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February 2017

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28/02/2017Human medicines European public assessment report (EPAR): Prialt,

ziconotide

Revision: 19, Authorised
28/02/2017Human medicines European public assessment report (EPAR): Adcetris,

brentuximab vedotin

Revision: 17, Authorised
28/02/2017CAT monthly report of application procedures, guidelines and related documents on advanced therapies: February 2017
28/02/2017Opinion/decision on a Paediatric investigation plan (PIP): Tesavel,

Sitagliptin (phosphate monohydrate)

Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
28/02/2017Human medicines European public assessment report (EPAR): Benepali,

etanercept

Revision: 4, Authorised
28/02/2017Human medicines European public assessment report (EPAR): Matever,

levetiracetam

Revision: 14, Authorised
28/02/2017European Union International Organization for Standardization (ISO) for the identification of medicinal products (IDMP) / Substance, Product, Organisation and Referential data (SPOR) task force meeting, European Medicines Agency, London, UK, From: 10-Mar-2017, To: 10-Mar-2017
28/02/2017Human medicines European public assessment report (EPAR): Lopinavir/Ritonavir Mylan,

lopinavir/ritonavir

Revision: 2, Authorised
28/02/2017Human medicines European public assessment report (EPAR): Zytiga,

abiraterone

Revision: 16, Authorised
28/02/2017Choice of timetable for type II variations and worksharing applications
28/02/2017Report: Scientific recommendation on classification of advanced therapy medicinal products: In vitro transcribed mRNA sequences encoding six non-small cell lung cancer (NSCLC) associated antigens
28/02/2017Report: Scientific recommendation on classification of advanced therapy medicinal products: Allogeneic Epstein-Barr Virus Cytotoxic T Lymphocytes
28/02/2017Report: Scientific recommendation on classification of advanced therapy medicinal products: Allogeneic cytomegalovirus-specific cytotoxic T lymphocytes
28/02/2017Report: Scientific recommendation on classification of advanced therapy medicinal products: Genetically engineered AAV8 that lacks all of the viral protein-coding sequences and encodes a human MTM1 complementary DNA
28/02/2017Report: Scientific recommendation on classification of advanced therapy medicinal products: Allogeneic bone marrow derived mesenchymal stem cells
28/02/2017Report: Scientific recommendation on classification of advanced therapy medicinal products: mRNA sequence encoding the wild type human OX40L protein
28/02/2017Type II variation and worksharing application alternative monthly assessment timetables (updated)
28/02/2017Type II variation and worksharing application monthly assessment timetables (updated)
28/02/2017Type II variation and worksharing application weekly assessment timetables (updated)
28/02/2017HMPC work plan 2017
28/02/2017News and press releases: Regulatory information – adjusted fees for applications to EMA from 1 April 2017
28/02/2017Human medicines European public assessment report (EPAR): Revlimid,

lenalidomide

Revision: 32, Authorised
28/02/2017List of European Union reference dates and frequency of submission of periodic safety update reports (updated)
28/02/2017Patient registries (updated)
28/02/2017Human medicines European public assessment report (EPAR): Tivicay,

dolutegravir

Revision: 10, Authorised
28/02/2017Herbal medicinal products: Ribes , Ribis nigri folium, Ribes nigrum L. (updated)
28/02/2017Draft European Union herbal monograph on Ribes nigrum L., folium , draft: consultation open
28/02/2017Public statement: Draft public statement on Glycine max (L.) Merr., semen
28/02/2017Herbal medicinal products: Glycine, Glycini semen, Glycine max (L.) Merr.
27/02/2017Referral: Article 31 referrals, Dienogest/ethinylestradiol-containing medicinal products indicated in acne,

dienogest / ethinylestradiol

(updated)
27/02/2017Work plan for the Working Party on European Union Monographs and List (MLWP) 2017
27/02/2017Work plan for the HMPC Quality Drafting Group (Q DG) 2017
27/02/2017Work plan for the Organisational Matters Drafting Group (ORGAM DG) 2017
27/02/2017Human medicines European public assessment report (EPAR): Odefsey,

emtricitabine / rilpivirine / tenofovir alafenamide

Revision: 3, Authorised
27/02/2017PRAC recommendations on signals adopted at the PRAC meeting of 4-8 July 2016, adopted (updated)
27/02/2017Human medicines European public assessment report (EPAR): Imvanex,

modified vaccinia Ankara virus

Revision: 10, Authorised
27/02/2017Minutes of the COMP meeting 6-8 December 2016
27/02/2017Minutes of the COMP meeting 17-19 January 2017
27/02/2017Human medicines European public assessment report (EPAR): Caelyx,

doxorubicin

Revision: 27, Authorised
27/02/2017Plasma-master-file certifications (updated)
27/02/2017Human medicines European public assessment report (EPAR): Descovy,

emtricitabine / tenofovir alafenamide

Revision: 3, Authorised
27/02/2017Work instructions for business analysis and forecasting manual, guidance for the business pipeline activity at the European Medicines Agency, adopted
27/02/2017Work instructions for review of granted paediatric product-specific and class waivers, adopted (updated)
27/02/2017European medicines agency Standard operating procedure (SOP): Standard operating procedure for paediatric investigation plan or a waiver from pre-submission to start of procedure (updated)
27/02/2017Work instructions for paediatric core master files and numbering, adopted (updated)
27/02/2017Human medicines European public assessment report (EPAR): Genvoya,

elvitegravir / cobicistat / emtricitabine / tenofovir alafenamide

Revision: 6, Authorised
27/02/2017Human medicines European public assessment report (EPAR): Sylvant,

siltuximab

Revision: 5, Authorised
27/02/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Damoctocog alfa pegol

