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28/06/2019 Human medicines European public assessment report (EPAR): Adasuve, loxapine, Schizophrenia, Bipolar Disorder, 20/02/2013, 12, Authorised
28/06/2019 Periodic safety update single assessment: Meningococcal group c polysaccharide conjugate vaccine: List of nationally authorised medicinal products - PSUSA/00001971/201810
28/06/2019 Orphan designation: PEGylated recombinant factor VIII (turoctocog alfa pegol) for the: Treatment of haemophilia A, 26/04/2012, Withdrawn
28/06/2019 Periodic safety update single assessment: Didanosine: List of nationally authorised medicinal products - PSUSA/00001054/201810
28/06/2019 Other: Annual list of specific contracts based on framework contracts – 2018
28/06/2019 Stem cell-based products for veterinary use: Specific questions on extraneous agents to be addressed by Ad Hoc Expert Group on Veterinary Novel Therapies (ADVENT)
28/06/2019 Opinion/decision on a Paediatric investigation plan (PIP): Complex of povidone and iodine,dexamethasone (SHP640), PM: decision on the application for modification of an agreed PIP, P/0369/2018
28/06/2019 Product-information templates
28/06/2019 Other: Annual list of contractors 2018 - contract values Euro 15,000 - 134.999
28/06/2019 Other: Annual list of contract modifications 2018
28/06/2019 PIP - Notification of discontinuation of a paediatric development which is covered by an agreed PIP decision: Complex Povidone-Iodine and Dexamethasone (SHP640) - Notification of discontinuation of a paediatric development which is covered by an agreed paediatric-investigation-plan decision
28/06/2019 Procurement activities 2018
28/06/2019 Stem cell-based products for veterinary use: specific questions on sterility to be addressed by the Ad Hoc Expert Group on Veterinary Novel Therapies (ADVENT)
28/06/2019 Orphan designation: copper meso-5,15-bis[3-[(1,2-dicarba-closo-dodecaboranyl)methoxy]phenyl]-meso-10,20-dinitroporphyrin for the: Treatment of squamous-cell carcinoma of the head and neck in patients undergoing radiotherapy, 27/06/2013, Positive
28/06/2019 Orphan designation: melatonin for the: Treatment of perinatal asphyxia, 11/01/2019, Positive
28/06/2019 Annex to CHMP highlights: Start of union reviews adopted during the CHMP meeting 24 - 27 June 2019
28/06/2019 News and press releases: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 24-27 June 2019
28/06/2019 Annex to CHMP highlights: Overview of (invented) names reviewed in May 2019 by the Name Review Group (NRG) adopted at the CHMP meeting of 24-27 June 2019
28/06/2019 News and press releases: Bacterial lysate medicines for respiratory conditions to be used only for prevention of recurrent infections
28/06/2019 Withdrawn application: ABP 710, infliximab, Date of withdrawal: 27/05/2019, Initial authorisation
28/06/2019 Veterinary medicines European public assessment report (EPAR): Ingelvac PCV FLEX, porcine circovirus type 2 ORF2 protein, 24/05/2017, 2, Withdrawn
28/06/2019 Other: Member states contact points for review of national versions of the content of mobile scanning and other technologies
28/06/2019 News and press releases: New treatment for children with type 2 diabetes
28/06/2019 Template or form: QRD product-information annotated template (English) version 10.1
28/06/2019 Template or form: QRD annex related to the Article-127a template
28/06/2019 Other: List of official languages per country
28/06/2019 Template or form: QRD product-information annotated template (English) version 10.1 - highlighted
28/06/2019 Regulatory and procedural guideline: Appendix IV - Terms and abbreviations for batch number and expiry date to be used on the labelling of human medicinal products
28/06/2019 Template or form: PSUSA nationally authorised products template
28/06/2019 Template or form: QRD PSUR annex IV template
28/06/2019 Template or form: QRD annex A template
28/06/2019 Template or form: QRD annex IV conditional positive template
28/06/2019 Template or form: QRD annex IV exceptional circumstances positive template
27/06/2019 News and press releases: One additional country to benefit from EU-US mutual recognition agreement for inspections
27/06/2019 Agenda: Agenda - Enpr-EMA Coordinating Group and networks meeting on 19 February 2019
27/06/2019 Minutes: Minutes of the Enpr-EMA Coordinating Group and networks meeting on 19 February 2019
27/06/2019 European network of paediatric research at the European Medicines Agency (Enpr-EMA) Coordinating Group and networks meeting , European Medicines Agency via Adobe Connect, from 19/02/2019 to 19/02/2019
27/06/2019 Opinion/decision on a Paediatric investigation plan (PIP): 5-(4-Fluoro-1-benzothiophen-2-yl)-8-methyl-1,9-dihydro-2H-[1,3]oxazolo[4,5-H][2,3]benzodiazepin-2-one (S44819), P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0286/2017
