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October 2017

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31/10/2017Technical anonymisation group
31/10/2017Human medicines European public assessment report (EPAR): Esbriet,

pirfenidone

Revision: 18, Authorised
31/10/2017Human medicines European public assessment report (EPAR): Zoledronic acid Teva,

zoledronic acid

Revision: 9, Authorised
31/10/2017Agenda: Agenda - CAT agenda of the 30-31 October 2017 meeting
31/10/2017Human medicines European public assessment report (EPAR): Inhixa,

enoxaparin sodium

Revision: 4, Authorised
31/10/2017Scientific guideline: Draft procedure for the review and revision of European Union herbal monographs and European Union list entries, draft: consultation open (updated)
31/10/2017Scientific guideline: Concept paper on the need for a paediatric addendum of the guideline on clinical investigation of medicinal products for the treatment and prophylaxis of venous thromboembolic disease, draft: consultation open
31/10/2017Need for a paediatric addendum of the guideline on clinical investigation of medicinal products for the treatment and prophylaxis of venous thromboembolic disease
31/10/2017Questions & answers on the impact of Mutual Recognition Agreement between the European Union and the United States as of 1 November 2017
31/10/2017Mutual recognition agreements (updated)
31/10/2017News and press releases: EU-FDA mutual recognition of inspections of medicines manufacturers enters operational phase
31/10/2017Human medicines European public assessment report (EPAR): Tivicay,

dolutegravir

Revision: 12, Authorised
31/10/2017Cromoglicic acid : List of nationally authorised medicinal products - PSUSA/00000883/201702
31/10/2017Procedural timetables (updated)
31/10/2017Type II variation and worksharing application weekly assessment timetables (updated)
31/10/2017Timetable: Extension application - ATMP (updated)
31/10/2017Timetable: Extension application (updated)
31/10/2017Timetable accelerated assessment request for initial marketing authorisation applications (updated)
31/10/2017Timetable: Informed consent and multiple application (updated)
31/10/2017Timetable initial (full) marketing authorisation application - Accelerated assessment (updated)
31/10/2017Timetable: Initial (Full) marketing authorisation application - ATMP (updated)
31/10/2017Timetable: Initial (full) marketing authorisation application (updated)
31/10/2017Timetable: Periodic safety update report (PSUR) and PSUR single sssessment (PSUSA) - Advanced therapy medicinal products (ATMPs) (updated)
31/10/2017Timetable: Periodic safety update report (PSUR) and PSUR single assessment (PSUSA) (updated)
31/10/2017Agenda: Agenda - A common data model for Europe? – Why? Which? How?
31/10/2017Clinical investigation of medicinal products for the treatment of ankylosing spondylitis (updated)
31/10/2017Scientific guideline: Guideline on the clinical investigation of medicinal products for the treatment of axial spondyloarthritis - Revision 1, adopted
31/10/2017Human medicines European public assessment report (EPAR): Entresto,

sacubitril / valsartan

Revision: 5, Authorised
31/10/2017Scientific guideline: Concept paper on the development of a reflection paper on new analytical methods/technologies in the quality control of herbal medicinal products, draft: consultation open
31/10/2017Development of a reflection paper on new analytical methods/technologies in the quality control of herbal medicinal products
31/10/2017Clodronic acid : List of nationally authorised medicinal products - PSUSA-00000804-201702
31/10/2017Report: Highlights from the fourth European Medicines Agency industry platform meeting held on the 3rd of July 2017 on the operation of the centralised procedure for human medicinal products
31/10/2017Fourth industry stakeholder platform on the operation of the centralised procedure for human medicines, European Medicines Agency, London, UK, From: 03-Jul-2017, To: 03-Jul-2017 (updated)
31/10/2017Human medicines European public assessment report (EPAR): Mircera,

methoxy polyethylene glycol-epoetin beta

Revision: 21, Authorised
31/10/2017Eplerenone : List of nationally authorised medicinal products - PSUSA-00001236-201703
31/10/2017Human medicines European public assessment report (EPAR): Xyrem,

sodium oxybate

Revision: 26, Authorised
30/10/2017Human medicines European public assessment report (EPAR): Kaletra,

lopinavir / ritonavir

Revision: 46, Authorised
30/10/2017Hydroquinidine : List of nationally authorised medicinal products - PSUSA/00001688/201703
30/10/2017Human plasma (pooled and treated for virus inactivation) : List of nationally authorised medicinal products - PSUSA/00001635/201702
30/10/2017Outcomes of imposed non-interventional post-authorisation safety studies (updated)
30/10/2017Poly (o-2-hydroxyethyl) starch: List of nationally authorised medicinal products - EMEA/H/N/PSR/S/0009
30/10/2017Human medicines European public assessment report (EPAR): Zoledronic Acid Hospira,

zoledronic acid

Revision: 10, Authorised
30/10/2017News and press releases: How to develop vaccines and medicines that prevent and treat respiratory syncytial virus (RSV) infection
30/10/2017Scientific guideline: Draft guideline on the clinical evaluation of medicinal products indicated for the prophylaxis or treatment of respiratory syncytial virus (RSV) disease, draft: consultation open
30/10/2017Human medicines European public assessment report (EPAR): Xultophy,

insulin degludec / liraglutide

Revision: 8, Authorised
30/10/2017Clinical investigation of recombinant and human plasma-derived factor VIII products (updated)
30/10/2017Scientific guideline: Draft guideline on clinical investigation of recombinant and 4 human plasma-derived factor VIII products, draft: consultation open
30/10/2017Core summary of product characteristics for human plasma-derived and recombinant coagulation factor VIII products (updated)
30/10/2017Scientific guideline: Draft guideline on core SmPC for human plasma derived and recombinant coagulation factor VIII products, draft: consultation open
30/10/2017Human medicines European public assessment report (EPAR): Ibandronic acid Accord,

ibandronic acid

Revision: 7, Authorised
30/10/2017Agenda: Agenda – SME info day: supporting innovative medicines’ development and early access (updated)
30/10/2017SME info day "Supporting innovative medicines' development and early access", European Medicines Agency, London, UK, From: 17-Nov-2017, To: 17-Nov-2017 (updated)
30/10/2017Human medicines European public assessment report (EPAR): Glybera,

alipogene tiparvovec

Revision: 8, Withdrawn
30/10/2017Human medicines European public assessment report (EPAR): Prolia,

denosumab

Revision: 17, Authorised
30/10/2017CHMP opinions on consultation procedures (updated)
30/10/2017LifeGlobal Media: Consultation procedure Public Assessment Report (CPAR)
30/10/2017Report: Applications for new human medicines under evaluation by the CHMP: November 2017
30/10/2017EU Telematics (updated)
30/10/2017Information Technology Directors Group - List of nominated members (alphabetically by country) (updated)
30/10/2017Nominations to the European Union Telematics governance bodies (updated)
30/10/2017EU Telematics systems in operation (updated)
30/10/2017News and press releases: European Medicines Agency closed 1-3 November 2017
30/10/2017Adopted terms of reference (ToR) of the Telematics Change Management Board (CMB) and its key user groups
30/10/2017Fexofenadine: List of nationally authorised medicinal products - PSUSA/00001388/201703
30/10/2017Technetium (99mTc) pertechnetate: List of nationally authorised medicinal products - PSUSA/00002866/201703
27/10/2017United Kingdom’s withdrawal from the European Union ('Brexit') (updated)
27/10/2017Regulatory and procedural guideline: List of centrally authorised products requiring a notification of a change for update of annexes (updated)
27/10/2017Report: Medicinal products for human use: monthly figures - October 2017
27/10/2017Pimecrolimus: List of nationally authorised medicinal products - PSUSA/00002411/201703
27/10/2017Human medicines European public assessment report (EPAR): Epclusa,

sofosbuvir / velpatasvir

Revision: 3, Authorised
27/10/2017Procedures for monograph and list entry establishment (updated)
27/10/2017Acetyl salicylic acid / atorvastatin / ramipril: List of nationally authorised medicinal products - PSUSA/00010280/201702
27/10/2017Data anonymisation workshop , European Medicines Agency, London, UK, From: 30-Nov-2017, To: 01-Dec-2017
27/10/2017Human medicines European public assessment report (EPAR): Intelence,

