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Date Content
31/07/2020 Mosquirix H-W-2300 (updated)
31/07/2020 Human medicines European public assessment report (EPAR): Shingrix, Varicella Zoster Virus glycoprotein E antigen, Herpes Zoster, 21/03/2018, Additional monitoring, 4, Authorised (updated)
31/07/2020 Human medicines European public assessment report (EPAR): Olazax, olanzapine, Schizophrenia, Bipolar Disorder, 11/12/2009, Generic, 12, Authorised (updated)
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 (updated)
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 (updated)
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 (updated)
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 (updated)
31/07/2020 COVID-19: What's new (updated)
31/07/2020 Treatments and vaccines for COVID-19 (updated)
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 (updated)
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 (updated)
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 (updated)
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 (updated)
31/07/2020 Human medicines European public assessment report (EPAR): Zurampic, lesinurad, Hyperuricemia, 18/02/2016, Additional monitoring, 4, Withdrawn (updated)
31/07/2020 Human medicines European public assessment report (EPAR): Cimzia, Certolizumab pegol, Arthritis, Rheumatoid, 01/10/2009, 28, Authorised (updated)
31/07/2020 Umbipro H-W-3799 (updated)
31/07/2020 Human medicines European public assessment report (EPAR): Vitrakvi, larotrectinib sulfate, Abdominal Neoplasms, 19/09/2019, Additional monitoring, Conditional approval, 1, Authorised (updated)
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 (updated)
31/07/2020 Human medicines European public assessment report (EPAR): Tagrisso, osimertinib mesylate, Carcinoma, Non-Small-Cell Lung, 01/02/2016, Accelerated assessment, Additional monitoring, 11, Authorised (updated)
31/07/2020 Administration and Corporate Management (updated)
31/07/2020 Advisory functions (updated)
31/07/2020 Other: Organisation chart: Administration and Corporate Management (updated)
31/07/2020 Other: Organisation chart: Advisory functions (updated)
31/07/2020 Veterinary medicines European public assessment report (EPAR): Rabitec, attenuated live rabies vaccine virus, strain SPBN GASGAS, 01/12/2017, 2, Authorised (updated)
31/07/2020 Joint Audit Programme (updated)
31/07/2020 Human medicines European public assessment report (EPAR): Instanyl, Fentanyl citrate, Pain, Cancer, 20/07/2009, 25, Authorised (updated)
31/07/2020 Human medicines European public assessment report (EPAR): Translarna, Ataluren, Muscular Dystrophy, Duchenne, 31/07/2014, Orphan, Additional monitoring, Conditional approval, 17, Authorised (updated)
31/07/2020 Other: Summary on compassionate use for Remdesivir Gilead (updated)
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 (updated)
31/07/2020 Human medicines European public assessment report (EPAR): Picato, Ingenol mebutate, Keratosis, Actinic, 15/11/2012, Patient safety, Additional monitoring, 10, Withdrawn (updated)
31/07/2020 International Coalition of Medicines Regulatory Authorities (ICMRA) (updated)
31/07/2020 Herbal medicinal product: Sabalis serrulatae fructus, Sabalis serrulatae fructus, C: ongoing call for scientific data (updated)
31/07/2020 News and press releases: Global regulatory workshop on COVID-19 real-world evidence and observational studies
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 Herbal - Call for data: Call for scientific data for the periodic review of the monograph on Serenoa repens (Bartram) Small (Sabal serrulata (Michaux) Nichols) (new)
31/07/2020 Herbal medicinal product: Herniariae herba, Herniariae herba, F: Assessment finalised (updated)
31/07/2020 Human medicines European public assessment report (EPAR): Ecalta, anidulafungin, Candidiasis, 20/09/2007, 22, Authorised (updated)
