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31/07/2020 Mosquirix H-W-2300
31/07/2020 Task Forces
31/07/2020 Human medicines European public assessment report (EPAR): Olazax, olanzapine, Schizophrenia, Bipolar Disorder, 11/12/2009, Generic, 12, Authorised
31/07/2020 Opinion/decision on a Paediatric investigation plan (PIP): Forxiga, dapagliflozin, PM: decision on the application for modification of an agreed PIP, P/0086/2020
31/07/2020 Opinion/decision on a Paediatric investigation plan (PIP): Viread, tenofovir disoproxil fumarate, PM: decision on the application for modification of an agreed PIP, P/0121/2020
31/07/2020 Opinion/decision on a Paediatric investigation plan (PIP): Vipidia, alogliptin, PM: decision on the application for modification of an agreed PIP, P/0078/2020
31/07/2020 Opinion/decision on a Paediatric investigation plan (PIP): Noxafil, posaconazole, PM: decision on the application for modification of an agreed PIP, P/0101/2020
31/07/2020 Referral: Leuprorelin-containing depot medicinal products , leuprorelin , Daronda,Depo-Eligard,Eligard,Eligard Depot,Eligard Mensua,Eligard Semestral,Eligard Trimestral,Elityran 1 Month Depot (Dps),Elityran 3 Month Depot (Dps),Enanton Depot Dual,Enanton Depot Set,Enantone,Enantone L.P,Enantone Lp,Enantone Monats-Depot,Ginecrin Depot,Klebrocid 3-Monats-Depot,Klebrocid Depot Zweikammerspritze,Leptoprol,Lerin,Leugon,Leuprex 3,Leuprol,Leuprolin Ratiopharm,Leuprone 1-Monatsdepot,Leuprone 3-Monatsdepot,Leuprorelin 1-Month Depot Gp-Pharm,Leuprorelin Hexal,Leuprorelin Sandoz,Leuprorelina Gp-Pharm,Leupro-Sandoz 1-Monats-Depot,Leupro-Sandoz 3-Monats-Depot,Leuprorelina Trimestral Sandoz,Leuprostin,Leuproreline Sandoz,Lucrin,Lucrin Depot,Lucrin Pds Depot,Lucrin Pds Depot 1 Maand,Lucrin Pds Depot 3 Maanden,Lucrin Pds Depot 6 Maanden,Lupron Depo,Lutrate 1 Month Depot,Lutrate 3 Month Depot,Lutrate Depo,Lutrate Depot,Lutrate Depot Trimestral,Politrate,Politrate Politrate Depot,Procren Depot,Procren Depot Pds,Procrin Mensual,Procrin Semestral,Procrin Trimestral,Prostap 3 Dcs,Prostap 6 Dcs,Prostap Sr Dcs,Prostaplant,Sixantone,Trenantone,Trenantone-Gyn,Zeulide,Елигард,Лутрат Депо, Article 31 referrals, CMDh final position, 24/06/2020, 31/07/2020
31/07/2020 Opinion/decision on a Paediatric investigation plan (PIP): Fycompa, perampanel, PM: decision on the application for modification of an agreed PIP, P/0072/2020
31/07/2020 Opinion/decision on a Paediatric investigation plan (PIP): Xgeva, denosumab, PM: decision on the application for modification of an agreed PIP, P/0102/2020
31/07/2020 Opinion/decision on a Paediatric investigation plan (PIP): Verdiperstat, W: decision granting a waiver in all age groups for all conditions or indications, P/0110/2020
31/07/2020 Opinion/decision on a Paediatric investigation plan (PIP): Eftilagimod alpha, W: decision granting a waiver in all age groups for all conditions or indications, P/0118/2020
31/07/2020 Opinion/decision on a Paediatric investigation plan (PIP): Parsaclisib, W: decision granting a waiver in all age groups for all conditions or indications, P/0067/2020
31/07/2020 Opinion/decision on a Paediatric investigation plan (PIP): Zolbetuximab, W: decision granting a waiver in all age groups for all conditions or indications, P/0090/2020
31/07/2020 Opinion/decision on a Paediatric investigation plan (PIP): Brolucizumab, W: decision granting a waiver in all age groups for all conditions or indications, P/0112/2020
31/07/2020 Opinion/decision on a Paediatric investigation plan (PIP): 6 fluoro-7-(2-fluoro-6-hydroxyphenyl)-(1M)-1-[4-methyl-2-(propan-2-yl)pyridin-3-yl]-4-[(2S)-2- methyl-4-(prop-2-enoyl)piperazin-1-yl]pyrido[2,3-d]pyrimidin-2(1H)-one, W: decision granting a waiver in all age groups for all conditions or indications, P/0091/2020
31/07/2020 EPAR - Procedural steps taken and scientific information after authorisation: Olazax : EPAR - Procedural steps taken and scientific information after authorisation
31/07/2020 Human medicines European public assessment report (EPAR): Zurampic, lesinurad, Hyperuricemia, 18/02/2016, Additional monitoring, 4, Withdrawn
31/07/2020 Umbipro H-W-3799
31/07/2020 Human medicines European public assessment report (EPAR): BiResp Spiromax, budesonide, formoterol fumarate dihydrate, Pulmonary Disease, Chronic Obstructive, Asthma, 28/04/2014, 10, Authorised
31/07/2020 Administration and Corporate Management
31/07/2020 Other: Summary on compassionate use for Remdesivir Gilead
31/07/2020 Other: Conditions of use, conditions for distribution and patients targeted and conditions for safety monitoring adressed to member states for Remdesivir Gilead available for compassionate use
31/07/2020 Human medicines European public assessment report (EPAR): Picato, Ingenol mebutate, Keratosis, Actinic, 15/11/2012, Patient safety, Additional monitoring, 10, Withdrawn
31/07/2020 News and press releases: Global regulatory workshop on COVID-19 therapeutics #2: agreement on acceptable endpoints for clinical trials