etravirine

Revision: 22, Authorised
27/10/2017List of active substances involved in the pilot on signal detection in EudraVigilance by marketing authorisation holders
27/10/2017Human medicines European public assessment report (EPAR): Norvir,

ritonavir

Revision: 58, Authorised
27/10/2017Mannitol (all indications apart from cystic fibrosis): List of nationally authorised medicinal products - PSUSA/00010005/201702
27/10/2017Signal management (updated)
27/10/2017Naratriptan: List of nationally authorised medicinal products - PSUSA/00002126/201702
27/10/2017Zolmitriptan: List of nationally authorised medicinal products - PSUSA/ 00003150/201703
27/10/2017News and press releases: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 23-26 October 2017
27/10/2017Bicalutamide: List of nationally authorised medicinal products - PSUSA/00000407/201702
27/10/2017Human medicines European public assessment report (EPAR): Lymphoseek,

tilmanocept

Revision: 3, Authorised
27/10/2017Referral: Article 31 referrals, Flupirtine-containing medicinal products,

flupirtine

27/10/2017Referral: Article 107i procedures, Hydroxyethyl starch (HES) containing medicinal products,

hydroxyethyl starch (HES)

27/10/2017News and press releases: EMA starts new review of hydroxyethyl-starch containing medicines
27/10/2017News and press releases: Review of flupirtine-containing medicines started
27/10/2017Referral: Article 20 procedures, Zinbryta,

daclizumab

(updated)
27/10/2017News and press releases: PRAC recommends further restrictions for multiple sclerosis medicine Zinbryta due to risk of serious liver damage
27/10/2017Human medicines European public assessment report (EPAR): Vfend,

voriconazole

Revision: 41, Authorised
27/10/2017Human medicines European public assessment report (EPAR): Voriconazole Hikma (previously Voriconazole Hospira),

voriconazole

Revision: 4, Authorised
27/10/2017Human medicines European public assessment report (EPAR): Hexyon,

diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and Haemophilus influenzae type-b conjugate vaccine (adsorbed)

Revision: 16, Authorised
27/10/2017Human medicines European public assessment report (EPAR): Hexacima,

diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and Haemophilus influenzae type-b conjugate vaccine (adsorbed)

Revision: 15, Authorised
27/10/2017Report: Report - Industry stakeholder meeting on Brexit and operation of the centralised procedure for human medicinal products
26/10/2017Human medicines European public assessment report (EPAR): Edurant,

rilpivirine

Revision: 11, Authorised
26/10/2017Frovatriptan: List of nationally authorised medicinal products - PSUSA/00001484/201703
26/10/2017Fluconazole: List of nationally authorised medicinal products - PSUSA/00001404/201703
26/10/2017Influenza vaccine (surface antigen, inactivated): List of nationally authorised medicinal products - PSUSA/00001744/201703
26/10/2017Bacillus clausii multi-antibioresistant spores: List of nationally authorised medicinal products - PSUSA/00000284/201611
26/10/2017Bacillus clausii multi-antibioresistant spores: CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00000284/201611
26/10/2017Trainee programme (updated)
26/10/2017Opinion/decision on a Paediatric investigation plan (PIP): Rezolsta,

darunavir / cobicistat

Therapeutic area: Infectious diseases (updated)
26/10/2017Minutes of the CHMP meeting 11-14 September 2017
26/10/2017Agenda: Agenda - COMP agenda of the 30-31 October 2017 meeting
26/10/2017Influenza vaccine (split virion, inactivated, prepared in cell cultures): List of nationally authorised medicinal products - PSUSA/00010299/201703
26/10/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Entolimod

Therapeutic area: Other (updated)
26/10/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Darunavir, cobicistat, emtricitabine, tenofovir alafenamide

Therapeutic area: Infectious diseases (updated)
26/10/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Avacopan

Therapeutic area: Immunology-Rheumatology-Transplantation (updated)
26/10/2017Human medicines European public assessment report (EPAR): Blitzima,

rituximab

Revision: 1, Authorised
26/10/2017Influenza vaccine (split virion, inactivated) (non centrally authorised products): List of nationally authorised medicinal products - PSUSA/00010298/201703
26/10/2017Fish oil/olive oil/soybean oil/triglycerides medium-chain: List of nationally authorised medicinal products - PSUSA/00010223/201702
26/10/2017Influenza vaccine (surface antigen, inactivated, adjuvanted): List of nationally authorised medicinal products - PSUSA/00010300/201703
26/10/2017Opinion/decision on a Paediatric investigation plan (PIP): Zepatier,

Grazoprevir / elbasvir

Therapeutic area: Infectious diseases (updated)
26/10/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Autologous T cells transduced with lentiviral vector containing a chimeric antigen receptor directed against CD19 (CTL019)

Therapeutic area: Oncology (updated)
26/10/2017Human medicines European public assessment report (EPAR): Ifirmacombi,

irbesartan / hydrochlorothiazide

Revision: 5, Authorised
26/10/2017Opinion/decision on a Paediatric investigation plan (PIP): Latuda,

Lurasidone hydrochloride

Therapeutic area: Psychiatry (updated)
26/10/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Human fibrinogen

Therapeutic area: Haematology-Hemostaseology (updated)
26/10/2017News and press releases: EMA website briefly unavailable on 27 October
26/10/2017Opinion/decision on a Paediatric investigation plan (PIP): Lymphoseek,

Tilmanocept

Therapeutic area: Oncology/Diagnostic (updated)
26/10/2017List of the recruitment agencies used by the European Medicines Agency for interim staff (updated)
26/10/2017Requirements for quality documentation concerning biological investigational medicinal products in clinical trials (updated)
26/10/2017Overview of comments received on ‘Guideline on the requirements for quality documentation concerning biological investigational medicinal products in clinical trials’ (EMA/CHMP/BWP/534898/2008 Rev. 1)
26/10/2017Scientific guideline: Guideline on the requirements for quality documentation concerning biological investigational medicinal products in clinical trials - Revision 1, adopted
26/10/2017Orphan designation:

Inolimomab

for the: Treatment of graft versus host disease (updated)
26/10/2017Human medicines European public assessment report (EPAR): Perjeta,

pertuzumab

Revision: 12, Authorised
26/10/2017Report: ECDC, EFSA and EMA joint scientific opinion on a list of outcome indicators as regards surveillance of antimicrobial resistance and antimicrobial consumption in humans and food-producing animals
26/10/2017News and press releases: EU scientific opinion: how to assess progress on reduction of antimicrobial resistance and antimicrobial consumption
26/10/2017Human medicines European public assessment report (EPAR): Episalvan,

birch bark extract

Revision: 2, Authorised
26/10/2017Paediatric Regulation (updated)
26/10/2017Human medicines European public assessment report (EPAR): Renvela,

sevelamer carbonate

Revision: 13, Authorised
25/10/2017Human medicines European public assessment report (EPAR): Reyataz,

atazanavir sulphate

Revision: 44, Authorised
25/10/2017Human medicines European public assessment report (EPAR): Nuwiq,

simoctocog alfa (rFVIII)