27/06/2019 Referral: Closantel , closantel , Article 35, European Commission final decision, 21/02/2019, 20/05/2019
27/06/2019 Opinion/decision on a Paediatric investigation plan (PIP): Dexxience, Betrixaban, PM: decision on the application for modification of an agreed PIP, P/0168/2018
27/06/2019 Human medicines European public assessment report (EPAR): Macugen, pegaptanib, Wet Macular Degeneration, 31/01/2006, 15, Withdrawn
26/06/2019 Regulatory and procedural guideline: Detailed guide regarding the monitoring of medical literature and the entry of relevant information into the EudraVigilance database by the European Medicines Agency - Addendum 1
26/06/2019 Medicines under additional monitoring: Annex I - List of cyproterone-acetate / ethinylestradiol-containing medicinal products in the European Union
26/06/2019 Medicines under additional monitoring: Annex I - List of cyproterone-acetate / ethinylestradiol-containing medicinal products in the European Union
26/06/2019 Medicines under additional monitoring: Annex XIII - List of Valproate and related substances in the European Union
26/06/2019 Medicines under additional monitoring: Annex XIII - List of Valproate and related substances in the European Union
26/06/2019 Medicines under additional monitoring: Annex XIV – retinoid containing medicinal products and related substances (acitretin, alitretinoin, isotretinoin)
26/06/2019 Medicines under additional monitoring: Annex XIV – retinoid containing medicinal products and related substances (acitretin, alitretinoin, isotretinoin)
26/06/2019 Referral: Fenspiride containing medicinal products , fenspiride , Article 107i procedures, Position provided by CMDh, 29/05/2019, 26/06/2019
26/06/2019 Agenda: Agenda - PDCO agenda of the 25-28 June 2019 meeting
25/06/2019 Opinion/decision on a Paediatric investigation plan (PIP): Chemically modified extract of trees pollen from birch and alder, RPM: decision refers to a refusal on the application for modification of an agreed PIP, P/0086/2019
25/06/2019 Opinion/decision on a Paediatric investigation plan (PIP): Chemically modified house dust mites allergen extract (Dermatophagoides pteronyssinus and Dermatophagoides farinae), RPM: decision refers to a refusal on the application for modification of an agreed PIP, P/0087/2019
25/06/2019 Opinion/decision on a Paediatric investigation plan (PIP): Uptravi, Selexipag, PM: decision on the application for modification of an agreed PIP, P/0123/2019
25/06/2019 Orphan designation: Tazemetostat for the: Treatment of diffuse large B-cell lymphoma, 21/03/2018, Positive
25/06/2019 Opinion/decision on a Paediatric investigation plan (PIP): Refixia, Nonacog beta pegol, PM: decision on the application for modification of an agreed PIP, P/0139/2019
25/06/2019 Support for advanced-therapy developers
25/06/2019 Guidance on good manufacturing practice and good distribution practice: Questions and answers
25/06/2019 Opinion/decision on a Paediatric investigation plan (PIP): Xeljanz, Tofacitinib, PM: decision on the application for modification of an agreed PIP, P/0071/2019
25/06/2019 Opinion/decision on a Paediatric investigation plan (PIP): Xeljanz, Tofacitinib, PM: decision on the application for modification of an agreed PIP, P/0134/2019
25/06/2019 Human medicines European public assessment report (EPAR): Isentress, Raltegravir, HIV Infections, 19/12/2007, Accelerated assessment, 36, Authorised
25/06/2019 Orphan designation: Tazemetostat for the: Treatment of follicular lymphoma, 21/03/2018, Positive
25/06/2019 Orphan designation: Tazemetostat for the: Treatment of malignant mesothelioma, 21/03/2018, Positive
25/06/2019 Opinion/decision on a Paediatric investigation plan (PIP): Stivarga, regorafenib, PM: decision on the application for modification of an agreed PIP, P/0158/2019
25/06/2019 Opinion/decision on a Paediatric investigation plan (PIP): Mekinist, Trametinib (dimethyl sulfoxide), PM: decision on the application for modification of an agreed PIP, P/0076/2019
25/06/2019 Opinion/decision on a Paediatric investigation plan (PIP): Lefamulin, PM: decision on the application for modification of an agreed PIP, P/0066/2019
25/06/2019 Opinion/decision on a Paediatric investigation plan (PIP): Carotuximab, PM: decision on the application for modification of an agreed PIP, P/0072/2019
25/06/2019 Opinion/decision on a Paediatric investigation plan (PIP): Avalglucosidase alfa, PM: decision on the application for modification of an agreed PIP, P/0073/2019
25/06/2019 Opinion/decision on a Paediatric investigation plan (PIP): 3-[[5-chloro-1-[3-(methylsulfonyl)propyl]-1H-indol-2-yl]methyl]-1-(2,2,2-trifluoroethyl)-1,3-dihydro-3-[[5-chloro-1-[3-(methylsulfonyl)propyl]-1H-indol-2-yl]methyl]-1-(2,2,2-trifluoroethyl)-1,3-dihydro-2H-imidazo[4,5-c]pyridine-2-one (JNJ-53718678), PM: decision on the application for modification of an agreed PIP, P/0081/2019
