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January 2017

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31/01/2017Human medicines European public assessment report (EPAR): Pioglitazone Actavis,

pioglitazone

Revision: 4, Authorised
31/01/2017Human medicines European public assessment report (EPAR): Atazanavir Mylan,

atazanavir

Revision: 0, Authorised
31/01/2017Human medicines European public assessment report (EPAR): Granpidam,

sildenafil

Revision: 0, Authorised
31/01/2017Human medicines European public assessment report (EPAR): Budesonide/Formoterol Teva,

budesonide / formoterol

Revision: 2, Withdrawn
31/01/2017Human medicines European public assessment report (EPAR): Twynsta,

telmisartan / amlodipine

Revision: 7, Authorised
31/01/2017Report: 2015 annual report on independence
31/01/2017Human medicines European public assessment report (EPAR): Nimenrix,

meningococcal group A, C, W 135 and Y conjugate vaccine

Revision: 16, Authorised
31/01/2017Withdrawn-product notification: questions and answers (updated)
30/01/2017Human medicines European public assessment report (EPAR): Intuniv,

guanfacine

Revision: 3, Authorised
30/01/2017Opinion/decision on a Paediatric investigation plan (PIP): Bosulif,

Bosutinib

Therapeutic area: Oncology (updated)
30/01/2017Opinion/decision on a Paediatric investigation plan (PIP): Trajenta,

Linagliptin

Therapeutic area: Endocrinology, -gynacology-fertility-metabolism (updated)
30/01/2017List of European Union reference dates and frequency of submission of periodic safety update reports (updated)
30/01/2017List of the recruitment agencies used by the European Medicines Agency for interim staff (updated)
30/01/2017Extension of reserve lists for Contract Agent selection procedures: Contract Agent reserve lists expiring in 2016/2017 (updated)
30/01/2017Extension of reserve lists for external selection procedures: Temporary Agent reserve lists expiring on 31 December 2015 (updated)
30/01/2017List of eligible industry stakeholder organisations (updated)
30/01/2017Opinion/decision on a Paediatric investigation plan (PIP): Fycompa,

Perampanel

Therapeutic area: Neurology (updated)
30/01/2017Minutes of the CVMP meeting of 6-8 December 2016
30/01/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Botulinum toxin, Type A

Therapeutic area: Dermatology
30/01/2017Veterinary medicine European public assessment report (EPAR): Rabigen SAG2,

live vaccine against rabies

Revision: 8, Authorised
30/01/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Netarsudil

Therapeutic area: Ophthalmology
30/01/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

DNA plasmid encoding HPV type 16 consensus E6 and E7 proteins (pGX3001) / DNA plasmid encoding HPV type 18 consensus E6 and E7 proteins (pGX3002)

Therapeutic area: Vaccines/Infectious diseases
30/01/2017Veterinary medicine European public assessment report (EPAR): Easotic,

hydrocortisone aceponate / miconazole nitrate / gentamicin sulphate

Revision: 5, Authorised
30/01/2017Human medicines European public assessment report (EPAR): Budesonide/Formoterol Teva Pharma B.V.,

budesonide / formoterol fumarate dihydrate

Revision: 1, Withdrawn
30/01/2017Agenda: Agenda - HMPC agenda of the 30-31 January 2017 meeting
30/01/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Ibuprofen

Therapeutic area: Pain/Other
30/01/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Galcanezumab

Therapeutic area: Neurology
30/01/2017Opinion/decision on a Paediatric investigation plan (PIP): Volibris,

Ambrisentan

Therapeutic area: Cardiovascular diseases (updated)
30/01/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Dipalmitoylphosphatidylcholine / 1-palmitoyl-2-oleoyl-sn-glycero-3-phosphoglycerol sodium salt / synthetic surfactant protein C analogue / synthetic surfactant protein B analogue (CHF 5633)

Therapeutic area: Neonatology-Paediactric Intensive care
30/01/2017Opinion/decision on a Paediatric investigation plan (PIP): Sutent,

Sunitinib

Therapeutic area: Oncology (updated)
30/01/2017Human medicines European public assessment report (EPAR): Humira,

adalimumab

Revision: 53, Authorised
30/01/2017Opinion/decision on a Paediatric investigation plan (PIP): Soliris,

Eculizumab

Therapeutic area: Immunology-Rheumatology-Transplantation
30/01/2017Opinion/decision on a Paediatric investigation plan (PIP): Penthrox,

Methoxyflurane

Therapeutic area: Pain (updated)
30/01/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Betrixaban

Therapeutic area:
30/01/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Pimavanserin

Therapeutic area: Psychiatry
30/01/2017Opinion/decision on a Paediatric investigation plan (PIP): Recombinant human antithrombin,

Antithrombin alfa

Therapeutic area: Haematology-Hemostaseology
30/01/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Terguride (hydrogenmaleate)

