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June 2016

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24/06/2016EMA public workshop on extrapolation of efficacy and safety in medicine development, European Medicines Agency, London, UK, From: 17-May-2016, To: 18-May-2016 (updated)
24/06/2016Orphan designation:

temsirolimus

for the: Treatment of adrenoleukodystrophy
24/06/2016Orphan designation:

Gevokizumab

for the: Treatment of chronic non-infectious uveitis (updated)
24/06/2016Orphan designation:

Gevokizumab

for the: Treatment of Schnitzler syndrome (updated)
24/06/2016Orphan designation:

Recombinant humanised anti-human interleukin-1 beta monoclonal antibody

for the: Treatment of Behçet’s disease (updated)
24/06/2016Orphan designation:

vemurafenib

for the: Treatment of Langerhans’ cell histiocytosis
24/06/2016Withdrawn application: Kyndrisa,

drisapersen

Initial authorisation
24/06/2016Orphan designation:

2-{4-[(5,6-Diphenylpyrazin-2-yl)(isopropyl)amino]butoxy}-N-(methylsulfonyl)acetamide

for the: Treatment of pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension (updated)
24/06/2016Report: Applications for new human medicines under evaluation by the CHMP: June 2016 (updated)
24/06/2016Regulatory and procedural guideline: D80 assessment report - Overview guidance rev. 6.16 (updated)
24/06/2016Pending EC decision: Arzerra,

ofatumumab

Opinion date: 23-Jun-2016
24/06/2016News and press releases: EMA reviewing veterinary medicine Velactis
24/06/2016News and press releases: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 20-23 June 2016
24/06/2016News and press releases: New cell-based therapy to support stem cell transplantation in patients with high-risk blood cancer
24/06/2016News and press releases: Start of review of medicines manufactured at Pharmaceutics International Inc., USA
24/06/2016News and press releases: Studies from Alkem Laboratories Ltd cannot be used to support medicines approval in the EU
24/06/2016News and press releases: Adempas not for use in patients with pulmonary hypertension caused by idiopathic interstitial pneumonia
24/06/2016News and press releases: EMA warns that Noxafil tablets and oral suspension have different doses and are not interchangeable
24/06/2016Referral: Article 31 referrals, Alkem (updated)
24/06/2016Pending EC decision: Nordimet,

methotrexate

Opinion date: 23-Jun-2016
24/06/2016Pending EC decision: Cinqaero,

reslizumab

Opinion date: 23-Jun-2016
24/06/2016Pending EC decision: Atazanavir Mylan,

atazanavir

Opinion date: 23-Jun-2016
24/06/2016Start of community reviews: CHMP meeting of 20-23 June 2016
24/06/2016Pending EC decision: Nevanac,

nepafenac

Opinion date: 23-Jun-2016
24/06/2016Pending EC decision: Ilaris,

canakinumab

Opinion date: 23-Jun-2016
24/06/2016Withdrawn application: Arikayce,

amikacin

Initial authorisation
24/06/2016Referral: Article 31 referrals, Pharmaceutics International Inc.
24/06/2016Pending EC decision: Cervarix,

human papillomavirus vaccine [types 16, 18] (recombinant, adjuvanted, adsorbed)

Opinion date: 23-Jun-2016
24/06/2016Pending EC decision: Keytruda,

pembrolizumab

Opinion date: 23-Jun-2016
24/06/2016Pending EC decision: Aerivio Spiromax,

fluticasone propionate / salmeterol

Opinion date: 23-Jun-2016
24/06/2016Scientific advice and protocol assistance adopted during the CHMP meeting 20-23 June 2016, adopted
24/06/2016Overview of (invented) names reviewed in June 2016 by the Name Review Group (NRG) adopted at the CHMP meeting of 20-23 June 2016, adopted
24/06/2016Pending EC decision: Ryzodeg,

insulin degludec / insulin aspart

Opinion date: 23-Jun-2016
24/06/2016Pending EC decision: Zontivity,

vorapaxar

Opinion date: 23-Jun-2016
24/06/2016Withdrawn application: Alendronic Acid / Colecalciferol Mylan,

alendronic acid / colecalciferol

Initial authorisation
24/06/2016Pending EC decision: Airexar Spiromax,

fluticasone propionate / salmeterol

Opinion date: 23-Jun-2016
24/06/2016Pending EC decision: Zalmoxis,

Allogeneic T cells genetically modified with a retroviral vector encoding for a truncated form of the human low affinity nerve growth factor receptor (ΔLNGFR) and the herpes simplex I virus thymidine kinase (HSV-TK Mut2)

Opinion date: 23-Jun-2016
24/06/2016Pending EC decision: RoActemra,

tocilizumab

Opinion date: 23-Jun-2016
24/06/2016Withdrawn application: Docetaxel SUN,

docetaxel

Initial authorisation
23/06/2016Orphan designation:

Polyethylene glycol-modified human recombinant truncated cystathionine beta-synthase

for the: Treatment of homocystinuria
23/06/2016Orphan designation:

Autologous CD34+ cells transduced with lentiviral vector encoding the human beta globin gene

for the: Treatment of beta thalassaemia intermedia and major
23/06/2016Report: Medicinal products for human use: monthly figures - May 2016
23/06/2016Herbal medicinal products: Polygonum, Polygoni avicularis herba, Polygonum aviculare L. (updated)
23/06/2016Herbal medicinal products: Helichrysum, Helichrysi flos, Helichrysum arenarium (L.) Moench (updated)
23/06/2016Herbal medicinal products: Thymus / Primula , Thymi herba / Primulae radix, Thymus vulgaris L.; Thymus zygis L. / Primula veris L.; Primula elatior (L.) Hill (updated)
23/06/2016Orphan designation:

Rimiducid

for the: Treatment of graft-versus-host disease
23/06/2016Agenda: Agenda - Workshop on single-arm trials (SAT) in oncology (updated)
23/06/2016Workshop on single-arm trials (SAT) in oncology, European Medicines Agency, London, UK, From: 30-Jun-2016, To: 30-Jun-2016 (updated)
23/06/2016European Medicines Agency (EMA) Human Scientific Committees' Working Parties with Patients’ and Consumers’ Organisations (PCWP) and Healthcare Professionals’ Organisations (HCPWP) joint meeting, European Medicines Agency, London, UK, From: 09-Mar-2016, To: 09-Mar-2016 (updated)
23/06/2016Clinical Trial Regulation (updated)
23/06/2016Regulatory and procedural guideline: List of centrally authorised products requiring a notification of a change for update of annexes (updated)
23/06/2016Human medicines European public assessment report (EPAR): Thyrogen,

thyrotropin alfa

Revision: 19, Authorised
23/06/2016Regulatory and procedural guideline: Post-orphan medicinal product designation procedures: guidance for sponsors (updated)
23/06/2016Template - Orphan designation sponsor’s name and/or address change notification letter (updated)
23/06/2016COMP meeting report on the review of applications for orphan designation: June 2016
23/06/2016Orphan designation:

Rovalpituzumab tesirine

for the: Treatment of small cell lung cancer
23/06/2016Veterinary medicine European public assessment report (EPAR): Simparica,

sarolaner

Revision: 2, Authorised
23/06/2016Human medicines European public assessment report (EPAR): Prandin,

repaglinide

Revision: 15, Authorised
23/06/2016Q&A: Type II variations (updated)
23/06/2016Type-IB variations: questions and answers (updated)
23/06/2016Type-IA variations: questions and answers (updated)
23/06/2016Human medicines European public assessment report (EPAR): Defitelio,

defibrotide

Revision: 5, Authorised
23/06/2016Human medicines European public assessment report (EPAR): Synagis,

palivizumab

Revision: 33, Authorised
23/06/2016Human medicines European public assessment report (EPAR): Halaven,

eribulin

Revision: 13, Authorised
23/06/2016Human medicines European public assessment report (EPAR): Voriconazole Accord,

voriconazole

Revision: 5, Authorised
23/06/2016Human medicines European public assessment report (EPAR): Trobalt,

retigabine

Revision: 11, Authorised
23/06/2016Human medicines European public assessment report (EPAR): Plenadren,

hydrocortisone

Revision: 5, Authorised
22/06/2016Human medicines European public assessment report (EPAR): Docetaxel Winthrop,

docetaxel

Revision: 22, Authorised
22/06/2016Human medicines European public assessment report (EPAR): Xadago,

safinamide

Revision: 4, Authorised
22/06/2016Human medicines European public assessment report (EPAR): Rasagiline Mylan,

rasagiline

Revision: 1, Authorised
22/06/2016Human medicines European public assessment report (EPAR): Jevtana,

cabazitaxel

Revision: 13, Authorised
22/06/2016Orphan designation:

H-Phe-Ser-Arg-Tyr-Ala-Arg-OH acetate

for the: Treatment of amyotrophic lateral sclerosis
22/06/2016Orphan designation:

Sodium nitrite and ethylenediaminetetraacetic acid

for the: Treatment of cystic fibrosis
22/06/2016Human medicines European public assessment report (EPAR): Taxotere,

docetaxel

Revision: 38, Authorised
22/06/2016Human medicines European public assessment report (EPAR): Competact,

pioglitazone / metformin

Revision: 15, Authorised
22/06/2016Orphan designation:

Pentosan polysulfate sodium

for the: Treatment of interstitial cystitis
22/06/2016Veterinary medicine European public assessment report (EPAR): Bravecto,

Fluralaner

Revision: 2, Authorised
22/06/2016Withdrawn application: Xegafri,

rociletinib

Initial authorisation (updated)
22/06/2016Orphan designation:

Recombinant adeno-associated viral vector containing the human RPGR gene

for the: Treatment of retinitis pigmentosa caused by mutations in the RPGR gene
22/06/2016Terms of reference for the European Medicines Agency / Food and Drug Administration cluster on patient engagement
22/06/2016Cluster activities (updated)
22/06/2016Human medicines European public assessment report (EPAR): Tafinlar,

dabrafenib

Revision: 9, Authorised
22/06/2016Current tenders for €135,000 or more (updated)
22/06/2016Human medicines European public assessment report (EPAR): Ravicti,

 glycerol phenylbutyrate

Revision: 3, Authorised
22/06/2016Veterinary medicine European public assessment report (EPAR): BTVPUR,

bluetongue vaccine (inactivated) (multistrain:1-2 strains out of a set of 3)

Revision: 5, Authorised
22/06/2016News and press releases: EMA and FDA reinforce collaboration on patient engagement
21/06/2016Agenda: Agenda for the 92nd meeting of the Management Board (updated)
21/06/2016European Union (EU) workshop on ICH Q3D from a quality perspective, European Medicines Agency, London, UK, From: 05-Apr-2016, To: 06-Apr-2016 (updated)
21/06/2016Human medicines European public assessment report (EPAR): Duaklir Genuair,

aclidinium bromide / formoterol

Revision: 4, Authorised
21/06/2016Appendix to the European Medicines Agency Code of Conduct
21/06/2016Management Board meeting: 16 June 2016, European Medicines Agency, London, UK, From: 16-Jun-2016, To: 16-Jun-2016 (updated)
21/06/2016Summary of transfer of appropriations in the budget 2016
21/06/2016Outcome of written procedures finalised during the period from 20 February 2016 to 11 May 2016
21/06/2016Management Board meeting dates 2017-2018
21/06/2016European Medicines Agency’s interaction with patients, consumers, healthcare professionals and their organisations - Annual report 2015
21/06/2016The European Medicines Agency code of conduct (updated)
21/06/2016Human medicines European public assessment report (EPAR): Zebinix,

eslicarbazepine acetate

Revision: 17, Authorised
21/06/2016Human medicines European public assessment report (EPAR): Tygacil,

tigecycline

Revision: 24, Authorised
21/06/2016Referral: Article 30 referrals, Cymevene,

ganciclovir

(updated)
21/06/2016Conditions of employment (updated)
21/06/2016Application process (updated)
21/06/2016Human medicines European public assessment report (EPAR): Votubia,

everolimus

Revision: 18, Authorised
21/06/2016Careers (updated)
21/06/2016List of nationally authorised medicinal products: tetrabenazine PSUSA/00002911/201510
20/06/2016Human medicines European public assessment report (EPAR): Bortezomib Accord,