Revision: 3, Authorised
25/10/2017Human medicines European public assessment report (EPAR): Siklos,

hydroxycarbamide

Revision: 13, Authorised
25/10/2017Human medicines European public assessment report (EPAR): Yervoy,

ipilimumab

Revision: 17, Authorised
25/10/2017Human medicines European public assessment report (EPAR): Truxima,

rituximab

Revision: 4, Authorised
25/10/2017Human medicines European public assessment report (EPAR): Lopinavir/Ritonavir Mylan,

lopinavir/ritonavir

Revision: 5, Authorised
25/10/2017Human medicines European public assessment report (EPAR): Neparvis,

sacubitril / valsartan

Revision: 4, Authorised
25/10/2017Human medicines European public assessment report (EPAR): Vimizim,

elosulfase alfa

Revision: 8, Authorised
25/10/2017Human medicines European public assessment report (EPAR): Lamivudine Teva Pharma B.V.,

lamivudine

Revision: 11, Authorised
25/10/2017Referral: Article 35, Zanil and associated names, and generic products thereof,

oxyclozanide

25/10/2017Report: Scientific recommendation on classification of advanced therapy medicinal products: Nuclease resistant, synthetic double-stranded small interfering RNA (siRNA)
25/10/2017Report: Scientific recommendation on classification of advanced therapy medicinal products: Viable chondrocytes cultured within a 3D hydrogel
25/10/2017Summaries of scientific recommendations on classification of advanced therapy medicinal products (updated)
25/10/2017Report: Scientific recommendation on classification of advanced therapy medicinal products: Messenger RNAs (mRNAs) encoding immunostimulatory proteins caTLR4, CD40L and CD70 and tumour associated antigens (TAA) tyrosinase, gp100, MAGE A3, MAGE C2 and PRAME
25/10/2017Report: Scientific recommendation on classification of advanced therapy medicinal products: Allogeneic human glial-restricted precursors
25/10/2017Report: Scientific recommendation on classification of advanced therapy medicinal products: Allogeneic human glial-restricted precursors
25/10/2017Opinion/decision on a Paediatric investigation plan (PIP): Mekinist,

Trametinib (dimethyl sulfoxide)

Therapeutic area: Oncology (updated)
25/10/2017Opinion/decision on a Paediatric investigation plan (PIP): Praluent,

Alirocumab

Therapeutic area: Endocrinology, -gynacology-fertility-metabolism (updated)
25/10/2017Opinion/decision on a Paediatric investigation plan (PIP): Lonquex,

Lipegfilgrastim

Therapeutic area: Oncology (updated)
25/10/2017Opinion/decision on a Paediatric investigation plan (PIP): Tafinlar,

Dabrafenib (mesilate)

Therapeutic area: Oncology (updated)
25/10/2017Opinion/decision on a Paediatric investigation plan (PIP): Byetta, Bydureon,

Exenatide

Therapeutic area: Endocrinology, -gynacology-fertility-metabolism (updated)
25/10/2017Opinion/decision on a Paediatric investigation plan (PIP): Viread,

Tenofovir (disoproxil fumarate)

Therapeutic area: Infectious diseases (updated)
25/10/2017Opinion/decision on a Paediatric investigation plan (PIP): Dificlir,

Fidaxomicin

Therapeutic area: Infectious diseases (updated)
25/10/2017Human medicines European public assessment report (EPAR): Peyona (previously Nymusa),

caffeine

Revision: 8, Authorised
25/10/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

L-asparaginase encapsulated in erythrocytes

Therapeutic area: Oncology (updated)
25/10/2017Opinion/decision on a Paediatric investigation plan (PIP): Sutent,

Sunitinib

Therapeutic area: Oncology (updated)
25/10/2017Innovation in medicines (updated)
25/10/2017EMA support for innovative veterinary medicines
25/10/2017Annex I - List of cyproterone-acetate / ethinylestradiol-containing medicinal products in the European Union (updated)
25/10/2017Annex I - List of cyproterone-acetate / ethinylestradiol-containing medicinal products in the European Union (updated)
25/10/2017List of medicinal products under additional monitoring (updated)
25/10/2017List of medicines under additional monitoring (updated)
25/10/2017List of medicinal products under additional monitoring (updated)
24/10/2017Human medicines European public assessment report (EPAR): Ritemvia,

rituximab

Revision: 1, Authorised
24/10/2017Quinine: List of nationally authorised medicinal products - PSUSA/00002598/201611
24/10/2017Quinine: CMDh scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002598/201611
24/10/2017Patients and consumers (updated)
24/10/2017Human medicines European public assessment report (EPAR): Bemfola,

follitropin alfa

Revision: 5, Authorised
24/10/2017Human medicines European public assessment report (EPAR): Mozobil,

plerixafor

Revision: 14, Authorised
24/10/2017Human medicines European public assessment report (EPAR): Nulojix,

belatacept

Revision: 9, Authorised
24/10/2017Human medicines European public assessment report (EPAR): Yondelis,

trabectedin

Revision: 22, Authorised
24/10/2017Human medicines European public assessment report (EPAR): Epoetin Alfa Hexal,

epoetin alfa

Revision: 18, Authorised
24/10/2017Human medicines European public assessment report (EPAR): Clopidogrel Teva Pharma (previously Clopidogrel HCS),

clopidogrel

Revision: 9, Withdrawn
24/10/2017Human medicines European public assessment report (EPAR): Invokana,

canagliflozin

Revision: 8, Authorised
24/10/2017Human medicines European public assessment report (EPAR): Xarelto,

rivaroxaban

Revision: 23, Authorised
24/10/2017Minutes of CHMP written procedure 14-17 August 2017
24/10/2017Orphan designation:

(S)-ethyl 2-amino-3-(4-(2-amino-6((R)-1-(4-chloro-2-(3-methyl-1H-pyrazol-1-yl)phenyl)-2,2,2-trifluoroethoxy)pyrimidin-4-yl)phenyl)propanoate

for the: Treatment of carcinoid syndrome (updated)
24/10/2017Recommendation for maintenance of orphan designation at the time of marketing authorisation: Xermelo (telotristat) for the treatment of carcinoid syndrome
24/10/2017Human medicines European public assessment report (EPAR): Zoledronic acid Mylan,

zoledronic acid

Revision: 7, Authorised
24/10/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Atacicept

Therapeutic area: Immunology-Rheumatology-Transplantation
24/10/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Lefamulin

Therapeutic area: Infectious diseases
24/10/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Human normal immunoglobulin

Therapeutic area: Immunology-Rheumatology-Transplantation
24/10/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Human normal immunoglobulin

Therapeutic area: Immunology-Rheumatology-Transplantation
24/10/2017Opinion/decision on a Paediatric investigation plan (PIP): Darzalex,

Daratumumab

Therapeutic area: Oncology
24/10/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Human normal immunoglobulin

Therapeutic area: Immunology-Rheumatology-Transplantation/Haematology-Hemostaseology
24/10/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Autologous T cells transduced with lentiviral vector containing a chimeric antigen receptor directed against CD19 (CTL019)

Therapeutic area: Oncology
24/10/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Litoxetine (benzoate)

Therapeutic area: Immunology-Rheumatology-Transplantation/Haematology-Hemostaseology
24/10/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Salmeterol (xinafoate) / fluticasone (propionate)

Therapeutic area: Pneumology-allergology
24/10/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Fluticasone (propionate)

Therapeutic area: Pneumology-allergology
24/10/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Selonsertib

Therapeutic area: Gastroentology-Hepatology
24/10/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Fenfluramine (hydrochloride)

Therapeutic area: Neurology
24/10/2017Referral: Article 35, Moxidectin-containing veterinary medicines used in cattle, sheep and horses,

moxidectin

24/10/2017Human medicines European public assessment report (EPAR): Jinarc,

tolvaptan

Revision: 3, Authorised
24/10/2017Human medicines European public assessment report (EPAR): Ninlaro,

ixazomib

Revision: 2, Authorised
24/10/2017Octenidine dihydrochloride / phenoxyethanol: CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00002199/201701
24/10/2017Octenidine dihydrochloride / phenoxyethanol: List of nationally authorised medicinal products - PSUSA/00002199/201701
23/10/2017Agenda: Agenda - PRAC draft agenda of meeting 23-26 October 2017
23/10/2017Diacerein: CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00001026/201612
23/10/2017Diacerein: List of nationally authorised medicinal products - PSUSA/00001026/201612
23/10/2017Monthly report on application procedures guidelines and related documents for veterinary medicines: September 2017
23/10/2017Report: Report on multiple sclerosis registries (updated)
23/10/2017Human medicines European public assessment report (EPAR): Bortezomib Sun,

bortezomib

Revision: 3, Authorised
23/10/2017Report: Report on cystic fibrosis registries (updated)
23/10/2017Minutes of the CVMP meeting of 5-7 September 2017
23/10/2017Topiramate: List of nationally authorised medicinal products - PSUSA/00002996/201701
23/10/2017Topiramate: CMDh scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002996/201701
23/10/2017Clinical Trial Regulation (updated)
23/10/2017Human medicines European public assessment report (EPAR): Vibativ,

