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April 2017

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28/04/2017Veterinary medicine European public assessment report (EPAR): Porcilis ColiClos,

vaccine to provide passive immunity to the progeny against Escherichia coli in pigs

Revision: 3, Authorised
28/04/2017Formatted table template to be inserted in application submission cover letters for veterinary procedures
28/04/2017Human medicines European public assessment report (EPAR): Clopidogrel/Acetylsalicylic acid Teva,

clopidogrel / acetylsalicylic acid

Revision: 1, Withdrawn
28/04/2017Regulatory and procedural guideline: List of centrally authorised products requiring a notification of a change for update of annexes (updated)
28/04/2017Overview of comments received by EMA on the draft Addendum of the ‘ICH E11(R1) guideline on clinical investigation of medicinal products in the paediatric population’ (EMA/CPMP/ICH/2711/1999) (updated)
28/04/2017Human medicines European public assessment report (EPAR): Pandemic Influenza Vaccine H5N1 Baxter AG,

pandemic influenza vaccine (H5N1) (whole virion, inactivated, prepared in cell culture)

Revision: 5, Authorised
28/04/2017Outcome of UK referendum on EU membership (updated)
28/04/2017News and press releases: EMA and heads of national competent authorities discuss consequences of Brexit
28/04/2017Human medicines European public assessment report (EPAR): Unituxin,

dinutuximab

Revision: 3, Withdrawn
28/04/2017Human medicines European public assessment report (EPAR): Xydalba,

dalbavancin

Revision: 6, Authorised
28/04/2017Veterinary medicine European public assessment report (EPAR): Contacera,

meloxicam

Revision: 5, Authorised
28/04/2017Trainee programme (updated)
28/04/2017Human medicines European public assessment report (EPAR): Silgard,

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

Revision: 31, Authorised
28/04/2017Human medicines European public assessment report (EPAR): Aclasta,

zoledronic acid

Revision: 23, Authorised
28/04/2017Human medicines European public assessment report (EPAR): Briviact,

brivaracetam

Revision: 4, Authorised
28/04/2017New vacancy: Contract Agent, Assistants, Contract Staff, all services at the European Medicines Agency (FG III)
27/04/2017Human medicines European public assessment report (EPAR): Kyprolis,

carfilzomib

Revision: 5, Authorised
27/04/2017Human medicines European public assessment report (EPAR): Betaferon,

interferon beta-1b

Revision: 28, Authorised
27/04/2017News and press releases: European Medicines Agency closed 1 May 2017
27/04/2017Human medicines European public assessment report (EPAR): Dutrebis,

lamivudine / raltegravir potassium

Revision: 0, Withdrawn
27/04/2017Traineeship Application Form 2017
27/04/2017Human medicines European public assessment report (EPAR): Somatropin Biopartners,

somatropin

Revision: 3, Authorised
27/04/2017Human medicines European public assessment report (EPAR): Flebogamma DIF (previously Flebogammadif),

human normal immunoglobulin

Revision: 13, Authorised
26/04/2017Human medicines European public assessment report (EPAR): Natpar,

parathyroid hormone

Revision: 0, Authorised
26/04/2017Report: List of products granted eligibility to PRIME (updated)
26/04/2017Recommendations on eligibility to PRIME scheme - Adopted at the CHMP meeting of 18-21 April 2017, adopted
26/04/2017Human medicines European public assessment report (EPAR): Gardasil,

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

Revision: 35, Authorised
26/04/2017Human medicines European public assessment report (EPAR): Mysimba,

naltrexone / bupropion

Revision: 5, Authorised
26/04/2017List of European Union reference dates and frequency of submission of periodic safety update reports (updated)
26/04/2017Quality of medicines questions and answers: Part 2 (updated)
26/04/2017Core summary of product characteristics (SmPC) and package leaflet for iopamidol 370
26/04/2017Scientific guideline: Draft guideline on Guideline on core summary of product characteristics (SmPC) and package leaflet for iopamidol 370, draft: consultation open
26/04/2017Scientific guideline: Draft guideline on Guideline on core summary of product characteristics (SmPC) and package leaflet for iopamidol 300, draft: consultation open
26/04/2017Core summary of product characteristics (SmPC) and package leaflet for iopamidol 300
26/04/2017Hemoprostol H-W-2652 (updated)
26/04/2017Human medicines European public assessment report (EPAR): Insulatard,

insulin human (rDNA)

Revision: 16, Authorised
26/04/2017Orphan designation:

Recombinant human parathyroid hormone

for the: Treatment of hypoparathyroidism (updated)
26/04/2017Hemoprostol: Withdrawal of the Article 58 scientific opinion - Public statement
26/04/2017Ethinylestradiol / gestodene (transdermal application): List of nationally authorised medicinal products - PSUSA/00010145/201608
26/04/2017Human medicines European public assessment report (EPAR): Kisplyx,

lenvatinib

Revision: 2, Authorised
26/04/2017List of medicinal products under additional monitoring (updated)
26/04/2017List of medicinal products under additional monitoring (updated)
26/04/2017Annex I - List of cyproterone-acetate / ethinylestradiol-containing medicinal products in the European Union (updated)
26/04/2017Annex I - List of cyproterone-acetate / ethinylestradiol-containing medicinal products in the European Union (updated)
26/04/2017Annex X - List of domperidone-containing medicinal products in the European Union (updated)
26/04/2017Annex II - List of trimetazidine containing medicinal products in the European Union (updated)
26/04/2017Annex II - List of trimetazidine containing medicinal products in the European Union (updated)
26/04/2017Report: Workshop report - Making Article 58 and other European Medicines Agency outputs more relevant for non-EU regulators
26/04/2017Workshop on making Article 58 and other European Medicines Agency outputs more relevant for non-EU regulators, Malta, From: 02-Mar-2017, To: 03-Mar-2017
26/04/2017Scientific guideline: Guideline on core SmPC and Package Leaflet for sodium iodide (131I) therapy capsule, draft: consultation open
25/04/2017Withdrawn application: Zioxtenzo,

pegfilgrastim

Initial authorisation (updated)
25/04/2017Withdrawn application: Graspa,

eryaspase

Initial authorisation (updated)
25/04/2017Herbal medicinal products: Paeonia, Paeoniae radix rubra, Paeonia lactiflora Pall. or Paeonia veitchii Lynch (updated)
25/04/2017COMP meeting report on the review of applications for orphan designation: April 2017
25/04/2017Human medicines European public assessment report (EPAR): Soliris,

eculizumab

Revision: 20, Authorised
25/04/2017Heads of Medicines Agencies (updated)
25/04/2017Orphan designation:

3-[2-(4-carbamimidoyl-phenylcarbamoyl)-5-methoxy-4-vinyl-phenyl]-6-(cyclopropylmethyl-carbamoyl)-pyridine-2-carboxylic acid (avoralstat)

for the: Treatment of hereditary angioedema (updated)
25/04/2017Orphan designation:

Irinotecan hydrochloride (drug-eluting beads)

for the: Treatment of glioma (updated)
25/04/2017Herbal medicinal products: Paeonia, Paeoniae radix alba, Paeonia lactiflora Pallas (updated)
25/04/2017Orphan designation:

Doxorubicin hydrochloride (drug eluting beads)

for the: Treatment of glioma (updated)
25/04/2017Human medicines European public assessment report (EPAR): Xgeva,

denosumab

Revision: 10, Authorised
25/04/2017Orphan designation:

autologous T cells transduced with retroviral vector encoding an anti-CD19 CD28/CD3-zeta chimeric antigen receptor

for the: Treatment of follicular lymphoma (updated)
25/04/2017Orphan designation:

autologous T cells transduced with retroviral vector encoding an anti-CD19 CD28/CD3-zeta chimeric antigen receptor

for the: Treatment of acute lymphoblastic leukaemia (updated)
25/04/2017Orphan designation:

autologous T cells transduced with retroviral vector encoding an anti-CD19 CD28/CD3-zeta chimeric antigen receptor

for the: Treatment of chronic lymphocytic leukaemia / small lymphocytic lymphoma (updated)
25/04/2017Human medicines European public assessment report (EPAR): HyQvia,

human normal immunoglobulin

Revision: 9, Authorised
25/04/2017Orphan designation:

Autologous T cells transduced with retroviral vector encoding an anti-CD19 CD28/CD3-zeta chimeric antigen receptor

for the: Treatment of mantle cell lymphoma (updated)
25/04/2017Orphan designation:

Autologous T cells transduced with retroviral vector encoding an anti-CD19 CD28/CD3 zeta chimeric antigen receptor

for the: Treatment of diffuse large B cell lymphoma (updated)
25/04/2017CHMP ORGAM minutes for the meeting on 13 March 2017
25/04/2017News and press releases: European Immunisation Week: Statement of Guido Rasi, the Executive Director of the European Medicines Agency (EMA)
25/04/2017Human medicines European public assessment report (EPAR): Inhixa,

enoxaparin sodium

Revision: 2, Authorised
24/04/2017Human medicines European public assessment report (EPAR): Adenuric,

febuxostat

Revision: 15, Authorised
24/04/2017Detailed guidance on the electronic submission of information on medicinal products for human use by marketing-authorisation holders to the European Medicines Agency in accordance with Article 57(2), second subparagraph of Regulation (EC) No. 726/2004: Chapter 3.II: Extended EudraVigilance product report message (XEVPRM) user guidance (updated)
24/04/2017Electronic submission of Article 57(2) data: questions and answers (updated)
24/04/2017Questions and answers on serious non-fatal adverse events and reporting rules (updated)
24/04/2017Regulatory and procedural guideline: List of substances and products subject to worksharing for signal management (updated)
24/04/2017Conduct of bioequivalence studies for veterinary medicinal products (updated)
24/04/2017Scientific guideline: Draft revised guideline on the conduct of bioequivalence studies for veterinary medicinal products, draft: consultation open
24/04/2017Overview of comments received on the 'Reflection paper on anthelmintic resistance’ (updated)
24/04/2017Anthelmintic resistance (updated)
24/04/2017Scientific guideline: Reflection paper on anthelmintic resistance, adopted
24/04/2017Human medicines European public assessment report (EPAR): Daptomycin Hospira,

daptomycin

Revision: 0, Authorised
24/04/2017Human medicines European public assessment report (EPAR): Lenvima,

lenvatinib

Revision: 2, Authorised
24/04/2017Human medicines European public assessment report (EPAR): Hirobriz Breezhaler,

indacaterol

Revision: 10, Authorised
24/04/2017Information Technology Directors Group - List of nominated members (alphabetically by country) (updated)
24/04/2017Research and development (updated)
24/04/2017Human medicines European public assessment report (EPAR): Rezolsta,

darunavir / cobicistat

Revision: 4, Authorised
24/04/2017Human medicines European public assessment report (EPAR): Truvada,

emtricitabine / tenofovir disoproxil

Revision: 34, Authorised
24/04/2017Human medicines European public assessment report (EPAR): PegIntron,

peginterferon alfa-2b

Revision: 33, Authorised
24/04/2017Human medicines European public assessment report (EPAR): Yondelis,

trabectedin

Revision: 20, Authorised
24/04/2017Procurement (updated)
24/04/2017Human medicines European public assessment report (EPAR): Entresto,

sacubitril / valsartan

Revision: 4, Authorised
24/04/2017Work plan of the CHMP Blood Products Working Party for 2017 (updated)
24/04/2017Human medicines European public assessment report (EPAR): Prezista,

darunavir

Revision: 39, Authorised
24/04/2017Detailed guidance on the electronic submission of information on medicinal products for human use by marketing-authorisation holders to the European Medicines Agency in accordance with Article 57(2), second subparagraph of Regulation (EC) No. 726/2004: Chapter 3.II: Extended EudraVigilance product report message (XEVPRM) user guidance (updated)
21/04/2017Pending EC decision: Kevzara,

sarilumab

Opinion date: 21-Apr-2017
21/04/2017Pending EC decision: Avastin,

bevacizumab

Opinion date: 21-Apr-2017
21/04/2017Pending EC decision: Rixathon,

rituximab

Opinion date: 21-Apr-2017
21/04/2017Pending EC decision: Riximyo,

rituximab

Opinion date: 21-Apr-2017
21/04/2017Pending EC decision: Erelzi,

etanercept

Opinion date: 21-Apr-2017
21/04/2017Pending EC decision: Brineura,

cerliponase alfa

Opinion date: 21-Apr-2017
21/04/2017Withdrawn application: Solithromycin Triskel EU Services,

solithromycin

Initial authorisation
21/04/2017Pending EC decision: Spinraza,

nusinersen

Opinion date: 21-Apr-2017
21/04/2017Pending EC decision: Febuxostat Mylan,

febuxostat

Opinion date: 21-Apr-2017
21/04/2017Pending EC decision: Skilarence,

dimethyl fumarate

Opinion date: 21-Apr-2017
21/04/2017Referral: Article 30 referrals, Vepesid,

etoposide

21/04/2017Pending EC decision: Besponsa,

inotuzumab ozogamicin

Opinion date: 21-Apr-2017
21/04/2017Pending EC decision: Cuprior,

trientine tetrahydrochloride

Opinion date: 21-Apr-2017
21/04/2017Pending EC decision: Opdivo,

nivolumab

Opinion date: 21-Apr-2017
21/04/2017Referral: Article 30 referrals, Etopophos,

etoposide phosphate

21/04/2017News and press releases: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 18-21 April 2017
21/04/2017Pending EC decision: Celsentri,