bortezomib

Revision: 1, Authorised
20/06/2016Human medicines European public assessment report (EPAR): Betmiga,

mirabegron

Revision: 8, Authorised
20/06/2016Veterinary medicine European public assessment report (EPAR): Advocate,

imidacloprid / moxidectin

Revision: 15, Authorised
20/06/2016Template letter of intent for request of scientific advice or protocol assistance (updated)
20/06/2016European Surveillance of Veterinary Antimicrobial Consumption (ESVAC) web based data collection form (updated)
20/06/2016European Surveillance of Veterinary Antimicrobial Consumption (ESVAC) web based sales and and animal population data collection protocol (updated)
20/06/2016HMPC: overview of assessment work – priority list (updated)
20/06/2016Agenda: Agenda - CHMP agenda of the 20-23 June 2016 meeting
20/06/2016List of nationally authorised medicinal products: bromocriptine PSUSA/00000438/201510
20/06/2016Human medicines European public assessment report (EPAR): Repaglinide Teva,

repaglinide

Revision: 6, Authorised
20/06/2016Herbal medicinal products: Valeriana, Valerianae aetheroleum, Valeriana officinalis (updated)
20/06/2016Human medicines European public assessment report (EPAR): Velcade,

bortezomib

Revision: 38, Authorised
20/06/2016Veterinary medicine European public assessment report (EPAR): Fungitraxx,

itraconazole

Revision: 1, Authorised
17/06/2016Veterinary medicine European public assessment report (EPAR): Eurican Herpes 205,

Live adjuvanted vaccine against canine herpes virus

Revision: 8, Authorised
17/06/2016Delegating the EudraVigilance registration process
17/06/2016Veterinary medicine European public assessment report (EPAR): Veraflox,

pradofloxacin

Revision: 3, Authorised
17/06/2016Veterinary medicine European public assessment report (EPAR): Econor,

valnemulin

Revision: 18, Authorised
17/06/2016News and press releases: EMA Management Board: highlights of June 2016 meeting
17/06/2016Herbal medicinal products: Crataegus, Crataegi folium cum flore, Crataegus spp. (updated)
17/06/2016Pharmaceutical industry (updated)
17/06/2016Minutes of the CVMP meeting of 17-19 May 2016
17/06/2016EudraVigilance high level plan (updated)
17/06/2016EudraVigilance - Key project milestones and summary of associated ADR communications (updated)
17/06/2016Presentation - Introduction to training offering by EMA: Training module PhV-M0
17/06/2016eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) training: frequently asked questions
17/06/2016Electronic submission of Article 57(2) data: questions and answers (updated)
17/06/2016Pending EC decision: Metacam,

meloxicam

Opinion date: 16-Jun-2016
17/06/2016List of pharmaceutical dosage forms
17/06/2016Important medical event terms 19.0 list
17/06/2016EudraVigilance registration documents
17/06/2016News and press releases: Committee for Medicinal Products for Veterinary Use (CVMP) Meeting of 14-16 June 2016
17/06/2016Newsletter: Human medicines highlights - May 2016
17/06/2016Pending EC decision: Sedadex,

dexmedetomidine hydrochloride

Opinion date: 16-Jun-2016
17/06/2016List of nationally authorised medicinal products: clindamycin PSUSA/00000795/201510
17/06/2016List of nationally authorised medicinal products: piretanide PSUSA/00002433/201510
17/06/2016List of nationally authorised medicinal products: meningococcal group c polysaccharide conjugate vaccine PSUSA/00001971/201510
17/06/2016EudraVigilance training (updated)
17/06/2016Press release: EMA Management Board: highlights of June 2016 meeting
17/06/2016EudraVigilance: how to register
17/06/2016Access to EudraVigilance data
17/06/2016EudraVigilance change management
17/06/2016Extended EudraVigilance medicinal product dictionary (XEVMPD) training (updated)
17/06/2016Criteria to be fulfilled by industry stakeholder organisations involved in European Medicines Agency activities
17/06/2016European Medicines Agency (EMA) stakeholder relations management framework
17/06/2016Report: European Medicines Agency’s interaction with industry stakeholders - Annual report 2015
17/06/2016EudraVigilance registration: questions and answers
17/06/2016Human medicines European public assessment report (EPAR): Sylvant,

siltuximab

Revision: 4, Authorised
17/06/2016Human medicines European public assessment report (EPAR): MabThera,

rituximab

Revision: 37, Authorised
17/06/2016Agenda: Agenda - CAT agenda of the 16-17 June 2016 meeting
17/06/2016Human medicines European public assessment report (EPAR): Zinforo,

ceftaroline fosamil

Revision: 9, Authorised
17/06/2016EudraVigilance: electronic reporting
16/06/2016EMA response to a letter from a group of scientists clarifying the concept of adaptive pathways
16/06/2016Adaptive pathways (updated)
16/06/2016Follow up information session on the TransCelerate initiative , European Medicines Agency, London, UK, From: 17-Jun-2016, To: 17-Jun-2016
16/06/2016Report: EMA collaboration with general practitioners/ family physicians (GPs/FPs): Report from a joint EMA workshop with EFPC, UEMO and WONCA-Europe organised on 19 April 2016
16/06/2016Human medicines European public assessment report (EPAR): Nplate,

romiplostim

Revision: 14, Authorised
16/06/2016Human medicines European public assessment report (EPAR): Synjardy,

empagliflozin / metformin

Revision: 3, Authorised
16/06/2016Human medicines European public assessment report (EPAR): Brimica Genuair,

aclidinium / formoterol fumarate dihydrate

Revision: 4, Authorised
16/06/2016Human medicines European public assessment report (EPAR): Optimark,

gadoversetamide

Revision: 12, Authorised
16/06/2016Human medicines European public assessment report (EPAR): Humira,

adalimumab

Revision: 46, Authorised
16/06/2016Human medicines European public assessment report (EPAR): Edurant,

rilpivirine

Revision: 9, Authorised
15/06/2016Human medicines European public assessment report (EPAR): Efavirenz Teva,

efavirenz

Revision: 6, Authorised
15/06/2016CMDh scientific conclusions and grounds for the variation, amendments to the product information and implementation timetable: asparaginase PSUSA/00003161/201508
15/06/2016List of nationally authorised medicinal products: asparaginase PSUSA/00003161/201508
15/06/2016Human medicines European public assessment report (EPAR): Glybera,

