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July 2017

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Date Content
31/07/2017Trisenox (arsenic trioxide) supply shortage
31/07/2017European medicines agency Standard operating procedure (SOP): Standard operating procedure for management of periodic safety update reports (PSURs) for centrally authorised veterinary medicinal products: Annex I – contact details of national competent authorities (NCAs) for PSUR submission (updated)
31/07/2017Human medicines European public assessment report (EPAR): Onglyza,

saxagliptin

Revision: 15, Authorised
31/07/2017HMPC: overview of assessment work – priority list (updated)
31/07/2017Human medicines European public assessment report (EPAR): Votubia,

everolimus

Revision: 20, Authorised
31/07/2017HMPC meeting report on European Union herbal monographs, guidelines and other activities - 17-18 July 2017
31/07/2017Referral: Article 35, Tylosin injection for mastitis
31/07/2017Withdrawn-product notification: questions and answers (updated)
31/07/2017List of withdrawn medicinal products in accordance with Art. 123(4) of the Directive (31/07/2017)
31/07/2017Human medicines European public assessment report (EPAR): Voncento,

human coagulation factor VIII / human von willebrand factor

Revision: 7, Authorised
28/07/2017Human medicines European public assessment report (EPAR): Riximyo,

rituximab

Revision: 0, Authorised
28/07/2017Joint Biologics Working Party / Quality Working Party workshop with stakeholders in relation to prior knowledge and its use in regulatory applications, European Medicines Agency, London, UK, From: 23-Nov-2017, To: 23-Nov-2017
28/07/2017Organising committee - Joint Biologics Working Party / Quality Working Party workshop with stakeholders in relation to prior knowledge and its use in regulatory applications
28/07/2017Agenda: Agenda - Joint Biologics Working Party / Quality Working Party workshop with stakeholders in relation to prior knowledge and its use in regulatory applications
28/07/2017Human medicines European public assessment report (EPAR): Rixathon,

rituximab

Revision: 0, Authorised
28/07/2017Human medicines European public assessment report (EPAR): Xaluprine (previously Mercaptopurine Nova Laboratories),

mercaptopurine

Revision: 7, Authorised
28/07/2017Predictive biomarker-based assay development in the context of drug development and lifecycle
28/07/2017News and press releases: Concept paper on development and lifecycle of personalised medicines and companion diagnostics
28/07/2017Scientific guideline: Concept paper on predictive biomarker-based assay development in the context of drug development and lifecycle, draft: consultation open
28/07/2017Scientific guideline: Guideline on Influenza vaccines – Quality module Revision 1, adopted
28/07/2017Human medicines European public assessment report (EPAR): Fluenz Tetra,

influenza vaccine (live attenuated, nasal)

Revision: 12, Authorised
28/07/2017Public statement: Public statement on Enzepi: Withdrawal of the marketing authorisation in the European Union
28/07/2017Human medicines European public assessment report (EPAR): Cubicin,

daptomycin

Revision: 25, Authorised
28/07/2017Human 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: 14, Authorised
28/07/2017List of the recruitment agencies used by the European Medicines Agency for interim staff (updated)
28/07/2017Human 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: 15, Authorised
28/07/2017Human medicines European public assessment report (EPAR): NovoThirteen,

catridecacog

Revision: 5, Authorised
28/07/2017Public statement: Public statement on Repso: Withdrawal of the marketing authorisation in the European Union
28/07/2017Human medicines European public assessment report (EPAR): Mozobil,

plerixafor

Revision: 12, Authorised
28/07/2017Scientific guideline: Draft rilpivirine film-coated tablets 25 mg product-specific 4 bioequivalence guidance, draft: consultation open
28/07/2017Rilpivirine film-coated tablets 25 mg product-specific bioequivalence guidance
28/07/2017Scientific guideline: Draft dolutegravir film-coated tablets 10 mg, 25 mg and 50 mg product-specific bioequivalence guidance - First version, draft: consultation open
28/07/2017Dolutegravir, film-coated tablet, 10mg, 25mg, 50mg, product-specific bioequivalence guidance
28/07/2017Dronedarone film-coated tablets 400 mg product-specific bioequivalence guidance
28/07/2017Paracetamol oral use, immediate release formulations product-specific bioequivalence guidance
28/07/2017Scientific guideline: Draft dronedarone film-coated tablets 400 mg product-specific bioequivalence guidance - First version, draft: consultation open
28/07/2017Scientific guideline: Draft paracetamol oral use, immediate release formulations product-specific bioequivalence guidance - First version, draft: consultation open
27/07/2017Report: Report of the East African Community (EAC) benchmarking visit to the European Medicines Agency (updated)
27/07/2017CHMP meeting dates 2019, 2020 and 2021
27/07/2017Human medicines European public assessment report (EPAR): Travatan,

travoprost

Revision: 25, Authorised
27/07/2017Minutes of the PRAC meeting 6-9 June 2017
27/07/2017Rabeprazole: List of nationally authorised medicinal products - PSUSA/00002601/201610
27/07/2017Rabeprazole: CMDh scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002601/201610
27/07/2017Newsletter: News bulletin for small and medium-sized enterprises - Issue 40
27/07/2017Human medicines European public assessment report (EPAR): Adcetris,

brentuximab vedotin

Revision: 18, Authorised
27/07/2017Human medicines European public assessment report (EPAR): Forxiga,

dapagliflozin

Revision: 10, Authorised
27/07/2017Referral: Article 31 referrals, Factor VIII (updated)
27/07/2017Human medicines European public assessment report (EPAR): Kadcyla,

trastuzumab emtansine

Revision: 8, Authorised
27/07/2017Human medicines European public assessment report (EPAR): Rasilez,

aliskiren

Revision: 19, Authorised
27/07/2017ICH E2B (R3) Electronic transmission of individual case safety reports (ICSRs) - data elements and message specification - implementation guide (updated)
27/07/2017Scientific guideline: International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use topic E 2 B (R3): Questions and answers: Data elements for transmission of individual case safety reports - Step 5, adopted (updated)
27/07/2017ICH M7 Assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk (updated)
27/07/2017Scientific guideline: International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use guideline M7 (R1) on assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk - Step 5, adopted
27/07/2017Human medicines European public assessment report (EPAR): Pantoloc Control,

pantoprazole

Revision: 13, Authorised
27/07/2017News and press releases: EU report: more evidence on link between antibiotic use and antibiotic resistance
27/07/2017PRIME: priority medicines (updated)
27/07/2017Report: List of products granted eligibility to PRIME (updated)
27/07/2017Recommendations on eligibility to PRIME scheme - Adopted at the CHMP meeting of 17-20 July 2017, adopted
27/07/2017Report: ECDC/EFSA/EMA second joint report on the integrated analysis of the consumption of antimicrobial agents and occurrence of antimicrobial resistance in bacteria from humans and food-producing animals
27/07/2017Analysis of antimicrobial consumption and resistance ('JIACRA' reports)
27/07/2017Human medicines European public assessment report (EPAR): Temodal,

temozolomide

Revision: 29, Authorised
27/07/2017COMP meeting report on the review of applications for orphan designation: July 2017
27/07/2017Veterinary medicine European public assessment report (EPAR): Osurnia,

terbinafine / florfenicol / betamethasone

Revision: 4, Authorised
26/07/2017Human medicines European public assessment report (EPAR): Sevelamer carbonate Zentiva,

sevelamer carbonate

Revision: 7, Authorised
26/07/2017Plasma-master-file certifications (updated)
26/07/2017Human medicines European public assessment report (EPAR): Renvela,

sevelamer carbonate

Revision: 12, Authorised
26/07/2017Opinion/decision on a Paediatric investigation plan (PIP): Evotaz,

Atazanavir / cobicistat

Therapeutic area: Infectious diseases
26/07/2017Opinion/decision on a Paediatric investigation plan (PIP): Cresemba,

Isavuconazonium (sulfate)

Therapeutic area: Infectious diseases
26/07/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

1-(2,2-difluoro-1,3-benzodioxol-5-yl)-N-{1-[(2R)-2,3-dihydroxypropyl]-6-fluoro-2-(1-hydroxy-2-methylpropan-2-yl)-1H-indol-5-yl}cyclopropanecarboxamide (VX-661) / ivacaftor

Therapeutic area: Pneumology-allergology
26/07/2017Opinion/decision on a Paediatric investigation plan (PIP): Epclusa,

Sofosbuvir / velpatasvir

Therapeutic area: Infectious diseases
26/07/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Human recombinant IgG1 monoclonal antibody targeting fibroblast growth factor 23 (KRN23)

Therapeutic area: Other
26/07/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Enalapril (maleate)

Therapeutic area: Cardiovascular diseases
26/07/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Ozanimod

Therapeutic area: Neurology
26/07/2017Opinion/decision on a Paediatric investigation plan (PIP): Lartruvo,

Olaratumab

Therapeutic area: Oncology
26/07/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Autologous CD34+ enriched cell fraction that contains CD34+ cells transduced with lentiviral vector that encodes for the human ARSA cDNA sequence (GSK2696274)