Therapeutic area: Haematology-Hemostaseology (updated)
27/02/2017Human medicines European public assessment report (EPAR): Imatinib Actavis,

imatinib

Revision: 7, Authorised
24/02/2017Human medicines European public assessment report (EPAR): Votubia,

everolimus

Revision: 19, Authorised
24/02/2017Human medicines European public assessment report (EPAR): Kuvan,

sapropterin

Revision: 11, Authorised
24/02/2017Assessing the toxicological risk to human health and groundwater communities from veterinary pharmaceuticals in groundwater
24/02/2017Assessment and control of DNA reactive (mutagenic) impurities in veterinary medicinal products
24/02/2017Scientific guideline: Draft guideline on assessment and control of DNA reactive, mutagenic impurities in veterinary medicines, draft: consultation open
24/02/2017Scientific guideline: Draft guideline on assessing the toxicological risk to human health and groundwater communities from veterinary pharmaceuticals in groundwater, draft: consultation open
24/02/2017Scientific guideline: Draft VICH GL56 studies to evaluate the metabolism and residue kinetics of veterinary drugs in food-producing species: study design recommendations for residue studies in honey for establishing maximum residue limits and withdrawal periods, draft: consultation open
24/02/2017Scientific guideline: Superseding version - Draft revised recommendation for the basic surveillance of Eudravigilance Veterinary (EVVet) data for centrally authorised products (CAPs), draft: consultation open
24/02/2017Scientific guideline: Overview of comments received on ' Guideline on regulatory acceptance of 3R (replacement, reduction, refinement) testing approaches' (EMA/CHMP/CVMP/JEG-3Rs/450091/2012)
24/02/2017Regulatory and procedural guideline: Guidance to applicants / marketing authorisation holders on oral explanations at CVMP
24/02/2017Regulatory acceptance of 3R (replacement, reduction, refinement) testing approaches (updated)
24/02/2017VICH GL56 Studies to evaluate the metabolism and residue kinetics of veterinary drugs in food-producing species: study design recommendations for residue studies in honey for establishing MRLs and withdrawal periods
24/02/2017Regulatory and procedural guideline: CVMP Risk Management Strategy - Managing the risk of the potential presence of replication competent endogenous retrovirus RD114 in starting materials and final products of feline and canine vaccines
24/02/2017Human medicines European public assessment report (EPAR): Cometriq,

cabozantinib

Revision: 10, Authorised
24/02/2017Human medicines European public assessment report (EPAR): Incresync,

alogliptin / pioglitazone

Revision: 5, Authorised
24/02/2017Newsletter: Public bulletin: Veterinary pharmacovigilance 2016
24/02/2017Regulatory and procedural guideline: Dossier requirements for centrally authorised products (updated)
24/02/2017Human medicines European public assessment report (EPAR): Adempas,

riociguat

Revision: 5, Authorised
24/02/2017News and press releases: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 20-23 February 2017
24/02/2017News and press releases: First hormone replacement therapy for parathyroid disorder
24/02/2017News and press releases: SGLT2 inhibitors: information on potential risk of toe amputation to be included in prescribing information
24/02/2017Referral: Article 30 referrals, Saroten and associated names,

amitriptyline

24/02/2017Pending EC decision: Roteas,

edoxaban

Opinion date: 23-Feb-2017
24/02/2017Pending EC decision: Natpar,

parathyroid hormone

Opinion date: 23-Feb-2017
24/02/2017Pending EC decision: Lokelma,

sodium zirconium cyclosilicate

Opinion date: 23-Feb-2017
24/02/2017Referral: Article 30 referrals, Haldol and associated names,

haloperidol

24/02/2017Pending EC decision: Darzalex,

daratumumab

Opinion date: 23-Feb-2017
24/02/2017Scientific advice and protocol assistance adopted during the CHMP meeting 20 – 23 February 2017, adopted
24/02/2017Overview of (invented) names reviewed in February 2017 by the Name Review Group (NRG) adopted at the CHMP meeting of 20-23 February 2017, adopted
24/02/2017Pending EC decision: Tafinlar,

dabrafenib

Opinion date: 23-Feb-2017
24/02/2017Pending EC decision: Mekinist,

trametinib

Opinion date: 23-Feb-2017
24/02/2017Start of community reviews - CHMP meeting of 20-23 February 2017
24/02/2017Referral: Article 20 procedures, SGLT2 inhibitors (previously canagliflozin),

canagliflozin, empagliflozin, dapagliflozin, canagliflozin / metformin, empagliflozin / metformin, dapagliflozin / metformin

(updated)
24/02/2017Pending EC decision: Varuby,

rolapitant

Opinion date: 23-Feb-2017
24/02/2017Referral: Article 30 referrals, Haldol Decanoate and associated names,

haloperidol

24/02/2017Pending EC decision: Truvada,

emtricitabine / tenofovir disoproxil

Opinion date: 23-Feb-2017
24/02/2017Minutes of the CVMP meeting of 17-19 January 2017
23/02/2017Report: Cyproterone/ethinylestradiol: PRAC non-interventional imposed PASS final study report assessment report - EMEA/H/N/PSR/J/0005
23/02/2017Report: Cyproterone/ethinylestradiol: PRAC non-interventional imposed PASS final study report assessment report - EMEA/H/N/PSR/J/0006
23/02/2017Report: Cyproterone/ethinylestradiol: PRAC non-interventional imposed PASS final study report assessment report - EMEA/H/N/PSR/J/0003
23/02/2017Cyproterone/ethinylestradiol: List of nationally authorised medicinal products - EMEA/H/N/PSR/J/0003/0005/0006
23/02/2017Cyproterone/ethinylestradiol: CMDh scientific conclusions, amendments to product information and implementation timetable - EMEA/H/N/PSR/J/0006
23/02/2017Cyproterone/ethinylestradiol: CMDh scientific conclusions, amendments to product information and implementation timetable - EMEA/H/N/PSR/J/0003
23/02/2017Herbal medicinal products: Mentha, Menthae piperitae folium, Mentha x piperita L. (updated)
23/02/2017Draft European Union herbal monograph on Mentha x piperita L., folium, draft: consultation open
23/02/2017Human medicines European public assessment report (EPAR): Xyrem,

sodium oxybate

Revision: 25, Authorised
23/02/2017Human medicines European public assessment report (EPAR): Firdapse (previously Zenas),