telavancin

Revision: 10, Authorised
23/10/2017Human medicines European public assessment report (EPAR): Aerinaze,

desloratadine / pseudoephedrine

Revision: 14, Authorised
23/10/2017Human medicines European public assessment report (EPAR): Pradaxa,

dabigatran etexilate

Revision: 26, Authorised
23/10/2017Human medicines European public assessment report (EPAR): Xalkori,

crizotinib

Revision: 18, Authorised
23/10/2017Report: Scientific recommendation on classification of advanced therapy medicinal products: Autologous adipose tissue-derived mesenchymal stem cells
23/10/2017Report: Scientific recommendation on classification of advanced therapy medicinal products: Human autologous keratinocytes
23/10/2017Report: Scientific recommendation on classification of advanced therapy medicinal products: Stromal vascular fraction cells
23/10/2017Report: Scientific recommendation on classification of advanced therapy medicinal products: Human umbilical cord blood-derived mesenchymal stem cells
23/10/2017Human medicines European public assessment report (EPAR): Stribild,

elvitegravir / cobicistat / emtricitabine / tenofovir disoproxil

Revision: 12, Authorised
23/10/2017Report: Scientific recommendation on classification of advanced therapy medicinal products: Human autologous chondrocytes
23/10/2017Veterinary medicine European public assessment report (EPAR): Improvac,

gonadotropin-releasing-factor-analogue-protein conjugate

Revision: 16, Authorised
23/10/2017Allopurinol : List of nationally authorised medicinal products - PSUSA/00000095/201612
23/10/2017Allopurinol : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00000095/201612
23/10/2017Bendamustine hydrochloride: List of nationally authorised medicinal products - PSUSA/00003162/201701
23/10/2017Bendamustine hydrochloride: CMDh scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00003162/201701
23/10/2017Levobunolol (ophthalmic indication): List of nationally authorised medicinal products - PSUSA/00010109/201701
23/10/2017Levobunolol (ophthalmic indication): CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010109/201701
23/10/2017Scientific guideline: Reflection paper on the chemical structure and properties criteria to be considered for the evaluation of new active substance (NAS) status of chemical substances - Veterinary , adopted
23/10/2017Chemical structure and properties criteria to be considered for the evaluation of new active substance (NAS) status of chemical substances - Veterinary (updated)
23/10/2017List of signals discussed at the PRAC since September 2012 (updated)
23/10/2017New product information wording: extracts from PRAC recommendations on signals adopted at the 25-29 September 2017 PRAC
23/10/2017PRAC recommendations on signals adopted at the 25-29 September 2017 PRAC meeting, adopted
23/10/2017CAT monthly report of application procedures, guidelines and related documents on advanced therapies: October 2017
23/10/2017Human medicines European public assessment report (EPAR): Methylthioninium chloride Proveblue,

methylthioninium chloride

Revision: 17, Authorised
20/10/2017Minutes of the PRAC meeting 29 August -1 September 2017
20/10/2017PDCO monthly report of opinions on paediatric investigation plans and other activities 10-13 October 2017
20/10/2017Human medicines European public assessment report (EPAR): Dinutuximab beta EUSA (previously Dinutuximab beta Apeiron),

dinutuximab beta

Revision: 2, Authorised
20/10/2017News and press releases: Unparalleled access to clinical data - one year on
20/10/20171 year anniversary of clinical data publication
20/10/2017Human medicines European public assessment report (EPAR): Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva,

efavirenz / emtricitabine / tenofovir disoproxil

Revision: 0, Authorised
20/10/2017News and press releases: New action plan to foster development of advanced therapies
20/10/2017Advanced therapies: research and development (updated)
20/10/2017European Commission-DG Health and Food Safety and European Medicines Agency action plan on advanced therapy medicinal products (ATMPs)
20/10/2017Human medicines European public assessment report (EPAR): Olumiant,

baricitinib

Revision: 1, Authorised
20/10/2017Veterinary medicine European public assessment report (EPAR): Exzolt,

fluralaner

Revision: 0, Authorised
19/10/2017Human medicines European public assessment report (EPAR): Procysbi,

mercaptamine

Revision: 6, Authorised
19/10/2017Human medicines European public assessment report (EPAR): Neupro,

rotigotine

Revision: 24, Authorised
19/10/2017Human medicines European public assessment report (EPAR): Resolor,

prucalopride

Revision: 19, Authorised
19/10/2017Human medicines European public assessment report (EPAR): Imvanex,

modified vaccinia Ankara virus

Revision: 12, Authorised
19/10/2017News and press releases: Data privacy in the age of big data
19/10/2017European medicines agency Standard operating procedure (SOP): Standard operating procedure for review of orphan designation at the time of granting/varying a marketing authorisation (updated)
19/10/2017European medicines agency Standard operating procedure (SOP): Standard operating procedure for audit programmes and internal audits conducted by the Audit Advisory Function (updated)
19/10/2017Human medicines European public assessment report (EPAR): Rasilez,

aliskiren

Revision: 20, Authorised
19/10/2017European medicines agency Standard operating procedure (SOP): Standard operating procedure for recovery of amounts wrongly paid, off-setting of amounts wrongly paid - expenditure operations (updated)
19/10/2017European medicines agency Standard operating procedure (SOP): Standard operating procedure for amendment, cancellation or waiver of amounts receivable - revenue operations (updated)
19/10/2017Orphan designation:

Recombinant humanised monoclonal antibody against human complement component C5a

for the: Treatment of graft-versus-host disease (updated)
19/10/2017Orphan designation:

recombinant human alpha-N-acetylglucosaminidase

for the: Treatment of mucopolysaccharidosis type IIIB (Sanfilippo B syndrome) (updated)
19/10/2017Orphan designation:

(1-Methyl-2-nitro-1H-imidazole-5-yl)methyl N,N’-bis(2-bromoethyl)diamidophosphate

for the: Treatment of pancreatic cancer (updated)
19/10/2017Orphan designation:

Phenol, 4-[2-(aminomethyl)-4-thiazolyl]-2,6-bis(1,1-dimethylethyl) monohydrochloride

for the: Treatment of Huntington’s disease (updated)
19/10/2017Orphan designation:

Salirasib

for the: Treatment of pancreatic cancer (updated)
19/10/2017Human medicines European public assessment report (EPAR): Febuxostat Mylan,

febuxostat

Revision: 0, Authorised
19/10/2017Orphan designation:

Adeno-associated viral vector containing the human factor IX gene

for the: Treatment of haemophilia B (updated)
19/10/2017Roxithromycin : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002669/201612
19/10/2017Roxithromycin : List of nationally authorised medicinal products - PSUSA/00002669/201612
19/10/2017Human medicines European public assessment report (EPAR): Azilect,

rasagiline

Revision: 18, Authorised
19/10/2017Human medicines European public assessment report (EPAR): Aprovel,

irbesartan

Revision: 36, Authorised
19/10/2017Human medicines European public assessment report (EPAR): Tyverb,

lapatinib

Revision: 25, Authorised
19/10/2017Report: List of products granted eligibility to PRIME (updated)
19/10/2017Recommendations on eligibility to PRIME scheme - Adopted at the CHMP meeting of 9-12 October 2017, adopted
19/10/2017Human medicines European public assessment report (EPAR): Xagrid,

anagrelide

Revision: 31, Authorised
19/10/2017Human medicines European public assessment report (EPAR): Eviplera,

emtricitabine / rilpivirine / tenofovir disoproxil

Revision: 18, Authorised
19/10/2017Human medicines European public assessment report (EPAR): Nordimet,

methotrexate

Revision: 3, Authorised
18/10/2017Veterinary medicine European public assessment report (EPAR): Profender,

emodepside / praziquantel

Revision: 15, Authorised
18/10/2017Minutes of the COMP meeting 5-7 September 2017
18/10/2017Human medicines European public assessment report (EPAR): Pegasys,

peginterferon alfa-2a

Revision: 34, Authorised
18/10/2017Human medicines European public assessment report (EPAR): Pramipexole Teva,