31/07/2020 Human medicines European public assessment report (EPAR): Nimenrix, Neisseria meningitidis serogroup A polysaccharide conjugated to tetanus toxoid, Neisseria meningitidis serogroup C polysaccharide conjugated to tetanus toxoid / Neisseria meningitidis serogroup W-135 polysaccharide conjugated to tetanus toxoid, Neisseria meningitidis serogroup Y polysaccharide conjugated to tetanus toxoid, Meningitis, Meningococcal, 20/04/2012, 30, Authorised (updated)
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 (updated)
30/07/2020 Human medicines European public assessment report (EPAR): Teysuno, tegafur, gimeracil, oteracil, Stomach Neoplasms, 14/03/2011, Patient safety, 18, Authorised (updated)
30/07/2020 Human medicines European public assessment report (EPAR): Nitisinone MDK (previously Nitisinone MendeliKABS), nitisinone, Tyrosinemias, 24/08/2017, Generic, 4, Authorised (updated)
30/07/2020 Human medicines European public assessment report (EPAR): Piqray, Alpelisib, Breast Neoplasms, 27/07/2020, Additional monitoring, Authorised
30/07/2020 Herbal medicinal product: Filipendulae ulmariae herba, Filipendulae ulmariae herba, F: Assessment finalised (updated)
30/07/2020 Herbal medicinal product: Filipendulae ulmariae flos, Filipendulae ulmariae flos, F: Assessment finalised (updated)
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 Scientific publications (updated)
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 (updated)
30/07/2020 Human medicines European public assessment report (EPAR): Nordimet, Methotrexate, Arthritis, Psoriatic, Psoriasis, Arthritis, Juvenile Rheumatoid, Arthritis, Rheumatoid, 18/08/2016, 11, Authorised (updated)
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 (updated)
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 (updated)
29/07/2020 Human medicines European public assessment report (EPAR): Benlysta, belimumab, Lupus Erythematosus, Systemic, 13/07/2011, Additional monitoring, 22, Authorised (updated)
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 (updated)
29/07/2020 Human medicines European public assessment report (EPAR): Tybost, cobicistat on silicon dioxide, HIV Infections, 19/09/2013, 13, Authorised (updated)
29/07/2020 Other: List of European Union reference dates and frequency of submission of periodic safety update reports (updated)
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 (updated)
29/07/2020 Human medicines European public assessment report (EPAR): Kyprolis, carfilzomib, Multiple Myeloma, 19/11/2015, Orphan, Accelerated assessment, Additional monitoring, 17, Authorised (updated)
29/07/2020 Human medicines European public assessment report (EPAR): Neofordex, dexamethasone, Multiple Myeloma, 16/03/2016, 8, Authorised (updated)
29/07/2020 Template or form: Template for a public statement when no Community herbal monograph is established (updated)
29/07/2020 Template or form: Template for a public statement when no European Union herbal monograph is established (updated)
29/07/2020 Template or form: Template for a European Union list entry (updated)
29/07/2020 Template or form: Template for a European Union list entry (updated)
29/07/2020 Template or form: Template for submission of comments on draft European Union herbal monograph or draft European Union list entry (updated)
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 Medicines under additional monitoring: List of medicinal products under additional monitoring (updated)
29/07/2020 Medicines under additional monitoring: List of medicinal products under additional monitoring (updated)
29/07/2020 List of medicines under additional monitoring (updated)
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 Human medicines European public assessment report (EPAR): Ajovy, fremanezumab, Migraine Disorders, 28/03/2019, Additional monitoring, 3, Authorised (updated)
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 (updated)
29/07/2020 Human medicines European public assessment report (EPAR): Perjeta, pertuzumab, Breast Neoplasms, 04/03/2013, 19, Authorised (updated)