31/07/2020 News and press releases: Global regulatory workshop on COVID-19 real-world evidence and observational studies
31/07/2020 Herbal - Call for data: Call for scientific data for the periodic review of the monograph on Serenoa repens (Bartram) Small (Sabal serrulata (Michaux) Nichols)
31/07/2020 Human medicines European public assessment report (EPAR): Ecalta, anidulafungin, Candidiasis, 20/09/2007, 22, Authorised
31/07/2020 Human medicines European public assessment report (EPAR): Ecansya (previously Capecitabine Krka), capecitabine, Colonic Neoplasms, Breast Neoplasms, Colorectal Neoplasms, Stomach Neoplasms, 20/04/2012, Patient safety, Generic, 12, Authorised
30/07/2020 Human medicines European public assessment report (EPAR): Teysuno, tegafur, gimeracil, oteracil, Stomach Neoplasms, 14/03/2011, Patient safety, 18, Authorised
30/07/2020 Human medicines European public assessment report (EPAR): Nitisinone MDK (previously Nitisinone MendeliKABS), nitisinone, Tyrosinemias, 24/08/2017, Generic, 4, Authorised
30/07/2020 Herbal medicinal product: Filipendulae ulmariae herba, Filipendulae ulmariae herba, F: Assessment finalised
30/07/2020 Herbal medicinal product: Filipendulae ulmariae flos, Filipendulae ulmariae flos, F: Assessment finalised
30/07/2020 Opinion/decision on a Paediatric investigation plan (PIP): levodopa,carbidopa, W: decision granting a waiver in all age groups for all conditions or indications, P/0068/2020
30/07/2020 Opinion/decision on a Paediatric investigation plan (PIP): ( 2S )-2-[ [ 2-[ ( 4S)-4-( difluo romethyl )-2-oxo-oxazol idin-3-yl ]-5 ,6-dihydro i midazo [ 1,2- d] [ 1,4 ]benzoxazepin-9-yl]amino ]propanamide, W: decision granting a waiver in all age groups for all conditions or indications, P/0113/2020
30/07/2020 Opinion/decision on a Paediatric investigation plan (PIP): 5%-Δ9-tetrahydrocannabinol standardised Cannabis extract, W: decision granting a waiver in all age groups for all conditions or indications, P/0077/2020
30/07/2020 Opinion/decision on a Paediatric investigation plan (PIP): Recombinant anti-human CD20 and anti-human CD3 monoclonal antibody (RO7082859; CD20 CD3 TCB), P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0094/2020
30/07/2020 Human medicines European public assessment report (EPAR): Xeloda, capecitabine, Colonic Neoplasms, Breast Neoplasms, Colorectal Neoplasms, Stomach Neoplasms, 02/02/2001, Patient safety, 25, Authorised
30/07/2020 Standard Operating Procedure - SOP: Standard operating procedure for processing of requests for fee reduction falling under paragraph 1 of Article 9 of Council Regulation (EC) No 297/95
29/07/2020 Human medicines European public assessment report (EPAR): Capecitabine Teva, capecitabine, Colonic Neoplasms, Breast Neoplasms, Colorectal Neoplasms, Stomach Neoplasms, 20/04/2012, Patient safety, Generic, 13, Authorised
29/07/2020 Human medicines European public assessment report (EPAR): Harvoni, ledipasvir, Sofosbuvir, Hepatitis C, Chronic, 17/11/2014, Accelerated assessment, Additional monitoring, 21, Authorised
29/07/2020 Human medicines European public assessment report (EPAR): Tybost, cobicistat, HIV Infections, 19/09/2013, 13, Authorised
29/07/2020 Opinion/decision on a Paediatric investigation plan (PIP): Levothyroxine (sodium), W: decision granting a waiver in all age groups for all conditions or indications, P/0096/2018
29/07/2020 Template or form: Template for a public statement when no Community herbal monograph is established
29/07/2020 Template or form: Template for a public statement when no European Union herbal monograph is established
29/07/2020 Template or form: Template for a European Union list entry
29/07/2020 Template or form: Template for a European Union list entry
29/07/2020 Template or form: Template for submission of comments on draft European Union herbal monograph or draft European Union list entry
29/07/2020 Opinion/decision on a Paediatric investigation plan (PIP): Zoliflodacin, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/073/2020
29/07/2020 Opinion/decision on a Paediatric investigation plan (PIP): Efgartigimod alfa, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0097/2020
29/07/2020 Opinion/decision on a Paediatric investigation plan (PIP): Autologous CD34+enriched cells from patients with Fanconi anaemia subtype A transduced ex vivo with a lentiviral vector carrying the FANCA gene (PGK-FANCA-WPRE), P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0114/2020
29/07/2020 Opinion/decision on a Paediatric investigation plan (PIP): Soticlestat, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0115/2020
29/07/2020 Opinion/decision on a Paediatric investigation plan (PIP): cenobamate, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0120/2020
29/07/2020 Opinion/decision on a Paediatric investigation plan (PIP): Autologous CD34+ haematopoietic stem cells transduced ex vivo with a lentiviral vector encoding for the human Beta 2 Integrin/CD18 gene, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0106/2020