Therapeutic area: Other
26/07/2017Opinion/decision on a Paediatric investigation plan (PIP): Ruby-Fill (82Sr/82Rb Generator),

Rubidium (82Rb) chloride

Therapeutic area: Diagnostic
26/07/2017Opinion/decision on a Paediatric investigation plan (PIP): Sitavig and associated names,

Aciclovir

Therapeutic area: Infectious diseases
26/07/2017Opinion/decision on a Paediatric investigation plan (PIP): Aubagio,

Teriflunomide

Therapeutic area: Neurology
26/07/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Dobutamine

Therapeutic area: Cardiovascular diseases
26/07/2017Opinion/decision on a Paediatric investigation plan (PIP): Cimzia,

Certolizumab pegol

Therapeutic area: Immunology-Rheumatology-Transplantation
26/07/2017Opinion/decision on a Paediatric investigation plan (PIP): Feraccru,

Ferric maltol

Therapeutic area: Haematology-Hemostaseology
26/07/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Sirukumab

Therapeutic area: Immunology-Rheumatology-Transplantation
26/07/2017Opinion/decision on a Paediatric investigation plan (PIP): Afstyla,

Lonoctocog alfa

Therapeutic area: Haematology-Hemostaseology
26/07/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Laquinimod (sodium)

Therapeutic area: Neurology
26/07/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Damoctocog alfa pegol

Therapeutic area: Haematology-Hemostaseology
26/07/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Turoctocog alfa pegol

Therapeutic area: Haematology-Hemostaseology
26/07/2017Human medicines European public assessment report (EPAR): Incruse,

umeclidinium bromide

Revision: 7, Authorised
26/07/2017Human medicines European public assessment report (EPAR): Grepid,

clopidogrel

Revision: 14, Authorised
26/07/2017Human medicines European public assessment report (EPAR): Clopidogrel ratiopharm,

clopidogrel

Revision: 4, Authorised
26/07/2017Human medicines European public assessment report (EPAR): Kisplyx,

lenvatinib

Revision: 3, Authorised
26/07/2017Veterinary medicine European public assessment report (EPAR): Zolvix,

monepantel

Revision: 11, Authorised
26/07/2017List of medicines under additional monitoring (updated)
26/07/2017Annex X - List of domperidone-containing medicinal products in the European Union (updated)
26/07/2017Annex XIII - List of Valproate and related substances in the European Union (updated)
26/07/2017Annex X - List of domperidone-containing medicinal products in the European Union (updated)
26/07/2017Annex IX - List of combined hormonal contraceptives containing chlormadinone in the European Union (updated)
26/07/2017Annex IX - List of combined hormonal contraceptives containing chlormadinone in the European Union (updated)
26/07/2017Annex VIII - List of cilostazol-containing medicinal products in the European Union (updated)
26/07/2017Mandate of the Antimicrobial Advice Ad Hoc Expert Group (AMEG)
26/07/2017Recommendations on the use of antibiotics in animals (updated)
26/07/2017Annex VIII - List of cilostazol-containing medicinal products in the European Union (updated)
26/07/2017Annex I - List of cyproterone-acetate / ethinylestradiol-containing medicinal products in the European Union (updated)
26/07/2017List of medicinal products under additional monitoring (updated)
26/07/2017Annex I - List of cyproterone-acetate / ethinylestradiol-containing medicinal products in the European Union (updated)
26/07/2017List of medicinal products under additional monitoring (updated)
26/07/2017Signal management (updated)
26/07/2017Referral: Article 13 referrals, Cardioxane,

dexrazoxane

(updated)
26/07/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Indacaterol (acetate) / mometasone (furoate)

Therapeutic area: Pneumology-allergology
25/07/2017Minutes of the CHMP meeting 15-18 May 2017
25/07/2017News and press releases: Reducing off-label use of antimicrobials in veterinary medicine to reduce risk of resistance
25/07/2017Off-label use of antimicrobials in veterinary medicine in the European Union
25/07/2017News and press releases: Recommendations for use of aminoglycosides in animals to reduce risk of antimicrobial resistance
25/07/2017Scientific guideline: Draft reflection paper on use of aminoglycosides in animals in the European Union: development of resistance and impact on human and animal health, draft: consultation open
25/07/2017Stem cell-based products for veterinary use: Specific questions on extraneous agents to be addressed by Ad Hoc Expert Group on Veterinary Novel Therapies (ADVENT) (updated)
25/07/2017Scientific guideline: Draft reflection paper on off-label use of antimicrobials in veterinary medicine in the European Union, draft: consultation open
25/07/2017Human medicines European public assessment report (EPAR): Evra,

norelgestromin / ethinyl estradiol

Revision: 18, Authorised
25/07/2017Letrozole : CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00001842/201610
25/07/2017Baclofen (oral): CMDh scientific conclusions and grounds for the variation, amendments to the product information, and timetable for the implementation - PSUSA-00000294-201609 (updated)
25/07/2017Veterinary medicine European public assessment report (EPAR): Nobivac L4,

Vaccine to prevent Leptospira infections in dogs

Revision: 4, Authorised
25/07/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Rosuvastatin / amlodipine

Therapeutic area: Cardiovascular diseases
25/07/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Rosuvastatin (calcium) / ezetimibe

Therapeutic area: Cardiovascular diseases
25/07/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Rosuvastatin (calcium) / Ezetimibe-

Therapeutic area: Cardiovascular diseases
25/07/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Econazole (nitrate) / benzydamine (hydrochloride)

Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
25/07/2017Opinion/decision on a Paediatric investigation plan (PIP): Penthrox,

Methoxyflurane

Therapeutic area: Pain
25/07/2017Opinion/decision on a Paediatric investigation plan (PIP): Sebivo,

Telbivudine

Therapeutic area: Gastroentology-Hepatology
25/07/2017Opinion/decision on a Paediatric investigation plan (PIP): Entyvio,

Vedolizumab

Therapeutic area: Gastroentology-Hepatology
25/07/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Rosuvastatin (calcium) / ezetimibe

Therapeutic area: Cardiovascular diseases
25/07/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Abacavir / lamivudine / efavirenz

Therapeutic area: Infectious diseases
25/07/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Miridesap

Therapeutic area: Cardiovascular diseases
25/07/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Miridesap

Therapeutic area: Haematology-Hemostaseology
25/07/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Rosuvastatin / amlodipine

Therapeutic area: Cardiovascular diseases
25/07/2017Opinion/decision on a Paediatric investigation plan (PIP): Brilique,

Ticagrelor

Therapeutic area: Cardiovascular diseases
25/07/2017Opinion/decision on a Paediatric investigation plan (PIP): Relvar Ellipta and associated names,

Fluticasone (furoate) / vilanterol

Therapeutic area: Pneumology-allergology
25/07/2017Opinion/decision on a Paediatric investigation plan (PIP): Xarelto,

Rivaroxaban

Therapeutic area: Cardiovascular diseases
25/07/2017Opinion/decision on a Paediatric investigation plan (PIP): Vimpat,

Lacosamide

Therapeutic area: Neurology
25/07/2017Opinion/decision on a Paediatric investigation plan (PIP): Kalydeco,

Ivacaftor

Therapeutic area: Other
25/07/2017Opinion/decision on a Paediatric investigation plan (PIP): Palexia, Yantil, Tapentadol and associated names,

Tapentadol (hydrochloride)

Therapeutic area: Pain
25/07/2017Opinion/decision on a Paediatric investigation plan (PIP): Colobreathe,

Colistimethate sodium

Therapeutic area: Infectious diseases
25/07/2017Opinion/decision on a Paediatric investigation plan (PIP): Tecfidera,

Dimethyl fumarate

Therapeutic area: Neurology
25/07/2017Opinion/decision on a Paediatric investigation plan (PIP): Otezla,

Apremilast

Therapeutic area: Immunology-Rheumatology-Transplantation
25/07/2017Human medicines European public assessment report (EPAR): Norvir,

ritonavir

Revision: 56, Authorised
25/07/2017Opinion/decision on a Paediatric investigation plan (PIP): Votrient,

Pazopanib

Therapeutic area: Oncology
25/07/2017Opinion/decision on a Paediatric investigation plan (PIP): Otezla,

Apremilast

Therapeutic area: Dermatology
25/07/2017Presentation - MAHs access to EudraVigilance (Rodrigo Postigo)
25/07/2017Minutes - Highlights from the 11th EMA Industry Platform meeting on the operation of EU pharmacovigilance legislation
25/07/2017Presentation - Update on PRAC work plan and impact strategy (June M. Raine)
25/07/2017Presentation - Good pharmacovigilance practices for the European Union (EU-GVP) (Priya Bahri)
25/07/2017Presentation - GVP Module VI – ADR, pharmacovigilance guideline for paediatric medicines (Roberto De Lisa and Priya Bahri)
25/07/2017Presentation - Update on EudraVigilance Auditable Requirements project (Georgy Genov)
25/07/2017Presentation - GVP V and RMP template Rev 2 – update on implementation (Núria Semis-Costa and Emil Cochino)
25/07/2017Strategies to identify and mitigate risks for first-in-human and early clinical trials with investigational medicinal products (updated)
25/07/2017Scientific guideline: Guideline on strategies to identify and mitigate risks for first-in-human and early clinical trials with investigational medicinal products - Revision 1, adopted
25/07/2017Report: Medicinal products for human use: monthly figures - June 2017
25/07/2017Veterinary medicine European public assessment report (EPAR): Canigen L4,