maraviroc

Opinion date: 21-Apr-2017
21/04/2017Pending EC decision: Ucedane,

carglumic acid

Opinion date: 21-Apr-2017
21/04/2017News and press releases: First medicine for spinal muscular atrophy
21/04/2017News and press releases: New medicine for rare neurodegenerative disorder in children
21/04/2017Referral: Article 35, Veterinary medicinal products containing gentamicin presented as solutions for injection to be administered to cattle and pigs ,

gentamicin

21/04/2017Human medicines European public assessment report (EPAR): Zevalin,

ibritumomab tiuxetan

Revision: 20, Authorised
21/04/2017Human medicines European public assessment report (EPAR): Amyvid,

florbetapir (18F)

Revision: 9, Authorised
21/04/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Baclofen

Therapeutic area: Psychiatry
21/04/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Atorvastatin (calcium) / ezetimibe

Therapeutic area: Cardiovascular diseases
21/04/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Methylphenidate (hydrochloride)

Therapeutic area: Neurology
21/04/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Alpelisib

Therapeutic area: Oncology
21/04/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

T-lymphocytes enriched leukocyte preparation depleted ex vivo of host host-alloreactive T cells using photodynamic treatment (ATIR101)

Therapeutic area: Immunology-Rheumatology-Transplantation
21/04/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Autologous CD34+ hematopoietic stem cells transduced ex vivo with EFS lentiviral vector encoding for the human adenosine deaminase gene

Therapeutic area: Immunology-Rheumatology-Transplantation
21/04/2017Human medicines European public assessment report (EPAR): Viekirax,

ombitasvir / paritaprevir / ritonavir

Revision: 8, Authorised
21/04/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Gadolinium, [α3,α6,α9-tris[3-[(2,3-dihydroxypropyl)amino]-3-oxopropyl]-3,6,9,15-tetraazabicyclo[9.3.1]pentadeca-1(15),11,13-triene-3,6,9-triacetato(3-)-κN3,κN6,κN9,κN15,κO3,κO6,κO9]-(P03277)

Therapeutic area: Diagnostic
21/04/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Recombinant human alpha-glucosidase conjugated with synthetic bismannose-6-phosphate-tetra-mannose glycan (neoGAA)

Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
21/04/2017Human medicines European public assessment report (EPAR): Exviera,

dasabuvir

Revision: 8, Authorised
21/04/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Lamivudine / dolutegravir

Therapeutic area: Infectious diseases
21/04/2017Opinion/decision on a Paediatric investigation plan (PIP): Zerbaxa,

Ceftolozane / tazobactam

Therapeutic area: Infectious diseases (updated)
21/04/2017News and press releases: Revised guidelines to encourage development of veterinary medicines for minor uses and minor species
21/04/2017Scientific guideline: Overview of comments received on 'Guideline on data requirements for immunological veterinary medicinal products intended for minor use or minor species (MUMS)/limited market' (EMA/CVMP/IWP/123243/2006-Rev.3) - Revision 3, adopted
21/04/2017Scientific guideline: Guideline on data requirements for immunological veterinary medicinal products intended for minor use or minor species (MUMS)/limited market - Revision 3, adopted
21/04/2017Data requirements for immunological veterinary medicinal products intended for minor use or minor species (updated)
21/04/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

8-chloro-5-methyl-1-[trans-4-(pyridin-2-yloxy)cyclohexyl]-5,6-dihydro-4H-[1,2,4]triazolo[4,3-a][1,4]benzodiazepine (RO5285119)

Therapeutic area: Neurology
21/04/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

5-(4-cyclopropyl-1H-imidazol-1-yl)-2-fluoro-N-(6-(4-isopropyl-4H-1,2,4-triazol-3-yl)pyridi-2-yl)-4-methylbenzamide

Therapeutic area: Gastroentology-Hepatology
21/04/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Avelumab

Therapeutic area: Oncology
21/04/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Somapacitan

Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
21/04/2017Ex ante publicity of a negotiated procedure: EMA/2017/03/COM - Provision of modular exhibition solutions
21/04/2017Opinion/decision on a Paediatric investigation plan (PIP): Imlygic,

Talimogene laherparepvec

Therapeutic area: Oncology (updated)
21/04/2017Opinion/decision on a Paediatric investigation plan (PIP): Orkambi,

Lumacaftor / ivacaftor

Therapeutic area: Other (updated)
20/04/2017Human medicines European public assessment report (EPAR): Exforge HCT,

amlodipine besylate / valsartan / hydrochlorothiazide

Revision: 11, Authorised
20/04/2017Human medicines European public assessment report (EPAR): Zaltrap,

aflibercept

Revision: 6, Authorised
20/04/2017Human medicines European public assessment report (EPAR): Dynastat,

parecoxib

Revision: 25, Authorised
20/04/2017Human medicines European public assessment report (EPAR): Olazax Disperzi,

olanzapine

Revision: 8, Authorised
20/04/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

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

Therapeutic area: Neurology (updated)
20/04/2017Orphan designation:

Antisense oligonucleotide targeted to the SMN2 gene

for the: Treatment of 5q spinal muscular atrophy (updated)
20/04/2017Orphan designation:

Cysteamine

for the: Treatment of cystic fibrosis (updated)
20/04/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Vigabatrin

Therapeutic area: Neurology (updated)
20/04/2017Human medicines European public assessment report (EPAR): Cerdelga,

eliglustat

Revision: 3, Authorised
20/04/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Vericiguat

Therapeutic area: Cardiovascular diseases (updated)
20/04/2017Opinion/decision on a Paediatric investigation plan (PIP): Viekirax,

Ombitasvir / paritaprevir / ritonavir

Therapeutic area: Infectious diseases (updated)
20/04/2017Opinion/decision on a Paediatric investigation plan (PIP): Exviera,

Dasabuvir (sodium monohydrate)

Therapeutic area: Infectious diseases (updated)
20/04/2017Opinion/decision on a Paediatric investigation plan (PIP): Cotellic,

Cobimetinib

Therapeutic area: Oncology (updated)
20/04/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Sirolimus

Therapeutic area: Ophthalmology (updated)
20/04/2017Opinion/decision on a Paediatric investigation plan (PIP): Harvoni,