alipogene tiparvovec

Revision: 7, Authorised
15/06/2016Human medicines European public assessment report (EPAR): Cialis,

tadalafil

Revision: 23, Authorised
15/06/2016Human medicines European public assessment report (EPAR): Imatinib medac,

imatinib

Revision: 2, Authorised
15/06/2016List of nationally authorised medicinal products: letrozole PSUSA/00001842/201510
15/06/2016List of nationally authorised medicinal products: milrinone PSUSA/00002064/201510
15/06/2016News and press releases: David Murphy elected new Chair of EMA Committee for Medicinal Products for Veterinary Use (CVMP)
15/06/2016Human medicines European public assessment report (EPAR): Modigraf,

tacrolimus

Revision: 9, Authorised
15/06/2016HMPC meeting report on European Union herbal monographs, guidelines and other activities - 30-31 May 2016
15/06/2016Call for scientific data for the systematic review of the monograph on Avena sativa L., herba and Avena sativa L., fructus, draft: consultation open
15/06/2016Call for scientific data for the systematic review of the monograph on Avena sativa L., herba and Avena sativa L., fructus, draft: consultation open
15/06/2016Herbal medicinal products: Verbascum , Verbasci flos, Verbascum thapsus L.; V. densiflorum Bertol. (V. thapsiforme Schrad); V. phlomoides L. (updated)
15/06/2016Call for scientific data for the systematic review of the monograph on Tanacetum parthenium (L.) Schulz Bip., herba, draft: consultation open
15/06/2016Herbal medicinal products: Calendula, Calendulae flos, Calendula officinalis L. (updated)
15/06/2016Herbal medicinal products: Tanacetum, Tanaceti parthenii herba, Tanacetum parthenium (L.) Schultz Bip. (updated)
15/06/2016Herbal medicinal products: Avena , Avenae fructus, Avena sativa L. (updated)
15/06/2016Call for scientific data for the systematic review of the monograph on Verbascum thapsus L., V. densiflorum Bertol., V. phlomoides L., flos, draft: consultation open
15/06/2016Herbal medicinal products: Avena , Avenae herba, Avena sativa L. (updated)
15/06/2016Call for scientific data for the systematic review of the monograph on Calendula officinalis L., flos, draft: consultation open
14/06/2016Human medicines European public assessment report (EPAR): Puregon,

follitropin beta

Revision: 23, Authorised
14/06/2016Human medicines European public assessment report (EPAR): RotaTeq,

rotavirus vaccine, live

Revision: 22, Authorised
14/06/2016Hexaxim : Summary for the public (updated)
14/06/2016Calls for tender €15,000 - €135,000 (updated)
14/06/2016Human medicines European public assessment report (EPAR): Aflunov,

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

Revision: 7, Authorised
14/06/2016Human 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: 1, Authorised
14/06/2016Ex-ante publicity of a negotiated procedure : EMA/2016/45/IT – Quality review of software deliverables for the Pharmacovigilance Adverse Drug Report (ADR) solution
14/06/2016List of nationally authorised medicinal products: methylphenidate PSUSA/00002024/201510
14/06/2016Human medicines European public assessment report (EPAR): Glubrava,

pioglitazone / metformin

Revision: 13, Authorised
14/06/2016Referral: Article 31 referrals, Gadolinium-containing contrast agents,

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

(updated)
14/06/2016List of nationally authorised medicinal products: rabeprazole PSUSA/00002601/201510
14/06/2016List of nationally authorised medicinal products: artemether / lumefantrin (dispersible tablet) PSUSA/00009060/201510
14/06/2016Agenda: Agenda - Periodic safety update report information day
14/06/2016Periodic safety update report information day , European Medicines Agency, London, UK, From: 28-Oct-2016, To: 28-Oct-2016
14/06/2016Human medicines European public assessment report (EPAR): Tandemact,

pioglitazone / glimepiride

Revision: 13, Authorised
14/06/2016List of nationally authorised medicinal products: rilmenidine PSUSA/00002643/201508
14/06/2016CMDh Scientific conclusions and grounds for the variation, amendments to the Product Information and timetable for the implementation: rilmenidine PSUSA/00002643/201508
14/06/2016EudraVigilance support guide (updated)
13/06/2016Human medicines European public assessment report (EPAR): Ebilfumin,

oseltamivir

Revision: 3, Authorised
13/06/2016Agenda: Agenda - CVMP agenda of the 14-16 June 2016 meeting
13/06/2016Monthly report on application procedures guidelines and related documents for veterinary medicines: May 2016
13/06/2016Human medicines European public assessment report (EPAR): Maci,

matrix-applied characterised autologous cultured chondrocytes

Revision: 3, Suspended
13/06/2016List of nationally authorised medicinal products: human coagulation factor VIII / human von Willebrand factor PSUSA/00001621/201510
13/06/2016List of nationally authorised medicinal products : didanosine PSUSA/00001054/201510
13/06/2016Regulatory and procedural guideline: Procedure for calls for scientific data for use in HMPC assessment work, adopted (updated)
13/06/2016Veterinary medicine European public assessment report (EPAR): Prac-tic,

pyriprole

Revision: 8, Authorised
13/06/2016Veterinary medicine European public assessment report (EPAR): Onsior,

robenacoxib

Revision: 9, Authorised
13/06/2016Veterinary medicine European public assessment report (EPAR): Fortekor Plus,

benazepril / pimobendan

Revision: 2, Authorised
13/06/2016List of nationally authorised medicinal products: ceftazidime PSUSA/00000608/201510
13/06/2016Human medicines European public assessment report (EPAR): Mysimba,

naltrexone / bupropion

Revision: 2, Authorised
13/06/2016Human medicines European public assessment report (EPAR): Methylthioninium chloride Proveblue,

methylthioninium chloride

Revision: 13, Authorised
13/06/2016Human medicines European public assessment report (EPAR): Arava,

leflunomide

Revision: 32, Authorised
13/06/2016Veterinary medicine European public assessment report (EPAR): Clomicalm,