Therapeutic area: Immunology-Rheumatology-Transplantation
30/01/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Chlorhexidine gluconate / isopropyl alcohol

Therapeutic area: Dermatology
30/01/2017Opinion/decision on a Paediatric investigation plan (PIP): Palexia and associated names; Yantil and associated names; Tapentadol and associated names,

Tapentadol (hydrochloride)

Therapeutic area: Pain (updated)
30/01/2017Opinion/decision on a Paediatric investigation plan (PIP): Entresto,

sacubitril / valsartan

Therapeutic area: Cardiovascular diseases (updated)
30/01/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Synthetic double-stranded siRNA oligonucleotide directed against p53 mRNA (QPI-1002)

Therapeutic area: Immunology-Rheumatology-Transplantation
30/01/2017Opinion/decision on a Paediatric investigation plan (PIP): Vibativ,

Telavancin (hydrochloride)

Therapeutic area: Infectious diseases (updated)
30/01/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

N-[5-(4-Bromophenyl)-6-[2-[(5-bromo-2-pyrimidinyl)oxy]ethoxy]-4-pyrimidinyl]-sulfamide

Therapeutic area: Cardiovascular diseases
30/01/2017Opinion/decision on a Paediatric investigation plan (PIP): Zevtera and associated names,

Ceftobiprole medocaril (sodium)

Therapeutic area: Infectious diseases (updated)
30/01/2017Opinion/decision on a Paediatric investigation plan (PIP): Sativex,

Cannabidiol, delta-9-tetrahydrocannabinol

Therapeutic area: Neurology (updated)
30/01/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Teprotumumab

Therapeutic area:
30/01/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Inebilizumab

Therapeutic area: Neurology
30/01/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Octenidine (dihydrochloride)

Therapeutic area: Neonatology-Paediactric Intensive care
27/01/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

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

Therapeutic area: Haematology-Hemostaseology
27/01/2017Opinion/decision on a Paediatric investigation plan (PIP): Yantil and associated names; Palexia and associated names; Tapentadol and associated names,

Tapentadol (hydrochloride)

Therapeutic area: Pain (updated)
27/01/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

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

Therapeutic area: Haematology-Hemostaseology
27/01/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Galcanezumab

Therapeutic area: Neurology
27/01/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Derivative of 4H-pyrazolo[3,4-d]pyrimidin-4-one

Therapeutic area: Psychiatry
27/01/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Complex of povidone and iodine / dexamethasone (SHP640)

Therapeutic area: Ophthalmology
27/01/2017Thiopental: List of nationally authorised medicinal products - PSUSA/00002929/201603
27/01/2017Thiopental: CMDh scientific conclusions and grounds for the variation, amendments to the product information and timetable for the implementation - PSUSA/00002929/201603
27/01/2017Captopril / hydrochlorothiazide: CMDh scientific conclusions and grounds for the variation, amendments to the product information and timetable for the implementation - PSUSA/00000536/201604
27/01/2017Captopril / hydrochlorothiazide: List of nationally authorised medicinal products - PSUSA/00000536/201604
27/01/2017European Union International Organization for Standardization (ISO) for the identification of medicinal products (IDMP) task force meeting, European Medicines Agency, London, UK, From: 13-Dec-2016, To: 13-Dec-2016 (updated)
27/01/2017News and press releases: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 January 2017
27/01/2017News and press releases: Dienogest/ethinylestradiol can be used for acne after certain other treatments have failed
27/01/2017Pending EC decision: Daptomycin Hospira,

daptomycin

Opinion date: 26-Jan-2017
27/01/2017Pending EC decision: Yargesa,

miglustat

Opinion date: 26-Jan-2017
27/01/2017Pending EC decision: Xeljanz,

tofacitinib citrate

Opinion date: 26-Jan-2017
27/01/2017Withdrawn application: Zioxtenzo,

pegfilgrastim

Initial authorisation
27/01/2017Pending EC decision: Revlimid,

lenalidomide

Opinion date: 26-Jan-2017
27/01/2017Pending EC decision: Solymbic,

adalimumab

Opinion date: 26-Jan-2017
27/01/2017Pending EC decision: Synjardy,

empagliflozin / metformin

Opinion date: 26-Jan-2017
27/01/2017Withdrawn application: Xgeva,

denosumab

Post-authorisation
27/01/2017Pending EC decision: Amgevita,

adalimumab

Opinion date: 26-Jan-2017
27/01/2017Pending EC decision: Rolufta,

umeclidinium

Opinion date: 26-Jan-2017
27/01/2017Pending EC decision: Jylamvo,

methotrexate

Opinion date: 26-Jan-2017
27/01/2017Pending EC decision: Tadalafil Lilly,

tadalafil

Opinion date: 26-Jan-2017
27/01/2017Scientific advice and protocol assistance adopted during the CHMP meeting 23 – 26 January 2017, adopted
27/01/2017Start of community reviews - CHMP meeting of 23-26 January 2017
27/01/2017Human medicines European public assessment report (EPAR): Rekovelle,