pramipexole

Revision: 17, Authorised
18/10/2017Human medicines European public assessment report (EPAR): Lifmior,

etanercept

Revision: 1, Authorised
18/10/2017Human medicines European public assessment report (EPAR): Pemetrexed Accord,

pemetrexed

Revision: 1, Authorised
18/10/2017Human medicines European public assessment report (EPAR): Descovy,

emtricitabine / tenofovir alafenamide

Revision: 8, Authorised
18/10/2017Agenda: Programme and registration form - European Medicines Agency information day on measuring the impact of pharmacovigilance activities, 14 November 2017 (updated)
18/10/2017Minutes of the HMPC 17-18 July 2017 meeting
18/10/2017Human medicines European public assessment report (EPAR): Sovaldi,

sofosbuvir

Revision: 12, Authorised
18/10/2017Human medicines European public assessment report (EPAR): Eperzan,

albiglutide

Revision: 8, Authorised
18/10/2017PSUR roadmap: joint industry/assessor training, European Medicines Agency, London, UK, From: 22-Sep-2017, To: 22-Sep-2017 (updated)
17/10/2017Human medicines European public assessment report (EPAR): Aerivio Spiromax,

salmeterol / fluticasone propionate

Revision: 2, Authorised
17/10/2017Human medicines European public assessment report (EPAR): Selincro,

nalmefene

Revision: 7, Authorised
17/10/2017Quality of medicines questions and answers: Part 1 (updated)
17/10/2017Human medicines European public assessment report (EPAR): Xigduo,

dapagliflozin / metformin

Revision: 7, Authorised
17/10/2017News and press releases: EMA’s procedural handling of safety review was complete and independent
17/10/2017Human medicines European public assessment report (EPAR): Lumark,

lutetium, isotope of mass 177

Revision: 3, Authorised
17/10/2017List of European Union reference dates and frequency of submission of periodic safety update reports (updated)
17/10/2017Human medicines European public assessment report (EPAR): Orkambi,

lumacaftor / ivacaftor

Revision: 6, Authorised
17/10/2017Orphan designation:

Tacrolimus

for the: Treatment of pulmonary arterial hypertension
17/10/2017Orphan designation:

Purified pasteurised and freeze-dried cell-wall fragments from Mycobacterium tuberculosis strain RUTI

for the: Treatment of tuberculosis
17/10/2017Human medicines European public assessment report (EPAR): EndolucinBeta,

lutetium (177 Lu) chloride

Revision: 1, Authorised
17/10/2017Orphan designation:

Antisense oligonucleotide targeting exon 13 in the USH2A gene

for the: Treatment of retinitis pigmentosa
17/10/2017Orphan designation:

Recombinant truncated N-terminal fragment of human lens epithelium-derived growth factor

for the: Treatment of retinitis pigmentosa
17/10/2017Orphan designation:

Teicoplanin

for the: Treatment of cystic fibrosis
17/10/2017Orphan designation:

Sodium 2-hydroxylinoleate

for the: Treatment of pancreatic cancer
17/10/2017Orphan designation:

Salmonella typhi Ty21a strain transfected with a plasmid vector encoding the human vascular endothelial growth factor receptor 2

for the: Treatment of glioma
17/10/2017Orphan designation:

Recombinant adeno-associated viral vector serotype 5 carrying the gene for the human frataxin protein

for the: Treatment of Friedreich’s ataxia
17/10/2017Orphan designation:

Adeno-associated viral vector serotype Anc80 containing the truncated human ATP7B gene under the control of the human alpha-1 antitrypsin promoter

for the: Treatment of Wilson's disease
17/10/2017Orphan designation:

Asunercept

for the: Treatment of myelodysplastic syndromes
17/10/2017Human medicines European public assessment report (EPAR): Exviera,

dasabuvir

Revision: 9, Authorised
17/10/2017Referral: Article 31 referrals, Quinolone- and fluoroquinolone-containing medicinal products,

nalidixic acid, pipemidic acid, cinoxacin, enoxacin, pefloxacin, lomefloxacin, ciprofloxacin, levofloxacin, ofloxacin, moxifloxacin, norfloxacin, prulifloxacin, rufloxacin, flumequin

(updated)
17/10/2017Orphan designation:

Itraconazole

for the: Treatment of naevoid basal-cell carcinoma syndrome (Gorlin syndrome)
17/10/2017Orphan designation:

N-{2-[(6-{[(2,6-dichloro-3,5-dimethoxyphenyl)carbamoyl](methyl)amino}pyrimidin-4-yl)amino]-5-(4-ethylpiperazin-1-yl)phenyl}prop-2-enamide

for the: Treatment of hepatocellular carcinoma
17/10/2017Orphan designation:

Recombinant fragment of human surfactant protein-D

for the: Prevention of bronchopulmonary dysplasia
17/10/2017Orphan designation:

Sirolimus

for the: Treatment of tuberous sclerosis
17/10/2017Orphan designation:

Odiparcil

for the: Treatment of mucopolysaccharidosis type VI (Maroteaux-Lamy syndrome)
17/10/2017Orphan designation:

Picropodophyllin

for the: Treatment of glioma
16/10/2017Human medicines European public assessment report (EPAR): Hizentra,

human normal immunoglobulin (SCIg)

Revision: 15, Authorised
16/10/2017News and press releases: EMA’s Business Continuity Plan for Brexit published
16/10/2017PRIME: priority medicines (updated)
16/10/2017European Medicines Agency Brexit Preparedness Business Continuity Plan
16/10/2017PRIME eligibility requests: 2018 deadlines for submission and timetable for assessment;
16/10/2017Human medicines European public assessment report (EPAR): Viekirax,

ombitasvir / paritaprevir / ritonavir

Revision: 9, Authorised
16/10/2017Veterinary medicine European public assessment report (EPAR): Porcilis PCV M Hyo,

porcine circovirus and Mycoplasma hyopneumoniae vaccine (inactivated)

Revision: 3, Authorised
16/10/2017Human medicines European public assessment report (EPAR): Toviaz,

fesoterodine

Revision: 19, Authorised
16/10/2017European Surveillance of Veterinary Antimicrobial Consumption (ESVAC) (updated)
16/10/2017Report: Seventh ESVAC report: sales of veterinary antimicrobial agents in 30 European countries in 2015
16/10/2017News and press releases: Sales of antibiotics for animal use decrease by 13% in Europe between 2011 and 2015
16/10/2017COMP meeting report on the review of applications for orphan designation: October 2017
16/10/2017A common data model in Europe? – Why? Which? How?, European Medicines Agency, London, UK, From: 11-Dec-2017, To: 12-Dec-2017
16/10/2017HMPC: overview of assessment work – priority list (updated)
16/10/2017EudraVigilance go-live plan (updated)
16/10/2017Launch of the new EudraVigilance system: questions and answers from stakeholders (updated)
16/10/2017Scientific guideline: Draft guideline on implementation of risk assessment requirements to control elemental impurities in veterinary medicinal products, draft: consultation open
16/10/2017PDCO monthly report of opinions on paediatric investigation plans and other activities 12–15 September 2017
14/10/2017Extended EudraVigilance medicinal product dictionary (XEVMPD) training (updated)
13/10/2017Referral: Article 30 referrals, Scandonest and associated names,

mepivacaine

(updated)
13/10/2017Orphan designation:

Recombinant human monoclonal IgG1 antibody against programmed death ligand-1 (avelumab)

for the: Treatment of Merkel cell carcinoma (updated)
13/10/2017Human medicines European public assessment report (EPAR): Bavencio,

avelumab

Revision: 0, Authorised
13/10/2017Pending EC decision: Bydureon,

exenatide

Opinion date: 12-Oct-2017
13/10/2017Pending EC decision: Zytiga,

abiraterone

Opinion date: 12-Oct-2017
13/10/2017Pending EC decision: Pegasys,

peginterferon alfa-2a

Opinion date: 12-Oct-2017
13/10/2017Referral: Article 29(4) referrals, Alcover and associated names,

sodium oxybate

(updated)
13/10/2017Pending EC decision: Alecensa,

alectinib

Opinion date: 12-Oct-2017
13/10/2017Pending EC decision: Tacforius,

tacrolimus

Opinion date: 12-Oct-2017
13/10/2017Pending EC decision: Faslodex,

fulvestrant

Opinion date: 12-Oct-2017
13/10/2017News and press releases: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 9-12 October 2017
13/10/2017Pending EC decision: Cubicin,

daptomycin

Opinion date: 12-Oct-2017
13/10/2017Human medicines European public assessment report (EPAR): Elonva,

corifollitropin alfa

Revision: 11, Authorised
13/10/2017Human medicines European public assessment report (EPAR): Brimica Genuair,

aclidinium / formoterol fumarate dihydrate

Revision: 7, Authorised
13/10/2017Multiple sclerosis workshop - Registries initiative , European Medicines Agency, London, UK, From: 07-Jul-2017, To: 07-Jul-2017
13/10/2017Cystic fibrosis workshop - Registries initiative , European Medicines Agency, London, UK, From: 14-Jun-2017, To: 14-Jun-2017
13/10/2017Extrapolation of efficacy and safety in paediatric medicine development (updated)
13/10/2017Scientific guideline: Reflection paper on the use of extrapolation in the development of medicines for paediatrics, draft: consultation open
13/10/2017Human medicines European public assessment report (EPAR): Translarna,

ataluren

Revision: 7, Authorised
13/10/2017Human medicines European public assessment report (EPAR): Duaklir Genuair,

aclidinium bromide / formoterol

Revision: 7, Authorised
12/10/2017Human medicines European public assessment report (EPAR): Hirobriz Breezhaler,

indacaterol

Revision: 11, Authorised
12/10/2017Human medicines European public assessment report (EPAR): Onbrez Breezhaler,

indacaterol

Revision: 10, Authorised
12/10/20172017 Pharmacovigilance Inspectors Working Group training course, European Medicines Agency, London, UK, From: 16-Oct-2017, To: 18-Oct-2017
12/10/2017Human medicines European public assessment report (EPAR): Oslif Breezhaler,

indacaterol

Revision: 10, Authorised
12/10/2017Human medicines European public assessment report (EPAR): Aranesp,

darbepoetin alfa

Revision: 38, Authorised
12/10/2017PSUSA nationally authorised products template (updated)
12/10/2017Human medicines European public assessment report (EPAR): Vargatef,

nintedanib

Revision: 7, Authorised
12/10/2017Human medicines European public assessment report (EPAR): Zaltrap,

aflibercept

Revision: 7, Authorised
12/10/2017Report: Medicinal products for human use: monthly figures - September 2017
12/10/2017Herbal medicinal products: Cassia , Sennae fructus, Cassia senna L.; Cassia angustifolia Vahl (updated)
12/10/2017Draft European Union herbal monograph on Senna alexandrina Mill. (Cassia senna L.; Cassia angustifolia Vahl), fructus – Revision 1, draft: consultation open
12/10/2017HMPC meeting report on European Union herbal monographs, guidelines and other activities - 18-19 September 2017
12/10/2017Work programme of the European Medicines Agency 2017 (updated)
12/10/2017Human medicines European public assessment report (EPAR): Keytruda,

pembrolizumab

Revision: 10, Authorised
12/10/2017Scientific guideline: Guideline on good pharmacovigilance practices (GVP): Module XV – Safety communication with tracked changes (Rev. 1)
12/10/2017Comments received from public consultation on good pharmacovigilance practices (GVP): Module XV – Safety communication (Rev. 1)
12/10/2017Scientific guideline: Guideline on good pharmacovigilance practices: Module XV – Safety communication (Rev. 1), adopted (updated)
12/10/2017Scientific guideline: Guideline on good pharmacovigilance practices (GVP) - Module VIII – Post-authorisation safety studies (Rev. 3), adopted (updated)
12/10/2017Scientific guideline: Guideline on good pharmacovigilance practices: Annex I - Definitions (Rev. 4), adopted (updated)
12/10/2017Guideline on good pharmacovigilance practices: Annex II – Templates: Direct Healthcare Professional Communication (DHPC) (Rev. 1), adopted (updated)
12/10/2017Comments received from public consultation on good pharmacovigilance practices (GVP): Module IX Addendum I – Methodological aspects of signal detection from spontaneous reports of suspected adverse reactions
12/10/2017Scientific guideline: Guideline on good pharmacovigilance practices (GVP): Module IX Addendum I – Methodological aspects of signal detection from spontaneous reports of suspected adverse reactions, adopted
12/10/2017Draft European Union herbal monograph on Senna alexandrina Mill. (Cassia senna L.; Cassia angustifolia Vahl), folium – Revision 1, draft: consultation open
12/10/2017Regulatory and procedural guideline: Guidelines on good pharmacovigilance practices (GVP): Introductory cover note, last updated on 12 October 2017
12/10/2017Comments received from public consultation on good pharmacovigilance practices (GVP): Annex II – Templates: Communication Plan for Direct Healthcare Professional Communication (CP DHPC)
12/10/2017Guideline on good pharmacovigilance practices (GVP): Annex II – Templates: Communication Plan for Direct Healthcare Professional Communication (CP DHPC), adopted
12/10/2017Herbal medicinal products: Cassia , Sennae folium, Cassia senna L.; Cassia angustifolia Vahl (updated)
12/10/2017Scientific guideline: Guideline on good pharmacovigilance practices: Annex V – Abbreviations (Rev. 1), adopted (updated)
12/10/2017Scientific guideline: Guideline on good pharmacovigilance practices (GVP): Module IX – Signal management (Rev. 1), adopted
12/10/2017Scientific guideline: Guideline on good pharmacovigilance practices (GVP): Module VIII – Post-authorisation safety studies with tracked changes (Rev. 3)
12/10/2017Scientific guideline: Guideline on good pharmacovigilance practices: Module IX Addendum I – Methodological aspects of signal detection from spontaneous reports of suspected adverse reactions with tracked changes
12/10/2017Comments received from public consultation on good pharmacovigilance practices (GVP): Module IX – Signal management (Rev. 1)
12/10/2017Scientific guideline: Guideline on good pharmacovigilance practices (GVP): Module IX – Signal management with tracked changes (Rev. 1)
11/10/2017Human medicines European public assessment report (EPAR): Odefsey,

emtricitabine / rilpivirine / tenofovir alafenamide

Revision: 8, Authorised
11/10/2017Human medicines European public assessment report (EPAR): IntronA,

interferon alfa-2b

Revision: 29, Authorised
11/10/2017Human medicines European public assessment report (EPAR): Cerdelga,

eliglustat

Revision: 5, Authorised
11/10/2017Human medicines European public assessment report (EPAR): Dupixent,

dupilumab

Revision: 0, Authorised
11/10/2017Human medicines European public assessment report (EPAR): Genvoya,

elvitegravir / cobicistat / emtricitabine / tenofovir alafenamide

Revision: 11, Authorised
11/10/2017Human medicines European public assessment report (EPAR): Taxotere,

docetaxel

Revision: 41, Authorised
10/10/2017Sodium (updated)
10/10/2017Human medicines European public assessment report (EPAR): Kyntheum,

brodalumab

Revision: 1, Authorised
10/10/2017Human medicines European public assessment report (EPAR): Docetaxel Winthrop,

docetaxel

Revision: 25, Authorised
10/10/2017Human medicines European public assessment report (EPAR): Fareston,

toremifene

Revision: 20, Authorised
10/10/2017Human medicines European public assessment report (EPAR): Entecavir Mylan,

entecavir

Revision: 0, Authorised
10/10/2017Human medicines European public assessment report (EPAR): Suliqua,

insulin glargine / lixisenatide

Revision: 2, Authorised
10/10/2017Minutes - PDCO minutes of the 18-21 July 2017 meeting
10/10/2017Minutes - PDCO minutes of the 15-18 August 2017 meeting
10/10/2017Agenda: Agenda - PDCO agenda of the 10-13 October 2017 meeting
10/10/2017Human medicines European public assessment report (EPAR): Trevicta (previously Paliperidone Janssen),

paliperidone

Revision: 6, Authorised
10/10/2017Veterinary medicine European public assessment report (EPAR): Sileo,