Clomipramine

Revision: 11, Authorised
13/06/2016Human medicines European public assessment report (EPAR): Neparvis,

sacubitril / valsartan

Revision: 0, Authorised
13/06/2016Human medicines European public assessment report (EPAR): Zoledronic acid medac,

zoledronic acid

Revision: 7, Authorised
13/06/2016Human medicines European public assessment report (EPAR): Imnovid (previously Pomalidomide Celgene),

pomalidomide

Revision: 6, Authorised
13/06/2016Human medicines European public assessment report (EPAR): Senshio,

ospemifene

Revision: 1, Authorised
13/06/2016Opinions on annual re-assessments, renewals of marketing authorisations and accelerated assessment procedures adopted at the CHMP meeting of 23–26 May 2016
13/06/2016Opinions on safety variations/periodic safety update reports adopted at the CHMP meeting of 23–26 May 2016
13/06/2016Organisational matters: CHMP meeting 23-26 May 2016
13/06/2016Guidelines and concept papers adopted during the CHMP meeting 23-26 May 2016
13/06/2016Human medicines European public assessment report (EPAR): Fertavid,

follitropin beta

Revision: 8, Authorised
13/06/2016Human medicines European public assessment report (EPAR): Marixino (previously Maruxa),

memantine

Revision: 3, Authorised
13/06/2016Human medicines European public assessment report (EPAR): Glustin,

pioglitazone

Revision: 24, Authorised
13/06/2016Minutes of the HMPC 4-5 April 2016 meeting
13/06/2016Human medicines European public assessment report (EPAR): RoActemra,

tocilizumab

Revision: 19, Authorised
13/06/2016Veterinary medicine European public assessment report (EPAR): Aftovaxpur DOE,

Foot-and-mouth disease vaccine (inactivated) (multistrain: 1-3 strains out of set of 8)

Revision: 2, Authorised
10/06/2016Orphan designation:

1-Deoxygalactonojirimycin hydrochloride

for the: Treatment of Fabry disease (updated)
10/06/2016Human medicines European public assessment report (EPAR): Azomyr,

desloratadine

Revision: 38, Authorised
10/06/2016Human medicines European public assessment report (EPAR): Ixiaro,

Japanese-encephalitis vaccine (inactivated, adsorbed)

Revision: 11, Authorised
10/06/2016Human medicines European public assessment report (EPAR): Xarelto,

rivaroxaban

Revision: 18, Authorised
10/06/2016Human medicines European public assessment report (EPAR): Ristempa,

pegfilgrastim

Revision: 2, Authorised
10/06/2016Human medicines European public assessment report (EPAR): Edistride,

dapagliflozin

Revision: 2, Authorised
10/06/2016Human medicines European public assessment report (EPAR): Leflunomide Winthrop,

leflunomide

Revision: 12, Authorised
10/06/2016Human medicines European public assessment report (EPAR): Cubicin,

daptomycin

Revision: 20, Authorised
10/06/2016Human medicines European public assessment report (EPAR): Pandemrix,

influenza vaccine (H1N1)v (split virion, inactivated, adjuvanted) A/California/7/2009 (H1N1)v like strain (x-179a)

Revision: 23, Withdrawn
10/06/2016Healthcare Professionals' Organisations Working Party (HCPWP) workshop with academia, European Medicines Agency, London, UK, From: 15-Jun-2016, To: 15-Jun-2016
10/06/2016Agenda: Agenda - Healthcare Professionals Organisations Working Party (HCPWP) workshop with academia
10/06/2016News and press releases: EMA celebrates ten years of its patients and consumers working party
10/06/2016Agenda: Agenda - 10th anniversary of European Medicines Agency’s Patients' and Consumers' Working Party (PCWP)
10/06/201610th anniversary of European Medicines Agency’s Patients' and Consumers' Working Party (PCWP), European Medicines Agency, London, UK, From: 14-Jun-2016, To: 14-Jun-2016 (updated)
10/06/2016European Medicines Agency Human Scientific Committees' Working Party with Patients’ and Consumers’ Organisations (PCWP) meeting, European Medicines Agency, London, UK, From: 14-Jun-2016, To: 14-Jun-2016
10/06/2016Agenda: Agenda - European Medicines Agency Human Scientific Committees' Working Party with Patients’ and Consumers’ Organisations (PCWP) meeting
10/06/2016Human medicines European public assessment report (EPAR): Glivec,

imatinib

Revision: 28, Authorised
10/06/2016Human medicines European public assessment report (EPAR): Tecfidera,

dimethyl fumarate

Revision: 6, Authorised
10/06/2016Human medicines European public assessment report (EPAR): Levodopa/Carbidopa/Entacapone Orion,

levodopa / carbidopa / entacapone

Revision: 8, Authorised
10/06/2016Human medicines European public assessment report (EPAR): Levetiracetam Actavis Group,

levetiracetam

Revision: 7, Authorised
10/06/2016Human medicines European public assessment report (EPAR): Kinzalmono (previously Telmisartan Boehringer Ingelheim Pharma KG),

telmisartan

Revision: 26, Authorised
10/06/2016Human medicines European public assessment report (EPAR): Atripla,

efavirenz / emtricitabine / tenofovir disoproxil

Revision: 23, Authorised
10/06/2016Human medicines European public assessment report (EPAR): Bosulif,

bosutinib

Revision: 9, Authorised
10/06/2016European medicines agency Standard operating procedure (SOP): Standard operating procedure for provision of scientific recommendation on classification of advanced-therapy medicinal products (updated)
10/06/2016News and press releases: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 6-9 June 2016
10/06/2016Referral: Article 20 procedures, Zydelig,

idelalisib

(updated)
10/06/2016Human medicines European public assessment report (EPAR): Cyramza,