Sofosbuvir / ledipasvir

Therapeutic area: Infectious diseases (updated)
20/04/2017Opinion/decision on a Paediatric investigation plan (PIP): Zavicefta,

Ceftazidime / avibactam

Therapeutic area: Infectious diseases (updated)
20/04/2017Opinion/decision on a Paediatric investigation plan (PIP): Taflotan and associated names,

Tafluprost

Therapeutic area: Ophthalmology (updated)
20/04/2017Opinion/decision on a Paediatric investigation plan (PIP): Tybost,

Cobicistat

Therapeutic area: Infectious diseases (updated)
20/04/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Treosulfan

Therapeutic area: Immunology-Rheumatology-Transplantation/Oncology (updated)
20/04/2017Opinion/decision on a Paediatric investigation plan (PIP): Dificlir,

Fidaxomicin

Therapeutic area: Infectious diseases (updated)
20/04/2017Seventh 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 (updated)
20/04/2017Opinion/decision on a Paediatric investigation plan (PIP): Aflunov and associated names,

Influenza virus surface antigens - A/turkey/Turkey/1/05 (H5N1)

Therapeutic area: Vaccines (updated)
20/04/2017Opinion/decision on a Paediatric investigation plan (PIP): Betmiga,

Mirabegron

Therapeutic area: Uro-nephrology (updated)
20/04/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Tofacitinib

Therapeutic area: Dermatology (updated)
20/04/2017eXtended EudraVigilance Medicinal Product Dictionary face-to-face training course, European Medicines Agency, London, UK, From: 19-Oct-2017, To: 20-Oct-2017
20/04/2017eXtended EudraVigilance Medicinal Product Dictionary face-to-face training course, European Medicines Agency, London, UK, From: 07-Dec-2017, To: 08-Dec-2017
20/04/2017eXtended EudraVigilance Medicinal Product Dictionary face-to-face training course , European Medicines Agency, London, UK, From: 21-Sep-2017, To: 22-Sep-2017
20/04/2017eXtended EudraVigilance Medicinal Product Dictionary face-to-face training course, European Medicines Agency, London, UK, From: 23-Nov-2017, To: 24-Nov-2017
20/04/2017EudraVigilance information day, European Medicines Agency, London, UK, From: 07-Jun-2017, To: 07-Jun-2017
20/04/2017HMPC: overview of assessment work – priority list (updated)
20/04/2017Minutes of the CVMP meeting of 14-16 March 2017
20/04/2017Human medicines European public assessment report (EPAR): Cervarix,

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

Revision: 28, Authorised
20/04/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Tofacitinib

Therapeutic area: Immunology-Rheumatology-Transplantation (updated)
20/04/2017Opinion/decision on a Paediatric investigation plan (PIP): Ecalta,

Anidulafungin

Therapeutic area: Infectious diseases (updated)
20/04/2017Opinion/decision on a Paediatric investigation plan (PIP): Ruconest,

Conestat alfa

Therapeutic area: Other (updated)
20/04/2017New vacancy: Contract Agent, Contracts, Procurement, Vendor and Finance Officer
20/04/2017Opinion/decision on a Paediatric investigation plan (PIP): Onglyza,

Saxagliptin

Therapeutic area: Endocrinology, -gynacology-fertility-metabolism (updated)
20/04/2017Opinion/decision on a Paediatric investigation plan (PIP): Mircera,

Methoxy polyethylene glycol-epoetin beta

Therapeutic area: Haematology-Hemostaseology (updated)
20/04/2017Opinion/decision on a Paediatric investigation plan (PIP): Nucala,

Mepolizumab

Therapeutic area: Pneumology-allergology (updated)
19/04/2017Monthly report on application procedures guidelines and related documents for veterinary medicines: March 2017
19/04/2017Human medicines European public assessment report (EPAR): Jylamvo,

methotrexate

Revision: 0, Authorised
19/04/2017EudraVigilance: security principles and responsibilities
19/04/2017Human medicines European public assessment report (EPAR): Herceptin,

trastuzumab

Revision: 31, Authorised
19/04/2017Quality by design (updated)
19/04/2017Human medicines European public assessment report (EPAR): Olanzapine Glenmark,

olanzapine

Revision: 11, Authorised
19/04/2017Human medicines European public assessment report (EPAR): Zepatier,

elbasvir / grazoprevir

Revision: 2, Authorised
19/04/2017Human medicines European public assessment report (EPAR): Olazax,

olanzapine

Revision: 9, Authorised
19/04/2017Orphan designation:

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

for the: Treatment of medulloblastoma
19/04/2017Final CHMP work plan 2017 (updated)
19/04/2017Orphan designation:

(4R,5R)-1-[[4-[[4-[3,3-dibutyl-7-(dimethylamino)-2,3,4,5- tetrahydro-4-hydroxy-1,1-dioxido-1-benzothiepin-5-yl]phenoxy]methyl]phenyl]methyl]-4-aza-1-azoniabicyclo[2.2.2]octane chloride

for the: Treatment of primary sclerosing cholangitis (updated)
19/04/2017Information security when using the EudraVigilance system: Best practice guide for management of authorised access to EudraVigilance
19/04/2017Olanzapine Glenmark : EPAR - All Authorised presentations (updated)
18/04/2017Human medicines European public assessment report (EPAR): Nucala,

mepolizumab

Revision: 3, Authorised
18/04/2017Nominations to the European Union Telematics governance bodies (updated)
18/04/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Testosterone

Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
18/04/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Ciprofloxacin (hydrochloride)

Therapeutic area: Infectious diseases
18/04/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Naldemedine (tosylate)

Therapeutic area: Gastroentology-Hepatology (updated)
18/04/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Rilpivirine / Dolutegravir

Therapeutic area: Infectious diseases (updated)
18/04/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Dupilumab

Therapeutic area: Pneumology-allergology (updated)
18/04/2017Diallertest - Notification of discontinuation of a paediatric development which is covered by an agreed paediatric-investigation-plan decision
18/04/2017Soliris - Notification of discontinuation of a paediatric development which is covered by an agreed paediatric-investigation-plan decision
18/04/2017MRL pending EC decision: Alarelin - Summary opinion of the CVMP on the establishment of maximum residue limits
18/04/2017Pending EC decision: Prevomax,

maropitant

Opinion date: 12-Apr-2017
18/04/2017Pending EC decision: Activyl Tick Plus,

indoxacarb / permethrin

Opinion date: 12-Apr-2017
18/04/2017Agenda: Agenda - CHMP agenda of the 18-21 April 2017 meeting
18/04/2017Opinion/decision on a Paediatric investigation plan (PIP): Vimpat,