follitropin delta

Revision: 0, Authorised
27/01/2017Human medicines European public assessment report (EPAR): Abilify,

aripiprazole

Revision: 39, Authorised
26/01/2017Human medicines European public assessment report (EPAR): Olanzapine Apotex,

olanzapine

Revision: 6, Authorised
26/01/2017Veterinary medicines highlights 2016 (updated)
26/01/2017Mandate, objectives and rules of procedure of the Scientific Advice Working Party (SAWP) (updated)
26/01/2017Work plan for the joint CHMP/ CVMP Quality Working Party for 2017
26/01/2017Regulatory and procedural guideline: Post-orphan medicinal product designation procedures: guidance for sponsors (updated)
26/01/2017Agenda: Agenda - PDCO agenda of the 24-27 January 2017 meeting
26/01/2017Conduct of efficacy studies for intramammary products for use in cattle (updated)
26/01/2017Overview of comments received on Guideline on the conduct of efficacy studies for intramammary products for use in cattle (EMA/CVMP/344/1999-Rev.2)
26/01/2017Scientific guideline: Guideline on the conduct of efficacy studies for intramammary products for use in cattle, adopted
26/01/2017Regulatory and procedural guideline: Union guidance on record keeping and archiving of documents obtained or resulting from pharmacovigilance inspections, adopted
26/01/2017Agenda: Agenda and registration form - EudraVigilance training on electronic reporting of ICSRs in the EEA (San Marino)
26/01/2017Agenda: Agenda and registration form - EudraVigilance training on electronic reporting of ICSRs in the EEA (Bucharest, Romania)
26/01/2017EudraVigilance training on electronic reporting of ICSRs in the EEA, Grand Hotel San Marino, Republic of San Marino, From: 03-Apr-2017, To: 05-Apr-2017
26/01/2017EudraVigilance training on electronic reporting of ICSRs in the EEA, EDV-GmbH, Berlin, Germany, From: 06-Mar-2017, To: 08-Mar-2017
26/01/2017Agenda: Agenda and registration form - EudraVigilance training on electronic reporting of ICSRs in the EEA (Paris, France)
26/01/2017EudraVigilance training on electronic reporting of ICSRs in the EEA, Eurosites, Paris, France, From: 20-Mar-2017, To: 22-Mar-2017
26/01/2017Agenda: Agenda and registration form - EudraVigilance training on electronic reporting of ICSRs in the EEA (Berlin, Germany)
26/01/2017EudraVigilance training on electronic reporting of ICSRs in the EEA, Novotel Bucharest City Centre, Bucharest, Romania, From: 20-Feb-2017, To: 22-Feb-2017
26/01/2017eXtended EudraVigilance Medicinal Product Dictionary face-to-face training course, Eurosites La Chapelle, Paris, France, From: 23-Mar-2017, To: 24-Mar-2017
26/01/2017Joint EMA / European Directorate for the Quality of Medicines and Healthcare (EDQM) event on biosimilars, EDQM, 7 allée Kastner, 67081 Strasbourg, France, From: 08-Feb-2017, To: 08-Feb-2017
26/01/2017Human medicines European public assessment report (EPAR): Tadalafil Generics,

tadalafil

Revision: 0, Authorised
26/01/2017Human medicines European public assessment report (EPAR): Vylaer Spiromax,

budesonide / formoterol

Revision: 3, Withdrawn
26/01/2017Human medicines European public assessment report (EPAR): NovoMix,

insulin aspart

Revision: 25, Authorised
26/01/2017Human medicines European public assessment report (EPAR): Jetrea,

ocriplasmin

Revision: 6, Authorised
26/01/2017Agenda: Programme and registration form - eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) face-to-face training course
25/01/2017Human medicines European public assessment report (EPAR): Liprolog,

insulin lispro

Revision: 22, Authorised
25/01/2017Human medicines European public assessment report (EPAR): Jakavi,

ruxolitinib

Revision: 13, Authorised
25/01/2017Human medicines European public assessment report (EPAR): Trisenox,

arsenic trioxide

Revision: 22, Authorised
25/01/2017Template letter of intent for request of scientific advice or protocol assistance (updated)
25/01/2017Medicine evaluation figures (updated)
25/01/2017Human medicines European public assessment report (EPAR): DuoPlavin,

clopidogrel / acetylsalicylic acid

Revision: 15, Authorised
25/01/2017Human medicines European public assessment report (EPAR): Clopidogrel/Acetylsalicylic acid Zentiva (previously DuoCover),

clopidogrel / acetylsalicylic acid

Revision: 18, Authorised
25/01/2017Work plan for the Radiopharmaceuticals Drafting Group 2017 (updated)
24/01/2017Human medicines European public assessment report (EPAR): Colobreathe,

