcg, 50 mcg, 75 mcg, 100 mcg (and additional strengths) and 200 mcg product-specific bioequivalence guidance
15/06/2020 Levothyroxine product-specific bioequivalence guidance
15/06/2020 Periodic safety update single assessment: Clevidipine: List of nationally authorised medicinal products - PSUSA/00010288/201911
15/06/2020 Human medicines European public assessment report (EPAR): Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva, efavirenz, emtricitabine, tenofovir disoproxil, phosphate, HIV Infections, 17/07/2017, Generic, 5, Authorised
15/06/2020 Human medicines European public assessment report (EPAR): Zometa, zoledronic acid, zoledronic acid monohydrate, Cancer, Fractures, Bone, 20/03/2001, 33, Authorised
15/06/2020 Human medicines European public assessment report (EPAR): Mysildecard, sildenafil citrate, Hypertension, Pulmonary, 15/09/2016, Generic, 2, Authorised
15/06/2020 Agenda: Agenda - COMP agenda of the 16-18 June 2020 meeting
12/06/2020 Human medicines European public assessment report (EPAR): Aclasta, zoledronic acid, Osteoporosis, Osteitis Deformans, Osteoporosis, Postmenopausal, 15/04/2005, 27, Authorised
12/06/2020 Opinion/decision on a Paediatric investigation plan (PIP): (RS)-Bacoflen,Naltrexone HCl,D-Sorbitol (PXT3003), PM: decision on the application for modification of an agreed PIP, P/0030/2020
12/06/2020 Orphan designation: Humanised monoclonal antibody against CD38 for the treatment of plasma cell myeloma (isatuximab) for the: Treatment of plasma cell myeloma, 29/04/2014, Positive
12/06/2020 Human medicines European public assessment report (EPAR): Sarclisa, Isatuximab, Multiple Myeloma, 30/05/2020, Additional monitoring, Authorised
12/06/2020 Opinion/decision on a Paediatric investigation plan (PIP): Cannabidiol, PM: decision on the application for modification of an agreed PIP, P/0047/2020
12/06/2020 Opinion/decision on a Paediatric investigation plan (PIP): Vamorolone, PM: decision on the application for modification of an agreed PIP, P/0032/2020
12/06/2020 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/0037/2037
12/06/2020 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), PM: decision on the application for modification of an agreed PIP, P/0064/2020
12/06/2020 Opinion/decision on a Paediatric investigation plan (PIP): Trelegy Ellipta, fluticasone furoate,umeclidinium bromide,vilanterol trifenatate, RPM: decision refers to a refusal on the application for modification of an agreed PIP, P/0058/2020
12/06/2020 Opinion/decision on a Paediatric investigation plan (PIP): Vosoritide (BMN 111), PM: decision on the application for modification of an agreed PIP, P/0060/2020
12/06/2020 Opinion/decision on a Paediatric investigation plan (PIP): Opdivo, nivolumab, PM: decision on the application for modification of an agreed PIP, P/0026/2020
12/06/2020 Opinion/decision on a Paediatric investigation plan (PIP): avapritinib, PM: decision on the application for modification of an agreed PIP, P/0007/2020
12/06/2020 Other: Mandate of the European Innovation Network
12/06/2020 Other: European Medicines Agency’s privacy statement for electronic newsletters
12/06/2020 Opinion/decision on a Paediatric investigation plan (PIP): Lumasiran (ALN-GO1), PM: decision on the application for modification of an agreed PIP, P/0004/2020
12/06/2020 Opinion/decision on a Paediatric investigation plan (PIP): Vosevi, Sofosbuvir,velpatasvir,voxilaprevi, PM: decision on the application for modification of an agreed PIP, P/0006/2020
12/06/2020 Opinion/decision on a Paediatric investigation plan (PIP): Autologous CD34+ haematopoietic stem cells transduced with lentiviral vector encoding the human βA-T87Q-globin gene, PM: decision on the application for modification of an agreed PIP, P/0020/2020
12/06/2020 Opinion/decision on a Paediatric investigation plan (PIP): tezepelumab, PM: decision on the application for modification of an agreed PIP, P/0012/2020
12/06/2020 Opinion/decision on a Paediatric investigation plan (PIP): Abrocitinib, PM: decision on the application for modification of an agreed PIP, P/0023/2020
12/06/2020 News and press releases: Highlights of Management Board: June 2020 meeting
12/06/2020 Opinion/decision on a Paediatric investigation plan (PIP): Ozanimod, PM: decision on the application for modification of an agreed PIP, P/0008/2020
12/06/2020 Report: Report on veterinary medicinal products regarding good pharmacovigilance practice
12/06/2020 Report: Report on veterinary medicinal products regarding the pharmacovigilance system master file
12/06/2020 Opinion/decision on a Paediatric investigation plan (PIP): Vemlidy, Tenofovir alafenamide (as fumarate), PM: decision on the application for modification of an agreed PIP, P/0063/2020