Lacosamide

Therapeutic area: Neurology (updated)
18/04/2017Opinion/decision on a Paediatric investigation plan (PIP): Briviact,

brivaracetam

Therapeutic area: Neurology (updated)
18/04/2017Ajmaline: List of nationally authorised medicinal products - PSUSA/00000072/201608
18/04/2017News and press releases: Committee for Medicinal Products for Veterinary Use (CVMP) Meeting of 10-12 April 2017
18/04/2017Human medicines European public assessment report (EPAR): Vivanza,

vardenafil

Revision: 22, Authorised
18/04/2017Human medicines European public assessment report (EPAR): Zyclara,

imiquimod

Revision: 5, Authorised
18/04/2017Veterinary medicine European public assessment report (EPAR): ProZinc,

insulin human

Revision: 5, Authorised
18/04/2017Work instructions for inspection of quality control facilities located in third countries, adopted (updated)
18/04/2017European medicines agency Standard operating procedure (SOP): Standard operating procedure for notifications from marketing authorisation holders on pharmacovigilance non-compliance issues
18/04/2017Minutes of the CHMP meeting 20-23 February 2017
12/04/2017External guidance on the implementation of the European Medicines Agency policy on the publication of clinical data for medicinal products for human use (updated)
12/04/2017Support for industry on clinical data publication (updated)
12/04/2017Plasma-master-file certifications (updated)
12/04/2017Regulatory and procedural guideline: External guidance on the implementation of the European Medicines Agency policy on the publication of clinical data for medicinal products for human use - Version 1.2, adopted
12/04/2017Regulatory and procedural guideline: Questions and answers (Q&As) on the external guidance of Policy 0070 on clinical data publication (CDP)
12/04/2017Summary of changes to the ‘External guidance on the implementation of the European Medicines Agency policy on the publication of clinical data for medicinal products for human use’ - Published 12 April 2017
12/04/2017Herbal medicinal products: Melilotus, Meliloti herba, Melilotus officinalis (L.) Lam. (updated)
12/04/2017Draft European Union herbal monograph on Melilotus officinalis (L.) Lam., herba, draft: consultation open
12/04/2017Scientific guideline: Draft guideline on good -clinical -practice compliance in relation to trial master file (paper and/or electronic) for content, management, archiving, audit and inspection of clinical trials, draft: consultation open
12/04/2017Herbal medicinal products: Arctostaphylos, Uvae ursi folium, Arctostaphylos uva-ursi (L.) Spreng. (updated)
12/04/2017Draft European Union herbal monograph on Arctostaphylos uva-ursi (L.) Spreng., folium, draft: consultation open
12/04/2017News and press releases: Update of EMA recommendations for 2017/2018 seasonal flu vaccine composition
12/04/2017Herbal medicinal products: Combination; maximum 4 out of 13 possible genera, Combination: Species diureticae, Combination: maximum 4 out of 13 possible plants (updated)
12/04/2017Regulatory and procedural guideline: Biologics Working Party (BWP) Ad-hoc Influenza Working Group: Amended European Union recommendations for the seasonal influenza vaccine composition for the season 2017/2018 (updated)
12/04/2017Human medicines European public assessment report (EPAR): Vihuma,

simoctocog alfa

Revision: 0, Authorised
11/04/2017Referral: Article 31 referrals, Valproate and related substances,

sodium valproate, valproate magnesium, valproate semisodium, valproic acid, valpromide

(updated)
11/04/2017Fosfomycin (oral formulation): List of nationally authorised medicinal products - PSUSA/00010326/201607, adopted
11/04/2017Fluocinolone acetonide (intravitreal implant in applicator): List of nationally authorised medicinal products - PSUSA/00010224/201608, adopted
11/04/2017Budesonide / formoterol (apart from centrally authorised products): List of nationally authorised medicinal products - PSUSA/00000450/201608, adopted
11/04/2017Timolol (eye preparations): List of nationally authorised medicinal products - PSUSA/00010439/201607, adopted
11/04/2017Fosfomycin (IV formulation): List of nationally authorised medicinal products - PSUSA/00010336/201607, adopted
11/04/2017Newsletter: What's new in pharmacovigilance - QPPV Update - Issue 1 - 2017
11/04/2017European medicines agency Standard operating procedure (SOP): Standard operating procedure for CHMP / CAT / PRAC rapporteur / co-rapporteur / peer-reviewer appointment in the centralised procedure (updated)
11/04/2017European medicines agency Standard operating procedure (SOP): Standard operating procedure for tracking and handling in SIAMED of SDA post-authorisation measures for centrally authorised products
11/04/2017Veterinary medicine European public assessment report (EPAR): Zulvac 1+8 Bovis,

inactivated bluetongue virus, serotypes 1 and 8

Revision: 5, Authorised
11/04/2017Agenda: Agenda - CAT agenda of the 10-12 April 2017 meeting
11/04/2017PDCO monthly report of opinions on paediatric investigation plans and other activities 21-24 March 2017
11/04/2017EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) substances (updated)
11/04/2017EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) organisations (updated)
11/04/2017Minutes of the PRAC meeting 9-12 January 2017
11/04/2017New functionalities in support of the medical literature monitoring service - User manual: EV ICHISCR Export Manager, MLM EVWEB and tracking spreadsheets (updated)
11/04/2017Human medicines European public assessment report (EPAR): Alecensa,

alectinib

Revision: 0, Authorised
11/04/2017Human medicines European public assessment report (EPAR): Trajenta,

linagliptin

Revision: 9, Authorised
11/04/2017Veterinary medicine European public assessment report (EPAR): Zulvac SBV,

Inactivated Schmallenberg virus, strain BH80/11-4

Revision: 2, Authorised
11/04/2017Veterinary medicine European public assessment report (EPAR): Palladia,

toceranib

Revision: 7, Authorised
11/04/2017Veterinary medicine European public assessment report (EPAR): Zulvac 8 Ovis,

inactivated bluetongue virus, serotype 8

Revision: 8, Authorised
11/04/2017Veterinary medicine European public assessment report (EPAR): Zulvac 8 Bovis,

inactivated bluetongue virus, serotype 8

Revision: 7, Authorised
11/04/2017Veterinary medicine European public assessment report (EPAR): Zulvac 1 Ovis,

inactivated bluetongue virus, serotype-1

Revision: 5, Authorised
11/04/2017Veterinary medicine European public assessment report (EPAR): Zulvac 1 Bovis,

inactivated bluetongue virus, serotype 1

Revision: 6, Authorised
11/04/2017Veterinary medicine European public assessment report (EPAR): Zulvac 1+8 Ovis,