29/07/2020 Opinion/decision on a Paediatric investigation plan (PIP): Tris(hydroxymethyl)aminomethane trihydrate (PF-05221304-82), P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0098/2020
29/07/2020 Opinion/decision on a Paediatric investigation plan (PIP): 1-[ 4-bromo-5-[ 1-ethyl-7-( methylamino )-2-oxo-1,2-dihydro-1,6-naphthyridin-3-yl ]-2-fluorophenyl]-3-, W: decision granting a waiver in all age groups for all conditions or indications, P/0122/2020
29/07/2020 Opinion/decision on a Paediatric investigation plan (PIP): Ladarixin, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0124/2020
29/07/2020 Orphan designation: cholic acid for the: Treatment of inborn errors in primary bile acid synthesis responsive to treatment with cholic acid, 29/10/2009, Withdrawn
29/07/2020 Human medicines European public assessment report (EPAR): Perjeta, pertuzumab, Breast Neoplasms, 04/03/2013, 19, Authorised
29/07/2020 Orphan designation: (6aR,10aR)-3-(1,1-dimethylheptyl)-delta8-tetrahydro-cannabinol-9-carboxylic acid for the: Treatment of dermatomyositis, Positive
28/07/2020 Periodic safety update single assessment: Methylphenidate: List of nationally authorised medicinal products - PSUSA/00002024/201910
28/07/2020 Herbal medicinal product: Sennae fructus, Sennae fructus, F: Assessment finalised
28/07/2020 Herbal medicinal product: Rhamni purshianae cortex, Rhamni purshianae cortex, F: Assessment finalised
28/07/2020 Agenda: Agenda - PDCO agenda of the 21-24 July 2020 meeting
28/07/2020 Annex to CHMP highlights: Recommendations on eligibility to PRIME scheme - Adopted at the CHMP meeting of 20-23 July 2020
28/07/2020 Opinion/decision on a Paediatric investigation plan (PIP): Mosunetuzumab, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0108/2020
28/07/2020 Opinion/decision on a Paediatric investigation plan (PIP): Timrepigene emparvovec, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0085/2020
28/07/2020 Opinion/decision on a Paediatric investigation plan (PIP): avapritinib, W: decision granting a waiver in all age groups for all conditions or indications, P/0083/2020
28/07/2020 Opinion/decision on a Paediatric investigation plan (PIP): Gefapixant (citrate salt), W: decision granting a waiver in all age groups for all conditions or indications, P/0100/2020
28/07/2020 Opinion/decision on a Paediatric investigation plan (PIP): Rosuvastatin,Ezetimibe, W: decision granting a waiver in all age groups for all conditions or indications, P/0079/2020
28/07/2020 Opinion/decision on a Paediatric investigation plan (PIP): Darzalex, Daratumumab, W: decision granting a waiver in all age groups for all conditions or indications, P/0116/2020
28/07/2020 Herbal medicinal product: Sennae folium, Sennae folium, F: Assessment finalised
28/07/2020 Minutes: Minutes of the PRAC meeting 10-13 February 2020
28/07/2020 Opinion/decision on a Paediatric investigation plan (PIP): Allogeneic, ex vivo expanded, umbilical cord blood-derived, haematopoietic CD34+progenitor cells (CF),Allogeneic, non-expanded, umbilical cord blood-derived, haematopoietic mature myeloid and lymphoid cells (NF), P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0099/2020
28/07/2020 Opinion/decision on a Paediatric investigation plan (PIP): Nemolizumab, W: decision granting a waiver in all age groups for all conditions or indications, P/0119/2020
28/07/2020 Opinion/decision on a Paediatric investigation plan (PIP): Olumiant, baricitinib, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0070/2020
28/07/2020 Orphan designation: 4-[3-(Methylsulfonyl)phenyl]-1-propylpiperidine x HC1 (pridopidine hydrochloride) for the: Treatment of Huntington’s disease, 20/06/2005, Positive
28/07/2020 Human medicines European public assessment report (EPAR): Fetcroja, cefiderocol sulfate tosilate, Gram-Negative Bacterial Infections, 23/04/2020, Additional monitoring, 1, Authorised
28/07/2020 Opinion/decision on a Paediatric investigation plan (PIP): Doptelet, avatrombopag maleate, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0096/2020
28/07/2020 Opinion/decision on a Paediatric investigation plan (PIP): Tysabri, natalizumab, W: decision granting a waiver in all age groups for all conditions or indications, P/0123/2020
27/07/2020 Periodic safety update single assessment: Opium: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010670/201909
27/07/2020 Periodic safety update single assessment: Opium: List of nationally authorised medicinal products - PSUSA/00010670/201909
27/07/2020 Withdrawn application: Doxorubicin Hydrochloride Tillomed, doxorubicin, Date of withdrawal: 02/03/2020, Initial authorisation
27/07/2020 Annex to CHMP highlights: Overview of invented names reviewed in June 2020 by the Name Review Group (NRG) adopted at the CHMP meeting of 2-3 June 2020