29/07/2020 Referral: Varilrix , live attenuated varicella virus (OKA strain) , Article 30 referrals, Under evaluation, 29/07/2020 (updated)
29/07/2020 Orphan designation: (6aR,10aR)-3-(1,1-dimethylheptyl)-delta8-tetrahydro-cannabinol-9-carboxylic acid for the: Treatment of dermatomyositis, Positive (updated)
29/07/2020 Regulatory and procedural guideline: Pharmacovigilance regulatory recommendations for centrally authorised veterinary medicinal products during 2020 (updated)
28/07/2020 Periodic safety update single assessment: Methylphenidate: List of nationally authorised medicinal products - PSUSA/00002024/201910 (new)
28/07/2020 Herbal medicinal product: Sennae fructus, Sennae fructus, F: Assessment finalised (updated)
28/07/2020 Human medicines European public assessment report (EPAR): Celsentri, maraviroc, HIV Infections, 18/09/2007, 25, Authorised (updated)
28/07/2020 Herbal medicinal product: Rhamni purshianae cortex, Rhamni purshianae cortex, F: Assessment finalised (updated)
28/07/2020 Human medicines European public assessment report (EPAR): Ziagen, abacavir, HIV Infections, 08/07/1999, 41, Authorised (updated)
28/07/2020 Regulatory and procedural guideline: List of centrally authorised products requiring a notification of a change for update of annexes (updated)
28/07/2020 Agenda: Agenda - PDCO agenda of the 21-24 July 2020 meeting (new)
28/07/2020 Human medicines European public assessment report (EPAR): Trizivir, abacavir (as sulfate), lamivudine, zidovudine, HIV Infections, 27/12/2000, 35, Authorised (updated)
28/07/2020 Human medicines European public assessment report (EPAR): Suboxone, buprenorphine, naloxone, Opioid-Related Disorders, 26/09/2006, 16, Authorised (updated)
28/07/2020 Report: List of products granted eligibility to PRIME (updated)
28/07/2020 Annex to CHMP highlights: Recommendations on eligibility to PRIME scheme - Adopted at the CHMP meeting of 20-23 July 2020 (new)
28/07/2020 Human medicines European public assessment report (EPAR): Ofev, nintedanib, Idiopathic Pulmonary Fibrosis, 14/01/2015, Accelerated assessment, 14, Authorised (updated)
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 (updated)
28/07/2020 Minutes: Minutes of the PRAC meeting 10-13 February 2020 (new)
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 Herbal medicinal product: Rhei radix, Rhei radix, F: Assessment finalised (updated)
28/07/2020 Human medicines European public assessment report (EPAR): Zejula, Niraparib (tosylate monohydrate), Fallopian Tube Neoplasms, Peritoneal Neoplasms, Ovarian Neoplasms, 16/11/2017, Orphan, Additional monitoring, 9, Authorised (updated)
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 (updated)
28/07/2020 Human medicines European public assessment report (EPAR): Enbrel, etanercept, Spondylitis, Ankylosing, Arthritis, Juvenile Rheumatoid, Arthritis, Psoriatic, Psoriasis, Arthritis, Rheumatoid, 02/02/2000, 61, Authorised (updated)
28/07/2020 Human medicines European public assessment report (EPAR): Lynparza, Olaparib, Ovarian Neoplasms, 16/12/2014, 10, Authorised (updated)
28/07/2020 Human medicines European public assessment report (EPAR): Sivextro, tedizolid phosphate, Soft Tissue Infections, Skin Diseases, Bacterial, 23/03/2015, 12, Authorised (updated)
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 (updated)
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
28/07/2020 Human medicines European public assessment report (EPAR): Pioglitazone Teva, pioglitazone hydrochloride, Diabetes Mellitus, Type 2, 26/03/2012, Generic, 10, Authorised (updated)
28/07/2020 Human medicines European public assessment report (EPAR): Zercepac, trastuzumab, Breast Neoplasms, Stomach Neoplasms, 27/07/2020, Additional monitoring, Biosimilar, Authorised
28/07/2020 Summary of opinion: Arikayce liposomal, amikacin, 23/07/2020, Positive (updated)
27/07/2020 Guidance for medicine developers and companies on COVID-19 (updated)