inactivated bluetongue serotype 1+8 vaccine

Revision: 5, Authorised
11/04/2017Ex ante publicity of a negotiated procedure: EMA/2017/12/COM – Financial information on companies and legal entities
10/04/2017Human medicines European public assessment report (EPAR): Yargesa,

miglustat

Revision: 0, Authorised
10/04/2017Buserelin: List of nationally authorised medicinal products - PSUSA/00000462/201608
10/04/2017Human plasma protease C1 inhibitor (nationally authorised products): List of nationally authorised medicinal products - PSUSA/00010163/201608
10/04/2017Paricalcitol: List of nationally authorised medicinal products - PSUSA/00002316/201608
10/04/2017Agenda: Agenda - CVMP agenda of the 10-12 April 2017 meeting
10/04/2017Human medicines European public assessment report (EPAR): Firazyr,

icatibant

Revision: 12, Authorised
10/04/2017Human medicines European public assessment report (EPAR): Aerivio Spiromax,

salmeterol / fluticasone propionate

Revision: 1, Authorised
10/04/2017Veterinary medicine European public assessment report (EPAR): Versican Plus Pi/L4,

Canine parainfluenza virus (live attenuated) and canine leptospirosis (inactivated) vaccine

Revision: 2, Authorised
10/04/2017Report: Summary report - Stakeholder focus group meeting on availability of Lumpy Skin Disease (LSD) vaccines authorised to EU standards held
10/04/2017Veterinary medicine European public assessment report (EPAR): Versican Plus Pi/L4R,

Canine parainfluenza virus (live attenuated), canine leptospirosis and rabies (inactivated) vaccine

Revision: 3, Authorised
10/04/2017Veterinary medicine European public assessment report (EPAR): Versican Plus Pi,

canine parainfluenza virus vaccine (live attenuated)

Revision: 2, Authorised
10/04/2017Veterinary medicine European public assessment report (EPAR): Versican Plus L4,

Canine leptospirosis vaccine (inactivated)

Revision: 2, Authorised
10/04/2017Veterinary medicine European public assessment report (EPAR): Versican Plus DHPPi,

canine distemper, canine adenovirus, canine parvovirosis and canine parainfluenza virus vaccine (live attenuated)

Revision: 4, Authorised
10/04/2017Veterinary medicine European public assessment report (EPAR): Versican Plus DHPPi/L4,

canine distemper, canine adenovirus, canine parvovirosis, canine parainfluenza virus (live attenuated) and canine leptospirosis (inactivated) vaccine

Revision: 4, Authorised
10/04/2017Veterinary medicine European public assessment report (EPAR): VarroMed,

oxalic acid dihydrate / formic acid

Revision: 0, Authorised
10/04/2017Human medicines European public assessment report (EPAR): Neulasta,

pegfilgrastim

Revision: 28, Authorised
10/04/2017Veterinary medicine European public assessment report (EPAR): Versican Plus DHPPi/L4R,

canine distemper, canine adenovirus, canine parvovirosis, canine parainfluenza virus (live attenuated), canine leptospirosis and rabies (inactivated) vaccine

Revision: 4, Authorised
10/04/2017Veterinary medicine European public assessment report (EPAR): Cerenia,

maropitant

Revision: 17, Authorised
10/04/2017Veterinary medicine European public assessment report (EPAR): Pirsue,

pirlimycin

Revision: 13, Authorised
10/04/2017Veterinary medicine European public assessment report (EPAR): Equip WNV (previously Duvaxyn WNV),

adjuvanted vaccine against West Nile virus in horses

Revision: 13, Authorised
10/04/2017Veterinary medicine European public assessment report (EPAR): Simparica,

sarolaner

Revision: 3, Authorised
10/04/2017Human medicines European public assessment report (EPAR): Instanyl,

fentanyl

Revision: 18, Authorised
10/04/2017Veterinary medicine European public assessment report (EPAR): Trifexis,

spinosad / milbemycin oxime

Revision: 3, Authorised
10/04/2017Veterinary medicine European public assessment report (EPAR): Fevaxyn Pentofel,

inactivated feline panleukopenia virus, calicivirus, rhinotracheitis virus, leukaemia virus and Chlamydophila felis

Revision: 18, Authorised
10/04/2017Veterinary medicine European public assessment report (EPAR): Convenia,

cefovecin

Revision: 9, Authorised
10/04/2017Human medicines European public assessment report (EPAR): Vidaza,

azacitidine

Revision: 15, Authorised
10/04/2017Veterinary medicine European public assessment report (EPAR): Apoquel,

oclacitinib maleate

Revision: 3, Authorised
10/04/2017Q&A: 1-20 (updated)
10/04/2017Orphan designation:

{2-amino-8-[4-(pyrrolidinylcarbonyl)phenyl]-(3H-benzo[f]azepin-4-yl)}-N,N-dipropylcarboxamide

for the: Treatment of ovarian cancer (updated)
10/04/2017Human medicines European public assessment report (EPAR): Zinforo,

ceftaroline fosamil

Revision: 12, Authorised
10/04/2017Regulatory and procedural guideline: Patient Leaflet template concerning advice on the preparation of herbal teas as (traditional) herbal medicinal products by end-users, adopted
10/04/2017HMPC meeting report on European Union herbal monographs, guidelines and other activities - 27-28 March 2017
10/04/2017Report: Applications for new human medicines under evaluation by the CHMP: April 2017
10/04/2017Handling reports of alleged improprieties from external sources
10/04/2017News and press releases: Reporting irregularities that may affect medicines
10/04/2017Policy 72: European Medicines Agency policy on handling of information from external sources disclosing alleged improprieties concerning EMA activities related to the authorisation, supervision and maintenance of human and veterinary medicinal products
10/04/2017Agenda: CHMP ORGAM agenda for the meeting on 10 April 2017
10/04/2017Herbal medicinal products: Aloe, Aloe bardadensis / Aloe capensis, Aloe barbadensis Miller / Aloe ferox Miller (updated)
10/04/2017Minutes of the PRAC meeting 28 November - 1 December 2016
10/04/2017Agenda: Agenda - COMP agenda of the 10-11 April 2017
07/04/2017Human medicines European public assessment report (EPAR): Solymbic,

adalimumab

Revision: 0, Authorised
07/04/2017Human medicines European public assessment report (EPAR): Tadalafil Lilly,

tadalafil

Revision: 0, Authorised
07/04/2017Referral: Article 31 referrals, Gadolinium-containing contrast agents,