25/06/2019 Opinion/decision on a Paediatric investigation plan (PIP): Tralokinumab, PM: decision on the application for modification of an agreed PIP, P/0104/2019
25/06/2019 Report: Medicinal products for human use: monthly figures - May 2019
25/06/2019 Minutes: Minutes of the CHMP meeting 23-26 April 2019
25/06/2019 Opinion/decision on a Paediatric investigation plan (PIP): Inebilizumab, PM: decision on the application for modification of an agreed PIP, P/0129/2019
25/06/2019 Other: Questions and answers on the use of out-of-specification batches of authorised cell and tissue-based advanced therapy medicinal products
25/06/2019 Opinion/decision on a Paediatric investigation plan (PIP): Angiotensin II (LJPC-501), PM: decision on the application for modification of an agreed PIP, P/0159/2019
25/06/2019 Opinion/decision on a Paediatric investigation plan (PIP): Oxervate, Cenegermin, W: decision granting a waiver in all age groups for all conditions/indications, P/0118/2019
25/06/2019 Opinion/decision on a Paediatric investigation plan (PIP): Multivalent, live, recombinant, non-replicating in human cells, Modified Vaccinia Ankara vectored vaccine, expressing the EBOV Mayinga glycoprotein, the Sudan virus Gulu GP, the Marburg virus Musoke GP, and the Taï Forest virus nucleoprotein [MVA-BN-Filo], P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0117/2019
25/06/2019 Opinion/decision on a Paediatric investigation plan (PIP): Monovalent, live, recombinant, replication-incompetent adenoviral serotype 26 vectored vaccine expressing the full length glycoprotein of the Ebola virus Mayinga variant [Ad26.ZEBOV], P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0116/2019
24/06/2019 Opinion/decision on a Paediatric investigation plan (PIP): Tafinlar, Dabrafenib (mesilate), PM: decision on the application for modification of an agreed PIP, P/0065/2019
24/06/2019 Opinion/decision on a Paediatric investigation plan (PIP): Zerbaxa, Ceftolozane,tazobactam, PM: decision on the application for modification of an agreed PIP, P/0154/2019
24/06/2019 Opinion/decision on a Paediatric investigation plan (PIP): Autologous cartilage derived cultured chondrocytes, PM: decision on the application for modification of an agreed PIP, P/0074/2019
24/06/2019 Committee meeting report: PDCO monthly report of opinions on paediatric investigation plans and other activities 27-29 May 2019
24/06/2019 Opinion/decision on a Paediatric investigation plan (PIP): Peanut flour, PM: decision on the application for modification of an agreed PIP, P/0114/2019
24/06/2019 Opinion/decision on a Paediatric investigation plan (PIP): Upadacitinib (ABT-494), PM: decision on the application for modification of an agreed PIP, P/0068/2019
24/06/2019 Opinion/decision on a Paediatric investigation plan (PIP): Upadacitinib (ABT-494), PM: decision on the application for modification of an agreed PIP, P/0069/2019
24/06/2019 Opinion/decision on a Paediatric investigation plan (PIP): Neisseria meningitidis serogroup B recombinant lipoprotein (rLP2086; subfamily A; Escherichia coli),Neisseria meningitidis serogroup B recombinant lipoprotein (rLP2086; subfamily B; Escherichia coli), PM: decision on the application for modification of an agreed PIP, P/0098/2019
24/06/2019 Opinion/decision on a Paediatric investigation plan (PIP): Quizartinib, PM: decision on the application for modification of an agreed PIP, P/0163/2019
24/06/2019 Opinion/decision on a Paediatric investigation plan (PIP): Chemically modified extract of grass pollen from Holcus lanatus, Phleum pratense and Poa pratensis, RPM: decision refers to a refusal on the application for modification of an agreed PIP, P/0083/2019
24/06/2019 Opinion/decision on a Paediatric investigation plan (PIP): Maviret, glecaprevir,pibrentasvir, PM: decision on the application for modification of an agreed PIP, P/0128/2019
24/06/2019 Opinion/decision on a Paediatric investigation plan (PIP): Chemically modified extract of grass pollen from Holcus lanatus, Phleum pratense and Poa pratensis, RPM: decision refers to a refusal on the application for modification of an agreed PIP, P/0084/2019
24/06/2019 Opinion/decision on a Paediatric investigation plan (PIP): Chemically modified house dust mites allergen extract (Dermatophagoides pteronyssinus and Dermatophagoides farinae), RPM: decision refers to a refusal on the application for modification of an agreed PIP, P/0101/2019
24/06/2019 Opinion/decision on a Paediatric investigation plan (PIP): Aimovig, erenumab, PM: decision on the application for modification of an agreed PIP, P/0107/2019
24/06/2019 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/0133/2019
24/06/2019 Careers
24/06/2019 Opinion/decision on a Paediatric investigation plan (PIP): Chemically modified extract of trees pollen from birch and alder, RPM: decision refers to a refusal on the application for modification of an agreed PIP, P/0085/2019