27/07/2020 Human medicines European public assessment report (EPAR): Lyumjev (previously Liumjev), insulin lispro, Diabetes Mellitus, 24/03/2020, Additional monitoring, 1, Authorised (updated)
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 (new)
27/07/2020 Periodic safety update single assessment: Opium: List of nationally authorised medicinal products - PSUSA/00010670/201909 (new)
27/07/2020 Withdrawn application: Doxorubicin Hydrochloride Tillomed, doxorubicin, Date of withdrawal: 02/03/2020, Initial authorisation (updated)
27/07/2020 Human medicines European public assessment report (EPAR): Puregon, follitropin beta, Infertility, Hypogonadism, 02/05/1996, 28, Authorised (updated)
27/07/2020 Human medicines European public assessment report (EPAR): Prevymis, Letermovir, Cytomegalovirus Infections, 08/01/2018, Orphan, Additional monitoring, 7, Authorised (updated)
27/07/2020 Referral: Picato , ingenol mebutate , Article 20 procedures, European Commission final decision, 30/04/2020, 02/07/2020, 27/07/2020 (updated)
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 (new)
27/07/2020 Human medicines European public assessment report (EPAR): Halimatoz, adalimumab, Hidradenitis Suppurativa, Psoriasis, Arthritis, Juvenile Rheumatoid, Uveitis, Arthritis, Rheumatoid, Spondylitis, Ankylosing, Arthritis, Psoriatic, 26/07/2018, Additional monitoring, Biosimilar, 7, Authorised (updated)
27/07/2020 Human medicines European public assessment report (EPAR): Aripiprazole Accord, aripiprazole, Schizophrenia, Bipolar Disorder, 15/11/2015, Generic, 10, Authorised (updated)
27/07/2020 Human medicines European public assessment report (EPAR): Resolor, Prucalopride succinate, Constipation, 14/10/2009, 24, Authorised (updated)
27/07/2020 Human medicines European public assessment report (EPAR): Kyntheum, brodalumab, Psoriasis, 17/07/2017, Additional monitoring, 4, Authorised (updated)
27/07/2020 Human medicines European public assessment report (EPAR): Duloxetine Lilly, duloxetine, Neuralgia, Diabetic Neuropathies, Depressive Disorder, Major, 08/12/2014, 7, Authorised (updated)
27/07/2020 Committee meeting report: Monthly report on application procedures, guidelines and related documents for veterinary medicines: June 2020 (new)
27/07/2020 EPAR - Public assessment report: Rybelsus : EPAR - Public assessment report (updated)
27/07/2020 Committee meeting report: CAT monthly report of application procedures, guidelines and related documents on advanced therapies: July 2020 (new)
27/07/2020 Agenda: Agenda - CHMP agenda of the 20-23 July 2020 meeting (updated)
27/07/2020 Human medicines European public assessment report (EPAR): Namuscla, mexiletine hcl, Myotonic Disorders, 18/12/2018, Orphan, 3, Authorised (updated)
27/07/2020 Human medicines European public assessment report (EPAR): Alunbrig, brigatinib, Carcinoma, Non-Small-Cell Lung, 22/11/2018, Additional monitoring, 3, Authorised (updated)
27/07/2020 Human medicines European public assessment report (EPAR): Odefsey, emtricitabine, rilpivirine hydrochloride, tenofovir alafenamide, HIV Infections, 21/06/2016, Additional monitoring, 16, Authorised (updated)
24/07/2020 Human medicines European public assessment report (EPAR): Nepexto, etanercept, Arthritis, Rheumatoid, Arthritis, Juvenile Rheumatoid, Arthritis, Psoriatic, Spondylarthropathies, Spondylitis, Ankylosing, Psoriasis, 20/05/2020, Additional monitoring, Biosimilar, 1, Authorised (updated)
24/07/2020 Human medicines European public assessment report (EPAR): Yentreve, duloxetine hydrochloride, Urinary Incontinence, Stress, 11/08/2004, 26, Authorised (updated)
24/07/2020 Herbal medicinal product: Menthae piperitae folium, Menthae piperitae folium, F: Assessment finalised (updated)
24/07/2020 Human medicines European public assessment report (EPAR): Firmagon, degarelix, Prostatic Neoplasms, 17/02/2009, 15, Authorised (updated)
24/07/2020 Herbal medicinal product: Menthae piperitae aetheroleum, Menthae piperitae aetheroleum, F: Assessment finalised (updated)