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

(updated)
07/04/2017News and press releases: Pharmacovigilance Risk Assessment Committee (PRAC): 3-6 April 2017
07/04/2017News and press releases: EMA concludes safety review of Uptravi
07/04/2017Investigation of drug interactions (updated)
07/04/2017Scientific guideline: Concept paper on a revision of the guideline on the investigation of drug interactions, draft: consultation open
06/04/2017Human medicines European public assessment report (EPAR): Tygacil,

tigecycline

Revision: 26, Authorised
06/04/2017Human medicines European public assessment report (EPAR): Zavicefta,

ceftazidime / avibactam

Revision: 1, Authorised
06/04/2017Human medicines European public assessment report (EPAR): Puregon,

follitropin beta

Revision: 24, Authorised
06/04/2017Human medicines European public assessment report (EPAR): ProQuad,

measles, mumps, rubella and varicella vaccine (live)

Revision: 22, Authorised
06/04/2017Human medicines European public assessment report (EPAR): Pradaxa,

dabigatran etexilate

Revision: 25, Authorised
06/04/2017Human medicines European public assessment report (EPAR): Rapamune,

sirolimus

Revision: 35, Authorised
06/04/2017Human medicines European public assessment report (EPAR): Efient,

prasugrel

Revision: 14, Authorised
06/04/2017Human medicines European public assessment report (EPAR): Fertavid,

follitropin beta

Revision: 9, Authorised
06/04/2017Veterinary medicine European public assessment report (EPAR): Circovac,

adjuvanted inactivated vaccine against porcine circovirus type 2

Revision: 8, Authorised
06/04/2017Human medicines European public assessment report (EPAR): Amgevita,

adalimumab

Revision: 0, Authorised
06/04/2017Human medicines European public assessment report (EPAR): Levitra,

vardenafil

Revision: 25, Authorised
06/04/2017Human medicines European public assessment report (EPAR): Prolia,

denosumab

Revision: 14, Authorised
06/04/2017Human medicines European public assessment report (EPAR): Vantavo (previously Alendronate sodium and colecalciferol, MSD),

alendronic acid / colecalciferol

Revision: 11, Authorised
06/04/2017Veterinary medicine European public assessment report (EPAR): Suvaxyn PCV,

adjuvanted inactivated vaccine against porcine circovirus type 2 in piglets

Revision: 11, Authorised
06/04/2017Human medicines European public assessment report (EPAR): Fosavance,

alendronic acid / colecalciferol

Revision: 19, Authorised
06/04/2017Human medicines European public assessment report (EPAR): Pioglitazone Teva Pharma,

pioglitazone

Revision: 7, Authorised
06/04/2017Human medicines European public assessment report (EPAR): Ristempa,

pegfilgrastim

Revision: 3, Authorised
06/04/2017Human medicines European public assessment report (EPAR): Icandra (previously Vildagliptin / metformin hydrochloride Novartis),

vildagliptin / metformin

Revision: 15, Authorised
06/04/2017Human medicines European public assessment report (EPAR): Cystadane,

betaine anhydrous

Revision: 10, Authorised
06/04/2017News and press releases: Optimising safety information for medicines in Europe throughout product lifecycle
06/04/2017Regulatory and procedural guideline: European Medicines Agency post-authorisation procedural advice for users of the centralised procedure: document with track changes (updated)
06/04/2017Regulatory and procedural guideline: Pre-submission checklist for 5-year renewal applications (updated)
06/04/2017Periodic safety update reports: questions and answers (updated)
06/04/2017Regulatory and procedural guideline: European Medicines Agency post-authorisation procedural advice for users of the centralised procedure (updated)
06/04/2017Scientific guideline: Guideline on good pharmacovigilance practices (GVP): Module VII – Periodic safety update report - Explanatory note, adopted
06/04/2017Regulatory and procedural guideline: Questions and answers on PSUSA: Guidance document for assessors
06/04/2017Periodic safety update reports (updated)
06/04/2017Human medicines European public assessment report (EPAR): Levetiracetam Actavis,

levetiracetam

Revision: 11, Authorised
06/04/2017Veterinary medicine European public assessment report (EPAR): SevoFlo,

sevoflurane

Revision: 14, Authorised
06/04/2017Human medicines European public assessment report (EPAR): Telzir,

fosamprenavir

Revision: 38, Authorised
06/04/2017Human medicines European public assessment report (EPAR): Imatinib Accord,

imatinib

Revision: 9, Authorised
06/04/2017Human medicines European public assessment report (EPAR): Pixuvri,

pixantrone dimaleate

Revision: 15, Authorised
06/04/2017News and press releases: EU cooperation on rare diseases honoured with new EU Ombudsman prize
06/04/2017Human medicines European public assessment report (EPAR): Aranesp,

darbepoetin alfa

Revision: 36, Authorised
06/04/2017Veterinary medicine European public assessment report (EPAR): Suvaxyn Circo+MH RTU,

Porcine circovirus and porcine enzootic pneumonia vaccine (inactivated)

Revision: 2, Authorised
06/04/2017Annex B Word template (updated)
05/04/2017Regulatory and procedural guideline: Member states contact points for translation review (v.6.6) (updated)
05/04/2017Scientific advice request template
05/04/2017Frequently asked questions: Translations (updated)
05/04/2017About us (updated)
05/04/2017Human medicines European public assessment report (EPAR): Teysuno,

tegafur / gimeracil / oteracil

Revision: 13, Authorised
05/04/2017Pending EC decision: Lokelma,

sodium zirconium cyclosilicate

Opinion date: 23-Feb-2017 (updated)
05/04/2017CHMP summary of positive opinion for Lokelma, adopted (updated)
05/04/2017Veterinary medicine European public assessment report (EPAR): Stronghold,

selamectin

Revision: 22, Authorised
05/04/2017Human medicines European public assessment report (EPAR): Humalog,

insulin lispro

Revision: 26, Authorised
05/04/2017Veterinary medicine European public assessment report (EPAR): Stronghold Plus,

selamectin / sarolaner

Revision: 1, Authorised
05/04/2017Human medicines European public assessment report (EPAR): Xadago,

safinamide

Revision: 5, Authorised
05/04/2017Orphan designation:

Resminostat

for the: Treatment of hepatocellular carcinoma (updated)
05/04/2017Veterinary medicine European public assessment report (EPAR): Draxxin,

tulathromycin

Revision: 17, Authorised
05/04/2017Human medicines European public assessment report (EPAR): Revlimid,

lenalidomide

Revision: 33, Authorised
05/04/2017Veterinary medicine European public assessment report (EPAR): Suvaxyn CSF Marker,

classical swine fever vaccine (live recombinant)