24/06/2019 Opinion/decision on a Paediatric investigation plan (PIP): Steglatro, Ertugliflozin, PM: decision on the application for modification of an agreed PIP, P/0141/2019
24/06/2019 Veterinary medicines European public assessment report (EPAR): Recocam, meloxicam, 13/09/2011, Generic, 5, Authorised
24/06/2019 Opinion/decision on a Paediatric investigation plan (PIP): Molgramostim, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0094/2019
24/06/2019 Opinion/decision on a Paediatric investigation plan (PIP): Natpar, Recombinant parathyroid hormone, PM: decision on the application for modification of an agreed PIP, P/0136/2019
24/06/2019 Opinion/decision on a Paediatric investigation plan (PIP): Luspatercept, PM: decision on the application for modification of an agreed PIP, P/0130/2019
24/06/2019 Opinion/decision on a Paediatric investigation plan (PIP): Acalabrutinib, PM: decision on the application for modification of an agreed PIP, P/0062/2019
24/06/2019 Opinion/decision on a Paediatric investigation plan (PIP): Lartruvo, Olaratumab, W: decision granting a waiver in all age groups for all conditions/indications, P/0112/2019
24/06/2019 Opinion/decision on a Paediatric investigation plan (PIP): Cresemba, Isavuconazonium (sulfate), PM: decision on the application for modification of an agreed PIP, P/0100/2019
24/06/2019 Opinion/decision on a Paediatric investigation plan (PIP): Praxbind, idarucizumab, PM: decision on the application for modification of an agreed PIP, P/0151/2019
24/06/2019 Opinion/decision on a Paediatric investigation plan (PIP): Orbactiv, Oritavancin (diphosphate), PM: decision on the application for modification of an agreed PIP, P/0131/2019
24/06/2019 Opinion/decision on a Paediatric investigation plan (PIP): Voclosporin, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0152/2019
24/06/2019 Opinion/decision on a Paediatric investigation plan (PIP): Galafold, Migalastat (hydrochloride), PM: decision on the application for modification of an agreed PIP, P/0137/2019
24/06/2019 Opinion/decision on a Paediatric investigation plan (PIP): 177Lu-PSMA-617, W: decision granting a waiver in all age groups for all conditions/indications, P/0127/2019
24/06/2019 Opinion/decision on a Paediatric investigation plan (PIP): Ridinilazole, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0109/2019
24/06/2019 Agenda: Agenda - CHMP agenda of the 24-27 June 2019 meeting
24/06/2019 Opinion/decision on a Paediatric investigation plan (PIP): Oteseconazole, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0147/2019
24/06/2019 Opinion/decision on a Paediatric investigation plan (PIP): Chemically modified recombinant human sulfamidase, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0113/2019
24/06/2019 Opinion/decision on a Paediatric investigation plan (PIP): Liposomal vinorelbine (tartrate), P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0155/2019
24/06/2019 Opinion/decision on a Paediatric investigation plan (PIP): N-hydroxy-5-methylfuran-2-sulfonamide (BMS-986231), P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0110/2019
24/06/2019 Opinion/decision on a Paediatric investigation plan (PIP): 1-{[(2S,3S)-2-carboxylato-3-methyl-4,4,7-trioxo-4-{6}-thia-1-azabi-cyclo[3.2.0]heptan-3- yl]methyl}-3-methyl-1H-1,2,3-triazol-3-ium (AAI101), P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0093/2019
24/06/2019 Opinion/decision on a Paediatric investigation plan (PIP): Orvepitant, W: decision granting a waiver in all age groups for all conditions/indications, P/0119/2019
24/06/2019 Opinion/decision on a Paediatric investigation plan (PIP): Rosuvastatin (calcium) / fenofibrate, W: decision granting a waiver in all age groups for all conditions/indications, P/0120/2019
24/06/2019 Opinion/decision on a Paediatric investigation plan (PIP): N2’-Deacetyl-N2’-[4-methyl-4-(oxobutyldithio)-1-oxopentyl]-maytansine-hu769_4D4 Antibody, W: decision granting a waiver in all age groups for all conditions/indications, P/0132/2019
24/06/2019 Opinion/decision on a Paediatric investigation plan (PIP): Mavacamten, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0106/2019
24/06/2019 Opinion/decision on a Paediatric investigation plan (PIP): Anti-IL-21 humanized immunoglobulin G1-kappa monoclonal antibody (BOS161721), P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0148/2019
24/06/2019 Opinion/decision on a Paediatric investigation plan (PIP): Serlopitant, W: decision granting a waiver in all age groups for all conditions/indications, P/0135/2019
24/06/2019 Opinion/decision on a Paediatric investigation plan (PIP): ivacaftor / tezacaftor/ potassium (benzenesulfonyl)({[6-(3-{2-[1-(trifluoromethyl)cyclopropyl]ethoxy}-1H-pyrazol-1-yl)-2-[(4S)-2,2,4-trimethylpyrrolidin-1-yl]pyridin-3-yl]carbonyl})azanide (VX-659), P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0090/2019