27/07/2020 Human medicines European public assessment report (EPAR): Resolor, Prucalopride succinate, Constipation, 14/10/2009, 24, Authorised
27/07/2020 Human medicines European public assessment report (EPAR): Kyntheum, brodalumab, Psoriasis, 17/07/2017, Additional monitoring, 4, Authorised
27/07/2020 Committee meeting report: Monthly report on application procedures, guidelines and related documents for veterinary medicines: June 2020
27/07/2020 EPAR - Public assessment report: Rybelsus : EPAR - Public assessment report
27/07/2020 Committee meeting report: CAT monthly report of application procedures, guidelines and related documents on advanced therapies: July 2020
27/07/2020 Agenda: Agenda - CHMP agenda of the 20-23 July 2020 meeting
27/07/2020 Human medicines European public assessment report (EPAR): Namuscla, Mexiletine hydrochloride, Myotonic Disorders, 18/12/2018, Orphan, 3, Authorised
24/07/2020 Herbal medicinal product: Hippocastani semen, Hippocastani semen, F: Assessment finalised
24/07/2020 Minutes: Minutes of the CAT meeting 17-19 June 2020
24/07/2020 News and press releases: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 20-23 July 2020
24/07/2020 News and press releases: Authorised uses of cancer medicine Yondelis unchanged following review of new data
24/07/2020 News and press releases: Panexcell Clinical Laboratories: suspension of medicines over flawed studies
24/07/2020 News and press releases: Vaginal ring to reduce the risk of HIV infection for women in non-EU countries with high disease burden
24/07/2020 Annex to CHMP highlights: Scientific advice and protocol assistance adopted during the CHMP meeting 20-23 July 2020
24/07/2020 News and press releases: First antibody-drug conjugate for multiple myeloma patients with limited treatment options
24/07/2020 Leaflet: Infographic: Medicines for use outside the EU – EU-M4all
24/07/2020 Annex to CHMP highlights: Overview of invented names reviewed in June/July 2020 by the Name Review Group (NRG) adopted at the CHMP meeting of 20-23 July 2020
24/07/2020 Stem cell-based products for veterinary use: Specific question on target animal safety addressed by CVMP/ADVENT
24/07/2020 Other: Questions and answers on adverse event reporting
23/07/2020 Referral: Fluorouracil and fluorouracil related substances (capecitabine, tegafur and flucytosine) containing medicinal products , capecitabine, fluorouracil, tegafur, flucytosine , Article 31 referrals, European Commission final decision, 30/04/2020, 07/07/2020, 23/07/2020
23/07/2020 Human medicines European public assessment report (EPAR): Tygacil, Tigecycline, Bacterial Infections, Skin Diseases, Bacterial, Soft Tissue Infections, 24/04/2006, 31, Authorised
23/07/2020 Human medicines European public assessment report (EPAR): Atripla, efavirenz, emtricitabine, tenofovir disoproxil fumarate, HIV Infections, 13/12/2007, 34, Authorised
23/07/2020 Human medicines European public assessment report (EPAR): Sialanar, glycopyrronium bromide, Sialorrhea, 15/09/2016, 5, Authorised
23/07/2020 Committee meeting report: COMP meeting report on the review of applications for orphan designation: July 2020
23/07/2020 Human medicines European public assessment report (EPAR): Ibandronic acid Accord, ibandronic acid, Wounds and Injuries, Breast Diseases, Neoplastic Processes, Calcium Metabolism Disorders, Neoplasms by Site, Water-Electrolyte Imbalance, 18/11/2012, Generic, 10, Authorised
23/07/2020 Human medicines European public assessment report (EPAR): Emtriva, emtricitabine, HIV Infections, 24/10/2003, 30, Authorised
23/07/2020 Minutes: Minutes of the HMPC 4-6 May 2020 meeting
23/07/2020 Report: HMPC meeting report on European Union herbal monographs, guidelines and other activities - 6-8 July 2020
23/07/2020 Regulatory and procedural guideline: EudraVigilance registration manual
23/07/2020 Human medicines European public assessment report (EPAR): Zabdeno, Recombinant Adenovirus type 26 (Ad26) encoding the glycoprotein (GP) of the Ebola virus Zaire (ZEBOV) Mayinga strain, Hemorrhagic Fever, Ebola, 01/07/2020, Additional monitoring, Exceptional circumstances, Authorised
22/07/2020 Human medicines European public assessment report (EPAR): Lacosamide Accord, lacosamide, Epilepsy, 18/09/2017, Generic, 5, Authorised
22/07/2020 Human medicines European public assessment report (EPAR): Voriconazole Accord, voriconazole, Aspergillosis, Candidiasis, Mycoses, 16/05/2013, Generic, 12, Authorised
22/07/2020 Human medicines European public assessment report (EPAR): Temozolomide Hexal, temozolomide, Glioma, Glioblastoma, 15/03/2010, Generic, 16, Authorised
22/07/2020 Periodic safety update single assessment: Chloroquine phosphate / proguanil hydrochloride: List of nationally authorised medicinal products - PSUSA/00010207/201911
21/07/2020 Human medicines European public assessment report (EPAR): Leflunomide medac, leflunomide, Arthritis, Rheumatoid, 27/07/2010, Generic, 15, Authorised
21/07/2020 News and press releases: COVID-19: EMA sets up infrastructure for real-world monitoring of treatments and vaccines