24/07/2020 Herbal medicinal product: Hippocastani semen, Hippocastani semen, F: Assessment finalised (updated)
24/07/2020 Other: HMPC: overview of assessment work - priority list (updated)
24/07/2020 Minutes: Minutes of the CAT meeting 17-19 June 2020 (new)
24/07/2020 Q&A: Good clinical practice (GCP) (updated)
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 Summary of opinion: Gamifant, emapalumab, 23/07/2020, Negative
24/07/2020 Referral: Yondelis , trabectedin , Article 20 procedures, Opinion provided by Committee for Medicinal Products for Human Use, 24/07/2020, 24/07/2020 (updated)
24/07/2020 Referral: Panexcell , Article 31 referrals, Opinion provided by Committee for Medicinal Products for Human Use, 27/02/2020, 24/07/2020 (updated)
24/07/2020 Summary of opinion: Adakveo, crizanlizumab, 23/07/2020, Positive
24/07/2020 Summary of opinion: Ayvakyt, avapritinib, 23/07/2020, Positive
24/07/2020 Summary of opinion: NovoThirteen, catridecacog, 23/07/2020, Positive
24/07/2020 Summary of opinion: Latuda, lurasidone, 23/07/2020, Positive
24/07/2020 Summary of opinion: Blenrep, belantamab mafodotin, 23/07/2020, Positive
24/07/2020 Summary of opinion: Equidacent, bevacizumab, 23/07/2020, Positive
24/07/2020 Summary of opinion: Fampridine Accord, fampridine, 23/07/2020, Positive
24/07/2020 Summary of opinion: Arsenic trioxide medac, arsenic trioxide, 23/07/2020, Positive
24/07/2020 Summary of opinion: Fortacin, lidocaine / prilocaine, 23/07/2020, Positive
24/07/2020 Summary of opinion: Zynrelef, bupivacaine / meloxicam, 23/07/2020, Positive
24/07/2020 Summary of opinion: Jyseleca, filgotinib, 23/07/2020, Positive
24/07/2020 Summary of opinion: Reyataz, atazanavir sulphate, 23/07/2020, Positive
24/07/2020 Summary of opinion: Shingrix, herpes zoster vaccine (recombinant, adjuvanted), 23/07/2020, Positive
24/07/2020 Summary of opinion: Crysvita, burosumab, 23/07/2020, Positive
24/07/2020 Withdrawn application: Rayoqta, abicipar pegol, Date of withdrawal: 17/07/2020, Initial authorisation
24/07/2020 News and press releases: Authorised uses of cancer medicine Yondelis unchanged following review of new data
24/07/2020 Summary of opinion: Kalydeco, ivacaftor, 23/07/2020, Positive
24/07/2020 Dapivirine Vaginal Ring 25 mg H-W-2168
24/07/2020 News and press releases: EMA starts review of dexamethasone for treating adults with COVID-19 requiring respiratory support
24/07/2020 News and press releases: Panexcell Clinical Laboratories: suspension of medicines over flawed studies
24/07/2020 Summary of opinion: Calquence, acalabrutinib, 23/07/2020, Positive
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 Summary of opinion: Imfinzi, durvalumab, 23/07/2020, Positive
24/07/2020 Summary of opinion: Prezista, darunavir, 23/07/2020, Positive
24/07/2020 Summary of opinion: HyQvia, human normal immunoglobulin, 23/07/2020, Positive
24/07/2020 Annex to CHMP highlights: Scientific advice and protocol assistance adopted during the CHMP meeting 20-23 July 2020 (new)
24/07/2020 Summary of opinion: Elzonris, tagraxofusp, 23/07/2020, Negative
24/07/2020 News and press releases: First antibody-drug conjugate for multiple myeloma patients with limited treatment options
24/07/2020 Referral: Ibuprofen Kabi 400 mg Infusionslösung and associated names , ibuprofen , Ibuprofen Fresenius Kabi 400 mg oplossing voor infusie,Ibuprofen Fresenius Kabi 400 mg solution pour perfusion,Ibuprofen Kabi,Ibuprofen Kabi 400 mg oldatos infúzió,Ibuprofen Kabi 400 mg soluţie perfuzabilă,Ibuprofen Kabi 400 mg,Ibuprofen Kabi 400 mg raztopina za infundiranje,Ibuprofeno Kabi 400 mg solución para perfusion,Ibuprofen Kabi 400 mg Solution for Infusion, Article 29(4) referrals, Opinion provided by Committee for Medicinal Products for Human Use, 23/07/2020
24/07/2020 Leaflet: Infographic: Medicines for use outside the EU – EU-M4all (updated)
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 (new)
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 (updated)