24/06/2019 Opinion/decision on a Paediatric investigation plan (PIP): Rivoceranib (mesylate), W: decision granting a waiver in all age groups for all conditions/indications, P/0140/2019
24/06/2019 Opinion/decision on a Paediatric investigation plan (PIP): Tislelizumab, W: decision granting a waiver in all age groups for all conditions/indications, P/0142/2019
24/06/2019 Opinion/decision on a Paediatric investigation plan (PIP): (R)-azasetron (besylate) (SENS-401), P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0105/2019
24/06/2019 Opinion/decision on a Paediatric investigation plan (PIP): N-benzyl-2-(5-(4-(2-morpholinoethoxy)phenyl) pyridin-2-yl) acetamide (KX2-391), W: decision granting a waiver in all age groups for all conditions/indications, P/0075/2019
24/06/2019 Opinion/decision on a Paediatric investigation plan (PIP): Dihomo-γ-linolenic acid (DS107), P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0102/2019
24/06/2019 Opinion/decision on a Paediatric investigation plan (PIP): Pyrimidinyl-aminopyridine dual leucine zipper kinase inhibitor (GDC-0134), RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s), P/0099/2019
24/06/2019 Opinion/decision on a Paediatric investigation plan (PIP): Spartalizumab, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0089/2019
24/06/2019 Opinion/decision on a Paediatric investigation plan (PIP): Genetically modified Mycobacterium bovis BCG, W: decision granting a waiver in all age groups for all conditions/indications, P/0078/2019
24/06/2019 Opinion/decision on a Paediatric investigation plan (PIP): (6aR,10aR)-1-Hydroxy-6,6-dimethyl-3-(2-methyl-2-octanyl)-6a,7,10,10a-tetrahydro-6H- benzo[c]chromene-9-carboxylic acid (lenabasum), P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0095/2019
24/06/2019 Opinion/decision on a Paediatric investigation plan (PIP): Rosuvastatin (calcium),Amlodipine (besylate), W: decision granting a waiver in all age groups for all conditions/indications, P/0079/2019
24/06/2019 Opinion/decision on a Paediatric investigation plan (PIP): Gadopiclenol, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0145/2019
24/06/2019 Opinion/decision on a Paediatric investigation plan (PIP): N-(1,3-dimethyl-1H-pyrazole-4-sulfonyl)-6-[3-(3,3,3-trifluoro-2,2-dimethylpropoxy)-1H-pyrazol-1-yl]-2-[(4S)-2,2,4-trimethylpyrrolidin-1-yl]pyridine-3-carboxamide (VX-445) / tezacaftor / ivacaftor, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0091/2019
24/06/2019 Opinion/decision on a Paediatric investigation plan (PIP): Inactivated patients own (autologous) microorganism (Escherichia coli, Candida spp., Enterococcus spp., Streptococcus spp., Staphylococcus spp., Prevotella intermedia, Fusobacterium nucleatum and others), W: decision granting a waiver in all age groups for all conditions/indications, P/0161/2019
24/06/2019 Opinion/decision on a Paediatric investigation plan (PIP): Upadacitinib, W: decision granting a waiver in all age groups for all conditions/indications, P/0103/2019
24/06/2019 Opinion/decision on a Paediatric investigation plan (PIP): Rogaratinib, W: decision granting a waiver in all age groups for all conditions/indications, P/0156/2019
24/06/2019 Opinion/decision on a Paediatric investigation plan (PIP): Relugolix,estradiol,norethisterone acetate, W: decision granting a waiver in all age groups for all conditions/indications, P/0108/2019
24/06/2019 Opinion/decision on a Paediatric investigation plan (PIP): isoflurane, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0092/2019
24/06/2019 Opinion/decision on a Paediatric investigation plan (PIP): Vipidia, alogliptin, PM: decision on the application for modification of an agreed PIP, P/0097/2019
24/06/2019 Opinion/decision on a Paediatric investigation plan (PIP): Xarelto, rivaroxaban, PM: decision on the application for modification of an agreed PIP, P/0126/2019
21/06/2019 Healthcare Professionals' Working Party
21/06/2019 News and press releases: Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 18-20 June 2019
21/06/2019 Opinion/decision on a Paediatric investigation plan (PIP): Methoxyflurane, PM: decision on the application for modification of an agreed PIP, P/0063/2019
21/06/2019 Opinion/decision on a Paediatric investigation plan (PIP): Stelara, Ustekinumab, PM: decision on the application for modification of an agreed PIP, P/0096/2019
21/06/2019 Opinion/decision on a Paediatric investigation plan (PIP): MabThera, rituximab, PM: decision on the application for modification of an agreed PIP, P/0064/2019
21/06/2019 Human medicines European public assessment report (EPAR): Gefitinib Mylan, gefitinib, Carcinoma, Non-Small-Cell Lung, 27/09/2018, Generic, 1, Authorised
21/06/2019 European Medicines Agency stakeholder interaction on the development of medicinal products for chronic non-infectious liver diseases (PBC, PSC, NASH) , European Medicines Agency, London, UK, from 03/12/2018 to 03/12/2018