colistimethate sodium

Revision: 7, Authorised
24/01/2017Referral: Article 31 referrals, Micro Therapeutic Research (updated)
24/01/2017Template of the request to the CVMP to (re)classify a veterinary medicinal product as minor use minor species (MUMS) / intended for use in a limited market (updated)
24/01/2017Human medicines European public assessment report (EPAR): Saxenda,

liraglutide

Revision: 2, Authorised
24/01/2017Human medicines European public assessment report (EPAR): Ovitrelle,

choriogonadotropin alfa

Revision: 17, Authorised
24/01/2017Report: Medicinal products for human use: monthly figures - December 2016
24/01/2017Orphan medicines figures 2000-2016 (updated)
24/01/2017Human medicines European public assessment report (EPAR): Vimpat,

lacosamide

Revision: 21, Authorised
24/01/2017Human medicines European public assessment report (EPAR): Orkambi,

lumacaftor / ivacaftor

Revision: 5, Authorised
24/01/2017Human medicines European public assessment report (EPAR): Zonegran,

zonisamide

Revision: 26, Authorised
24/01/2017Questions and answers: Article 31 non-pharmacovigilance referrals (updated)
24/01/2017Regulatory and procedural guideline: Questions and answers on Article 31 non-pharmacovigilance referrals (updated)
24/01/2017Human medicines European public assessment report (EPAR): Fluenz Tetra,

influenza vaccine (live attenuated, nasal)

Revision: 11, Authorised
24/01/2017Veterinary medicine European public assessment report (EPAR): Leucofeligen FeLV/RCP,

adjuvanted vaccine against feline calicivirosis, feline viral rhinotrachieitis, feline panleucopenia and feline leukaemia

Revision: 4, Authorised
24/01/2017Human prothrombin complex: List of nationally authorised medicinal products - PSUSA/00001638/201604
24/01/2017Benazepril / hydrochlorothiazide: List of nationally authorised medicinal products - PSUSA/00000314/201605
24/01/2017Goserelin: List of nationally authorised medicinal products - PSUSA/00001562/201605
24/01/2017Recommendations on the use of antibiotics in animals (updated)
24/01/2017News and press releases: It’s time to reduce, replace and re-think the use of antimicrobials in animals
24/01/2017Report: EMA and EFSA Joint Scientific Opinion on measures to reduce the need to use antimicrobial agents in animal husbandry in the European Union, and the resulting impacts on food safety (RONAFA)
24/01/2017Report: Annex - Replies to EFSA/EMA questions on the use of antimicrobials in food-producing animals in EU and possible measures to reduce antimicrobial use
24/01/2017Veterinary medicine European public assessment report (EPAR): Cortavance,

hydrocortisone

Revision: 5, Authorised
23/01/2017Report: Conditional marketing authorisation - Report on ten years of experience at the European Medicines Agency
23/01/2017Conditional Marketing Authorisation - How early access to medicines has helped patients from 2006 to 2016
23/01/2017News and press releases: Conditional marketing authorisations give patients access to important new medicines earlier
23/01/2017Monthly report on application procedures guidelines and related documents for veterinary medicines: December 2016
23/01/2017EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) substances (updated)
23/01/2017Opinion/decision on a Paediatric investigation plan (PIP): Nucala,

Mepolizumab

Therapeutic area: Pneumology-allergology (updated)
23/01/2017EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) organisations (updated)
23/01/2017Opinion/decision on a Paediatric investigation plan (PIP): Pradaxa,

Dabigatran etexilate

Therapeutic area: Haematology-Hemostaseology/Cardiovascular diseases (updated)
23/01/2017Veterinary medicine European public assessment report (EPAR): Suprelorin,

deslorelin acetate

Revision: 7, Authorised
23/01/2017Veterinary medicine European public assessment report (EPAR): Leucogen,

Adjuvanted vaccine against feline leukaemia

Revision: 3, Authorised
23/01/2017Opinion/decision on a Paediatric investigation plan (PIP): Translarna,

Ataluren

Therapeutic area: Neurology (updated)
23/01/2017Opinion/decision on a Paediatric investigation plan (PIP): Translarna,

Ataluren

Therapeutic area: Pneumology-allergology (updated)
23/01/2017Opinion/decision on a Paediatric investigation plan (PIP): Glybera,

Alipogene tiparvovec

Therapeutic area: Cardiovascular diseases (updated)
23/01/2017List of medicines under additional monitoring (updated)
23/01/2017List of medicinal products under additional monitoring (updated)
23/01/2017Annex I - List of cyproterone-acetate / ethinylestradiol-containing medicinal products in the European Union (updated)
23/01/2017List of medicinal products under additional monitoring (updated) (updated)
23/01/2017Opinion/decision on a Paediatric investigation plan (PIP): NAXIGLO and associated names,