24/07/2020 Summary of opinion: Imbruvica, ibrutinib, 23/07/2020, Positive
24/07/2020 Withdrawn application: Abilify MyCite, aripiprazole, Date of withdrawal: 17/07/2020, Initial authorisation
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 (updated)
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 (updated)
23/07/2020 Human medicines European public assessment report (EPAR): Atripla, efavirenz, emtricitabine, tenofovir disoproxil fumarate, HIV Infections, 13/12/2007, 34, Authorised (updated)
23/07/2020 Human medicines European public assessment report (EPAR): Inhixa, enoxaparin sodium, Venous Thromboembolism, 15/09/2016, Additional monitoring, Biosimilar, 16, Authorised (updated)
23/07/2020 Human medicines European public assessment report (EPAR): Sialanar, Glycopyrronium bromide, Sialorrhea, 15/09/2016, 5, Authorised (updated)
23/07/2020 Human medicines European public assessment report (EPAR): Kivexa, abacavir, lamivudine, HIV Infections, 16/12/2004, 32, Authorised (updated)
23/07/2020 Human medicines European public assessment report (EPAR): Jakavi, ruxolitinib (as phosphate), Myeloproliferative Disorders, 23/08/2012, 20, Authorised (updated)
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 (updated)
23/07/2020 Human medicines European public assessment report (EPAR): Emtriva, emtricitabine, HIV Infections, 24/10/2003, 30, Authorised (updated)
23/07/2020 Human medicines European public assessment report (EPAR): Roteas, edoxaban tosylate, Stroke, Venous Thromboembolism, 19/04/2017, Additional monitoring, 5, Authorised (updated)
23/07/2020 Procurement (updated)
23/07/2020 Minutes: Minutes of the HMPC 4-6 May 2020 meeting (new)
23/07/2020 Report: HMPC meeting report on European Union herbal monographs, guidelines and other activities - 6-8 July 2020 (new)
23/07/2020 Regulatory and procedural guideline: EudraVigilance registration manual (updated)
23/07/2020 Human medicines European public assessment report (EPAR): Lixiana, edoxaban tosylate, Stroke, Venous Thromboembolism, 19/06/2015, Additional monitoring, 11, Authorised (updated)
23/07/2020 Human medicines European public assessment report (EPAR): Zytiga, abiraterone acetate, Prostatic Neoplasms, 05/09/2011, Accelerated assessment, 22, Authorised (updated)
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
23/07/2020 Human medicines European public assessment report (EPAR): Mvabea, Recombinant Modified Vaccinia Ankara Bavarian Nordic Virus encoding the: Ebola virus Zaire (ZEBOV) Mayinga strain glycoprotein (GP); Ebola virus Sudan Gulu strain GP; Ebola virus Taï Forest strain nucleoprotein and the Marburg virus Musoke strain GP, Hemorrhagic Fever, Ebola, 01/07/2020, Additional monitoring, Exceptional circumstances, Authorised
22/07/2020 Human medicines European public assessment report (EPAR): Veklury, remdesivir, Coronavirus Infections, 03/07/2020, Additional monitoring, Conditional approval, 1, Authorised (updated)
22/07/2020 Human medicines European public assessment report (EPAR): Lacosamide Accord, lacosamide, Epilepsy, 18/09/2017, Generic, 5, Authorised (updated)
22/07/2020 Human medicines European public assessment report (EPAR): Voriconazole Accord, voriconazole, Aspergillosis, Candidiasis, Mycoses, 16/05/2013, Generic, 12, Authorised (updated)
22/07/2020 Human medicines European public assessment report (EPAR): Temozolomide Hexal, temozolomide, Glioma, Glioblastoma, 15/03/2010, Generic, 16, Authorised (updated)
22/07/2020 Human medicines European public assessment report (EPAR): Viekirax, Ombitasvir, paritaprevir, ritonavir, Hepatitis C, Chronic, 14/01/2015, Accelerated assessment, Additional monitoring, 20, Authorised (updated)
22/07/2020 Periodic safety update single assessment: Chloroquine phosphate / proguanil hydrochloride: List of nationally authorised medicinal products - PSUSA/00010207/201911 (new)
22/07/2020 Human medicines European public assessment report (EPAR): Entresto, sacubitril, valsartan, Heart Failure, 19/11/2015, 10, Authorised (updated)