21/07/2020 Human medicines European public assessment report (EPAR): Enerzair Breezhaler, indacaterol, glycopyrronium bromide, mometasone, Asthma, 03/07/2020, Authorised
21/07/2020 Human medicines European public assessment report (EPAR): Otezla, apremilast, Arthritis, Psoriatic, Psoriasis, 15/01/2015, 14, Authorised
21/07/2020 Human medicines European public assessment report (EPAR): Lemtrada, alemtuzumab, Multiple Sclerosis, 12/09/2013, Patient safety, Additional monitoring, 10, Authorised
21/07/2020 Human medicines European public assessment report (EPAR): Riarify (previously CHF 5993 Chiesi Farmaceutici S.p.A.), formoterol fumarate dihydrate, glycopyrronium, Beclometasone dipropionate, Pulmonary Disease, Chronic Obstructive, 23/04/2018, 2, Authorised
21/07/2020 Human medicines European public assessment report (EPAR): Pioglitazone Teva Pharma, pioglitazone hydrochloride, Diabetes Mellitus, Type 2, 26/03/2012, Generic, 11, Authorised
21/07/2020 Other: Orientation guide for industry - EMA building
21/07/2020 Other: Orientation guide for delegates - EMA building
21/07/2020 Human medicines European public assessment report (EPAR): Voncento, Human coagulation factor VIII, human von willebrand factor, Hemophilia A, von Willebrand Diseases, 12/08/2013, 14, Authorised
21/07/2020 Human medicines European public assessment report (EPAR): Dexmedetomidine Accord, dexmedetomidine, Premedication, 13/02/2020, Generic, 1, Authorised
21/07/2020 EPAR - Risk-management-plan summary: Pregabalin Accord : EPAR - Risk-management-plan summary
21/07/2020 Human medicines European public assessment report (EPAR): Trydonis, Beclometasone dipropionate, formoterol fumarate dihydrate, glycopyrronium, Pulmonary Disease, Chronic Obstructive, 26/04/2018, 2, Authorised
21/07/2020 Referral: Carbamazepin Tillomed , carbamazepin , Carbamazepin Tillomed,Carbamazepina Tillomed,Karbamazepin Tillomed,Karbamazepina Tillomed, Article 29(4) referrals, European Commission final decision, 30/04/2020, 25/06/2020, 21/07/2020
21/07/2020 Direct healthcare professional communication (DHPC): Insuman Implantable 400 IU/ml insulin solution for infusion: no new patients should be started due to discontinuation of MiniMed Implantable Pump, Active substance: insulin human, DHPC type: Type II variation, Last updated: 21/07/2020
21/07/2020 Orphan designation: Marzeptacog alfa (activated) for the: Treatment of haemophilia B, 01/04/2019, Positive
21/07/2020 Veterinary medicines European public assessment report (EPAR): Coxevac, inactivated Coxiella burnetii vaccine, strain Nine Mile, 30/09/2010, 7, Authorised
20/07/2020 Other: Privacy statement for legal entity and bank account validation
20/07/2020 Scientific guideline: Guideline on the quality of water for pharmaceutical use
20/07/2020 Overview of comments: Overview of comments received on the draft 'Guideline on the quality of water for pharmaceutical use' (EMA/CHMP/CVMP/QWP/496873/2018)
20/07/2020 Veterinary medicines European public assessment report (EPAR): Credelio, lotilaner, 23/04/2017, 5, Authorised
20/07/2020 Human medicines European public assessment report (EPAR): Glidipion (previously Pioglitazone Actavis Group), pioglitazone hydrochloride, Diabetes Mellitus, Type 2, 15/03/2012, Generic, 7, Authorised
20/07/2020 Regulatory and procedural guideline: Concept paper for the development of a reflection paper on criteria for the application of Article 40(5) of Regulation (EU) 2019/6
20/07/2020 Orphan designation: Recombinant human factor IX protein modified with three point mutations (dalcinonacog alfa) for the: Treatment of haemophilia B, 20/06/2017, Positive
20/07/2020 Procurement: Ex ante publicity of a negotiated procedure : EMA/2020/23/DED – Catering consultancy services - Corrigendum
20/07/2020 Minutes: Minutes - PDCO minutes of the 25-28 February 2020 meeting
20/07/2020 Template or form: Change of applicant checklist - pre-submission guidance (human)
17/07/2020 Regulatory and procedural guideline: Draft Union Product Database (UPD) Access Policy - Veterinary Medicinal Products - Policy no 0082
17/07/2020 News and press releases: Meeting highlights from the Committee for Medicinal Products for Veterinary Use (CVMP) 14-16 July 2020
16/07/2020 Periodic safety update single assessment: Anthrax vaccine: List of nationally authorised medicinal products - PSUSA/00010771/201912
16/07/2020 Periodic safety update single assessment: Domperidone: List of nationally authorised medicinal products - PSUSA/00001158/201911
16/07/2020 Periodic safety update single assessment: Tibole: List of nationally authorised medicinal products - PSUSA/00002947/201912
16/07/2020 Periodic safety update single assessment: Sulbactam: List of nationally authorised medicinal products - PSUSA/00002800/201911
16/07/2020 Periodic safety update single assessment: Drospirenone / estradiol: List of nationally authorised medicinal products - PSUSA/00001184/201912