Human normal immunoglobulin

Therapeutic area: Immunology-Rheumatology-Transplantation/Haematology-Hemostaseology (updated)
23/01/2017Opinion/decision on a Paediatric investigation plan (PIP): Betmiga,

Mirabegron

Therapeutic area: Uro-nephrology (updated)
23/01/2017Opinion/decision on a Paediatric investigation plan (PIP): Betmiga,

Mirabegron

Therapeutic area: Uro-nephrology (updated)
20/01/2017Human medicines European public assessment report (EPAR): Clopidogrel Zentiva (previously Clopidogrel Winthrop),

clopidogrel

Revision: 19, Authorised
20/01/2017Human medicines European public assessment report (EPAR): Olysio,

simeprevir

Revision: 8, Authorised
20/01/2017Human medicines European public assessment report (EPAR): Plavix,

clopidogrel

Revision: 33, Authorised
20/01/2017Bemiparin: List of nationally authorised medicinal products - PSUSA/00000312/201604
20/01/2017Loperamide: List of nationally authorised medicinal products - PSUSA/00001903/201605
20/01/2017Hydroxyzine chloride / hydroxyzine pamoate and all fixed combination, hydroxyzine: List of nationally authorised medicinal products - PSUSA/00001696/201605
20/01/2017Human medicines European public assessment report (EPAR): Plegridy,

peginterferon beta-1a

Revision: 10, Authorised
20/01/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Metreleptin

Therapeutic area: Endocrinology, -gynacology-fertility-metabolism (updated)
20/01/2017Minutes of the CHMP meeting 25-28 April 2016 (updated)
20/01/2017News and press releases: Committee for Medicinal Products for Veterinary Use (CVMP) Meeting of 17-19 January 2017
20/01/2017Opinion/decision on a Paediatric investigation plan (PIP): Samsca and associated names,

Tolvaptan

Therapeutic area: Endocrinology, -gynacology-fertility-metabolism (updated)
20/01/2017Human medicines European public assessment report (EPAR): Incruse,

umeclidinium bromide

Revision: 5, Authorised
20/01/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Autologous CD34+ haematopoietic stem cells transduced with lentiviral vector encoding the human βA-T87Q-globin gene

Therapeutic area: Haematology-Hemostaseology (updated)
20/01/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Daclatasvir

Therapeutic area: Infectious diseases (updated)
20/01/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Human fibrinogen / human thrombin

Therapeutic area: Haematology-Hemostaseology/Other (updated)
20/01/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Sodium zirconium cyclosilicate

Therapeutic area: Endocrinology, -gynacology-fertility-metabolism (updated)
20/01/2017Human medicines European public assessment report (EPAR): Iscover,

clopidogrel

Revision: 35, Authorised
20/01/2017Human medicines European public assessment report (EPAR): Cimzia,

certolizumab pegol

Revision: 18, Authorised
20/01/2017Human medicines European public assessment report (EPAR): Vepacel,

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

Revision: 7, Authorised
20/01/2017SME info day on the new clinical trial regulation, European Medicines Agency, London, UK, From: 20-Mar-2017, To: 20-Mar-2017
20/01/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Olaratumab

Therapeutic area: Oncology (updated)
20/01/2017Human medicines European public assessment report (EPAR): Pantozol Control,

pantoprazole

Revision: 10, Authorised
20/01/2017Agenda: Agenda - SME info day on the new clinical trial regulation
19/01/2017Opinion/decision on a Paediatric investigation plan (PIP): Adempas,

Riociguat

Therapeutic area: Cardiovascular diseases (updated)
19/01/2017Opinion/decision on a Paediatric investigation plan (PIP): Pixuvri,

pixantrone (dimaleate)

Therapeutic area: Oncology (updated)
19/01/2017Regulatory and procedural guideline: List of centrally authorised products requiring a notification of a change for update of annexes (updated)
19/01/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Potassium (chloride) / magnesium (sulphate heptahydrate) / procaine (hydrochloride) / xylitol

Therapeutic area: Other (updated)
19/01/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Serelaxin

Therapeutic area: Cardiovascular diseases (updated)
19/01/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Elvitegravir / emtricitabine / tenofovir disoproxil (as fumarate) / cobicistat