Canine leptospirosis vaccine (inactivated)

Revision: 2, Authorised
25/07/2017News and press releases: Revised guideline on first-in-human clinical trials
25/07/2017Human medicines European public assessment report (EPAR): Oxervate,

cenegermin

Revision: 0, Authorised
25/07/2017Cetirizine / pseudoephedrine: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00000629/201608 (updated)
25/07/2017Herbal medicinal products: Salix , Salicis cortex, Salix [various species including S. purpurea L.; S. daphnoides Vill.; S. fragilis L.] (updated)
25/07/2017Letrozole : List of nationally authorised medicinal products - PSUSA/00001842/201610
25/07/2017Human medicines European public assessment report (EPAR): Eylea,

aflibercept

Revision: 11, Authorised
25/07/2017Evra : EPAR - Summary for the public (updated)
24/07/2017Human medicines European public assessment report (EPAR): Spherox,

spheroids of human autologous matrix-associated chondrocytes

Revision: 0, Authorised
24/07/2017Scientific guideline: Questions and Answers on allogenic stem cell-based products for veterinary use: Specific questions on extraneous agents, adopted
24/07/2017Scientific guideline: Concept paper on the revision of the guideline on quality, non-clinical and clinical aspects of medicinal products containing genetically modified cells - Superseeding document, draft: consultation open
24/07/2017Human medicines European public assessment report (EPAR): Ziagen,

abacavir

Revision: 34, Authorised
24/07/2017Quality, non-clinical and clinical aspects of medicinal products containing genetically modified cells (updated)
24/07/2017Human medicines European public assessment report (EPAR): Sancuso,

granisetron

Revision: 10, Authorised
24/07/2017Scientific guideline: Reflection paper on promotion of pharmacovigilance reporting, adopted (updated)
24/07/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Olmesartan medoxomil / amlodipine (besilate) / hydrochlorothiazide

Therapeutic area: Cardiovascular diseases
24/07/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Buprenorphine (hydrochloride)

Therapeutic area: Psychiatry
24/07/2017Human medicines European public assessment report (EPAR): Kiovig,

human normal immunoglobulin

Revision: 19, Authorised
24/07/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Soybean oil / Medium-chain triglycerides / Olive oil / Fish oil / Acetyl-cysteine / Alanine / Arginine / Glycine / Histidine / Isoleucin / Leucine / Lysine acetate / Methionine / Phenylalanine / Proline / Serine / Threonine / Tryptophan / Tyrosine / Valine / Glucose / Calcium chloride / Sodium glycerophosphate / Magnesium sulphate / Potassium chloride / Sodium acetate / Zinc sulphate / Malic acid

Therapeutic area: Nutrition
24/07/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Nimodipine

Therapeutic area: Neurology
24/07/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Dezamizumab

Therapeutic area: Cardiovascular diseases
24/07/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Polihexanide (PHMB)

Therapeutic area: Ophthalmology
24/07/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Mexiletine (hydrochloride)

Therapeutic area: Other
24/07/2017Opinion/decision on a Paediatric investigation plan (PIP): Xofigo,

Radium Ra223 dichloride

Therapeutic area: Oncology
24/07/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Pimodivir

Therapeutic area: Infectious diseases
24/07/2017Opinion/decision on a Paediatric investigation plan (PIP): Vimpat,

Lacosamide

Therapeutic area: Neurology
24/07/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Larotrectinib

Therapeutic area: Oncology
24/07/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Cannabidiol

Therapeutic area: Neurology
24/07/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Live, attenuated, chimeric dengue virus, serotype 1 / live, attenuated dengue virus, serotype 2 / live, attenuated, chimeric dengue virus, serotype 3 / live attenuated, chimeric dengue virus, serotype 4

Therapeutic area: Vaccines
24/07/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Rimiducid

Therapeutic area: Immunology-Rheumatology-Transplantation
24/07/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Expanded donor-derived allogenic T cells transduced with the retroviral vector expressing the transgenes for inducible caspase9 and the truncated CD19 selectable marker (BPX-501)

Therapeutic area: Immunology-Rheumatology-Transplantation
24/07/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Dezamizumab

Therapeutic area: Haematology-Hemostaseology
24/07/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Fluocinolone acetonide

Therapeutic area: Ophthalmology
24/07/2017Opinion/decision on a Paediatric investigation plan (PIP): Jardiance,

Empagliflozin

Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
24/07/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Ibuprofen / pseudoephedrine

Therapeutic area: Infectious diseases
24/07/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Omadacycline

Therapeutic area: Infectious diseases
24/07/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Omadacycline

Therapeutic area: Infectious diseases
24/07/2017Human medicines European public assessment report (EPAR): HyQvia,

human normal immunoglobulin

Revision: 10, Authorised
24/07/2017Submission of Day +25 (235) final product information annexes (QRD Form2 and Checklist) (updated)
24/07/2017Regulatory and procedural guideline: The linguistic review process of product information in the centralised procedure - Human (updated)
24/07/2017Report: Report of the 2017 annual workshop of the European network of paediatric research at the European Medicines Agency (Enpr-EMA)
24/07/2017Minutes of the second 2017 meeting of the coordinating group of the European network of paediatric research at the European Medicines Agency (Enpr-EMA)
24/07/2017Minutes of the 2017 annual members meeting of the European network of paediatric research at the European Medicines Agency (Enpr-EMA)
24/07/2017Regulatory and procedural guideline: Post-orphan medicinal product designation procedures: guidance for sponsors (updated)
24/07/2017Regulatory and procedural guideline: Dates of 2018 Scientific Advice Working Party meetings and deadlines for submission of scientific advice, protocol assistance, qualification of biomarkers and parallel consultation (EMA / EUnetHTA) requests
21/07/2017Decision of the Executive Director on a 1-year initiative for fee reductions for notifications of parallel distribution
21/07/2017Herbal medicinal products: Combination: Species diureticae, Combination: Species diureticae, Combination: maximum 4 out of 13 possible plants (updated)
21/07/2017Human medicines European public assessment report (EPAR): Dacogen,

decitabine

Revision: 9, Authorised
21/07/2017Human medicines European public assessment report (EPAR): Brimica Genuair,

aclidinium / formoterol fumarate dihydrate

Revision: 6, Authorised
21/07/2017Work plan of the CHMP Blood Products Working Party for 2017 (updated)
21/07/2017Referral: Article 29(4) referrals, Alcover and associated names,

sodium oxybate

(updated)
21/07/2017News and press releases: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 17-20 July 2017
21/07/2017News and press releases: New medicine for rare form of eye allergy in children and teenagers
21/07/2017Pending EC decision: Verkazia,

ciclosporin

Opinion date: 20-Jul-2017
21/07/2017Withdrawn application: Infinia,

alpha-1-antitrypsin

Initial authorisation
21/07/2017Pending EC decision: Humira,

adalimumab

Opinion date: 20-Jul-2017
21/07/2017Scientific advice and protocol assistance adopted during the CHMP meeting 17 – 20 July 2017, adopted
21/07/2017News and press releases: EMA’s final opinion confirms restrictions on use of linear gadolinium agents in body scans
21/07/2017Pending EC decision: Entecavir Accord,

entecavir

Opinion date: 20-Jul-2017
21/07/2017Pending EC decision: Bydureon,

exenatide

Opinion date: 20-Jul-2017
21/07/2017Pending EC decision: RoActemra,

tocilizumab

Opinion date: 20-Jul-2017
21/07/2017Pending EC decision: Sovaldi,

sofosbuvir

Opinion date: 20-Jul-2017
21/07/2017Pending EC decision: Dupixent,

dupilumab

Opinion date: 20-Jul-2017
21/07/2017Pending EC decision: Entecavir Mylan,

entecavir

Opinion date: 20-Jul-2017
21/07/2017Pending EC decision: Symtuza,

darunavir / cobicistat / emtricitabine / tenofovir alafenamide

Opinion date: 20-Jul-2017
21/07/2017Pending EC decision: Fanaptum,

iloperidone

Opinion date: 20-Jul-2017
21/07/2017Pending EC decision: Xermelo,

telotristat ethyl

Opinion date: 20-Jul-2017
21/07/2017Pending EC decision: Vimpat,

lacosamide

Opinion date: 20-Jul-2017
21/07/2017Pending EC decision: Signifor,

pasireotide

Opinion date: 20-Jul-2017
21/07/2017Pending EC decision: Lutathera,

lutetium (177Lu) oxodotreotide

Opinion date: 20-Jul-2017
21/07/2017Pending EC decision: Bavencio,

avelumab

Opinion date: 20-Jul-2017
21/07/2017Referral: Article 31 referrals, Gadolinium-containing contrast agents,

gadobenic acid / gadobutrol / gadodiamide /  gadopentetic acid / gadoteric acid / gadoteridol /  gadoversetamide / gadoxetic acid