amifampridine

Revision: 13, Authorised
23/02/2017Human medicines European public assessment report (EPAR): Revatio,

sildenafil

Revision: 33, Authorised
23/02/2017Human medicines European public assessment report (EPAR): Humira,

adalimumab

Revision: 55, Authorised
23/02/2017Adaptive pathways (updated)
23/02/2017Agenda: Programme and registration form - European Medicines Agency (EMA)/DIA signal management information day
23/02/2017Adaptive pathways workshop, European Medicines Agency, UK, From: 08-Dec-2016, To: 08-Dec-2016 (updated)
23/02/2017European Medicines Agency / DIA signal management information day, European Medicines Agency, London, UK, From: 27-Oct-2017, To: 27-Oct-2017
23/02/2017Report: Adaptive Pathways Workshop - Report on a meeting with stakeholders (8 December 2016)
23/02/2017Human medicines European public assessment report (EPAR): Pioglitazone Teva Pharma,

pioglitazone

Revision: 6, Authorised
23/02/2017Pending EC decision: Emtricitabine/Tenofovir disoproxil Krka d.d.,

emtricitabine / tenofovir disoproxil

Opinion date: 23-Feb-2017
23/02/2017Human medicines European public assessment report (EPAR): Cresemba,

isavuconazole

Revision: 1, Authorised
23/02/2017Human medicines European public assessment report (EPAR): ProQuad,

measles, mumps, rubella and varicella vaccine (live)

Revision: 21, Authorised
23/02/2017Human medicines European public assessment report (EPAR): Torisel,

temsirolimus

Revision: 24, Authorised
23/02/2017Human medicines European public assessment report (EPAR): Pioglitazone Teva,

pioglitazone

Revision: 7, Authorised
22/02/2017European Medicines Agency and Association of the European Self-Medication Industry (AESGP) annual bilateral meeting, European Medicines Agency, London, UK, From: 11-Jan-2017, To: 11-Jan-2017 (updated)
22/02/2017Report: Report - European Medicines Agency and Association of the European Self-Medication Industry (AESGP) annual bilateral meeting
22/02/2017Human medicines European public assessment report (EPAR): Alimta,

pemetrexed

Revision: 21, Authorised
22/02/2017Human medicines European public assessment report (EPAR): Ameluz,

5-aminolevulinic acid hydrochloride

Revision: 9, Authorised
22/02/2017Regulatory 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 European Medicines Agency-health-technology-assessment requests (updated)
22/02/2017Human medicines European public assessment report (EPAR): Triumeq,

abacavir sulfate / dolutegravir sodium / lamivudine

Revision: 7, Authorised
22/02/2017Human medicines European public assessment report (EPAR): Kaletra,

lopinavir / ritonavir

Revision: 43, Authorised
22/02/2017Annex XII - List of Dexamed and associated names (dexamfetamine sulphate-containing medicinal products) in the European Union (updated)
22/02/2017Annex XII - List of Dexamed and associated names (dexamfetamine sulphate-containing medicinal products) in the European Union (updated)
22/02/2017List of medicinal products under additional monitoring (updated)
22/02/2017List of medicinal products under additional monitoring (updated)
22/02/2017Information Technology Directors Group - List of nominated members (alphabetically by country) (updated)
22/02/2017Opinion/decision on a Paediatric investigation plan (PIP): Victoza,

liraglutide

Therapeutic area: Endocrinology, -gynacology-fertility-metabolism (updated)
22/02/2017Type-IA variations: questions and answers (updated)
22/02/2017Human medicines European public assessment report (EPAR): Cymbalta,

duloxetine

Revision: 25, Authorised
22/02/2017Human medicines European public assessment report (EPAR): Fasturtec,

rasburicase

Revision: 23, Authorised
22/02/2017Referral: Article 31 referrals, Quinolone- and fluoroquinolone-containing medicinal products,

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

(updated)
22/02/2017Minutes of the PRAC meeting 24-27 October 2016
22/02/2017Dienogest / estradiol (HRT indication): List of nationally authorised medicinal products - PSUSA/00010443/201606
22/02/2017Human medicines European public assessment report (EPAR): Amyvid,

florbetapir (18F)

Revision: 8, Authorised
22/02/2017Human medicines European public assessment report (EPAR): Stribild,

elvitegravir / cobicistat / emtricitabine / tenofovir disoproxil

Revision: 9, Authorised
22/02/2017Human medicines European public assessment report (EPAR): Eliquis,

apixaban

Revision: 12, Authorised
22/02/2017Human medicines European public assessment report (EPAR): Cystadrops,

mercaptamine

Revision: 0, Authorised
22/02/2017Orphan designation:

Cysteamine hydrochloride

for the: Treatment of cystinosis (updated)
22/02/2017Report: Report - Workshop on identifying opportunities for ‘big data’ in medicines development and regulatory science
21/02/2017Workplan for Good Clinical Practice (GCP) Inspectors Working Group for 2017
21/02/2017Agenda: Agenda - CAT agenda of the 15-17 February 2017 meeting
21/02/2017Human medicines European public assessment report (EPAR): Imatinib medac,

imatinib

Revision: 3, Authorised
21/02/2017Human medicines European public assessment report (EPAR): Synflorix,

pneumococcal polysaccharide conjugate vaccine (adsorbed)

Revision: 26, Authorised
21/02/2017Minutes of the HMPC 21-22 November 2016 meeting
21/02/2017HMPC meeting report on European Union herbal monographs, guidelines and other activities - 30-31 January 2017
21/02/2017Human medicines European public assessment report (EPAR): Fabrazyme,

agalsidase beta

Revision: 23, Authorised
21/02/2017Human medicines European public assessment report (EPAR): Evista,

raloxifene

Revision: 20, Authorised
21/02/2017Human medicines European public assessment report (EPAR): Avastin,

bevacizumab

Revision: 46, Authorised
21/02/2017Newsletter: Human medicines highlights - February 2017
21/02/2017Minutes of the PRAC meeting 26-29 September 2016
21/02/2017New vacancy: Temporary Agent, IT Contracts, Procurement and Vendor Manager
21/02/2017National experts on secondment (updated)
20/02/2017Human medicines European public assessment report (EPAR): LeukoScan,

sulesomab

Revision: 7, Authorised
20/02/2017Human medicines European public assessment report (EPAR): Xeristar,

duloxetine

Revision: 26, Authorised
20/02/2017Orphan designation:

Gallium (68Ga)-edotreotide

for the: Diagnosis of gastro-entero-pancreatic neuroendocrine tumours (updated)
20/02/2017Orphan designation:

Recombinant human type I pancreatic elastase for the prevention of arteriovenous access dysfunction in haemodialysis patients (vonapanitase)

for the: Prevention of arteriovenous access dysfunction in haemodialysis patients (updated)
20/02/2017Online training course for bioequivalence inspectors, European Medicines Agency, London, UK, From: 08-Mar-2017, To: 08-Mar-2017
20/02/2017Regulatory and procedural guideline: List of centrally authorised products requiring a notification of a change for update of annexes (updated)
20/02/2017Agenda: Agenda - PDCO agenda of the 21-24 February 2017 meeting
20/02/2017Minutes - PDCO minutes of the 13-16 December 2016 meeting
20/02/2017Minutes of the CAT meeting 8-9 December 2016
20/02/2017Monthly report on application procedures guidelines and related documents for veterinary medicines: January 2017
20/02/2017Human medicines European public assessment report (EPAR): SomaKit TOC,

edotreotide

Revision: 0, Authorised
20/02/2017Human medicines European public assessment report (EPAR): M-M-RVAXPRO,

measles, mumps and rubella vaccine (live)

Revision: 16, Authorised
20/02/2017Human medicines European public assessment report (EPAR): Gardasil,

human papillomavirus vaccine [types 6, 11, 16, 18] (recombinant, adsorbed)

Revision: 33, Authorised
17/02/2017News and press releases: First monoclonal antibody in veterinary medicine recommended for a marketing authorisation
17/02/2017Pending EC decision: Cytopoint,

lokivetmab

Opinion date: 16-Feb-2017
17/02/2017Pending EC decision: Zulvac BTV Ovis,

bluetongue virus vaccine, serotype 1 (inactivated) / bluetongue virus vaccine, serotype 4 (inactivated) / bluetongue virus vaccine, serotype 8 (inactivated) / bluetongue virus vaccine, serotype 8 (inactivated)

Opinion date: 16-Feb-2017
17/02/2017Pending EC decision: Credelio,

lotilaner

Opinion date: 16-Feb-2017
17/02/2017News and press releases: Committee for Medicinal Products for Veterinary Use (CVMP) Meeting of 14-16 February 2017
17/02/2017Access to documents (updated)
17/02/2017News and press releases: Consultation on revised policy on access to documents
17/02/2017Report: Report - Patient registries workshop
17/02/2017News and press releases: Martina Schüssler-Lenz elected as new chair of Committee for Advanced Therapies
17/02/2017Opinion of the Committee for Medicinal Products for Veterinary Use on the establishment of maximum residue limits: Fluralaner, adopted
17/02/2017Questions and answers: Good manufacturing practice (updated)
17/02/2017Human Normal Immunoglobulin - Notification of discontinuation of a paediatric development which is covered by an agreed paediatric-investigation-plan decision
17/02/2017Eleclazine (GS-6615) - Notification of discontinuation of a paediatric development which is covered by an agreed paediatric-investigation-plan decision
17/02/2017PF-04950615 - Notification of discontinuation of a paediatric development which is covered by an agreed paediatric-investigation-plan decision New document (updated)
16/02/2017Early paediatric interaction meeting template (updated)
16/02/2017Register of deadlines to put a medicinal product on the market in accordance with Article 33 of the Paediatric Regulation (updated)
16/02/2017Committee for Orphan Medicinal Products (COMP) work plan 2017
16/02/2017Human 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: 13, Authorised
16/02/2017MRL report: Fluralaner (poultry): European public maximum-residue-limit assessment report (EPMAR) - CVMP
16/02/2017Orgalutran (ganirelix) supply shortage
16/02/2017Scientific guideline: Concept paper on developing a guideline on quality requirements of medicinal products containing a device component for delivery or use of the medicinal product, draft: consultation open
16/02/2017Ganciclovir: List of nationally authorised medicinal products - PSUSA/00001516/201606
15/02/2017Human medicines European public assessment report (EPAR): Zebinix,

eslicarbazepine acetate

Revision: 19, Authorised
15/02/2017Regulatory and procedural guideline: Question and answer on the information contained within section 5.1 of the summary of product characteristics on pharmacodynamic properties for pharmaceutical products
15/02/2017Agenda: CHMP ORGAM agenda for the meeting on 13 February 2017
15/02/2017Product-information templates (updated)
15/02/2017Regulatory and procedural guideline: Quality Review of Documents veterinary product-information template version 8.1 - highlighted
15/02/2017Regulatory and procedural guideline: Implementation plan (veterinary) (updated)
15/02/2017Regulatory and procedural guideline: Quality Review of Documents veterinary product-information annotated template (English) version 8.1 - highlighted (updated)
15/02/2017Quality Review of Documents veterinary product-information template version 8.1 (updated)
15/02/2017Regulatory and procedural guideline: Quality Review of Documents veterinary product-information annotated template (English) version 8.1 - clean (updated)
14/02/2017Levonorgestrel / ethinylestradiol, ethinylestradiol (combination pack): List of nationally authorised medicinal products - PSUSA/00010442/201607
14/02/2017European 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)
14/02/2017Human medicines European public assessment report (EPAR): Ofev,

nintedanib

Revision: 4, Authorised
14/02/2017Conditions of employment (updated)
14/02/2017Pharmacovigilance fees: questions and answers (updated)
14/02/2017Pharmacovigilance fees: questions and answers (updated)
14/02/2017Orphan designation:

(-)-17(Cyclopropylmethyl)-1,14 beta-dihydroxy-4,5 alpha-epoxy-6beta-[N-methyl-trans-3-(3-furyl) acrylamido] morphinan hydrochloride (nalfurafine)

for the: Treatment of uremic pruritus (updated)
14/02/2017Human medicines European public assessment report (EPAR): Keppra,

levetiracetam

Revision: 40, Authorised
14/02/2017Agenda: Agenda - COMP agenda of the 14-16 February 2017
14/02/2017Agenda: Agenda - CVMP agenda of the 14-16 February 2017 meeting
14/02/2017Report: Innovative medicines initiative WEB-RADR workshop report: mobile technologies and social media as new tools in pharmacovigilance
14/02/2017Report: European Medicines Agency mid-year report 2016 from the Executive Director
14/02/2017Work programme of the European Medicines Agency 2017
14/02/2017Orphan designation:

Rovalpituzumab tesirine

for the: Treatment of small cell lung cancer (updated)
14/02/2017Human medicines European public assessment report (EPAR): Memantine Merz,

memantine hydrochloride

Revision: 4, Authorised
14/02/2017Human medicines European public assessment report (EPAR): Zonegran,

zonisamide

Revision: 27, Authorised
13/02/2017Ibuprofen / pseudoephedrine: List of nationally authorised medicinal products - PSUSA/00001711/201607
13/02/2017Human medicines European public assessment report (EPAR): Filgrastim Hexal,

filgrastim

Revision: 11, Authorised
13/02/2017Midodrine: List of nationally authorised medicinal products - PSUSA/00003178/201606
13/02/2017Human 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: 12, Authorised
13/02/2017Human medicines European public assessment report (EPAR): Thyrogen,

thyrotropin alfa

Revision: 20, Authorised
13/02/2017Human medicines European public assessment report (EPAR): Daklinza,

daclatasvir

Revision: 9, Authorised
13/02/2017Human medicines European public assessment report (EPAR): Caspofungin Accord,

caspofungin

Revision: 3, Authorised
13/02/2017Medicines under evaluation (updated)
13/02/2017Report: Medicinal products for human use: monthly figures - January 2017
13/02/2017ICH S9 Non-clinical evaluation for anticancer pharmaceuticals (updated)
13/02/2017ICH guideline E17 on general principles for planning and design of multi-regional clinical trials (updated)
13/02/2017Referral: Article 31 referrals, Factor VIII (updated)
13/02/2017Human medicines European public assessment report (EPAR): Rotarix,

rotavirus vaccine, live, attenuated

Revision: 24, Authorised
13/02/2017Human medicines European public assessment report (EPAR): Mirvaso,

brimonidine

Revision: 5, Authorised
13/02/2017Misoprostol (gastrointestinal indication): List of nationally authorised medicinal products - PSUSA/00010291/201606
13/02/2017Human medicines European public assessment report (EPAR): Optaflu,

influenza vaccine (surface antigen, inactivated, prepared in cell cultures)

Revision: 16, Authorised
10/02/2017Veterinary focus group meeting with stakeholders: revision of the reflection paper on anthelmintic resistance, European Medicines Agency, London, UK, From: 13-Jun-2016, To: 13-Jun-2016 (updated)
10/02/2017News and press releases: Over 1,000 studies now recorded in EU register of post-authorisation studies
10/02/2017Human medicines European public assessment report (EPAR): Pandemic influenza vaccine H5N1 MedImmune,

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

Revision: 1, Authorised
10/02/2017Human medicines European public assessment report (EPAR): Vaxelis,

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

Revision: 2, Authorised
10/02/2017News and press releases: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 6-9 February 2017
10/02/2017Orphan designation:

Mifepristone

for the: Treatment of Cushing's syndrome secondary to ectopic ACTH secretion (updated)
10/02/2017Orphan designation:

Pomalidomide

for the: Treatment of post-essential thrombocythaemia myelofibrosis (updated)
10/02/2017Orphan designation:

Pomalidomide

for the: Treatment of post-polycythaemia vera myelofibrosis (updated)
10/02/2017Orphan designation:

Recombinant human factor XIII (composed of two A subunits)

for the: Treatment of hereditary factor-XIII deficiency (updated)
10/02/2017Orphan designation:

Pomalidomide

for the: Treatment of primary myelofibrosis (updated)
10/02/2017Human medicines European public assessment report (EPAR): Cinacalcet Mylan,

cinacalcet

Revision: 1, Authorised
10/02/2017Orphan designation:

Axitinib

for the: Treatment of renal-cell carcinoma (updated)
10/02/2017Human medicines European public assessment report (EPAR): Ravicti,

 glycerol phenylbutyrate

Revision: 4, Authorised
10/02/2017Orphan designation:

Ponatinib hydrochloride

for the: Treatment of gastrointestinal stromal tumours (updated)
09/02/2017Human medicines European public assessment report (EPAR): Simponi,

golimumab

Revision: 27, Authorised
09/02/2017Human medicines European public assessment report (EPAR): Caprelsa,

vandetanib

Revision: 8, Authorised
09/02/2017Human medicines European public assessment report (EPAR): Enbrel,

etanercept

Revision: 49, Authorised
09/02/2017European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA) (updated)
09/02/2017Veterinary medicine European public assessment report (EPAR): Meloxoral,

meloxicam

Revision: 5, Authorised
09/02/20172017 Annual workshop of the European network of paediatric research at the EMA (Enpr-EMA), European Medicines Agency, London, UK, From: 16-May-2017, To: 16-May-2017
09/02/2017Agenda: Agenda - 2017 Annual workshop of the European network of paediatric research at the EMA (Enpr-EMA)
09/02/2017Registration form - 2017 Annual workshop of the European network of paediatric research at the EMA (Enpr-EMA)
09/02/2017Decision of the Executive Director on rules governing the secondment of national experts to the European Medicines Agency (updated)
09/02/2017Human medicines European public assessment report (EPAR): Harvoni,

ledispavir 90 mg / sofosbuvir 400 mg

Revision: 8, Authorised
09/02/2017Human medicines European public assessment report (EPAR): Beromun,

tasonermin

Revision: 11, Authorised
08/02/2017Work plan for Biostatistics Working Party 2016 (updated)
08/02/2017Human medicines European public assessment report (EPAR): Stelara,

ustekinumab

Revision: 19, Authorised
08/02/2017Human medicines European public assessment report (EPAR): Ivabradine JensonR,

ivabradine

Revision: 0, Authorised
08/02/2017Human medicines European public assessment report (EPAR): Evotaz,

atazanavir / cobicistat

Revision: 2, Authorised
08/02/2017Report: Annual report on the use of the special contribution for orphan medicinal products
08/02/2017Orphan designation:

Azacitidine

for the: Treatment of nasopharyngeal carcinoma (updated)
08/02/2017Work plan for the European Medicines Agency Human Scientific Committees’ Working Party with Patients’ and Consumers’ Organisations (PCWP) 2017 (updated)
08/02/2017Work plan for the European Medicines Agency Human Scientific Committees’ Working Party with Healthcare Professionals’ Organisations (HCPWP) 2017 (updated)
08/02/2017Human medicines European public assessment report (EPAR): Inhixa,

enoxaparin sodium

Revision: 1, Authorised
08/02/2017Human medicines European public assessment report (EPAR): Arzerra,

ofatumumab

Revision: 15, Authorised
08/02/2017Human medicines European public assessment report (EPAR): Opsumit,

macitentan

Revision: 7, Authorised
08/02/2017Human medicines European public assessment report (EPAR): Taxotere,

docetaxel

Revision: 39, Authorised
08/02/2017Orphan designation:

Anagrelide hydrochloride

for the: Treatment of essential thrombocythaemia (updated)
08/02/2017Orphan designation:

Iduronate-2-sulfatase

for the: Treatment of mucopolysaccharidosis, type II (Hunter Syndrome) (updated)
08/02/2017Orphan designation:

Stiripentol

for the: Treatment of severe myoclonic epilepsy in infancy (updated)
08/02/2017Orphan designation:

Dasatinib

for the: Treatment of acute lymphoblastic leukaemia (updated)
08/02/2017Orphan designation:

Dasatinib

for the: Treatment of chronic myeloid leukaemia (updated)
08/02/2017Human medicines European public assessment report (EPAR): Granpidam,

sildenafil

Revision: 1, Authorised
08/02/2017Human medicines European public assessment report (EPAR): Inovelon,

rufinamide

Revision: 13, Authorised
08/02/2017Questions and answers on the outcome of an extension of indication application for Inovelon (rufinamide) (updated)
07/02/2017Minutes of the 94th meeting of the Management Board: 14-15 December 2016
07/02/2017Q&A: Classification of centrally authorised veterinary medicinal products
07/02/2017Orphan designation:

Alisertib

for the: Treatment of peripheral T-cell lymphoma (nodal, other extranodal and leukaemic / disseminated) (updated)
07/02/2017Orphan designation:

Alisertib

for the: Treatment of ovarian cancer (updated)
07/02/2017Human medicines European public assessment report (EPAR): RotaTeq,

rotavirus vaccine, live

Revision: 23, Authorised
07/02/2017Nominations to the European Union Telematics governance bodies (updated)
07/02/2017Human medicines European public assessment report (EPAR): Uptravi,

selexipag

Revision: 2, Authorised
07/02/2017Orphan designation:

Allogeneic bone marrow stem cells treated ex vivo with 16,16-dimethyl prostaglandin E2

for the: Treatment of acute myeloid leukaemia (updated)
07/02/2017Human medicines European public assessment report (EPAR): Lymphoseek,

tilmanocept

Revision: 2, Authorised
07/02/2017Orphan designation:

Folic acid to be used with N-[4-[[(2-amino-3,4-dihydro-4-oxo-6-pteridinyl)methyl]amino]benzoyl]-D-gamma-glutamyl-(2S)-2-amino-beta-alanyl-L-alpha-aspartyl-L-cysteine

for the: Diagnosis of positive folate-receptor status in ovarian cancer (updated)
07/02/2017Regulatory and procedural guideline: European Surveillance of Veterinary Antimicrobial Consumption (ESVAC) Vision and Strategy 2016-2020 , adopted
07/02/2017Overview of the comments received on draft European Surveillance of Veterinary Antimicrobial Consumption (ESVAC) Vision and Strategy 2016-2020 (EMA/326299/2015)
07/02/2017Orphan designation:

Allogeneic umbilical cord blood cells treated ex vivo with 16,16-dimethyl prostaglandin E2

for the: Treatment of acute lymphoblastic leukaemia (updated)
07/02/2017Orphan designation:

Fingolimod

for the: Treatment of chronic inflammatory demyelinating polyneuropathy (updated)
07/02/2017Veterinary medicine European public assessment report (EPAR): Ypozane,

osaterone acetate

Revision: 2, Authorised
07/02/2017Regulatory and procedural guideline: Support for applications on Article 58
07/02/2017Pre-authorisation guidance (updated)
07/02/2017Regulatory and procedural guideline: European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure: document with tracked changes
07/02/2017Regulatory and procedural guideline: European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure (updated)
07/02/2017Regulatory and procedural guideline: European Medicines Agency post-authorisation procedural advice for users of the centralised procedure (updated)
07/02/2017Regulatory and procedural guideline: European Medicines Agency post-authorisation procedural advice for users of the centralised procedure: document with track changes (updated)
07/02/2017Post-authorisation safety studies: questions and answers (updated)
07/02/2017Article 58 applications: Regulatory and procedural guidance (updated)
07/02/2017European Surveillance of Veterinary Antimicrobial Consumption (ESVAC) (updated)
07/02/2017Human medicines European public assessment report (EPAR): Urorec,

silodosin

Revision: 13, Authorised
06/02/2017Agenda: Agenda - PRAC draft agenda of meeting 6-9 February 2017
06/02/2017Human medicines European public assessment report (EPAR): Yentreve,

duloxetine

Revision: 23, Authorised
06/02/2017Seventh Framework Programme (FP7) small-population research methods projects and regulatory application workshop, European Medicines Agency, London, UK, From: 29-Mar-2017, To: 30-Mar-2017
06/02/2017Human medicines European public assessment report (EPAR): Janumet,

sitagliptin / metformin

Revision: 19, Authorised
06/02/2017Agenda: Agenda - FP7 Small-population research methods projects and regulatory application workshop
06/02/2017Veterinary medicine European public assessment report (EPAR): Coliprotec F4/F18,