dexmedetomidine

Revision: 4, Authorised
10/10/2017Withdrawn application: Tigecycline Accord, Initial authorisation (updated)
09/10/2017European Medicines Agency - Payer Community meeting, European Medicines Agency,London, UK, From: 19-Sep-2017, To: 19-Sep-2017
09/10/2017Human medicines European public assessment report (EPAR): Aptivus,

tipranavir

Revision: 34, Authorised
09/10/2017Human medicines European public assessment report (EPAR): Movymia,

teriparatide

Revision: 2, Authorised
09/10/2017Human medicines European public assessment report (EPAR): Sivextro,

tedizolid phosphate

Revision: 6, Authorised
09/10/2017Fructose and sorbitol (updated)
09/10/2017Fragrances containing allergens (updated)
09/10/2017Aspartame and phenylalanine (updated)
09/10/2017Boric acid and borates (updated)
09/10/2017Benzyl alcohol (updated)
09/10/2017Benzoic acid and benzoates (updated)
09/10/2017Phosphates (updated)
09/10/2017Propylene glycol and esters (updated)
09/10/2017Sodium laurilsulfate (updated)
09/10/2017Annex to the European Commission guideline on ‘Excipients in the labelling and package leaflet of medicinal products for human use’ (updated)
09/10/2017Cyclodextrins (updated)
09/10/2017EMA Human Scientific Committees' Working Parties with Patients’ and Consumers’ Organisations (PCWP) and Healthcare Professionals’ Organisations (HCPWP) joint meeting: info session on antimicrobial resistance, European Medicines Agency, London, UK, From: 19-Sep-2017, To: 19-Sep-2017 (updated)
09/10/2017Wheat starch containing gluten (updated)
09/10/2017Excipients labelling (updated)
09/10/2017News and press releases: Better labelling of excipients for safe use of medicines
09/10/2017Human medicines European public assessment report (EPAR): Bortezomib Hospira,

bortezomib

Revision: 2, Authorised
09/10/2017Regulatory and procedural guideline: EudraVigilance XCOMP release - EudraVigilance web application (EVWEB) version 1.0 (updated)
09/10/2017European Union BFC conversion (v.2.3) (updated)
09/10/2017UCUM units for E2B (R3) v1.0 (updated)
09/10/2017Human medicines European public assessment report (EPAR): Vaxelis,

diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and Haemophilus type b conjugate vaccine (adsorbed)

Revision: 4, Authorised
09/10/2017Agenda: Agenda - CHMP agenda of the 09-12 October 2017 meeting
09/10/2017Human medicines European public assessment report (EPAR): Constella,

linaclotide

Revision: 14, Authorised
09/10/2017Human medicines European public assessment report (EPAR): Zyllt,

clopidogrel

Revision: 9, Authorised
09/10/2017Human medicines European public assessment report (EPAR): Opdivo,

nivolumab

Revision: 11, Authorised
06/10/2017Fellowships (updated)
06/10/2017Japan (updated)
06/10/2017Scientific guideline: ICH guideline E18 on genomic sampling and management of genomic data - First version, adopted
06/10/2017ICH E11(R1) step 5 guideline on clinical investigation of medicinal products in the pediatric population (updated)
06/10/2017Scientific guideline: ICH E11(R1) guideline on clinical investigation of medicinal products in the pediatric population - Revision 1 (addendum), adopted
06/10/2017ICH E18 Guideline on genomic sampling and management of genomic data (updated)
06/10/2017ICH Q11 Development and manufacture of drug substances (chemical entities and biotechnological/biological entities) (updated)
06/10/2017ICH guideline Q11 on development and manufacture of drug substances (chemical entities and biotechnological / biological entities) – questions and answers adopted
06/10/2017News and press releases: Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 3–5 October 2017
06/10/2017MRL pending EC decision: Solvent naphtha, light aromatic - Summary opinion of the CVMP on the establishment of maximum residue limits
06/10/2017MRL pending EC decision: Fluazuron - Summary opinion of the CVMP on the establishment of maximum residue limits
06/10/2017Pending EC decision: MiPet Easecto,

sarolaner

Opinion date: 05-Oct-2017
06/10/2017Pending EC decision: SevoFlo,

sevoflurane

Opinion date: 05-Oct-2017
06/10/2017Regulatory and procedural guideline: Q&A - European Medicines Agency guidance for companies requesting classification as minor uses minor species (MUMS) / limited markets, adopted (updated)
06/10/2017Human medicines European public assessment report (EPAR): Ranexa (previously Latixa),

ranolazine

Revision: 15, Authorised
06/10/2017New product information wording: extracts from PRAC recommendations on signals adopted at the 29 August-1 September 2017 PRAC (updated)
06/10/2017Report: Summary of transfers of appropriations in budget 2017 - Management Board meeting: 5 October 2017
06/10/2017Guidance on the classification of veterinary medicinal products indicated for minor use minor species (MUMS) / limited market (updated)
06/10/2017Decision on amending budget No 1-2017
06/10/2017Scientific guideline: Guidance on the classification of veterinary medicinal products indicated for minor use minor species (MUMS) / limited market - Revision 1, adopted
06/10/2017Report: Revision of budget structure from financial year 2018
06/10/2017Outcome of written procedures during the period 12 May 2017 to 12 September 2017
06/10/2017Human medicines European public assessment report (EPAR): Blincyto,

blinatumomab

Revision: 5, Authorised
06/10/2017PRAC recommendations on signals adopted at the 29 August - 1 September 2017 PRAC meeting, adopted (updated)
06/10/2017Pending EC decision: Rabitec,

live attenuated rabies virus

Opinion date: 05-Oct-2017
06/10/2017Ipratropium: List of nationally authorised medicinal products - PSUSA/00001780/201701
06/10/2017Levosalbutamol, salbutamol : List of nationally authorised medicinal products - PSUSA/00010330/201701
06/10/2017Orphan designation:

Recombinant human growth hormone modified by fusion with two hydrophilic polypeptide chains (somavaratan)

for the: Treatment of growth-hormone deficiency (updated)
06/10/2017Human medicines European public assessment report (EPAR): Amyvid,

florbetapir (18F)

Revision: 10, Authorised
06/10/2017News and press releases: EMA Management Board: highlights of October 2017 meeting
06/10/2017Human medicines European public assessment report (EPAR): Vizamyl,

flutemetamol (18F)

Revision: 7, Authorised
06/10/2017Agenda: Agenda - CAT agenda of the 4-6 October 2017 meeting
06/10/2017Joint Drug Information Association (DIA) / European Forum for Good Clinical Practice (EFGCP) /European Medicines Agency (EMA) conference on how to optimise children's access to innovative medicines, European Medicines Agency, London, UK, From: 16-Oct-2017, To: 17-Oct-2017
06/10/2017Human medicines European public assessment report (EPAR): Orphacol,

cholic acid

Revision: 4, Authorised
05/10/2017Report: Applications for new human medicines under evaluation by the CHMP: October 2017
05/10/2017Human medicines European public assessment report (EPAR): Eylea,

aflibercept

Revision: 12, Authorised
05/10/2017European Medicines Agency process for engaging in external regulatory sciences and process improvement research activities for public and animal health (updated)
05/10/2017News and press releases: Regulatory update - EMA encourages companies to submit type I variations for 2017 by end of November
05/10/2017Human medicines European public assessment report (EPAR): Nitisinone MDK (previously Nitisinone MendeliKABS),

nitisinone

Revision: 0, Authorised
05/10/2017Newsletter: Human medicines highlights - October 2017
05/10/2017Herbal medicinal products: Artemisia, Absinthii herba, Artemisia absinthium L. (updated)
05/10/2017Loratadine : List of nationally authorised medicinal products - PSUSA/00001907/201702
05/10/2017Loratadine / pseudoephedrine : List of nationally authorised medicinal products - PSUSA/00001908/201702
05/10/2017Human medicines European public assessment report (EPAR): Humira,