ramucirumab

Revision: 4, Authorised
10/06/2016European Medicines Agency Human Scientific Committee’s Working Party with Healthcare Professionals’ Organisations (HCPWP) meeting, European Medicines Agency, London, UK, From: 15-Jun-2016, To: 15-Jun-2016
10/06/2016Agenda: Agenda - European Medicines Agency Human Scientific Committee’s Working Party with Healthcare Professionals’ Organisations (HCPWP) meeting on 15 June 2016
10/06/2016Committee for Orphan Medicinal Products (COMP): 14-16 June 2016, European Medicines Agency, London, UK, From: 14-Jun-2016, To: 16-Jun-2016 (updated)
10/06/2016Agenda: Agenda - COMP agenda of the 14-16 June 2016 meeting
10/06/2016Interested Parties to the HMPC (updated)
10/06/2016Periodic safety update reports (updated)
10/06/2016News and press releases: Single, central platform now mandatory for all periodic safety update reports
10/06/2016Regulatory and procedural guideline: European Medicines Agency post-authorisation procedural advice for users of the centralised procedure (updated)
10/06/2016Regulatory and procedural guideline: European Medicines Agency post-authorisation procedural advice for users of the centralised procedure: document with track changes (updated)
10/06/2016Periodic safety update reports: questions and answers (updated)
10/06/2016Regulatory and procedural guideline: Periodic Safety Update Report (PSUR) repository mandatory use: questions and answers
09/06/2016Shortages catalogue (updated)
09/06/2016Taxotere (docetaxel) supply shortage (updated)
09/06/2016Referral: Article 20 procedures, Canagliflozin,

canagliflozin

(updated)
09/06/2016Targeted consultation on the guideline for development of new medicinal products for the treatment of rheumatoid arthritis, European Medicines Agency, London, UK, From: 07-Jun-2016, To: 07-Jun-2016 (updated)
09/06/2016Human medicines European public assessment report (EPAR): Noxafil,

posaconazole

Revision: 18, Authorised
09/06/2016Human medicines European public assessment report (EPAR): Dexdor,

dexmedetomidine

Revision: 6, Authorised
09/06/2016Human medicines European public assessment report (EPAR): Bridion,

sugammadex

Revision: 11, Authorised
09/06/2016Information day on risk management planning and post-authorisation studies, European Medicines Agency, London, UK, From: 07-Nov-2016, To: 07-Nov-2016
09/06/2016Referral: Article 20 procedures, Direct-acting antivirals indicated for treatment of hepatitis C (interferon-free),

daclatasvir / dasabuvir / sofosbuvir / ledipasvir / simeprevir / ombitasvir/paritaprevir / ritonavir

(updated)
09/06/2016Human medicines European public assessment report (EPAR): Galafold,

migalastat

Revision: 0, Authorised
09/06/2016Human medicines European public assessment report (EPAR): Imbruvica,

ibrutinib

Revision: 6, Authorised
09/06/2016Human medicines European public assessment report (EPAR): Yervoy,

ipilimumab

Revision: 12, Authorised
09/06/2016Human medicines European public assessment report (EPAR): Flixabi,

infliximab

Revision: 0, Authorised
09/06/2016Human medicines European public assessment report (EPAR): Entyvio,

vedolizumab

Revision: 6, Authorised
08/06/2016Orphan designation:

Daratumumab

for the: Treatment of plasma-cell myeloma (updated)
08/06/2016Human medicines European public assessment report (EPAR): Ebymect,

dapagliflozin / metformin

Revision: 2, Authorised
08/06/2016Orphan designation:

Autologous CD34+ cells transfected with retroviral vector containing adenosine deaminase gene

for the: Treatment of severe combined immunodeficiency (SCID) due to adenosine deaminase (ADA) deficiency (updated)
08/06/2016Human medicines European public assessment report (EPAR): Strimvelis,

autologous CD34+ enriched cell fraction that contains CD34+ cells transduced with retroviral vector that encodes for the human ADA cDNA sequence

Revision: 0, Authorised
08/06/2016Human medicines European public assessment report (EPAR): Palonosetron Accord,

palonosetron

Revision: 0, Authorised
08/06/2016Human medicines European public assessment report (EPAR): Pantoloc Control,

pantoprazole

Revision: 10, Authorised
08/06/2016Public statement: Public statement on contamination of herbal medicinal products/traditional herbal medicinal products with pyrrolizidine alkaloids
08/06/2016CMDh scientific conclusions and grounds for variation, amendments to product information and implementation timetable
08/06/2016List of nationally authorised medicinal products: meropenem PSUSA/00001989/201508
08/06/2016Pre-submission meeting request form for an application for a centralised marketing authorisation for veterinary medicinal products (updated)
07/06/2016Fabrazyme (agalsidase beta) supply shortage (updated)
07/06/2016EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) routes of administration (updated)
07/06/2016EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) substances (updated)
07/06/2016EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) pharmaceutical dose forms (updated)
07/06/2016EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) organisations (updated)
07/06/2016Human medicines European public assessment report (EPAR): Actos,

pioglitazone

Revision: 24, Authorised
07/06/2016Human medicines European public assessment report (EPAR): Zytiga,

abiraterone

Revision: 13, Authorised
07/06/2016CMDh scientific conclusions and grounds for the variation, amendments to the Product Information, and timetable for the implementation: nifedipine PSUSA/00002156/201508
07/06/2016List of nationally authorised medicinal products: nifedipine PSUSA/00002156/201508
07/06/2016Human medicines European public assessment report (EPAR): Constella,

linaclotide

Revision: 11, Authorised
07/06/2016Information Day on Medication Errors, European Medicines Agency, London, UK, From: 20-Oct-2016, To: 20-Oct-2016 (updated)
07/06/2016Agenda: Agenda and registration form - EudraVigilance information day: 21 June 2016 (updated)
07/06/2016Human medicines European public assessment report (EPAR): Erivedge,

vismodegib

Revision: 6, Authorised
07/06/2016Human medicines European public assessment report (EPAR): Fampyra,

fampridine

Revision: 8, Authorised
07/06/2016Human medicines European public assessment report (EPAR): Dacogen,

decitabine

Revision: 5, Authorised
07/06/2016Human medicines European public assessment report (EPAR): Cotellic,

cobimetinib

Revision: 2, Authorised
06/06/2016Agenda: Agenda - PRAC draft agenda of meeting 6-9 June 2016
06/06/2016Calculating 'chargeable units' for pharmacovigilance fees as specified in Regulation (EU) No 658/2014: guidance on how 'chargeable units' are derived from medicinal product information held within the 'Article 57' database (updated)
06/06/2016Explanatory note on general fees payable to the European Medicines Agency as of 1 June 2016
06/06/2016Decision of the Executive Director on fee reductions for scientific advice requests on PRIME products for SMEs and applicants from the academic sector
06/06/2016New product information wording: extracts from PRAC recommendations on signals adopted at the 10-13 May 2016 PRAC
06/06/2016List of signals discussed at the PRAC since September 2012 (updated)
06/06/2016PRAC recommendations on signals adopted at the PRAC meeting of 10-13 May 2016, adopted
06/06/2016Human medicines European public assessment report (EPAR): Holoclar,