Porcine post-weaning diarrhoea vaccine (live)

Revision: 0, Authorised
06/02/2017Human medicines European public assessment report (EPAR): Relistor,

methylnaltrexone bromide

Revision: 14, Authorised
06/02/2017PRAC recommendations on signals adopted at the PRAC meeting of 9-12 January 2017, adopted
06/02/2017New product information wording: extracts from PRAC recommendations on signals adopted at the 9-12 January 2017 PRAC
06/02/2017List of signals discussed at the PRAC since September 2012 (updated)
06/02/2017Human medicines European public assessment report (EPAR): Amlodipine / Valsartan Mylan ,

amlodipine / valsartan

Revision: 1, Authorised
06/02/2017Human medicines European public assessment report (EPAR): Stivarga,

regorafenib

Revision: 9, Authorised
06/02/2017Human medicines European public assessment report (EPAR): Levemir,

insulin detemir

Revision: 25, Authorised
06/02/2017Human medicines European public assessment report (EPAR): Zarzio,

filgrastim

Revision: 12, Authorised
06/02/2017Veterinary medicine European public assessment report (EPAR): Zulvac 1+8 Bovis,

inactivated bluetongue virus, serotypes 1 and 8

Revision: 4, Authorised
06/02/2017Human medicines European public assessment report (EPAR): Intanza,

influenza vaccine (split virion, inactivated)

Revision: 17, Authorised
06/02/2017Human medicines European public assessment report (EPAR): Axura,

memantine

Revision: 23, Authorised
06/02/2017Human medicines European public assessment report (EPAR): Lumark,

lutetium, isotope of mass 177

Revision: 2, Authorised
06/02/2017Multi-stakeholder advanced therapy medicinal products (ATMPs) expert meeting: exploring solutions to foster ATMPs’ development and patient access in Europe, European Medicines Agency, London, UK, From: 27-May-2016, To: 27-May-2016 (updated)
06/02/2017Issues identified by stakeholders at the workshop - Multi-stakeholder advanced therapy medicinal products (ATMPs) expert meeting: exploring solutions to foster ATMPs’ development and patient access in Europe
06/02/2017Human medicines European public assessment report (EPAR): Infanrix Hexa,

diphtheria (D), tetanus (T), pertussis (acellular, component) (Pa), hepatitis B (rDNA) (HBV), poliomyelitis (inactivated) (IPV) and Haemophilus influenzae type-b (Hib) conjugate vaccine (adsorbed)

Revision: 31, Authorised
06/02/2017Human medicines European public assessment report (EPAR): Ruconest,

conestat alfa

Revision: 6, Authorised
06/02/2017Human medicines European public assessment report (EPAR): Zinbryta,

daclizumab

Revision: 2, Authorised
03/02/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

KEOC liquid extract ethanolic 30 per cent (w/w) of Allium cepa L. (fresh bulb) and Citrus lemon (L.) Burm. (fresh fruit) / Paullinia cupana Kunth / Theobroma cacao L.

Therapeutic area: Dermatology (updated)
03/02/2017Opinion/decision on a Paediatric investigation plan (PIP): -, Therapeutic area: Infectious diseases (updated)
03/02/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Finerenone

Therapeutic area: Uro-nephrology (updated)
03/02/2017Human medicines European public assessment report (EPAR): Azilect,

rasagiline

Revision: 17, Authorised
03/02/2017Human medicines European public assessment report (EPAR): Ariclaim,

duloxetine

Revision: 26, Authorised
03/02/2017Human medicines European public assessment report (EPAR): Feraccru,

ferric maltol

Revision: 3, Authorised
03/02/2017Human medicines European public assessment report (EPAR): Ikervis,

ciclosporin

Revision: 4, Authorised
03/02/2017Human medicines European public assessment report (EPAR): Emtricitabine / Tenofovir disoproxil Mylan,

emtricitabine / tenofovir disoproxil

Revision: 0, Authorised
03/02/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Allantoin

Therapeutic area: Dermatology (updated)
03/02/2017Core summary of product characteristics (SmPC) and package leaflet for nanocolloidal technetium (99mTc) albumin (updated)
03/02/2017Scientific guideline: Guideline on core SmPC and Package Leaflet for nanocolloidal technetium (99mTc) albumin - First version, adopted
03/02/2017Summary report - EMA / European Biopharmaceutical Enterprises (EBE) fifth annual regulatory conference on optimising the development of advanced therapies to meet patient needs
03/02/2017Human medicines European public assessment report (EPAR): Zepatier,

elbasvir / grazoprevir

Revision: 1, Authorised
03/02/2017e-Transmission of individual case safety reports (ICSRs) to the EMA - Steps to follow in case of system failure (updated)
03/02/2017eXtended EudraVigilance medicinal product dictionary (XEVMPD) data-entry tool user manual (updated)
03/02/2017Veterinary medicine European public assessment report (EPAR): Activyl Tick Plus,

indoxacarb / permethrin

Revision: 4, Authorised
03/02/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Eravacycline

Therapeutic area: Infectious diseases (updated)
03/02/2017Opinion/decision on a Paediatric investigation plan (PIP): Ionsys,

Fentanyl (hydrochloride)

Therapeutic area: Pain (updated)
03/02/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Semaglutide