Therapeutic area: Infectious diseases (updated)
19/01/2017Agenda: Agenda - CAT agenda of the 18-20 January 2017 meeting
19/01/2017Nominations to the European Union Telematics governance bodies - 2017 (updated)
19/01/2017Human medicines European public assessment report (EPAR): Riluzole Zentiva,

riluzole

Revision: 8, Authorised
19/01/2017Human medicines European public assessment report (EPAR): Reyataz,

atazanavir sulphate

Revision: 43, Authorised
19/01/2017Human medicines European public assessment report (EPAR): Valdoxan,

agomelatine

Revision: 17, Authorised
19/01/2017Human medicines European public assessment report (EPAR): Adenuric,

febuxostat

Revision: 14, Authorised
19/01/2017Human medicines European public assessment report (EPAR): Biograstim,

filgrastim

Revision: 8, Withdrawn
19/01/2017Human medicines European public assessment report (EPAR): Strensiq,

asfotase alfa

Revision: 3, Authorised
19/01/2017Human medicines European public assessment report (EPAR): Ranexa (previously Latixa),

ranolazine

Revision: 14, Authorised
19/01/2017PDCO monthly report of opinions on paediatric investigation plans and other activities 13-16 December 2016
18/01/2017Human medicines European public assessment report (EPAR): Competact,

pioglitazone / metformin

Revision: 16, Authorised
18/01/2017Granisetron: CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00001568/201602 (updated)
18/01/2017Organisation chart: Veterinary Medicines (updated)
18/01/2017Bilastine: CMDh scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00003163/201603 (updated)
18/01/2017Human medicines European public assessment report (EPAR): Sovaldi,

sofosbuvir

Revision: 10, Authorised
18/01/2017Human medicines European public assessment report (EPAR): Humalog,

insulin lispro

Revision: 25, Authorised
18/01/2017Human medicines European public assessment report (EPAR): Descovy,

emtricitabine / tenofovir alafenamide

Revision: 2, Authorised
18/01/2017Human medicines European public assessment report (EPAR): Briviact,

brivaracetam

Revision: 3, Authorised
18/01/2017Latanoprost (except for products with paediatric indication): List of nationally authorised medicinal products - PSUSA/00001832/201604
18/01/2017Human medicines European public assessment report (EPAR): Bretaris Genuair,

aclidinium bromide

Revision: 12, Authorised
18/01/2017Human medicines European public assessment report (EPAR): Prevenar 13,

pneumococcal polysaccharide conjugate vaccine (13-valent, adsorbed)

Revision: 27, Authorised
17/01/2017Human medicines European public assessment report (EPAR): Abseamed,

epoetin alfa

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

pantoprazole

Revision: 12, Authorised
17/01/2017Human medicines European public assessment report (EPAR): Ibrance,

palbociclib

Revision: 1, Authorised
17/01/2017Human medicines European public assessment report (EPAR): Glubrava,

pioglitazone / metformin

Revision: 14, Authorised
17/01/2017News and press releases: Human medicines: highlights of 2016
17/01/2017Human medicines European public assessment report (EPAR): Jevtana,

cabazitaxel

Revision: 14, Authorised
17/01/2017Agenda: Agenda - COMP agenda of the 17-19 January 2017
17/01/2017Multinational assessment team concept - The next phase – Broadening the concept to the post-authorisation phase
17/01/2017European medicines regulatory network (updated)
17/01/2017Fusidic acid (systemic use): List of nationally authorised medicinal products - PSUSA/00010226/201605
17/01/2017Human medicines European public assessment report (EPAR): Eklira Genuair,

aclidinium bromide

Revision: 12, Authorised
17/01/2017Human medicines European public assessment report (EPAR): Twinrix Paediatric,

hepatitis-A (inactivated) and hepatitis-B (rDNA) (HAB) vaccine (adsorbed)

Revision: 18, Authorised
16/01/2017Human medicines European public assessment report (EPAR): Bydureon,

exenatide

Revision: 10, Authorised
16/01/2017Pharmaceutical industry (updated)
16/01/2017Human medicines European public assessment report (EPAR): Twinrix Adult,

hepatitis A (inactivated) and hepatitis B (rDNA) (HAB) vaccine (adsorbed)

Revision: 18, Authorised
16/01/2017Human medicines European public assessment report (EPAR): Glivec,

imatinib

Revision: 31, Authorised
16/01/2017Human medicines European public assessment report (EPAR): Ambirix,

hepatitis-A (inactivated) and hepatitis-B (rDNA) (HAB) vaccine (adsorbed)

Revision: 13, Authorised
16/01/2017Human hemin: List of nationally authorised medicinal products - PSUSA/00001629/201605
16/01/2017Lactulose: List of nationally authorised medicinal products - PSUSA/00001821/201605
16/01/2017Mxifloxacin (topical ophthalmic use): List of nationally authorised medicinal products - PSUSA/00002094/201605
16/01/2017F(ab’)2 fragments of equine antirabies immunoglobulin: List of nationally authorised medicinal products - PSUSA/00001348/201605
16/01/2017Human medicines European public assessment report (EPAR): Tamiflu,

oseltamivir

Revision: 29, Authorised
16/01/2017Human medicines European public assessment report (EPAR): Zelboraf,

vemurafenib

Revision: 13, Authorised
16/01/2017Human medicines European public assessment report (EPAR): Bronchitol,

mannitol

Revision: 10, Authorised
16/01/2017Human medicines European public assessment report (EPAR): NovoSeven,

eptacog alfa (activated)