22/07/2020 Veterinary medicines European public assessment report (EPAR): Easotic, hydrocortisone aceponate / miconazole nitrate, gentamicin sulphate, 19/11/2008, 8, Authorised (updated)
21/07/2020 Human medicines European public assessment report (EPAR): Leflunomide medac, leflunomide, Arthritis, Rheumatoid, 27/07/2010, Generic, 15, Authorised (updated)
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): Lenvima, lenvatinib mesylate, Thyroid Neoplasms, 28/05/2015, Accelerated assessment, Additional monitoring, 12, Authorised (updated)
21/07/2020 Human medicines European public assessment report (EPAR): Otezla, apremilast, Arthritis, Psoriatic, Psoriasis, 15/01/2015, 14, Authorised (updated)
21/07/2020 Human medicines European public assessment report (EPAR): Wakix, pitolisant, Narcolepsy, 31/03/2016, Orphan, Additional monitoring, 8, Authorised (updated)
21/07/2020 Human medicines European public assessment report (EPAR): Lemtrada, alemtuzumab, Multiple Sclerosis, 12/09/2013, Patient safety, Additional monitoring, 10, Authorised (updated)
21/07/2020 Human medicines European public assessment report (EPAR): Dafiro, amlodipine, valsartan, Hypertension, 15/01/2007, 26, Authorised (updated)
21/07/2020 Human medicines European public assessment report (EPAR): Riarify (previously CHF 5993 Chiesi Farmaceutici S.p.A.), beclometasone dipropionate anhydrous, formoterol fumarate dihydrate, glycopyrronium, Pulmonary Disease, Chronic Obstructive, 23/04/2018, 2, Authorised (updated)
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 (updated)
21/07/2020 Other: Orientation guide for patient representatives and healthcare professionals - EMA building (updated)
21/07/2020 Other: Orientation guide for industry - EMA building (updated)
21/07/2020 Other: Orientation guide for delegates - EMA building (updated)
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 (updated)
21/07/2020 Human medicines European public assessment report (EPAR): Dexmedetomidine Accord, dexmedetomidine, Premedication, 13/02/2020, Generic, 1, Authorised (updated)
21/07/2020 EPAR - Risk-management-plan summary: Pregabalin Accord : EPAR - Risk-management-plan summary (updated)
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 (updated)
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 (updated)
21/07/2020 Human medicines European public assessment report (EPAR): Brintellix, Vortioxetine, Depressive Disorder, Major, 18/12/2013, 15, Authorised (updated)
21/07/2020 EPAR - Public assessment report: Isturisa : EPAR - Public assessment report (updated)
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, Last updated: 21/07/2020
21/07/2020 Orphan designation: Marzeptacog alfa (activated) for the: Treatment of haemophilia B, 01/04/2019, Positive (updated)
21/07/2020 Veterinary medicines European public assessment report (EPAR): Arti-Cell Forte, chondrogenic induced equine allogeneic peripheral blood-derived mesenchymal stem cells, 29/03/2019, 1, Authorised (updated)
21/07/2020 Veterinary medicines European public assessment report (EPAR): Coxevac, inactivated Coxiella burnetii vaccine, strain Nine Mile, 30/09/2010, 7, Authorised (updated)
21/07/2020 Human medicines European public assessment report (EPAR): Copalia HCT, amlodipine, valsartan, hydrochlorothiazide, Hypertension, 03/11/2009, 16, Authorised (updated)
20/07/2020 Other: Privacy statement for legal entity and bank account validation (updated)
20/07/2020 Quality of water for pharmaceutical use (updated)
20/07/2020 Scientific guideline: Guideline on the quality of water for pharmaceutical use (new)
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) (new)
20/07/2020 Human medicines European public assessment report (EPAR): Exjade, deferasirox, beta-Thalassemia, Iron Overload, 28/08/2006, Additional monitoring, 45, Authorised (updated)
20/07/2020 Human medicines European public assessment report (EPAR): Pregabalin Accord, pregabalin, Anxiety Disorders, Epilepsy, 28/08/2015, Generic, 8, Authorised (updated)