12/06/2020 Opinion/decision on a Paediatric investigation plan (PIP): Dengvaxia, Live, attenuated, chimeric dengue virus, serotype 1,Live, attenuated, chimeric dengue virus, serotype 2,live, attenuated, chimeric dengue virus, serotype 3,Live, attenuated, chimeric dengue virus, serotype 4, PM: decision on the application for modification of an agreed PIP, P/0065/2020
12/06/2020 Opinion/decision on a Paediatric investigation plan (PIP): Luspatercept, PM: decision on the application for modification of an agreed PIP, P/0024/2020
12/06/2020 Opinion/decision on a Paediatric investigation plan (PIP): Dupixent, dupilumab, PM: decision on the application for modification of an agreed PIP, P/0011/2020
12/06/2020 Opinion/decision on a Paediatric investigation plan (PIP): Besponsa, inotuzumab ozogamicin, PM: decision on the application for modification of an agreed PIP, P/0062/2020
12/06/2020 Opinion/decision on a Paediatric investigation plan (PIP): Opdivo, nivolumab, PM: decision on the application for modification of an agreed PIP, P/0027/2020
12/06/2020 News and press releases: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 8-11 June 2020
12/06/2020 Opinion/decision on a Paediatric investigation plan (PIP): daclizumab, PM: decision on the application for modification of an agreed PIP, P/0005/2020
12/06/2020 Opinion/decision on a Paediatric investigation plan (PIP): Tolvaptan, PM: decision on the application for modification of an agreed PIP, P/0002/2020
12/06/2020 Human medicines European public assessment report (EPAR): Velcade, bortezomib, Multiple Myeloma, 26/04/2004, 43, Authorised
12/06/2020 Human medicines European public assessment report (EPAR): Emgality, Galcanezumab, Migraine Disorders, 14/11/2018, Additional monitoring, 5, Authorised
12/06/2020 Opinion/decision on a Paediatric investigation plan (PIP): Ciprofloxacin (hydrochloride), PM: decision on the application for modification of an agreed PIP, P/0253/2018
12/06/2020 Human medicines European public assessment report (EPAR): Lyrica, pregabalin, Epilepsy, Anxiety Disorders, Neuralgia, 05/07/2004, 45, Authorised
12/06/2020 Human medicines European public assessment report (EPAR): Evicel, human fibrinogen, human thrombin, Hemostasis, Surgical, 05/10/2008, 15, Authorised
12/06/2020 Human medicines European public assessment report (EPAR): Brineura, cerliponase alfa, Neuronal Ceroid-Lipofuscinoses, 30/05/2017, Orphan, Accelerated assessment, Additional monitoring, Exceptional circumstances, 4, Authorised
11/06/2020 Veterinary medicines European public assessment report (EPAR): Dexdomitor, dexmedetomidine hydrochloride, 30/08/2002, 19, Authorised
11/06/2020 Human medicines European public assessment report (EPAR): Simbrinza, brinzolamide, brimonidine tartrate, Ocular Hypertension, Glaucoma, Open-Angle, 18/07/2014, 7, Authorised
11/06/2020 Opinion/decision on a Paediatric investigation plan (PIP): Akynzeo, Fosnetupitant,Palonosetron, PM: decision on the application for modification of an agreed PIP, P/0025/2020
11/06/2020 Opinion/decision on a Paediatric investigation plan (PIP): Lenvima, Lenvatinib, PM: decision on the application for modification of an agreed PIP, P/0033/2020
11/06/2020 Opinion/decision on a Paediatric investigation plan (PIP): Idelvion, albutrepenonacog alfa, PM: decision on the application for modification of an agreed PIP, P/0031/2020
11/06/2020 Opinion/decision on a Paediatric investigation plan (PIP): Human-cell-line recombinant human factor VIII (human-cl rhFVIII),Human Coagulation Factor VIII (rDNA), PM: decision on the application for modification of an agreed PIP, P/0014/2020
11/06/2020 Opinion/decision on a Paediatric investigation plan (PIP): Lonquex, lipegfilgrastim, PM: decision on the application for modification of an agreed PIP, P/0034/2020
11/06/2020 Opinion/decision on a Paediatric investigation plan (PIP): bupivacaine, PM: decision on the application for modification of an agreed PIP, P/0036/2020
11/06/2020 Opinion/decision on a Paediatric investigation plan (PIP): Lixiana, Edoxaban (tosylate), PM: decision on the application for modification of an agreed PIP, P/0013/2020
11/06/2020 Opinion/decision on a Paediatric investigation plan (PIP): Bydureon, exenatide, PM: decision on the application for modification of an agreed PIP, P/0017/2020
11/06/2020 Report: Applications for new human medicines under evaluation by the CHMP: June 2020
11/06/2020 Opinion/decision on a Paediatric investigation plan (PIP): Benlysta, belimumab, PM: decision on the application for modification of an agreed PIP, P/0003/2020
11/06/2020 Opinion/decision on a Paediatric investigation plan (PIP): Aclasta, zoledronic acid, PM: decision on the application for modification of an agreed PIP, P/0028/2020