21/06/2019 Report: Report - European Medicines Agency stakeholder interaction on the development of medicinal products for chronic non-infectious liver diseases (PBC, PSC, NASH)
20/06/2019 Committee for Medicinal Products for Human Use (CHMP): 25-28 March 2019 , European Medicines Agency, from 25/03/2019 to 28/03/2019
20/06/2019 Committee for Medicinal Products for Veterinary Use (CVMP): 19-21 March 2019 , European Medicines Agency, Amsterdam, the Netherlands, from 19/03/2019 to 21/03/2019
20/06/2019 Veterinary medicines European public assessment report (EPAR): Vectra 3D, dinotefuran, pyriproxyfen, permethrin, 04/12/2013, 4, Authorised
20/06/2019 Committee meeting report: Monthly report on application procedures, guidelines and related documents for veterinary medicines: March 2019
20/06/2019 Agenda: Agenda - CAT agenda of the 19-21 June 2019 meeting
20/06/2019 Minutes: CHMP ORGAM minutes for the meeting on 18 March 2019
20/06/2019 Agenda: CHMP ORGAM agenda for the meeting on 18 March 2019
20/06/2019 Opinion/decision on a Paediatric investigation plan (PIP): Elonva, corifollitropin alfa, PM: decision on the application for modification of an agreed PIP, P/0143/2019
20/06/2019 Periodic safety update single assessment: Methoxyflurane: List of nationally authorised medicinal products - PSUSA/00010484/201811
20/06/2019 Opinion/decision on a Paediatric investigation plan (PIP): Intelence, Etravirine, PM: decision on the application for modification of an agreed PIP, P/0121/2019
20/06/2019 Opinion/decision on a Paediatric investigation plan (PIP): Revolade, Eltrombopag, W: decision granting a waiver in all age groups for all conditions/indications, P/0070/2019
20/06/2019 Opinion/decision on a Paediatric investigation plan (PIP): Ozanimod, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0153/2019
20/06/2019 Opinion/decision on a Paediatric investigation plan (PIP): Delafloxacin, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0125/2019
20/06/2019 Opinion/decision on a Paediatric investigation plan (PIP): Ofev, nintedanib, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0150/2019
20/06/2019 Opinion/decision on a Paediatric investigation plan (PIP): Jardiance, empagliflozin, W: decision granting a waiver in all age groups for all conditions/indications, P/0082/2019
20/06/2019 Opinion/decision on a Paediatric investigation plan (PIP): Cosentyx, Secukinumab, W: decision granting a waiver in all age groups for all conditions/indications, P/0144/2019
20/06/2019 Opinion/decision on a Paediatric investigation plan (PIP): L-Asparaginase, W: decision granting a waiver in all age groups for all conditions/indications, P/0138/2019
20/06/2019 Opinion/decision on a Paediatric investigation plan (PIP): Eylea, aflibercept, P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), P/0115/2019
20/06/2019 Human medicines European public assessment report (EPAR): MicardisPlus, telmisartan, hydrochlorothiazide, Hypertension, 19/04/2002, 27, Authorised
20/06/2019 Human medicines European public assessment report (EPAR): Halaven, Eribulin, Breast Neoplasms, Liposarcoma, 17/03/2011, 20, Authorised
19/06/2019 Human medicines European public assessment report (EPAR): Ketek, telithromycin, Sinusitis, Tonsillitis, Bronchitis, Chronic, Pharyngitis, Community-Acquired Infections, Pneumonia, Bacterial, 09/07/2001, 25, Withdrawn
19/06/2019 Human medicines European public assessment report (EPAR): Veltassa, patiromer sorbitex calcium, Hyperkalemia, 19/07/2017, Additional monitoring, 1, Authorised
19/06/2019 Periodic safety update single assessment: Benzydamine: List of nationally authorised medicinal products - PSUSA/00000375/201810
19/06/2019 Periodic safety update single assessment: Ceftazidime: List of nationally authorised medicinal products - PSUSA/00000608/201810
19/06/2019 Periodic safety update single assessment: Azelastine / fluticasone: List of nationally authorised medicinal products - PSUSA/00010067/201810
19/06/2019 Veterinary medicines European public assessment report (EPAR): Innovax-ND-IBD, Cell-associated live recombinant turkey herpesvirus (strain HVP360), expressing the fusion protein of ND virus and the VP2 protein of IBD virus, 22/08/2017, 1, Authorised
19/06/2019 Agenda: Agenda - CVMP agenda of the 18-20 June 2019 meeting
19/06/2019 Referral: Septanest and associated names , articaine (hydrochloride) / adrenaline (tartrate) , Article 30 referrals, European Commission final decision, 28/06/2018, 28/03/2019, 19/06/2019
19/06/2019 Orphan designation: Recombinant human anti-interferon gamma monoclonal antibody (emapalumab) for the: Treatment of haemophagocytic lymphohistiocytosis, 09/06/2010, Positive
19/06/2019 Scientific guideline: Draft qualification opinion of clinically interpretable treatment effect measures based on recurrent event endpoints that allow for efficient statistical analyses
19/06/2019 Other: Qualification opinion - Treatment effect measures when using recurrent event endpoints - Applicant's responses to fourth list of issues