(updated)
21/07/2017Pending EC decision: Gazyvaro,

obinutuzumab

Opinion date: 20-Jul-2017
21/07/2017Pending EC decision: Keytruda,

pembrolizumab

Opinion date: 20-Jul-2017
21/07/2017Pending EC decision: Lacosamide Accord,

lacosamide

Opinion date: 20-Jul-2017
21/07/2017Pending EC decision: Rydapt,

midostaurin

Opinion date: 20-Jul-2017
21/07/2017Pending EC decision: Tecentriq,

atezolizumab

Opinion date: 20-Jul-2017
21/07/2017European Union Network data board - Terms of reference (updated)
21/07/2017Human medicines European public assessment report (EPAR): Avastin,

bevacizumab

Revision: 47, Authorised
21/07/2017List of European Union reference dates and frequency of submission of periodic safety update reports (updated)
21/07/2017Human medicines European public assessment report (EPAR): Cotellic,

cobimetinib

Revision: 4, Authorised
21/07/2017Work plan for the Safety Working Party 2017 (updated)
21/07/2017Minutes of the COMP meeting 10-12 May 2017
21/07/2017Pending EC decision: Onzeald,

etirinotecan pegol

Opinion date: 20-Jul-2017
20/07/2017Human medicines European public assessment report (EPAR): Edistride,

dapagliflozin

Revision: 5, Authorised
20/07/2017Human medicines European public assessment report (EPAR): Lixiana,

edoxaban

Revision: 6, Authorised
20/07/2017Human medicines European public assessment report (EPAR): Ventavis,

iloprost

Revision: 24, Authorised
20/07/2017Human medicines European public assessment report (EPAR): Vibativ,

telavancin

Revision: 9, Authorised
20/07/2017Human medicines European public assessment report (EPAR): Opdivo,

nivolumab

Revision: 10, Authorised
20/07/2017Veterinary medicine European public assessment report (EPAR): Clynav, Revision: 0, Authorised
20/07/2017Referral: Article 20 procedures, Zinbryta,

daclizumab

(updated)
20/07/2017Human medicines European public assessment report (EPAR): Duaklir Genuair,

aclidinium bromide / formoterol

Revision: 6, Authorised
20/07/2017P/0365/2016: EMA decision of 21 December 2016 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for galcanezumab (EMEA-001860-PIP04-16), adopted (updated)
20/07/2017Baclofen (oral): List of nationally authorised medicinal products - PSUSA/00002209/201610 - PSUSA-00000294-201609
20/07/2017Human medicines European public assessment report (EPAR): Pregabalin Zentiva,

pregabalin

Revision: 1, Authorised
20/07/2017Heads of Medicines Agencies (updated)
20/07/2017Human medicines European public assessment report (EPAR): Apidra,

insulin glulisine

Revision: 25, Authorised
20/07/2017Human medicines European public assessment report (EPAR): Aripiprazole Mylan Pharma (previously Aripiprazole Pharmathen),

aripiprazole

Revision: 5, Authorised
20/07/2017Human medicines European public assessment report (EPAR): Synflorix,

pneumococcal polysaccharide conjugate vaccine (adsorbed)

Revision: 27, Authorised
19/07/2017Human medicines European public assessment report (EPAR): Synjardy,

empagliflozin / metformin

Revision: 9, Authorised
19/07/2017Human medicines European public assessment report (EPAR): Potactasol,

topotecan

Revision: 5, Authorised
19/07/2017Human medicines European public assessment report (EPAR): Jentadueto,

linagliptin / metformin hydrochloride

Revision: 13, Authorised
19/07/2017Agenda: Agenda - PDCO agenda of the 18-21 July 2017 meeting (updated)
19/07/2017Human medicines European public assessment report (EPAR): Erbitux,

cetuximab

Revision: 25, Authorised
19/07/2017Human medicines European public assessment report (EPAR): Pregabalin Mylan,

pregabalin

Revision: 2, Authorised
19/07/2017Human medicines European public assessment report (EPAR): Uptravi,

selexipag

Revision: 3, Authorised
19/07/2017Human medicines European public assessment report (EPAR): Imatinib Accord,

imatinib

Revision: 12, Authorised
19/07/2017Human medicines European public assessment report (EPAR): Trajenta,

linagliptin

Revision: 10, Authorised
19/07/2017Human medicines European public assessment report (EPAR): Brintellix,

vortioxetine

Revision: 9, Authorised
19/07/2017Human medicines European public assessment report (EPAR): Natpar,

parathyroid hormone

Revision: 1, Authorised
19/07/2017Human medicines European public assessment report (EPAR): Zinbryta,

daclizumab

Revision: 4, Authorised
19/07/2017Human medicines European public assessment report (EPAR): Jardiance,

empagliflozin

Revision: 12, Authorised
19/07/2017Human medicines European public assessment report (EPAR): Glyxambi,

empagliflozin / linagliptin

Revision: 2, Authorised
19/07/2017Human medicines European public assessment report (EPAR): Tasigna,

nilotinib

Revision: 31, Authorised
19/07/2017Mutual recognition agreements
19/07/2017News and press releases: Involving young people in EMA activities
19/07/2017Regulatory and procedural guideline: Principles on the involvement of young patients/consumers within EMA activities, adopted
18/07/2017Human medicines European public assessment report (EPAR): Isentress,

raltegravir

Revision: 29, Authorised
18/07/2017Agenda: Agenda - HMPC agenda of the 17-18 July 2017 meeting
18/07/2017Mandate of the European network of paediatric research-European Medicines Agency working groups (updated)
18/07/2017Human medicines European public assessment report (EPAR): BeneFIX,

nonacog alfa

Revision: 36, Authorised
18/07/2017Regulatory and procedural guideline: List of centrally authorised products requiring a notification of a change for update of annexes (updated)
18/07/2017Human medicines European public assessment report (EPAR): Clopidogrel Krka d.d. (previously Zopya),

clopidogrel

Revision: 7, Authorised
18/07/2017Human medicines European public assessment report (EPAR): Bexsero,

meningococcal group-B vaccine (rDNA, component, adsorbed)

Revision: 15, Authorised
18/07/2017Withdrawn application: Elmisol,

levamisole

Initial authorisation (updated)
18/07/2017Human medicines European public assessment report (EPAR): Memantine Merz,

memantine hydrochloride

Revision: 5, Authorised
18/07/2017Human medicines European public assessment report (EPAR): Celsentri,

maraviroc

Revision: 20, Authorised
18/07/2017Human medicines European public assessment report (EPAR): Xagrid,

anagrelide

Revision: 30, Authorised
18/07/2017Human medicines European public assessment report (EPAR): Prezista,

darunavir

Revision: 40, Authorised
17/07/2017How to submit information (updated)
17/07/2017Paediatric investigation plans: questions and answers (updated)
17/07/2017Human medicines European public assessment report (EPAR): Xtandi,

enzalutamide

Revision: 11, Authorised
17/07/2017Methoxyflurane: List of nationally authorised medicinal products - PSUSA/00010484/201611
17/07/2017Procurement (updated)
17/07/2017Orphan designation:

Recombinant human factor IX protein modified with three point mutations

for the: Treatment of haemophilia B
17/07/2017Orphan designation:

Tripotassium citrate monohydrate and potassium hydrogen carbonate

for the: Treatment of distal renal tubular acidosis
17/07/2017Orphan designation:

Sirolimus

for the: Treatment of tuberous sclerosis
17/07/2017Orphan designation:

Avacopan

for the: Treatment of C3 glomerulopathy
17/07/2017Orphan designation:

Decitabine and tetrahydrouridine

for the: Treatment of sickle cell disease
17/07/2017Orphan designation:

Synthetic glucagon analogue modified to contain 7 amino acid substitutions

for the: Treatment of congenital hyperinsulinism
17/07/2017Orphan designation:

Sildenafil

for the: Treatment of congenital diaphragmatic hernia
17/07/2017Orphan designation:

Ibutamoren mesilate

for the: Treatment of growth hormone deficiency
17/07/2017Orphan designation:

Asp-Arg-Val-Tyr-Ile-His-Pro

for the: Treatment of epidermolysis bullosa
17/07/2017Orphan designation:

Pentamer formyl thiophene acetic acid

for the: Treatment of Creutzfeldt-Jakob disease
17/07/2017Human medicines European public assessment report (EPAR): Xeljanz,

tofacitinib

Revision: 1, Authorised
17/07/2017Human medicines European public assessment report (EPAR): Venclyxto,

venetoclax

Revision: 1, Authorised
17/07/2017Report: Report on the European Medicines Agency meeting with stakeholders - First anniversary of PRIME
17/07/2017Employee Assistance Programme and helpline
17/07/2017Agenda: Agenda - CHMP agenda of the 17-20 July 2017 meeting
17/07/2017Orphan designation:

Murine IgM monoclonal antibody binding to alpha beta T-cell receptor

for the: Prevention of graft rejection following solid organ transplantation (updated)
17/07/2017Orphan designation:

Adeno-associated viral vector serotype 9 containing the human glucocerebrosidase gene

for the: Treatment of Gaucher disease (updated)
17/07/2017Orphan designation:

Humanised monoclonal modified IgG4 antibody with bispecific structure targeting factors IX, IXa, X and Xa (emicizumab)

for the: Treatment of haemophilia A (updated)
17/07/2017Orphan designation:

Poloxamer 188

for the: Treatment of sickle-cell disease (updated)
17/07/2017Orphan designation:

DNA plasmid encoding a recombinant fusion protein consisting of the extracellular domain of human TNFα p55 receptor linked to the human IgG1 Fc domain

for the: Treatment of non-infectious uveitis (updated)
17/07/2017Orphan designation:

Sodium phenylbutyrate

for the: Treatment of 5q spinal muscular atrophy (updated)
17/07/2017Herbal medicinal products: Mentha, Menthae piperitae aetheroleum, Mentha x piperita L. (updated)
17/07/2017Orphan designation:

3-(4'Aminoisoindoline-1'-one)-1-piperidine-2,6-dione (lenalidomide)

for the: Treatment of multiple myeloma (updated)
17/07/2017Orphan designation:

3-(6-(1-(2,2-Difluorobenzo [d] [1,3] dioxol-5-yl)cyclopropanecarboxamido)-3-methylpyridin-2-yl)benzoic acid (lumacaftor)

for the: Treatment of cystic fibrosis (updated)
17/07/2017Herbal medicinal products: Aloe, Aloes folii succus siccatus, Aloe barbadensis Mill. and Aloe (various species, mainly Aloe ferox Mill. and its hybrids) (updated)
17/07/2017Orphan designation:

Betaine anhydrous

for the: Treatment of homocystinuria (updated)
14/07/2017Access to documents (updated)
14/07/2017Human medicines European public assessment report (EPAR): Tracleer,

bosentan

Revision: 30, Authorised
14/07/2017Referral: Article 30 referrals, Vepesid,

etoposide

(updated)
14/07/2017Veterinary medicine European public assessment report (EPAR): Rhiniseng,

inactivated vaccine to prevent progressive and non-progressive atrophic rhinitis in pigs

Revision: 3, Authorised
14/07/2017Referral: Article 30 referrals, Etopophos,

etoposide phosphate

(updated)
14/07/2017Human medicines European public assessment report (EPAR): Alecensa,

alectinib

Revision: 2, Authorised
14/07/2017Human medicines European public assessment report (EPAR): Somavert,

pegvisomant

Revision: 17, Authorised
14/07/2017Human medicines European public assessment report (EPAR): Lantus,

insulin glargine

Revision: 31, Authorised
14/07/2017Orphan designation:

Doxorubicin hydrochloride in a lipid-based pegylated nanoparticle modified with a 31-aminoacid peptide targeting nucleolin

for the: Treatment of malignant mesothelioma
14/07/2017Orphan designation:

(6aR, 10aR)-3-(1',1'-dimethylheptyl)-delta-8-tetrahydro-cannabinol-9-carboxylic acid

for the: Treatment of systemic sclerosis
14/07/2017Orphan designation:

Antroquinonol

for the: Treatment of pancreatic cancer
14/07/2017Post-authorisation safety studies: questions and answers (updated)
14/07/2017News and press releases: Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 11-13 July 2017
14/07/2017Timetable: Post-authorisation safety study (PASS) protocols and final results (updated)
14/07/2017Regulatory and procedural guideline: European Medicines Agency post-authorisation procedural advice for users of the centralised procedure - track changes (updated)
14/07/2017News and press releases: Regulatory information – EMA improves its guidance for post-authorisation activities
14/07/2017Appendix V - Adverse-drug-reaction reporting details (updated)
14/07/2017Regulatory and procedural guideline: Appendix IV - Terms and abbreviations for batch number and expiry date to be used on the labelling of human medicinal products (updated)
14/07/2017Arixtra (fondaparinux sodium) supply shortage (updated)
14/07/2017Agenda: Agenda - CAT agenda of the 12-14 July 2017 meeting
14/07/2017Orphan designation:

Humanised IgG1 monoclonal antibody against the receptor-binding site of human placental growth factor

for the: Treatment of medulloblastoma
14/07/2017Human medicines European public assessment report (EPAR): Bronchitol,

mannitol

Revision: 11, Authorised
14/07/2017Orphan designation:

Autologous dendritic cells incubated ex vivo with zebularine and factor VIII

for the: Treatment of haemophilia A
14/07/2017Orphan designation:

Recombinant IgG degrading enzyme of Streptococcus pyogenes

for the: Prevention of graft rejection following solid organ transplantation
14/07/2017Orphan designation:

3-pentylbenzeneacetic acid sodium salt

for the: Treatment of Alström syndrome
14/07/2017Human medicines European public assessment report (EPAR): Harvoni,

ledispavir 90 mg / sofosbuvir 400 mg

Revision: 12, Authorised
14/07/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Humanised monoclonal antibody IgG2 recognising the interleukin-31 receptor A (CIM331)

Therapeutic area: Dermatology (updated)
14/07/2017Orphan designation:

Recombinant adeno-associated viral vector serotype 9 containing the human N-alpha-acetylglucosaminidase gene

for the: Treatment of mucopolysaccharidosis type IIIB (Sanfilippo B syndrome)
14/07/2017Orphan designation:

Human hepatoma cell line HepaRG in bioartificial liver

for the: Treatment of acute liver failure
14/07/2017Human medicines European public assessment report (EPAR): Zerbaxa,

ceftolozane / tazobactam

Revision: 5, Authorised
13/07/2017Human medicines European public assessment report (EPAR): Atazanavir Mylan,

atazanavir

Revision: 1, Authorised
13/07/2017Orphan designation:

Enoxacin

for the: Treatment of amyotrophic lateral sclerosis (updated)
13/07/2017Orphan designation:

Recombinant human glutamate oxaloacetate transaminase 1

for the: Treatment of glioma (updated)
13/07/2017Orphan designation:

Combination of 4-hydroxyandrostenedione, Serenoa serrulata fruit extract and alpha lipoic acid

for the: Treatment of multiple symmetric lipomatosis (updated)
13/07/2017Human medicines European public assessment report (EPAR): Inflectra,

infliximab

Revision: 14, Authorised
13/07/2017Herbal medicinal products: Salvia, Salviae officinalis folium, Salvia officinalis L. (updated)
13/07/2017EU Innovation Network: E-mail addresses for users (updated)
13/07/2017Orphan designation:

Pr-D-Cys-Met-Pip-Arg-Leu-Arg-Sar-Cys-Lys-Arg-Pro-Tyr-Tle-Leu-OH

for the: Treatment of perinatal asphyxia
13/07/2017Orphan designation:

5-aminolevulinic acid

for the: Treatment of glioma
13/07/2017Veterinary medicine European public assessment report (EPAR): Econor,

valnemulin

Revision: 19, Authorised
13/07/2017Scientific guideline: Questions and answers: improving the understanding of normal operating range (NOR), proven acceptable range (PAR), design space (DSp) and normal variability of process parameters
13/07/2017Orphan designation:

Hydroxychloroquine

for the: Treatment of antiphospholipid syndrome
13/07/2017Orphan designation:

Trans-resveratrol

for the: Treatment of spinocerebellar ataxia
13/07/2017Human medicines European public assessment report (EPAR): Pemetrexed Sandoz,

pemetrexed

Revision: 2, Authorised
13/07/2017Orphan designation:

[5,10,15,20-tetrakis(4-carboxyphenyl)-21H,23H-porphine]manganese(III) chloride

for the: Treatment of Cockayne syndrome
13/07/2017Human medicines European public assessment report (EPAR): Eurartesim,

piperaquine tetraphosphate / dihydroartemisinin

Revision: 7, Authorised
13/07/2017Scientific guideline: ICH guideline Q4B Annex 10 on evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on polyacrylamide gel electrophoresis - general chapter - Step 5, adopted (updated)
13/07/2017Scientific guideline: ICH guideline Q4B Annex 9 on evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on tablet friability - general chapter - Step 5, adopted (updated)
13/07/2017Scientific guideline: ICH guideline Q4B Annex 5 on evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on disintegration test - general chapter - Step 5, adopted (updated)
13/07/2017Scientific guideline: ICH guideline Q4B Annex 4C on evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on acceptance criteria for pharmaceutical preparations and substances for pharmaceutical use - Step 5, adopted (updated)
13/07/2017Scientific guideline: ICH guideline Q4B Annex 4B on evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on Tests for specified micro-organisms - Step 5, adopted (updated)
13/07/2017Scientific guideline: ICH guideline Q4B Annex 4A on evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on micro enumeration - Step 5, adopted (updated)
13/07/2017Scientific guideline: ICH guideline Q4B Annex 3 on evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on test for particulate contamination: sub-visible particles general chapter - Step 5, adopted (updated)
13/07/2017Scientific guideline: ICH guideline Q4B annex 2 on evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on test for extractable volume of parenteral preparations general chapter - Step 5, adopted (updated)
13/07/2017Scientific guideline: ICH guideline Q4B Annex 1 on evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on residue on ignition/sulphated ash - Step 5, adopted (updated)
13/07/2017Scientific guideline: ICH guideline Q4B Annex 8 on evaluation and recommendation of pharmacopoeial texts for use in the ICH regions sterility test - general chapter - Step 5, adopted (updated)
13/07/2017Chloroquine phosphate / proguanil hydrochloride: List of nationally authorised medicinal products - PSUSA/00010207/201611
13/07/2017Pharmacovigilance Risk Assessment Committee (PRAC) (updated)
13/07/2017News and press releases: Call for independent scientific experts to join EMA’s Pharmacovigilance Risk Assessment Committee (PRAC)
13/07/2017CAT monthly report of application procedures, guidelines and related documents on advanced therapies: June 2017
13/07/2017PDCO monthly report of opinions on paediatric investigation plans and other activities 20-23 June 2017
13/07/2017Minutes of the CVMP meeting of 13-15 June 2017
13/07/2017Veterinary medicine European public assessment report (EPAR): Nexgard Spectra,

afoxolaner / milbemycin oxime

Revision: 1, Authorised
13/07/2017Human medicines European public assessment report (EPAR): Besponsa,

inotuzumab ozogamicin

Revision: 0, Authorised
13/07/2017Orphan designation:

Pegylated recombinant arginine deiminase

for the: Treatment of malignant mesothelioma (updated)
13/07/2017New vacancy: Temporary Agent (AD6), Database Administrator
13/07/2017Orphan designation:

Phosphorothioate oligonucleotide targeted to apolipoprotein C-III

for the: Treatment of familial chylomicronaemia syndrome (updated)
12/07/2017Veterinary medicine European public assessment report (EPAR): Evalon,

Eimeria acervulina, strain 003 / Eimeria brunetti, strain 034 / Eimeria maxima, strain 013 / Eimeria necatrix, strain 033 / Eimeria tenella, strain 004

Revision: 1, Authorised
12/07/2017Human medicines European public assessment report (EPAR): Zalviso,

sufentanil

Revision: 2, Authorised
12/07/2017Human medicines European public assessment report (EPAR): Onivyde,

irinotecan hydrochloride trihydrate

Revision: 1, Authorised
12/07/2017Apomorphine: List of nationally authorised medicinal products - PSUSA/00000227/201611
12/07/2017Veterinary medicine European public assessment report (EPAR): Recuvyra,

Fentanyl

Revision: 4, Withdrawn
12/07/2017Human medicines European public assessment report (EPAR): Vokanamet,

canagliflozin / metformin

Revision: 9, Authorised
12/07/2017Human medicines European public assessment report (EPAR): Removab,

catumaxomab

Revision: 5, Withdrawn
12/07/2017Monthly report on application procedures guidelines and related documents for veterinary medicines: June 2017
12/07/2017Human medicines European public assessment report (EPAR): Emtricitabine/Tenofovir disoproxil Krka d.d.,

emtricitabine / tenofovir disoproxil

Revision: 1, Authorised
11/07/2017Human medicines European public assessment report (EPAR): Tadalafil Lilly,

tadalafil

Revision: 1, Authorised
11/07/2017Ethinylestradiol / norgestimate: List of nationally authorised medicinal products - PSUSA/00001313/201610
11/07/2017Orphan designation:

Genetically modified adeno-associated viral vector serotype 9 expressing shRNA as well as a codon-optimised shRNA-insensitive wildtype PABPN1

for the: Treatment of oculopharyngeal muscular dystrophy
11/07/2017Orphan designation:

Human donor haematopoietic stem and progenitor cells that have been treated ex vivo with the protein transduction domain of the HIV-1 transactivation protein fused to MYC transcription factor

for the: Treatment in haematopoietic stem cell transplantation
11/07/2017Agenda: Agenda - COMP agenda of the 11-13 July 2017 meeting
11/07/2017Veterinary medicine European public assessment report (EPAR): Eravac,

Rabbit haemorrhagic disease vaccine (inactivated)

Revision: 1, Authorised
11/07/2017Orphan designation:

Pioglitazone hydrochloride

for the: Treatment of sudden sensorineural hearing loss
11/07/2017Orphan designation:

Pentosan polysulfate sodium

for the: Treatment of interstitial cystitis
11/07/2017Orphan designation:

Leuprorelin acetate

for the: Treatment of congenital hypogonadotropic hypogonadism
11/07/2017Veterinary medicine European public assessment report (EPAR): Eryseng Parvo,

porcine parvovirosis and swine erysipelas vaccine (inactivated)

Revision: 4, Authorised
11/07/2017Calcium salts / colecalciferol: List of nationally authorised medicinal products - PSUSA/00010386/201610
11/07/2017Regulatory and procedural guideline: EU Individual Case Safety Report (ICSR) implementation guide business rules spreadsheets
11/07/2017UCUM units for E2B (R3) v1.0
11/07/2017European Union BFC conversion (v.2.2) (updated)
11/07/2017Regulatory and procedural guideline: European Union individual case safety report (ICSR) implementation guide, adopted (updated)
11/07/2017Public hearings (updated)
11/07/2017Summary of safety concerns and list of questions for the public hearing on Valproate
11/07/2017Public hearing application form
11/07/2017Regulatory and procedural guideline: Public Hearing - Guidance for participants
11/07/2017News and press releases: EMA seeks views of public during its safety review of valproate
11/07/2017Veterinary medicine European public assessment report (EPAR): Eryseng,

swine erysipelas vaccine (inactivated)

Revision: 3, Authorised
11/07/2017Good Laboratory Practice (GLP) principles in relation to advanced therapy medicinal products (ATMPs)
11/07/2017Human medicines European public assessment report (EPAR): Clopidogrel HCS,

clopidogrel

Revision: 7, Authorised
11/07/2017Human medicines European public assessment report (EPAR): Skilarence,

dimethyl fumarate

Revision: 0, Authorised
11/07/2017Human medicines European public assessment report (EPAR): Darzalex,

daratumumab

Revision: 2, Authorised
11/07/2017Agenda: Programme and registration form - European Medicines Agency (EMA) / Drug Information Association (DIA) signal management information day (updated)
11/07/2017Human medicines European public assessment report (EPAR): Truvada,

emtricitabine / tenofovir disoproxil

Revision: 36, Authorised
11/07/2017Teicoplanin: List of nationally authorised medicinal products - PSUSA/00002878/201611
10/07/2017Human medicines European public assessment report (EPAR): Stayveer,

bosentan monohydrate

Revision: 6, Authorised
10/07/2017Human medicines European public assessment report (EPAR): Obizur,

susoctocog alfa

Revision: 3, Authorised
10/07/2017Human medicines European public assessment report (EPAR): Tadalafil Mylan,

tadalafil

Revision: 4, Authorised
10/07/2017Referral: Article 31 referrals, Micro Therapeutic Research,

-

(updated)
10/07/2017Human medicines European public assessment report (EPAR): Elonva,

corifollitropin alfa

Revision: 10, Authorised
10/07/2017Agenda: Agenda - CVMP agenda of the 11-13 July 2017 meeting
10/07/2017EudraVigilance information day, European Medicines Agency, London, UK, From: 19-Sep-2017, To: 19-Sep-2017
10/07/2017Agenda: Agenda and registration form - EudraVigilance information day on 19 September 2017
10/07/2017EMA Human Scientific Committees' Working Parties with Patients’ and Consumers’ Organisations (PCWP) and Healthcare Professionals’ Organisations (HCPWP) joint meeting, European Medicines Agency, London, UK, From: 15-Mar-2017, To: 15-Mar-2017 (updated)
10/07/2017Report: Assessment report for Article-5(3) procedure: Desloraradine-containing medicinal products
10/07/2017Agenda: Programme - Introduction to the European Union regulatory system and European Medicines Agency for international regulators and non-governmental organisations (updated)
10/07/2017Human medicines European public assessment report (EPAR): Translarna,

ataluren

Revision: 6, Authorised
10/07/2017Human coagulation factor VII: List of nationally authorised medicinal products - PSUSA/00001619/201610
10/07/2017Vortioxetine hydrobromide, 5 mg, 10 mg, 15 mg, and 20 mg immediate release tablets, vortioxetine lactate, oral drops solution 20 mg / ml product-specific bioequivalence guidance (updated)
10/07/2017Human medicines European public assessment report (EPAR): Erivedge,

vismodegib

Revision: 9, Authorised
10/07/2017Emtricitabine / rilpivirine / tenofovir disoproxil, film-coated tablets, 200 mg / 25 mg / 245 mg product-specific bioequivalence guidance (updated)
10/07/2017Clevidipine: List of nationally authorised medicinal products - PSUSA/00010288/201611
10/07/2017Lacidipine: List of nationally authorised medicinal products - PSUSA/00001815/201610
10/07/2017Elvitegravir / cobicistat / emtricitabine / tenofovir disoproxil film-coated tablets 150 mg / 150 mg / 200 mg / 245 mg product-specific bioequivalence guidance (updated)
10/07/2017Allergen for diagnostic - skin prick test containing only Phleum Pratense (product authorised via mutually recognition procedure): List of nationally authorised medicinal products - PSUSA/00010466/201610
10/07/2017Elvitegravir 85 mg & 150 mg film-coated tablets product-specific bioequivalence guidance (updated)
10/07/2017Hydroxycarbamide (except for centrally authorised product): List of nationally authorised medicinal products - PSUSA/00009182/201612
10/07/2017Isoflurane: List of nationally authorised medicinal products - PSUSA/00001786/201610
10/07/2017Crizotinib hard capsules 200 mg and 250 mg product-specific bioequivalence guidance (updated)
10/07/2017Treprostinil: List of nationally authorised medicinal products - PSUSA/00003013/201611
10/07/2017Human medicines European public assessment report (EPAR): Glybera,

alipogene tiparvovec

Revision: 8, Authorised
10/07/2017Benzalkonium chloride / chlorhexidine digluconate: List of nationally authorised medicinal products - PSUSA/00010070/201611
10/07/2017Human medicines European public assessment report (EPAR): Aflunov,

prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted)