Revision: 31, Authorised
13/01/2017Human medicines European public assessment report (EPAR): Odefsey,

emtricitabine / rilpivirine / tenofovir alafenamide

Revision: 2, Authorised
13/01/2017Human medicines European public assessment report (EPAR): ellaOne,

ulipristal acetate

Revision: 14, Authorised
13/01/2017MRL report: Purified semi-solid extract from Humulus lupuls L. containing approximately 48% of beta acids (as potassium salts): European public maximum-residue-limit assessment report (EPMAR) - CVMP (updated)
13/01/2017Human medicines European public assessment report (EPAR): Genvoya,

elvitegravir / cobicistat / emtricitabine / tenofovir alafenamide

Revision: 5, Authorised
13/01/2017Human medicines European public assessment report (EPAR): Xalkori,

crizotinib

Revision: 16, Authorised
13/01/2017European Medicines Agency and Medicines for Europe annual bilateral meeting, European Medicines Agency, London, UK, From: 24-Jan-2017, To: 24-Jan-2017
13/01/2017Human medicines European public assessment report (EPAR): Capecitabine Accord,

capecitabine

Revision: 7, Authorised
13/01/2017Newsletter: Human medicines highlights - January 2017
13/01/2017Classifications as minor-use-minor-species and limited-market classifications (updated)
13/01/2017Human medicines European public assessment report (EPAR): Capecitabine Teva,

capecitabine

Revision: 8, Authorised
13/01/2017News and press releases: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 9-12 January 2017
13/01/2017Human medicines European public assessment report (EPAR): Revolade,

eltrombopag

Revision: 17, Authorised
13/01/2017Human medicines European public assessment report (EPAR): Orfadin,

nitisinone

Revision: 12, Authorised
13/01/2017Human medicines European public assessment report (EPAR): Sancuso,

granisetron

Revision: 9, Authorised
13/01/2017Human medicines European public assessment report (EPAR): Entyvio,

vedolizumab

Revision: 7, Authorised
13/01/2017Human medicines European public assessment report (EPAR): Kadcyla,

trastuzumab emtansine

Revision: 6, Authorised
13/01/2017Human medicines European public assessment report (EPAR): Eucreas,

vildagliptin / metformin

Revision: 14, Authorised
12/01/2017Human medicines European public assessment report (EPAR): Xultophy,

insulin degludec / liraglutide

Revision: 6, Authorised
12/01/2017Human medicines European public assessment report (EPAR): ChondroCelect,

characterised viable autologous cartilage cells expanded ex vivo expressing specific marker proteins

Revision: 6, Withdrawn
12/01/2017Human medicines European public assessment report (EPAR): Stivarga,

regorafenib

Revision: 8, Authorised
12/01/2017Opinion of the Committee for Medicinal Products for Veterinary Use on the establishment of maximum residue limits: Gamithromycin, adopted
12/01/2017Human medicines European public assessment report (EPAR): Opdivo,

nivolumab

Revision: 7, Authorised
12/01/2017Human medicines European public assessment report (EPAR): Imvanex,

modified vaccinia Ankara virus

Revision: 9, Authorised
12/01/2017Human medicines European public assessment report (EPAR): Epoetin Alfa Hexal,

epoetin alfa

Revision: 17, Authorised
12/01/2017eXtended EudraVigilance Medicinal Product Dictionary face-to-face training course, European Medicines Agency, London, UK, From: 27-Apr-2017, To: 28-Apr-2017
12/01/2017Agenda: Agenda and registration form - eXtended EudraVigilance Medicinal Product Dictionary face-to-face training course
12/01/2017eXtended EudraVigilance Medicinal Product Dictionary face-to-face training course, European Medicines Agency, London, UK, From: 18-May-2017, To: 19-May-2017
12/01/2017eXtended EudraVigilance Medicinal Product Dictionary face-to-face training course, European Medicines Agency, London, UK, From: 02-Mar-2017, To: 03-Mar-2017
12/01/2017Letter of support for drug-induced renal tubular injury biomarker(s)
12/01/2017Human medicines European public assessment report (EPAR): Pradaxa,

dabigatran etexilate

Revision: 22, Authorised
12/01/2017Human medicines European public assessment report (EPAR): Bortezomib Sun,

bortezomib

Revision: 1, Authorised
12/01/2017Human medicines European public assessment report (EPAR): NovoThirteen,

catridecacog

Revision: 4, Authorised
12/01/2017Human medicines European public assessment report (EPAR): Tarceva,

erlotinib

Revision: 22, Authorised
12/01/2017Human medicines European public assessment report (EPAR): Telzir,

fosamprenavir

Revision: 37, Authorised
12/01/2017Human medicines European public assessment report (EPAR): Lusduna,