adalimumab

Revision: 60, Authorised
05/10/2017Agenda: Agenda for the 97th meeting of the Management Board (updated)
05/10/2017News and press releases: EMA takes yet another step in public engagement with its first public hearing
05/10/2017Human coagulation factor VIII (inhibitor bypassing fraction): List of nationally authorised medicinal products - PSUSA/00009174/201702
05/10/2017Amisulpride: List of nationally authorised medicinal products - PSUSA/00000167/201701
05/10/2017Olodaterol: List of nationally authorised medicinal products - PSUSA/00010245/201703
04/10/2017Summary of the EMA public hearing on valproate in pregnancy
04/10/2017Human medicines European public assessment report (EPAR): Tracleer,

bosentan

Revision: 31, Authorised
04/10/2017EudraVigilance (updated)
04/10/2017Data submission on authorised medicines (Article 57) (updated)
04/10/2017News and press releases: Countdown to launch of new EudraVigilance System
04/10/2017EudraVigilance change management (updated)
04/10/2017EudraVigilance: how to register (updated)
04/10/2017Technical note on the planned EudraVigilance downtime from 8 to 21 November 2017
04/10/2017Enabling science that works for patients – leaflet (updated)
04/10/2017Hydroxyethyl starch: List of nationally authorised medicinal products - PSUSA/00001694/201703
04/10/2017Tick-borne encephalitis vaccine (inactivated) : List of nationally authorised medicinal products - PSUSA/00002951/201701
04/10/2017Human medicines European public assessment report (EPAR): Lyxumia ,

lixisenatide

Revision: 8, Authorised
03/10/2017News and press releases: EMA publishes comments on Member States’ hosting bids
03/10/2017Annex A2 - EMA technical comments on the technical requirements with respect to the candidate host member states' offers to relocate EMA
03/10/2017Annex A3 - EMA technical comments on the technical requirements with respect to the candidate host Member States’ offers to relocate the European Medicines Agency (applied methodology)
03/10/2017Annex B2 - Other criteria essential to ensure that EMA remains operational to guarantee business continuity - EMA contributions (detailed tables)
03/10/2017Annex B3 - Candidate host Member States’ offers to relocate the European Medicines Agency - EMA comments on other criteria essential to ensure that EMA remains operational to guarantee business continuity (applied methodology)
03/10/2017Annex A1 - Summary of EMA technical comments on the technical requirements with respect to the candidate host Member States’ offers to relocate EMA
03/10/2017Annex B1 - Other criteria essential to ensure that EMA remains operational to guarantee business continuity – Summary of EMA contributions
03/10/2017Orphan designation:

Trientine tetrahydrochloride

for the: Treatment of Wilson's disease (updated)
03/10/2017Human medicines European public assessment report (EPAR): Cuprior,

trientine

Revision: 0, Authorised
03/10/2017Haemophilus type b and meningococcal group c conjugate vaccine : List of nationally authorised medicinal products - PSUSA/00001583/201702
03/10/2017Orphan designation:

Ecteinascidin 743 (trabectedin)

for the: Treatment of soft tissue sarcoma (updated)
03/10/2017Orphan designation:

5-Aminolevulinic acid hydrochloride

for the: Intra-operative photodynamic diagnosis of residual glioma (updated)
03/10/2017Moxonidine : List of nationally authorised medicinal products - PSUSA/00002095/201701
03/10/2017Orphan designation:

Nelarabine

for the: Treatment of acute lymphoblastic leukaemia (updated)
03/10/2017Orphan designation:

Mecasermin

for the: Treatment of primary insulin-like growth factor-1 deficiency due to molecular or genetic defects (updated)
03/10/2017Minutes of the CAT meeting August 2017 (written procedure)
03/10/2017Agenda: Agenda - CVMP agenda of the 3-5 October 2017 meeting
03/10/2017Minutes of the CAT meeting 12-14 July 2017
03/10/2017News and press releases: General Court finds no fault in 2011 appointment procedure of EMA Executive Director
03/10/2017Oxatomide: List of nationally authorised medicinal products - PSUSA/00002233/201701
03/10/2017Cilostazol : List of nationally authorised medicinal products - PSUSA/00010209/201702
02/10/2017Public hearing on valproate - Written interventions
02/10/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Sotagliflozin

Therapeutic area: Endocrinology, -gynacology-fertility-metabolism (updated)
02/10/2017Opinion/decision on a Paediatric investigation plan (PIP): Relenza,

Zanamivir

Therapeutic area: Infectious diseases (updated)
02/10/2017Human medicines European public assessment report (EPAR): Faslodex,

fulvestrant

Revision: 17, Authorised
02/10/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Sotagliflozin

Therapeutic area: Endocrinology, -gynacology-fertility-metabolism (updated)
02/10/2017Opinion/decision on a Paediatric investigation plan (PIP): Adcetris,

Brentuximab vedotin

Therapeutic area: Oncology (updated)
02/10/2017Opinion/decision on a Paediatric investigation plan (PIP): Albutrepenonacog alfa,

Recombinant fusion protein linking human coagulation factor IX with human albumin

Therapeutic area: Haematology-Hemostaseology (updated)
02/10/2017Opinion/decision on a Paediatric investigation plan (PIP): Genvoya,

Elvitegravir / cobicistat / emtricitabine / tenofovir alafenamide

Therapeutic area: Infectious diseases (updated)
02/10/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Recombinant varicella zoster virus (VZV) glycoprotein E

Therapeutic area: Vaccines (updated)
02/10/2017Opinion/decision on a Paediatric investigation plan (PIP): Dacogen,

Decitabine

Therapeutic area: Oncology (updated)
02/10/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Recombinant Fusion Protein Linking Coagulation Factor VIIa with Albumin (rVIIa-FP; CSL689)

Therapeutic area: Haematology-Hemostaseology (updated)
02/10/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Coagulation Factor VIIa (Recombinant)

Therapeutic area: Haematology-Hemostaseology (updated)
02/10/2017Opinion/decision on a Paediatric investigation plan (PIP): Triumeq,

Dolutegravir / abacavir / lamivudine

Therapeutic area: Infectious diseases (updated)
02/10/2017Opinion/decision on a Paediatric investigation plan (PIP): Nplate,

Romiplostim

Therapeutic area: Haematology-Hemostaseology (updated)
02/10/2017Opinion/decision on a Paediatric investigation plan (PIP): Orkambi,

Lumacaftor / ivacaftor

Therapeutic area: Other (updated)
02/10/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Semaglutide

Therapeutic area: Endocrinology, -gynacology-fertility-metabolism (updated)
02/10/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Luspatercept

Therapeutic area: Haematology-Hemostaseology (updated)
02/10/2017Opinion/decision on a Paediatric investigation plan (PIP): Lokelma,

Sodium zirconium cyclosilicate

Therapeutic area: Endocrinology, -gynacology-fertility-metabolism (updated)
02/10/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Allantoin

Therapeutic area: Dermatology (updated)
02/10/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Bivalent anti-human myostatin adnectin recombinant human IgG1-Fc fusion protein (BMS-986089)

Therapeutic area: Neurology (updated)
02/10/2017Opinion/decision on a Paediatric investigation plan (PIP): Ocaliva,

Obeticholic acid (6 alpha-ethylchenodeoxycholic acid)

Therapeutic area: Gastroentology-Hepatology (updated)
02/10/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Chlorhexidine gluconate / isopropyl alcohol

Therapeutic area: Other (updated)
02/10/2017Opinion/decision on a Paediatric investigation plan (PIP): Invokana,

Canagliflozin

Therapeutic area: Endocrinology, -gynacology-fertility-metabolism (updated)
02/10/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Recombinant Fusion Protein Linking Coagulation Factor VIIa with Albumin (rVIIa-FP; CSL689)

Therapeutic area: Haematology-Hemostaseology (updated)
02/10/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Treosulfan

Therapeutic area: Immunology-Rheumatology-Transplantation/Oncology (updated)
02/10/2017Referral: Article 31 referrals, Paracetamol-modified release,

paracetamol

(updated)
02/10/2017Human medicines European public assessment report (EPAR): Pioglitazone Actavis,

pioglitazone

Revision: 5, Authorised
02/10/2017Surgiflo haemostatic matrix kit - Ferrosan - Procedural steps and scientific information after initial consultation (updated)