Revision: 8, Authorised
10/07/2017Workshop on generation and use of Health Based Exposure Limits (HBEL), European Medicines Agency, London, UK, From: 20-Jun-2017, To: 21-Jun-2017 (updated)
07/07/2017Human medicines European public assessment report (EPAR): Pemetrexed Fresenius Kabi,

pemetrexed

Revision: 1, Authorised
07/07/2017Human medicines European public assessment report (EPAR): Descovy,

emtricitabine / tenofovir alafenamide

Revision: 6, Authorised
07/07/2017Human medicines European public assessment report (EPAR): Matever,

levetiracetam

Revision: 16, Authorised
07/07/2017Human medicines European public assessment report (EPAR): Genvoya,

elvitegravir / cobicistat / emtricitabine / tenofovir alafenamide

Revision: 9, Authorised
07/07/2017Human medicines European public assessment report (EPAR): Sprycel,

dasatinib

Revision: 28, Authorised
07/07/2017Report: Hearing the Association of the European Self-Medication Industry during the March 2017 Working Party on Community Monographs and Community List meeting
07/07/2017Human medicines European public assessment report (EPAR): Talmanco (previously Tadalafil Generics),

tadalafil

Revision: 2, Authorised
07/07/2017Human medicines European public assessment report (EPAR): Tolucombi,

telmisartan / hydrochlorothiazide

Revision: 5, Authorised
07/07/2017Electronic submission of Article 57(2) data: questions and answers (updated)
07/07/2017Human medicines European public assessment report (EPAR): Pandemic influenza vaccine H5N1 AstraZeneca (previously Pandemic influenza vaccine H5N1 Medimmune),

pandemic influenza vaccine (H5N1) (live attenuated, nasal)

Revision: 2, Authorised
07/07/2017Agenda: Agenda - Second EMA-EFPIA annual bilateral meeting
07/07/2017Second EMA-EFPIA annual bilateral meeting, European Medicines Agency, London, UK, From: 10-Jul-2017, To: 10-Jul-2017
07/07/2017Report: Applications for new human medicines under evaluation by the CHMP: July 2017
07/07/2017Formatted table template to be inserted in each procedural submission cover letter (updated)
07/07/2017Launch of the new EudraVigilance system: questions and answers from stakeholders
07/07/2017Addendum on terms and concepts of pharmacogenomic features related to metabolism to the Guideline on the use of pharmacogenetic methodologies in the pharmacokinetic evaluation of medicinal products
07/07/2017Scientific guideline: Concept paper on an addendum on terms and concepts of pharmacogenomic features related to metabolism to the Guideline on the use of pharmacogenetic methodologies in the pharmacokinetic evaluation of medicinal products (EMA/CHMP/37646/2009), draft: consultation open
07/07/2017Human medicines European public assessment report (EPAR): Dasselta,

desloratadine

Revision: 8, Authorised
07/07/2017News and press releases: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 3-6 July 2017
07/07/2017News and press releases: EMA restricts use of multiple sclerosis medicine Zinbryta
07/07/2017Human medicines European public assessment report (EPAR): Selincro,

nalmefene

Revision: 6, Authorised
07/07/2017Referral: Article 31 referrals, Paracetamol-modified release,

paracetamol

(updated)
07/07/2017Human medicines European public assessment report (EPAR): Clopidogrel Mylan,

clopidogrel

Revision: 10, Authorised
07/07/2017Human medicines European public assessment report (EPAR): Azomyr,

desloratadine

Revision: 39, Authorised
06/07/2017Herbal medicinal products: Rubus, Rubi idaei folium, Rubus idaeus L. (updated)
06/07/2017Veterinary medicine European public assessment report (EPAR): Hiprabovis IBR Marker Live,

live gene-deleted vaccine for intramuscular use for active immunisation of cattle against infectious bovine rhinotracheitis

Revision: 4, Authorised
06/07/2017Herbal medicinal products: Rosa, Rosae flos, Rosa centifolia L.; Rosa gallica L.; Rosa damascena Mill. (updated)
06/07/2017Human medicines European public assessment report (EPAR): Cosentyx,

secukinumab

Revision: 6, Authorised
06/07/2017Human medicines European public assessment report (EPAR): Holoclar,

ex vivo expanded autologous human corneal epithelial cells containing stem cells

Revision: 3, Authorised
06/07/2017Human medicines European public assessment report (EPAR): Rebif,

interferon beta-1a

Revision: 31, Authorised
06/07/2017Human medicines European public assessment report (EPAR): Strensiq,

asfotase alfa

Revision: 5, Authorised
06/07/2017Human medicines European public assessment report (EPAR): Kaletra,

lopinavir / ritonavir

Revision: 44, Authorised
06/07/2017SPOR data management services high level changes (updated)
06/07/2017Human medicines European public assessment report (EPAR): Axumin,

fluciclovine (18F)

Revision: 0, Authorised
06/07/2017Human medicines European public assessment report (EPAR): Clopidogrel ratiopharm GmbH,

clopidogrel

Revision: 9, Authorised
06/07/2017Human medicines European public assessment report (EPAR): Viread,

tenofovir disoproxil

Revision: 46, Authorised
06/07/2017Human medicines European public assessment report (EPAR): MabThera,

rituximab

Revision: 39, Authorised
06/07/2017Veterinary medicine European public assessment report (EPAR): Prevomax,

maropitant

Revision: 0, Authorised
06/07/2017Scientific guideline: Reflection paper on the requirements for selection and justification of starting materials for the manufacture of chemical active substances, adopted (updated)
06/07/2017Veterinary Dictionary for Drug Regulatory Activities (VeDDRA) V14 dataload friendly file including deprecated terms (updated)
06/07/2017Guidance notes on the use of Veterinary Dictionary for Drug Regulatory Activities (VeDDRA) terminology for reporting suspected adverse reactions in animals and humans (updated)
06/07/2017Scientific guideline: Combined Veterinary Dictionary for Drug Regulatory Activities list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products, adopted (updated)
06/07/2017Non-current Veterinary Dictionary for Drug Regulatory Activities (VeDDRA) low level terms (LLT) and codes (updated)
06/07/2017Call for comments on the Veterinary Dictionary for Drug Regulatory Activities (VeDDRA) standard list for EudraVigilance Veterinary (EVVet) (updated)
06/07/2017Scientific guideline: Combined Veterinary Dictionary for Drug Regulatory Activities (VeDDRA) list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products, adopted (updated)
06/07/2017Template for submission of comments for the Veterinary Dictionary for Drug Regulatory Activities (VeDDRA) standard list for EudraVigilance Veterinary (EVVet)
06/07/2017Scientific guideline: List of changes to combined Veterinary Dictionary for Drug Regulatory Activities (VeDDRA) list of clinical terms for reporting suspected adverse reactions in animal and humans to veterinary medicinal products for 2017, adopted (updated)
06/07/2017EudraVigilance Veterinary (updated)
06/07/2017Human medicines European public assessment report (EPAR): Nemdatine,

memantine

Revision: 6, Authorised
06/07/2017Human medicines European public assessment report (EPAR): Xadago,

safinamide

Revision: 6, Authorised
06/07/2017Q&A: Extension applications (updated)
06/07/2017Human medicines European public assessment report (EPAR): Pregabalin Accord,

pregabalin

Revision: 3, Authorised
06/07/2017Human medicines European public assessment report (EPAR): Zurampic,

lesinurad

Revision: 3, Authorised
06/07/2017Substance, product, organisation and referential (SPOR) master data (updated)
06/07/2017Data on medicines (ISO IDMP standards)
06/07/2017Substance and product data management services
06/07/2017Referentials Management Service RMS and Organisations Management Services OMS user on-boarding plan
06/07/2017Referentials and organisations management services (updated)
06/07/2017Human medicines European public assessment report (EPAR): DuoResp Spiromax,

budesonide / formoterol

Revision: 5, Authorised
06/07/2017Human medicines European public assessment report (EPAR): Noxafil,