16/07/2020 Periodic safety update single assessment: Dienogest:List of nationally authorised medicinal products - PSUSA/00003167/201912
16/07/2020 Periodic safety update single assessment: Apomorphine: List of nationally authorised medicinal products - PSUSA/00000227/201911
15/07/2020 Human medicines European public assessment report (EPAR): Temozolomide Accord, temozolomide, Glioma, Glioblastoma, 15/03/2010, Generic, 19, Authorised
15/07/2020 Human medicines European public assessment report (EPAR): Kolbam , cholic acid, Metabolism, Inborn Errors, 20/11/2015, Exceptional circumstances, 14, Withdrawn
15/07/2020 Human medicines European public assessment report (EPAR): Nuwiq, simoctocog alfa, Hemophilia A, 22/07/2014, 8, Authorised
15/07/2020 Human medicines European public assessment report (EPAR): NovoEight, turoctocog alfa, Hemophilia A, 13/11/2013, 12, Authorised
15/07/2020 Periodic safety update single assessment: Sumatriptan : CMDh Scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00002832/201909
15/07/2020 Periodic safety update single assessment: Sumatriptan : List of nationally authorised medicinal products - PSUSA/00002832/201909
15/07/2020 Human medicines European public assessment report (EPAR): Inovelon, Rufinamide, Epilepsy, 16/01/2007, 20, Authorised
14/07/2020 Other: Record of data processing for validation of proof of establishment when natural persons apply for orphan designation or a transfer of an orphan designation (public)
14/07/2020 Report: Medicinal products for human use: monthly figures - June 2020
14/07/2020 Regulatory and procedural guideline: Guidance notes on the use of Veterinary Dictionary for Drug Regulatory Activities (VeDDRA) terminology for reporting suspected adverse reactions in animals and humans
14/07/2020 Regulatory and procedural guideline: List of changes to combined Veterinary Dictionary for Drug Regulatory Activities (VeDDRA) list of clinical terms for reporting suspected adverse reactions in animal and humans to veterinary medicinal products
14/07/2020 Human medicines European public assessment report (EPAR): Delstrigo, Doravirine, lamivudine, tenofovir disoproxil fumarate, HIV Infections, 22/11/2018, Additional monitoring, 5, Authorised
14/07/2020 Periodic safety update single assessment: Artemether-lumefantrin (apart from the dispersible tablet): List of nationally authorised medicinal products - PSUSA/00000236/201910
14/07/2020 Periodic safety update single assessment: Artemether-lumefantrin (apart from the dispersible tablet): CMDh Scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00000236/201910
14/07/2020 Agenda: Agenda - CAT agenda of the 15-17 July 2020 meeting
14/07/2020 Agenda: Agenda - CVMP agenda of the 14-16 July 2020 meeting
13/07/2020 Human medicines European public assessment report (EPAR): Dynastat, parecoxib sodium, Pain, Postoperative, 22/03/2002, 30, Authorised
13/07/2020 Human medicines European public assessment report (EPAR): Mektovi, binimetinib, Melanoma, 20/09/2018, Additional monitoring, 3, Authorised
13/07/2020 Report: Applications for new human medicines under evaluation by the CHMP: July 2020
13/07/2020 Human medicines European public assessment report (EPAR): Kinzalkomb, telmisartan, hydrochlorothiazide, Hypertension, 19/04/2002, 36, Authorised
13/07/2020 Periodic safety update single assessment: Brotizolam: List of nationally authorised medicinal products - PSUSA/00000444/201912
13/07/2020 Periodic safety update single assessment: Human coagulation factor VIII (antihemophilic factor A): List of nationally authorised medicinal products - PSUSA/00001620/201911
13/07/2020 Periodic safety update single assessment: Cinolazepam: List of nationally authorised medicinal products - PSUSA/00000769/201912
13/07/2020 Agenda: Agenda - COMP agenda of the 14-16 July 2020 meeting
13/07/2020 Orphan designation: Humanised Fc engineered monoclonal antibody against CD19, active ingredient tafasitamab for the: Treatment of diffuse large B-cell lymphoma, 15/01/2015, Positive
13/07/2020 Periodic safety update single assessment: Flurbiprofen : List of nationally authorised medicinal products - PSUSA/00001450/201911
13/07/2020 Periodic safety update single assessment: 1-propanol / 2-propanol / lactic acid: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010414/201909
13/07/2020 Periodic safety update single assessment: 1-propanol / 2-propanol / lactic acid : List of nationally authorised medicinal products - PSUSA/000010414/201909
13/07/2020 Human medicines European public assessment report (EPAR): Hopveus, sodium oxybate, Substance Withdrawal Syndrome, Alcohol Abstinence, 06/07/2020, Refused
10/07/2020 Other: European Commission-DG Health and Food Safety and European Medicines Agency action plan on advanced therapy medicinal products (ATMPs)
10/07/2020 Human medicines European public assessment report (EPAR): Verkazia, ciclosporin, Conjunctivitis, Keratitis, 06/07/2018, Orphan, Accelerated assessment, 4, Authorised