19/06/2019 Other: Qualification opinion - Treatment effect measures when using recurrent event endpoints - Fourth list of issues
19/06/2019 Other: Qualification opinion - Treatment effect measures when using recurrent event endpoints - Applicant's responses to third list of issues
19/06/2019 Other: Qualification opinion - Treatment effect measures when using recurrent event endpoints - Third list of issues
19/06/2019 Other: Qualification opinion - Treatment effect measures when using recurrent event endpoints - Applicant's responses to second list of issues
19/06/2019 Other: Qualification opinion - Treatment effect measures when using recurrent event endpoints - Second list of issues
19/06/2019 Other: Qualification opinion - Treatment effect measures when using recurrent event endpoints - Applicant's responses to first list of issues
19/06/2019 Other: Qualification opinion - Treatment effect measures when using recurrent event endpoints - Applicant's submission
19/06/2019 Other: Qualification opinion - Treatment effect measures when using recurrent event endpoints - First list of issues
18/06/2019 Periodic safety update single assessment: Clindamycin: List of nationally authorised medicinal products - PSUSA/00000795/201810
18/06/2019 Orphan designation: Recombinant adeno-associated viral vector containing human acid alfa-glucosidase-gene for the: Treatment of glycogen storage disease type II (Pompe's disease), 04/07/2012, Positive
18/06/2019 Minutes: CHMP ORGAM minutes for the meeting on 18 February 2019
18/06/2019 Minutes: CHMP ORGAM minutes for the meeting on 21 January 2019
18/06/2019 Human medicines European public assessment report (EPAR): Competact, pioglitazone, metformin hydrochloride, Diabetes Mellitus, Type 2, 28/07/2006, 17, Authorised
18/06/2019 Human medicines European public assessment report (EPAR): Pedea, Ibuprofen, Ductus Arteriosus, Patent, 28/07/2004, 14, Authorised
18/06/2019 Veterinary post-authorisation Q&A: Introduction
18/06/2019 Q&A: Type II variations vs Extension applications
18/06/2019 Q&A: Mock-ups
18/06/2019 Q&A: Transparency
18/06/2019 Q&A: Application of the so-called 'sunset clause' to centrally authorised veterinary medicinal products
18/06/2019 Q&A: Other
18/06/2019 Herbal – European Union herbal monograph: Draft European Union herbal monograph on Aesculus hippocastanum L., semen - Revision 1
18/06/2019 Herbal medicinal product: Hippocastani semen, Hippocastani semen, F: Assessment finalised
18/06/2019 Human medicines European public assessment report (EPAR): Imnovid (previously Pomalidomide Celgene), Pomalidomide, Multiple Myeloma, 05/08/2013, Orphan, Additional monitoring, 15, Authorised
18/06/2019 Orphan designation: Pomalidomide for the: Treatment of multiple myeloma, 08/10/2009, Positive
18/06/2019 Regulatory and procedural guideline: Recommendations for the implementation of the exemptions to the labelling and package-leaflet obligations in the centralised procedure
18/06/2019 Periodic safety update single assessment: Piretanide: List of nationally authorised medicinal products - PSUSA/00002433/201810
18/06/2019 Agenda: Agenda - COMP agenda of the 18-20 June 2019 meeting
18/06/2019 Herbal medicinal product: Menthae piperitae aetheroleum, Menthae piperitae aetheroleum, D: Draft under discussion
18/06/2019 Herbal – European Union herbal monograph: Draft European Union herbal monograph on Mentha x piperita L., aetheroleum - Revision 1
18/06/2019 Herbal – European Union list entry: Draft European Union list entry on Mentha x piperita L., aetheroleum - Revision 1
17/06/2019 Work programme: EMA activities, other than the highest priority activities (category 1 activities), that will continue in 2019 - Annex 1
17/06/2019 News and press releases: Highlights of Management Board meeting: June 2019
17/06/2019 Orphan designation: 4-[2-(6-Methylpyridin-2-yl)-5,6-dihydro-4H-pyrrolo[1,2-b]pyrazol-3-yl]-quinoline-6-carboxamide monohydrate for the: Treatment of glioma, 26/04/2013, Withdrawn
17/06/2019 Orphan designation: 4-[2-(6-Methylpyridin-2-yl)-5,6-dihydro-4H-pyrrolo[1,2-b]pyrazol-3-yl]-quinoline-6-carboxamide monohydrate for the: Treatment of hepatocellular carcinoma, 12/03/2013, Withdrawn
17/06/2019 Orphan designation: Human/murine chimeric monoclonal antibody against endoglin (carotuximab) for the: Treatment of soft tissue sarcoma, 28/04/2016, Withdrawn
17/06/2019 Other: Rules for reimbursement of expenses for delegates attending meetings with effect from 14 June 2019
17/06/2019 Periodic safety update single assessment: Everolimus (indicated for rejection of transplanted organs) : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010269/201807
14/06/2019 Human medicines European public assessment report (EPAR): Wilzin, zinc, Hepatolenticular Degeneration, 12/10/2004, 11, Authorised