Therapeutic area: Endocrinology, -gynacology-fertility-metabolism (updated)
03/02/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

inotuzumab ozogamicin

Therapeutic area: Haematology-Hemostaseology (updated)
03/02/2017Opinion/decision on a Paediatric investigation plan (PIP): Mysimba,

Naltrexone (hydrochloride) / bupropion (hydrochloride)

Therapeutic area: Other (updated)
03/02/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Estetrol / drospirenone

Therapeutic area: Endocrinology, -gynacology-fertility-metabolism (updated)
03/02/2017Human medicines European public assessment report (EPAR): Fiasp,

insulin aspart

Revision: 0, Authorised
03/02/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

dobutamine (hydrochloride)

Therapeutic area: Cardiovascular diseases (updated)
03/02/2017Human medicines European public assessment report (EPAR): Darunavir Mylan,

darunavir

Revision: 0, Authorised
03/02/2017Opinion/decision on a Paediatric investigation plan (PIP): Halaven,

Eribulin

Therapeutic area: Oncology (updated)
03/02/2017Opinion/decision on a Paediatric investigation plan (PIP): Imlygic,

Talimogene laherparepvec

Therapeutic area: Oncology (updated)
03/02/2017Opinion/decision on a Paediatric investigation plan (PIP): Zinforo,

Ceftaroline fosamil

Therapeutic area: Infectious diseases (updated)
03/02/2017Opinion/decision on a Paediatric investigation plan (PIP): Galafold,

Migalastat (hydrochloride)

Therapeutic area: Endocrinology, -gynacology-fertility-metabolism (updated)
03/02/2017Procurement (updated)
03/02/2017News and press releases: Advanced therapy medicines: towards increased development and patient access
03/02/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

autologous haematopoietic stem cells transduced with lentiviral vector Lenti-D encoding the human ATP-binding cassette, sub-family D (ALD), member 1 (ABCD1) from cDNA

Therapeutic area: Neurology (updated)
03/02/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Deferiprone

Therapeutic area: Haematology-Hemostaseology (updated)
03/02/2017Opinion/decision on a Paediatric investigation plan (PIP): Adasuve,

Loxapine

Therapeutic area: Psychiatry (updated)
02/02/2017Human medicines European public assessment report (EPAR): IDflu,

influenza vaccine (split virion, inactivated)

Revision: 13, Authorised
02/02/2017Human medicines European public assessment report (EPAR): Xgeva,

denosumab

Revision: 9, Authorised
02/02/2017Agenda: Agenda - Tenth industry stakeholder platform on the operation of EU pharmacovigilance
02/02/2017Tenth industry stakeholder platform on the operation of pharmacovigilance in the European Union, European Medicines Agency, London, UK, From: 03-Feb-2017, To: 03-Feb-2017
02/02/2017Ninth industry stakeholder platform on the operation of EU pharmacovigilance legislation, European Medicines Agency, London, UK, From: 21-Sep-2016, To: 21-Sep-2016 (updated)
02/02/2017Summaries of scientific recommendations on classification of advanced therapy medicinal products (updated)
02/02/2017Report: Scientific recommendation on classification of advanced therapy medicinal products: Bone marrow derived lineage negative heterogenic stem and progenitor cells
02/02/2017Human medicines European public assessment report (EPAR): Effentora,

fentanyl

Revision: 17, Authorised
02/02/2017Human medicines European public assessment report (EPAR): Imatinib Teva,

imatinib

Revision: 9, Authorised
02/02/2017Ivermectin (topical use): List of nationally authorised medicinal products - PSUSA/00010376/201604
02/02/2017Ivermectin (topical use): CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010376/201604
02/02/2017Human medicines European public assessment report (EPAR): Prolia,

denosumab

Revision: 13, Authorised
02/02/2017Human medicines European public assessment report (EPAR): Ongentys,

opicapone

Revision: 1, Authorised
02/02/2017Macrogol 3350: List of nationally authorised medicinal products - PSUSA/00001924/201605
02/02/2017Macrogol 4000: List of nationally authorised medicinal products - PSUSA/00010392/201605
02/02/2017Newsletters (updated)
02/02/2017Tirofiban: List of nationally authorised medicinal products - PSUSA/00002974/201605
02/02/2017EudraVigilance system overview (updated)
02/02/2017Withdrawn application: Alendronic Acid / Colecalciferol Mylan,

alendronic acid / colecalciferol

Initial authorisation (updated)
02/02/2017Human medicines European public assessment report (EPAR): Epclusa,

sofosbuvir / velpatasvir

Revision: 1, Authorised
02/02/2017Human medicines European public assessment report (EPAR): Entacapone Orion,

entacapone

Revision: 7, Authorised
01/02/2017Report: List of products granted eligibility to PRIME (updated)
01/02/2017Recommendations on eligibility to PRIME scheme - Adopted at the CHMP meeting of 23-26 January 2017, adopted
01/02/2017Human medicines European public assessment report (EPAR): Multaq,

dronedarone

Revision: 10, Authorised
01/02/2017News and press releases: Clinical data for two more medicines now available online
01/02/2017Human medicines European public assessment report (EPAR): Comtess,

entacapone

Revision: 25, Authorised
01/02/2017Human medicines European public assessment report (EPAR): Mircera,

methoxy polyethylene glycol-epoetin beta

Revision: 20, Authorised
01/02/2017Human medicines European public assessment report (EPAR): Cholestagel,

colesevelam

Revision: 17, Authorised
01/02/2017Human medicines European public assessment report (EPAR): Jardiance,

empagliflozin

Revision: 9, Authorised
01/02/2017Human medicines European public assessment report (EPAR): Iclusig,

ponatinib

Revision: 14, Authorised
01/02/2017Human medicines European public assessment report (EPAR): Orfadin,

nitisinone

Revision: 13, Authorised
01/02/2017Organisation chart: Inspections, Human Medicines Pharmacovigilance and Committees Division (updated)
01/02/2017Human medicines European public assessment report (EPAR): Combivir,

lamivudine / zidovudine

Revision: 26, Authorised