Revision: 2, Authorised
05/04/2017Human medicines European public assessment report (EPAR): Eucreas,

vildagliptin / metformin

Revision: 15, Authorised
04/04/2017Human medicines European public assessment report (EPAR): Omidria,

phenylephrine / ketorolac

Revision: 1, Authorised
04/04/2017Clinical requirements for locally applied, locally acting products containing known constituents (updated)
04/04/2017Scientific guideline: Draft guideline on equivalence studies for the demonstration of therapeutic equivalence for products that are locally applied, locally acting in the gastrointestinal tract as addendum to the guideline on the clinical requirements for locally applied, locally acting products containing known constituents, draft: consultation open
04/04/2017Human medicines European public assessment report (EPAR): Obizur,

susoctocog alfa

Revision: 2, Authorised
04/04/2017List of signals discussed at the PRAC since September 2012 (updated)
04/04/2017Signal assessment report - template (updated)
04/04/2017PRAC recommendations on signals adopted at the PRAC meeting of 6-9 March 2017, adopted
04/04/2017New product information wording: extracts from PRAC recommendations on signals adopted at the 6-9 March 2017 PRAC
04/04/2017Agenda: Agenda - PRAC draft agenda of meeting 3-6 April 2017
04/04/2017Human medicines European public assessment report (EPAR): Emtricitabine / Tenofovir disoproxil Krka,

emtricitabine / tenofovir disoproxil

Revision: 0, Authorised
04/04/2017PRAC work plan 2017
04/04/2017Human medicines European public assessment report (EPAR): Airexar Spiromax,

salmeterol xinafoate / fluticasone propionate

Revision: 1, Authorised
04/04/2017Human medicines European public assessment report (EPAR): Protaphane,

insulin human (rDNA)

Revision: 14, Authorised
04/04/2017Human medicines European public assessment report (EPAR): Actraphane,

insulin human (rDNA)

Revision: 15, Authorised
04/04/2017Human medicines European public assessment report (EPAR): Zomarist,

vildagliptin / metformin

Revision: 15, Authorised
04/04/2017New vacancy: Temporary Agent, Head of Veterinary Medicines Division
04/04/2017New vacancy: Temporary Agent, Information System Manager
04/04/2017New vacancy: Temporary Agent (AD8), Portfolio Management Office (PMO) Lead
04/04/2017Obizur : EPAR - Product Information (updated)
03/04/2017Veterinary medicine European public assessment report (EPAR): Bravecto,

Fluralaner

Revision: 3, Authorised
03/04/2017Human medicines European public assessment report (EPAR): Zonisamide Mylan,

zonisamide

Revision: 1, Authorised
03/04/2017Submission of comments during the pilot phase for the QRD template ‘Particulars to appear on the immediate package – combined label and package leaflet’
03/04/2017Particulars to appear on the immediate package – combined label and package leaflet
03/04/2017Regulatory and procedural guideline: Quality review of documents (QRD) template ‘Particulars to appear on the immediate package – combined label and package leaflet’ for veterinary medicinal products authorised via the centralised, mutual recognition and decentralised procedures., draft: consultation open
03/04/2017European Surveillance of Veterinary Antimicrobial Consumption (ESVAC) stakeholders annual meeting 2017, European Medicines Agency, London, UK, From: 03-Mar-2017, To: 03-Mar-2017
03/04/2017Human medicines European public assessment report (EPAR): Pylobactell,

13C-urea

Revision: 9, Authorised
03/04/2017Inventory of herbal substances for assessment (updated)
03/04/2017Human medicines European public assessment report (EPAR): Lyxumia ,

lixisenatide

Revision: 7, Authorised
03/04/2017Regulatory and procedural guideline: Framework of collaboration between the European Medicines Agency and academia - Annex I – Action plan, adopted
03/04/2017Regulatory and procedural guideline: Framework of collaboration between the European Medicines Agency and academia, adopted
03/04/2017Resources for academia
03/04/2017Human medicines European public assessment report (EPAR): Genvoya,

elvitegravir / cobicistat / emtricitabine / tenofovir alafenamide

Revision: 7, Authorised
03/04/2017Human medicines European public assessment report (EPAR): Aripiprazole Accord,

aripiprazole

Revision: 4, Authorised
03/04/2017Human medicines European public assessment report (EPAR): Abasaglar (previously Abasria),

insulin glargine

Revision: 5, Authorised
03/04/2017Questions and answers: Good manufacturing practice (updated)
03/04/2017Management Board meeting: 16 March 2017, European Medicines Agency, London, UK, From: 16-Mar-2017, To: 16-Mar-2017 (updated)
03/04/2017Academia
03/04/2017News and press releases: Collaboration with academia to be reinforced
03/04/2017Particulars to appear on the immediate package – combined label and package leaflet (Latvian version)
03/04/2017Particulars to appear on the immediate package – combined label and package leaflet (Iceland version)
03/04/2017Particulars to appear on the immediate package – combined label and package leaflet (Dutch version)
03/04/2017Particulars to appear on the immediate package – combined label and package leaflet (Norway version)
03/04/2017Particulars to appear on the immediate package – combined label and package leaflet (Polish version)
03/04/2017Particulars to appear on the immediate package – combined label and package leaflet (Portuguese version)
03/04/2017Particulars to appear on the immediate package – combined label and package leaflet (Romanian version)
03/04/2017Particulars to appear on the immediate package – combined label and package leaflet (Slovak version)
03/04/2017Particulars to appear on the immediate package – combined label and package leaflet (French version)
03/04/2017Particulars to appear on the immediate package – combined label and package leaflet (Finnish version)
03/04/2017Particulars to appear on the immediate package – combined label and package leaflet (Estonian version)
03/04/2017Particulars to appear on the immediate package – combined label and package leaflet (Spanish version)
03/04/2017Particulars to appear on the immediate package – combined label and package leaflet (Bulgarian version)
03/04/2017Particulars to appear on the immediate package – combined label and package leaflet (Greek version)
03/04/2017Particulars to appear on the immediate package – combined label and package leaflet (German version)
03/04/2017Particulars to appear on the immediate package – combined label and package leaflet (Hungarian version)
03/04/2017Particulars to appear on the immediate package – combined label and package leaflet (Croatian version)
03/04/2017Particulars to appear on the immediate package – combined label and package leaflet (Danish version)
03/04/2017Particulars to appear on the immediate package – combined label and package leaflet (Czech version)
03/04/2017Particulars to appear on the immediate package – combined label and package leaflet (Lithuanian version)
03/04/2017Particulars to appear on the immediate package – combined label and package leaflet (Italian version)
03/04/2017Particulars to appear on the immediate package – combined label and package leaflet (Maltese version)