ex vivo expanded autologous human corneal epithelial cells containing stem cells

Revision: 1, Authorised
06/06/2016Human medicines European public assessment report (EPAR): Instanyl,

fentanyl

Revision: 16, Authorised
06/06/2016Human medicines European public assessment report (EPAR): Sirturo,

bedaquiline

Revision: 9, Authorised
06/06/2016Human medicines European public assessment report (EPAR): Zeffix,

lamivudine

Revision: 18, Authorised
06/06/2016Human medicines European public assessment report (EPAR): Ivabradine Anpharm,

ivabradine

Revision: 1, Authorised
06/06/2016Presubmission guidance: questions 1 to 11 (updated)
06/06/2016Veterinary medicine European public assessment report (EPAR): Profender,

emodepside / praziquantel

Revision: 11, Authorised
06/06/2016Human 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: 10, Authorised
06/06/2016List of nationally authorised medicinal products: lisinopril PSUSA/00001894/201509
03/06/2016List of European Union reference dates and frequency of submission of periodic safety update reports (updated)
03/06/2016News and press releases: Regulation of advanced therapy medicines
03/06/2016Report: Advanced therapy medicines: exploring solutions to foster development and expand patient access in Europe
03/06/2016Hexaxim H-W-2495 (updated)
03/06/2016Human medicines European public assessment report (EPAR): Trevicta (previously Paliperidone Janssen),

paliperidone

Revision: 4, Authorised
03/06/2016Human 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: 10, Authorised
03/06/2016Veterinary medicine European public assessment report (EPAR): Procox,

emodepside / toltrazuril

Revision: 9, Authorised
03/06/2016Human medicines European public assessment report (EPAR): Kivexa,

abacavir / lamivudine

Revision: 26, Authorised
03/06/2016Human medicines European public assessment report (EPAR): Exjade,

deferasirox

Revision: 26, Authorised
03/06/2016Minutes of the COMP meeting 19-21 April 2016
03/06/2016Human medicines European public assessment report (EPAR): Onglyza,

saxagliptin

Revision: 14, Authorised
02/06/2016Minutes of the PRAC meeting 11-14 April 2016
02/06/2016Human medicines European public assessment report (EPAR): Pandemic influenza vaccine H5N1 MedImmune,

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

Revision: 0, Authorised
02/06/2016Opinion/decision on a Paediatric investigation plan (PIP): -,

Solithromycin

Therapeutic area: Infectious diseases
02/06/2016Opinion/decision on a Paediatric investigation plan (PIP): -,

Gallium [68Ga]

Therapeutic area: Other
02/06/2016Opinion/decision on a Paediatric investigation plan (PIP): Cimzia,

Certolizumab pegol

Therapeutic area: Dermatology
02/06/2016Opinion/decision on a Paediatric investigation plan (PIP): -,

Humanised monoclonal antibody against myostatin

Therapeutic area: Neurology
02/06/2016Opinion/decision on a Paediatric investigation plan (PIP): -,

Recombinant human alpha-galactosidase A (PRX 102)

Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
02/06/2016Opinion/decision on a Paediatric investigation plan (PIP): -,

Finasteride

Therapeutic area: Dermatology
02/06/2016Opinion/decision on a Paediatric investigation plan (PIP): -,

Darunavir / cobicistat / emtricitabine / tenofovir alafenamide

Therapeutic area: Infectious diseases
02/06/2016Opinion/decision on a Paediatric investigation plan (PIP): -,

Atorvastatin / Perindopril (arginine)

Therapeutic area: Cardiovascular diseases
02/06/2016List of nationally authorised medicinal products: alfentanil PSUSA/00000082/201509
02/06/2016Opinion/decision on a Paediatric investigation plan (PIP): -,

Sofosbuvir / velpatasvir / a derivative of (2S,3S,4R)-3-ethyl-4- hydroxypyrrolidine-2-carboxylic acid

Therapeutic area: Infectious diseases
02/06/2016Opinion/decision on a Paediatric investigation plan (PIP): -,

Levodopa

Therapeutic area: Neurology
02/06/2016Opinion/decision on a Paediatric investigation plan (PIP): P/0114/2016,

Montelukast (sodium) / levocetirizine (dihydrochloride)

Therapeutic area: Pneumology-allergology
02/06/2016Human medicines European public assessment report (EPAR): Komboglyze,

saxagliptin / metformin hydrochloride

Revision: 10, Authorised
02/06/2016Veterinary medicine European public assessment report (EPAR): Draxxin,

tulathromycin

Revision: 15, Authorised
02/06/2016PDCO monthly report of opinions on paediatric investigation plans and other activities 25-27 May 2016
02/06/2016Notices of calls for tender - 2016 (updated)
02/06/2016Notices of calls for tender - 2015 (updated)
02/06/2016Human medicines European public assessment report (EPAR): Zerit,

stavudine

Revision: 28, Authorised
02/06/2016Opinion/decision on a Paediatric investigation plan (PIP): Inovelon,

Rufinamide

Therapeutic area: Neurology (updated)
02/06/2016Opinion/decision on a Paediatric investigation plan (PIP): Translarna,

Ataluren

Therapeutic area: Neurology (updated)
02/06/2016Opinion/decision on a Paediatric investigation plan (PIP): -,

Coagulation Factor VIIa (Recombinant)

Therapeutic area: Haematology-Hemostaseology/Oncology (updated)
02/06/2016Opinion/decision on a Paediatric investigation plan (PIP): -,

Ixekizumab

Therapeutic area: Immunology-Rheumatology-Transplantation (updated)
02/06/2016Opinion/decision on a Paediatric investigation plan (PIP): -,

Tralokinumab

Therapeutic area: Pneumology-allergology (updated)
02/06/2016Opinion/decision on a Paediatric investigation plan (PIP): Imlygic,