14/06/2019 Orphan designation: Diacerein for the: Treatment of epidermolysis bullosa, 08/11/2018, Negative
14/06/2019 Orphan designation: Sodium benzoate, Sodium phenylacetate for the: Treatment of ornithine transcarbamylase deficiency, 24/04/2019, Positive
14/06/2019 Orphan designation: Human culture expanded autologous mesenchymal stromal cells for the: Treatment of amyotrophic lateral sclerosis, 24/04/2019, Positive
14/06/2019 Report: Final programming document 2019-2021
14/06/2019 News and press releases: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 11-14 June 2019
14/06/2019 Orphan designation: Balipodect for the: 14/04/2019, Positive
14/06/2019 Orphan designation: Autologous human bone marrow-derived haematopoietic and mesenchymal stem cells depleted of erythrocytes, monocytes and lymphocytes for the: Treatment of spinal cord injury, 24/04/2019, Positive
14/06/2019 Orphan designation: 3-(3-(3,5-bis(trifluoromethyl)phenyl)-1h-pyrazol-1-yl)propanoic acid for the: Treatment of Stargardt's disease, 24/04/2019, Positive
14/06/2019 Report: Applications for new human medicines under evaluation by the CHMP: June 2019
14/06/2019 Agenda: Agenda for the 104th meeting of the Management Board
14/06/2019 Human medicines European public assessment report (EPAR): Docetaxel Kabi, docetaxel, Head and Neck Neoplasms, Carcinoma, Non-Small-Cell Lung, Adenocarcinoma, Prostatic Neoplasms, Breast Neoplasms, 22/05/2012, Generic, 12, Authorised
14/06/2019 Human medicines European public assessment report (EPAR): Cystadrops, mercaptamine hydrochloride, Cystinosis, 18/01/2017, Orphan, 5, Authorised
14/06/2019 Human medicines European public assessment report (EPAR): Velmetia, sitagliptin, metformin hydrochloride, Diabetes Mellitus, Type 2, 16/07/2008, 26, Authorised
14/06/2019 Minutes: Minutes of the 103rd meeting of the Management Board: 21 March 2019
14/06/2019 Management Board meeting: 21 March 2019 , European Medicines Agency, Amsterdam, the Netherlands, from 21/03/2019 to 21/03/2019
14/06/2019 Orphan designation: Modified messenger ribonucleic acid encoding human propionyl-coenzyme A carboxylase alpha and beta subunits encapsulated into lipid nanoparticle for the: Treatment of propionic acidaemia, 24/04/2019, Positive
13/06/2019 Referral: Omega-3 acid ethyl esters - containing medicinal products for oral in use in secondary prevention after myocardial infarction , Omega-3 fatty acid ethyl esters , Article 31 referrals, European Commission final decision, 13/12/2018, 06/06/2019, 13/06/2019
13/06/2019 Human medicines European public assessment report (EPAR): Sancuso, granisetron, Vomiting, Cancer, 20/04/2012, 12, Authorised
13/06/2019 Human medicines European public assessment report (EPAR): Accofil, filgrastim, Neutropenia, 17/09/2014, Biosimilar, 10, Authorised
13/06/2019 Human medicines European public assessment report (EPAR): Leflunomide Zentiva (previously Leflunomide Winthrop), leflunomide, Arthritis, Rheumatoid, Arthritis, Psoriatic, 08/01/2010, 15, Authorised
13/06/2019 Human medicines European public assessment report (EPAR): Cystadane, Betaine anhydrous, Homocystinuria, 14/02/2007, 13, Authorised
13/06/2019 Veterinary medicines European public assessment report (EPAR): Leucogen, purified p45 FeLV-envelope antigen, 17/06/2009, 7, Authorised
13/06/2019 Veterinary medicines European public assessment report (EPAR): Leucofeligen FeLV/RCP, live feline calicivirus (strain F9) / live feline viral rhinotracheitis virus (strain F2) / live feline panleucopenia virus, purified p45 feline leukaemia virus envelope antigen, 24/06/2009, 7, Authorised
12/06/2019 Veterinary medicines European public assessment report (EPAR): Nobivac LeuFel, purified Rp-45 FeLV-envelope antigen, 06/11/2017, 2, Authorised
12/06/2019 Veterinary medicines European public assessment report (EPAR): Suvaxyn PCV, porcine circovirus recombinant virus (CPCV) 1-2, inactivated, 24/07/2009, 13, Authorised
12/06/2019 Human medicines European public assessment report (EPAR): Alpivab, Peramivir, Influenza, Human, 13/04/2018, Additional monitoring, 1, Authorised
11/06/2019 Annex to CHMP highlights: Scientific advice and protocol assistance adopted during the CHMP meeting 27 – 29 May 2019
11/06/2019 Agenda: Agenda - PRAC draft agenda of meeting 11-14 June 2019
11/06/2019 News and press releases: Two additional countries to benefit from EU-US mutual recognition agreement for inspections
11/06/2019 Other: New product information wording: extracts from PRAC recommendations on signals adopted at the 13-16 May 2019 PRAC
11/06/2019 PRAC recommendation on signal: PRAC recommendations on signals adopted at the 13-16 May 2019 PRAC meeting
07/06/2019 Orphan designation: Recombinant human hepatocarcinoma-intestine-pancreas, pancreatic associated protein for the: Treatment of acute liver failure, 11/02/2009, Positive
07/06/2019 Q&A: Changing the (invented) name of a centrally authorised medicinal product