posaconazole

Revision: 22, Authorised
06/07/2017Human medicines European public assessment report (EPAR): RoActemra,

tocilizumab

Revision: 21, Authorised
05/07/2017Human medicines European public assessment report (EPAR): Sebivo,

telbivudine

Revision: 19, Authorised
05/07/2017Organisation Management Services OMS operating model (updated)
05/07/2017Human medicines European public assessment report (EPAR): Brinavess,

vernakalant hydrochloride

Revision: 10, Authorised
05/07/2017Human medicines European public assessment report (EPAR): Thymanax,

agomelatine

Revision: 17, Authorised
05/07/2017Human medicines European public assessment report (EPAR): Xigduo,

dapagliflozin / metformin

Revision: 6, Authorised
05/07/2017Human medicines European public assessment report (EPAR): Champix,

varenicline

Revision: 29, Authorised
05/07/2017Human medicines European public assessment report (EPAR): Darunavir Mylan,

darunavir

Revision: 1, Authorised
05/07/2017Agenda: Programme and registration form - Joint European Medicines Agency / Drug Information Association information day on measuring the impact of pharmacovigilance activities, 14 November 2017 (updated)
05/07/2017Human medicines European public assessment report (EPAR): Farydak,

panobinostat

Revision: 3, Authorised
05/07/2017Human medicines European public assessment report (EPAR): NovoRapid,

insulin aspart

Revision: 27, Authorised
05/07/2017Human medicines European public assessment report (EPAR): Clopidogrel Teva (hydrogen sulphate),

clopidogrel

Revision: 10, Authorised
05/07/2017Update on the implementation of policy on publication of clinical data (Policy 0070) – Industry associations webinar, European Medicines Agency, London, UK, From: 29-Jun-2017, To: 29-Jun-2017
05/07/2017Report: Annual accounts: Financial year 2016
05/07/2017Implementation plan for the introduction of the safety features on the packaging of centrally authorised medicinal products for human use (updated)
05/07/2017Committee for Herbal Medicinal Products (HMPC): 27-28 March 2017, European Medicines Agency, London, UK, From: 27-Mar-2017, To: 28-Mar-2017 (updated)
05/07/2017Minutes of the HMPC 27-28 March 2017 meeting
05/07/2017Report: Patients, consumers, healthcare professionals key figures - 2016
05/07/2017Human medicines European public assessment report (EPAR): Ebymect,

dapagliflozin / metformin

Revision: 5, Authorised
05/07/2017Human medicines European public assessment report (EPAR): Invokana,

canagliflozin

Revision: 7, Authorised
05/07/2017Information Technology Directors Group - List of nominated members (alphabetically by country) (updated)
04/07/2017Human medicines European public assessment report (EPAR): Flixabi,

infliximab

Revision: 3, Authorised
04/07/2017Human medicines European public assessment report (EPAR): Remsima,

infliximab

Revision: 10, Authorised
04/07/2017Human medicines European public assessment report (EPAR): Avamys,

fluticasone furoate

Revision: 16, Authorised
04/07/2017HMPC meeting report on European Union herbal monographs, guidelines and other activities - 29-30 May 2017
04/07/2017Committee for Herbal Medicinal Products (HMPC): 29-30 May 2017, European Medicines Agency, London, UK, From: 29-May-2017, To: 30-May-2017 (updated)
04/07/2017Human medicines European public assessment report (EPAR): Trulicity,

dulaglutide

Revision: 6, Authorised
04/07/2017Human medicines European public assessment report (EPAR): Twynsta,

telmisartan / amlodipine

Revision: 8, Authorised
04/07/2017Human medicines European public assessment report (EPAR): Neupro,

rotigotine

Revision: 23, Authorised
04/07/2017Human medicines European public assessment report (EPAR): Avonex,

interferon beta-1a

Revision: 28, Authorised
04/07/2017Regulatory and procedural guideline: Dossier requirements for referral, active substance master files (ASMF) and nationally authorised products (NAPs) submissions (PASS107, workshare, signal detection procedures) and ancillary medicinal substances in a medical device (updated)
04/07/2017Chlorquinaldol (vaginal tablet) / promestriene: CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00009272/201609
04/07/2017Chlorquinaldol (vaginal tablet) / promestriene: List of nationally authorised medicinal products - PSUSA/00009272/201609
04/07/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Ramipril / indapamide

Therapeutic area: Cardiovascular diseases
04/07/2017Regulatory and procedural guideline: European Medicines Agency guidance for applicants seeking scientific advice and protocol assistance (updated)
04/07/2017News and press releases: EMA and EUnetHTA step up interaction to align data requirements
04/07/2017Parallel consultation with regulators and health technology assessment bodies
04/07/2017Regulatory and procedural guideline: Dates of 2017 Scientific Advice Working Party meetings and deadlines for submission of scientific advice, protocol assistance, qualification of biomarkers and parallel consultation (EMA / EUnetHTA) requests (updated)
04/07/2017Health technology assessment bodies (updated)
04/07/2017Regulatory and procedural guideline: Guidance for parallel consultation
04/07/2017Parallel consultation: briefing document template (updated)
04/07/2017Template letter of intent for parallel consultation EMA / EUnetHTA (updated)
03/07/2017Regulatory and procedural guideline: Development of non-substantially manipulated cell-based advanced therapy medicinal products: flexibility introduced via the application of the risk-based approach
03/07/2017Human medicines European public assessment report (EPAR): Rixubis,

nonacog gamma

Revision: 5, Authorised
03/07/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Split influenza virus, inactivated containing antigens equivalent to the B-like strain (B/Yamagata lineage) / Split influenza virus, inactivated containing antigens equivalent to the B-like strain (B/Victoria lineage) / Split influenza virus, inactivated (B/Victoria lineage) / Split influenza virus, inactivated containing antigens equivalent to the A/H1N1-like strain / Split influenza virus, inactivated containing antigens equivalent to the A/H3N2-like strain

Therapeutic area: Vaccines (updated)
03/07/2017Opinion/decision on a Paediatric investigation plan (PIP): Mimpara,

Cinacalcet (hydrochloride)

Therapeutic area: Uro-nephrology (updated)
03/07/2017Opinion/decision on a Paediatric investigation plan (PIP): Iclusig,

Ponatinib

Therapeutic area: Oncology (updated)
03/07/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Erdafitinib

Therapeutic area: Oncology
03/07/2017Agenda: Agenda - PRAC draft agenda of meeting 3-6 July 2017
03/07/2017Opinion/decision on a Paediatric investigation plan (PIP): Vargatef; Ofev,

Nintedanib

Therapeutic area: Oncology
03/07/2017Human medicines European public assessment report (EPAR): Revestive,

teduglutide

Revision: 10, Authorised
03/07/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Dopamine

Therapeutic area: Cardiovascular diseases (updated)
03/07/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Small interfering RNA targeting human TRPV1 mRNA

Therapeutic area: Ophthalmology
03/07/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Recombinant modified human growth hormone

Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
03/07/2017(Co) Rapporteur (joint) assessment report of the grounds for the re-examination procedure rev. 06.17
03/07/2017Annex 1 - Active substance master file (ASMF) assessment report template - Restricted part rev. 06.17
03/07/2017Annex 1 - Active substance master file (ASMF) assessment report template - Applicant's part rev. 06.17
03/07/2017Peer reviewers comments at day 100
03/07/2017CHMP-CAT-PRAC member comments on rapporteur’s reports
03/07/2017CHMP and rapporteurs' joint assessment report template on assessment of similarity (updated)
03/07/2017Human medicines European public assessment report (EPAR): Yargesa,

miglustat

Revision: 1, Authorised
03/07/2017PRAC recommendations on signals adopted at the 6-9 June 2017 PRAC meeting, adopted
03/07/2017New product information wording: extracts from PRAC recommendations on signals adopted at the 6-9 June 2017 PRAC
03/07/2017List of signals discussed at the PRAC since September 2012 (updated)
03/07/2017Report: Annual activity report 2016
03/07/2017Human medicines European public assessment report (EPAR): Increlex,

mecasermin

Revision: 19, Authorised
03/07/2017Opinion/decision on a Paediatric investigation plan (PIP): Palexia and associated names; Yantil and associated names; Tapentadol and associated names,

Tapentadol (hydrochloride)

Therapeutic area: Pain
03/07/2017Opinion/decision on a Paediatric investigation plan (PIP): Nucala,

Mepolizumab

Therapeutic area: Pneumology-allergology
03/07/2017Opinion/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)

Therapeutic area: Infectious diseases (updated)
03/07/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

3,6-diamino-2,5-bis{N-[(1R)-1-carboxy-2-hydroxyethyl]carbamoyl}pyrazine (MB-102)

Therapeutic area: Uro-nephrology/Diagnostic
03/07/2017Human medicines European public assessment report (EPAR): Mysimba,

naltrexone / bupropion

Revision: 6, Authorised
03/07/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Avacopan

Therapeutic area: Immunology-Rheumatology-Transplantation
03/07/2017News and press releases: EMA and FDA encourage use of innovative approaches in the development of medicines for Gaucher disease
03/07/2017Cluster activities (updated)