Talimogene laherparepvec

Therapeutic area: Oncology (updated)
02/06/2016Opinion/decision on a Paediatric investigation plan (PIP): -,

Alirocumab

Therapeutic area: Endocrinology, -gynacology-fertility-metabolism (updated)
02/06/2016Opinion/decision on a Paediatric investigation plan (PIP): Livazo and associated names,

Pitavastatin (calcium)

Therapeutic area: Endocrinology, -gynacology-fertility-metabolism (updated)
02/06/2016Opinion/decision on a Paediatric investigation plan (PIP): Votubia,

Everolimus

Therapeutic area: Neurology (updated)
02/06/2016Opinion/decision on a Paediatric investigation plan (PIP): -,

Potassium citrate monohydrated / Potassium hydrogen carbonate

Therapeutic area: Uro-nephrology (updated)
02/06/2016Opinion/decision on a Paediatric investigation plan (PIP): -,

Solithromycin

Therapeutic area: Infectious diseases (updated)
02/06/2016Opinion/decision on a Paediatric investigation plan (PIP): Humira,

Adalimumab

Therapeutic area: Dermatology/Immunology-Rheumatology-Transplantation/Ophthalmology/Gastroentology-Hepatology (updated)
02/06/2016Opinion/decision on a Paediatric investigation plan (PIP): Victrelis,

Boceprevir

Therapeutic area: Infectious diseases (updated)
02/06/2016Agenda: Agenda and registration form - Information day on risk management planning and post-authorisation studies
02/06/2016Opinion/decision on a Paediatric investigation plan (PIP): Fycompa,

Perampanel

Therapeutic area: Neurology (updated)
02/06/2016Opinion/decision on a Paediatric investigation plan (PIP): Dificlir,

Fidaxomicin

Therapeutic area: Infectious diseases (updated)
02/06/2016Opinion/decision on a Paediatric investigation plan (PIP): Alipza and associated names,

Pitavastatin (calcium)

Therapeutic area: Endocrinology, -gynacology-fertility-metabolism (updated)
02/06/2016Opinion/decision on a Paediatric investigation plan (PIP): -,

Heterologous human adult liver-derived progenitor cells (HHALPC)

Therapeutic area: Gastroentology-Hepatology (updated)
02/06/2016Opinion/decision on a Paediatric investigation plan (PIP): -,

Indacaterol (acetate) / mometasone (furoate)

Therapeutic area: Pneumology-allergology (updated)
02/06/2016Opinion/decision on a Paediatric investigation plan (PIP): -,

Olesoxime

Therapeutic area: Neurology (updated)
02/06/2016Opinion/decision on a Paediatric investigation plan (PIP): -,

Human normal immunoglobulin

Therapeutic area: Immunology-Rheumatology-Transplantation
02/06/2016Human medicines European public assessment report (EPAR): Ziagen,

abacavir

Revision: 32, Authorised
02/06/2016Human medicines European public assessment report (EPAR): Buccolam,

midazolam

Revision: 6, Authorised
02/06/2016Human medicines European public assessment report (EPAR): Trizivir,

abacavir (as sulfate) / lamivudine / zidovudine

Revision: 29, Authorised
02/06/2016Regulatory and procedural guideline: European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure (updated)
02/06/2016Generic / hybrid applications: questions 35 to 43 (updated)
02/06/2016Renewals: questions and answers (updated)
02/06/2016Post-authorisation measures: questions and answers (updated)
02/06/2016Risk management plan (RMP): questions and answers
02/06/2016Other post-authorisation activities: questions and answers (updated)
02/06/2016Transfer of marketing authorisation: questions and answers (updated)
02/06/2016Regulatory and procedural guideline: European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure: document with track changes (updated)
02/06/2016Regulatory and procedural guideline: European Medicines Agency procedural advice for users of the centralised procedure for generic / hybrid applications (updated)
02/06/2016Regulatory and procedural guideline: European Medicines Agency procedural advice for users of the centralised procedure for generic / hybrid applications (track changes) (updated)
02/06/2016Type-IA variations: questions and answers (updated)
02/06/2016Classification of changes: questions and answers
02/06/2016Type-II variations: questions and answers (updated)
02/06/2016Type-IB variations: questions and answers (updated)
02/06/2016Annual re-assessment: questions and answers (updated)
02/06/2016Extension applications: questions and answers (updated)
02/06/2016News and press releases: Regulatory information - Management of changes to risk management plans and certain quality aspects simplified
02/06/2016Pre-submission queries service: questions and answers (updated)
02/06/2016Presubmission guidance: questions 45 to 56 (updated)
02/06/2016Post-authorisation safety studies: questions and answers (updated)
02/06/2016Post-authorisation efficacy studies: questions and answers (updated)
02/06/2016Human post-authorisation Q&A: Introduction (updated)
02/06/2016Veterinary medicine European public assessment report (EPAR): Letifend,

canine leishmaniasis vaccine (recombinant protein)

Revision: 0, Authorised
01/06/2016Human medicines European public assessment report (EPAR): Rivastigmine Actavis,

rivastigmine

Revision: 11, Authorised
01/06/2016Scientific guideline: Draft guideline on core SmPC and package leaflet for gadoteric acid, draft: consultation open
01/06/2016Scientific guideline: Draft guideline on core SmPC and package leaflet for fluorodopa (18F), draft: consultation open
01/06/2016European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA) (updated)
01/06/2016Scientific guideline: Draft guideline on core SmPC and package leaflet for (68Ge/68Ga) generator, draft: consultation open
01/06/2016Recommendations on eligibility to PRIME scheme - Adopted at the CHMP meeting of 23-26 May 2016
01/06/2016News and press releases: First statistics on PRIME are released
01/06/2016Minutes - PDCO minutes of the 27-29 April 2016 meeting
01/06/2016Minutes of the CHMP meeting 25-28 April 2016
01/06/2016COMP meeting report on the review of applications for orphan designation: May 2016
01/06/2016Human medicines European public assessment report (EPAR): Abasaglar (previously Abasria),

insulin glargine

Revision: 4, Authorised
01/06/2016Human medicines European public assessment report (EPAR): Descovy,

emtricitabine / tenofovir alafenamide

Revision: 0, Authorised