10/07/2020 Human medicines European public assessment report (EPAR): Aripiprazole Sandoz, aripiprazole, Schizophrenia, Bipolar Disorder, 20/08/2015, Generic, 8, Authorised
10/07/2020 News and press releases: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 6-9 July 2020
10/07/2020 Marketing authorisation
10/07/2020 Other: Validation checklist for initial marketing authorisation applications – immunologicals (applicable to submissions under Art. 12(3) of Directive 2001/82)
10/07/2020 Other: Validation checklist for initial marketing authorisation applications – pharmaceuticals (applicable to submissions under Art. 12(3) of Directive 2001/82)
10/07/2020 Human medicines European public assessment report (EPAR): Temozolomide Teva, temozolomide, Glioma, Glioblastoma, 28/01/2010, Generic, 19, Authorised
10/07/2020 Human medicines European public assessment report (EPAR): MicardisPlus, telmisartan, hydrochlorothiazide, Hypertension, 19/04/2002, 29, Authorised
10/07/2020 Orphan designation: Oleylphosphocholine for the: Treatment of leishmaniasis, 23/04/2012, Positive
09/07/2020 Human medicines European public assessment report (EPAR): Olanzapine Glenmark Europe, olanzapine, Schizophrenia, Bipolar Disorder, 03/12/2009, Generic, 13, Authorised
09/07/2020 Human medicines European public assessment report (EPAR): Trazimera, trastuzumab, Stomach Neoplasms, Breast Neoplasms, 26/07/2018, Additional monitoring, Biosimilar, 6, Authorised
09/07/2020 News and press releases: International regulators align positions on phase 3 COVID-19 vaccine trials
09/07/2020 News and press releases: EMA finalises opinion on presence of nitrosamines in medicines
09/07/2020 Veterinary medicines European public assessment report (EPAR): Novaquin, meloxicam, 08/09/2015, 3, Authorised
09/07/2020 Human medicines European public assessment report (EPAR): Targretin, bexarotene, Lymphoma, T-Cell, Cutaneous, 29/03/2001, 20, Authorised
09/07/2020 Human medicines European public assessment report (EPAR): Trajenta, linagliptin, Diabetes Mellitus, Type 2, 23/08/2011, 16, Authorised
08/07/2020 Human medicines European public assessment report (EPAR): Reblozyl, Luspatercept, Anemia, Myelodysplastic Syndromes, beta-Thalassemia, 25/06/2020, Orphan, Additional monitoring, Authorised
08/07/2020 News and press releases: Workshop: safe use of medicines during pregnancy and breastfeeding
08/07/2020 Regulatory and procedural guideline: Advice on implementing measures under Article 95(8) of Regulation (EU) 2019/6 on veterinary medicinal products - Good distribution practices (GDP) for active substances used as starting materials in veterinary medicinal products
08/07/2020 Regulatory and procedural guideline: Advice on implementing measures under Article 99(6) of Regulation (EU) 2019/6 on veterinary medicinal products - Good distribution practices (GDP) for veterinary medicinal products
08/07/2020 Regulatory and procedural guideline: Advice on implementing measures under Article 57(4) of Regulation (EU) 2019/6 on veterinary medicinal products - Report on the format of the data to be collected on antimicrobial medicinal products used in animals
08/07/2020 Classifications as minor-use-minor-species and limited-market
08/07/2020 Agenda: Agenda - HMPC agenda of the 6-8 July 2020 meeting
07/07/2020 Human medicines European public assessment report (EPAR): Dafiro HCT, valsartan, hydrochlorothiazide, Amlodipine besilate, Hypertension, 03/11/2009, 19, Authorised
07/07/2020 Human medicines European public assessment report (EPAR): Cotellic, cobimetinib hemifumarate, Melanoma, 20/11/2015, 8, Authorised
07/07/2020 Human medicines European public assessment report (EPAR): Exforge HCT, valsartan, hydrochlorothiazide, Amlodipine besilate, Hypertension, 15/10/2009, 17, Authorised
07/07/2020 Human medicines European public assessment report (EPAR): Paliperidone Janssen-Cilag International, paliperidone palmitate, Schizophrenia, 18/06/2020, Authorised
07/07/2020 Orphan designation: Osilodrostat for the: Treatment of Cushing's syndrome, 15/10/2014, Positive
07/07/2020 Periodic safety update single assessment: Carbidopa / levodopa: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00000548/201910
07/07/2020 Periodic safety update single assessment: Carbidopa / levodopa: List of nationally authorised medicinal products - PSUSA/00000548/201910
07/07/2020 Periodic safety update single assessment: Levosimendan: List of nationally authorised medicinal products - PSUSA/00001858/201909
07/07/2020 Periodic safety update single assessment: Levosimendan: CMDh Scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00001858/201909
07/07/2020 Human medicines European public assessment report (EPAR): PritorPlus, telmisartan, hydrochlorothiazide, Hypertension, 22/04/2002, 35, Authorised
06/07/2020 Human medicines European public assessment report (EPAR): Nevanac, nepafenac, Pain, Postoperative, Ophthalmologic Surgical Procedures, 11/12/2007, 16, Authorised
06/07/2020 Human medicines European public assessment report (EPAR): Tavlesse, Fostamatinib disodium, Thrombocytopenia, 09/01/2020, Additional monitoring, 2, Authorised
06/07/2020 Human medicines European public assessment report (EPAR): Cayston, aztreonam lysine, Cystic Fibrosis, Respiratory Tract Infections, 21/09/2009, 18, Authorised
06/07/2020 Maximum Residue Limits - Opinion: Opinion of the CVMP on the establishment of maximum residue limits: Ketoprofen
06/07/2020 Regulatory and procedural guideline: Rules of engagement for patients’ organisations and their representatives in repurposing activities and impact on involvement in EMA activities
06/07/2020 Other: European medicines agencies network strategy to 2025: Protecting public health at a time of rapid change
06/07/2020 News and press releases: Launch of public consultation on joint network strategy to 2025
06/07/2020 Referral: Fosfomycin-containing medicinal products , fosfomycin calcium, fosfomycin disodium, fosfomycin sodium, fosfomycin trometamol , Afastural,Berny Adulti,Danifos Adulti,Fomicyt,Fosfocin,Fosfocina,Fosfocine,Fosfopharm,Fosfuro,Fosmol,Fostrofemge,Gynofostrome,Infectofos,Infeur Adulti,Interfos,Monural,Monuril,Monurol,Rapidnorm,Solufos,Symural,Uridoz,Urifos,Urinex,Urofast,Uromaste,Uroseptic, Article 31 referrals, European Commission final decision, 26/03/2020, 09/06/2020, 06/07/2020
06/07/2020 Human medicines European public assessment report (EPAR): Stribild, elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil fumarate, HIV Infections, 24/05/2013, 22, Authorised
06/07/2020 Human medicines European public assessment report (EPAR): Intuniv, guanfacine hydrochloride, Attention Deficit Disorder with Hyperactivity, 17/09/2015, Additional monitoring, 7, Authorised
06/07/2020 Agenda: Agenda - PRAC draft agenda of meeting 6-9 July 2020
06/07/2020 Human medicines European public assessment report (EPAR): Afinitor, everolimus, Carcinoma, Renal Cell, Breast Neoplasms, Pancreatic Neoplasms, 02/08/2009, 25, Authorised
06/07/2020 PRAC recommendation on signal: New product information wording: extracts from PRAC recommendations on signals adopted at the 8-11 June 2020 PRAC
06/07/2020 PRAC recommendation on signal: PRAC recommendations on signals adopted at the 8-11 June 2020 PRAC meeting
03/07/2020 Scientific guideline: Questions and answers - ICH guideline M7 on assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk - Step 2b
03/07/2020 Committee meeting report: COMP meeting report on the review of applications for orphan designation: June 2020
03/07/2020 Work programme: Work plan for the Pharmacovigilance Inspectors Working Group for 2020
03/07/2020 Newsletter: Clinical Trials Information System (CTIS) highlights - June 2020
03/07/2020 Human medicines European public assessment report (EPAR): Fingolimod Accord, fingolimod hydrochloride , Multiple Sclerosis, Relapsing-Remitting, 25/06/2020, Generic, Authorised
03/07/2020 Human medicines European public assessment report (EPAR): Zoely, Nomegestrol acetate, estradiol, Contraception, 26/07/2011, Additional monitoring, 19, Authorised
03/07/2020 Report: Annual accounts: Financial year 2019
02/07/2020 European Medicines Agency (EMA) Patients' and Consumers' (PCWP) and Healthcare Professionals' (HCPWP) Working Parties Joint - Virtual meeting , Virtual meeting, from 24/06/2020 to 24/06/2020
02/07/2020 Paediatric Committee (PDCO): 9-11 December 2019 , European Medicines Agency, Amsterdam, The Netherlands, from 09/12/2019 to 11/12/2019
02/07/2020 Agenda: Agenda - PCWP/HCPWP joint meeting on 24 June 2020
02/07/2020 Human medicines European public assessment report (EPAR): Evra, norelgestromin, ethinyl estradiol, Contraception, 21/08/2002, 21, Authorised
02/07/2020 Minutes: Minutes - PDCO minutes of the 09-11 December 2019 meeting
02/07/2020 Minutes: Minutes - PDCO minutes of the 28-31 January 2020 meeting
02/07/2020 Annual Report: Annual report of the Pharmacovigilance Inspectors Working Group for 2018
02/07/2020 Maximum Residue Limits - Report: Ketoprofen (Bovine, Porcine and Equidae): European public maximum-residue-limit assessment report (EPMAR) - CVMP
02/07/2020 Veterinary medicines European public assessment report (EPAR): Bovilis Blue-8, bluetongue virus vaccine, serotype 8 (inactivated), 21/11/2017, 3, Authorised
02/07/2020 ISO/ICH E2B(R3) Individual case safety report (ICSR) in the EU: Virtual live hands-on training course using the EudraVigilance system (7-11 Sept 2020) , Virtual meeting, from 07/09/2020 to 11/09/2020
02/07/2020 ISO/ICH E2B(R3) Individual case safety report (ICSR) in the EU: Virtual live hands-on training course using the EudraVigilance system (28 Sept - 2 Oct 2020) , Virtual meeting, from 28/09/2020 to 02/10/2020
02/07/2020 ISO/ICH E2B(R3) Individual case safety report (ICSR) in the EU: Virtual live hands-on training course using the EudraVigilance system (12-16 Oct 2020) , Virtual meeting, from 12/10/2020 to 16/10/2020