insulin glargine

Revision: 0, Authorised
12/01/2017Human medicines European public assessment report (EPAR): Tagrisso,

osimertinib

Revision: 3, Authorised
12/01/2017Human medicines European public assessment report (EPAR): Crixivan,

indinavir

Revision: 37, Authorised
12/01/2017Q&A: 1-20 (updated)
12/01/2017Q&A: Post-authorisation measures (Recommendations, Conditions and Specific Obligations) (updated)
12/01/2017Q&A: Extension applications (updated)
12/01/2017Q&A: Transfer (updated)
12/01/2017Q&A: Worksharing of variations (updated)
12/01/2017Q&A: Renewals (updated)
12/01/2017Q&A: Type II variations (updated)
12/01/2017Q&A: Periodic Safety Update Report (PSUR) (updated)
12/01/2017Type-IB variations: questions and answers (updated)
12/01/2017Q&A: 21-37 (updated)
12/01/2017Type-IA variations: questions and answers (updated)
12/01/2017Human medicines European public assessment report (EPAR): Tecfidera,

dimethyl fumarate

Revision: 9, Authorised
12/01/2017Involvement of patient representatives in scientific advisory groups at the European Medicines Agency (updated)
12/01/2017Involvement of patient representatives in scientific advice procedures at the European Medicines Agency (updated)
12/01/2017Herbal medicinal products: Peumus, Boldi folium, Peumus boldus Molina (updated)
11/01/2017Policy 44: European Medicines Agency policy on the handling of declarations of interests of scientific committees’ members and experts (updated)
11/01/2017Minutes of the CHMP meeting 7-10 November 2016
11/01/2017Minutes - PDCO minutes of the 12-14 October 2016 meeting
10/01/2017Human medicines European public assessment report (EPAR): Imatinib Accord,

imatinib

Revision: 8, Authorised
10/01/2017Human medicines European public assessment report (EPAR): Adasuve,

loxapine

Revision: 9, Authorised
10/01/2017Human medicines European public assessment report (EPAR): Thymanax,

agomelatine

Revision: 16, Authorised
10/01/2017Human medicines European public assessment report (EPAR): Synflorix,

pneumococcal polysaccharide conjugate vaccine (adsorbed)

Revision: 25, Authorised
10/01/2017Human medicines European public assessment report (EPAR): Sebivo,

telbivudine

Revision: 18, Authorised
10/01/2017Human medicines European public assessment report (EPAR): Lucentis,

ranibizumab

Revision: 26, Authorised
10/01/2017Human medicines European public assessment report (EPAR): Tandemact,

pioglitazone / glimepiride

Revision: 15, Authorised
10/01/2017Human medicines European public assessment report (EPAR): PecFent,

fentanyl

Revision: 12, Authorised
10/01/2017European medicines agency Standard operating procedure (SOP): Standard operating procedure for review of orphan designation at the time of granting/varying a marketing authorisation (updated)
10/01/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Candesartan / amlodipine

Therapeutic area: Cardiovascular diseases
10/01/2017MRL report: Gamithromycin (all ruminants except bovine species): European public maximum-residue-limit assessment report (EPMAR) - CVMP
10/01/2017Minutes of the COMP meeting 3-4 November 2016
10/01/2017Human medicines European public assessment report (EPAR): Xoterna Breezhaler,

indacaterol / glycopyrronium bromide

Revision: 5, Authorised
10/01/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Amlodipine / atorvastatin

Therapeutic area: Cardiovascular diseases
10/01/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Amlodipine / Valsartan / Hydrochlorothiazide

Therapeutic area: Cardiovascular diseases
10/01/2017Orphan designation:

Udenafil

for the: Treatment of functional single ventricle congenital heart disease
10/01/2017Orphan designation:

Arsenic trioxide

for the: Treatment of graft-versus-host disease
10/01/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Perindopril / amlodipine

Therapeutic area: Cardiovascular diseases
10/01/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Ciclosporin

Therapeutic area: Ophthalmology
10/01/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Influenza virus surface antigens (haemagglutinin and neuraminidase)

Therapeutic area: Vaccines
10/01/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Naldemedine (tosylate)

Therapeutic area: Gastroentology-Hepatology
10/01/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Birch pollen extract (Betula verrucosa)

Therapeutic area: Pneumology-allergology
10/01/2017Human medicines European public assessment report (EPAR): Ulunar Breezhaler,

indacaterol / glycopyrronium bromide

Revision: 5, Authorised
10/01/2017Human medicines European public assessment report (EPAR): Aripiprazole Sandoz,

aripiprazole

Revision: 3, Authorised
10/01/2017New vacancy: Contract Agent, long term (FG IV), Scientific Officer
10/01/2017Human medicines European public assessment report (EPAR): Levetiracetam Actavis Group,

levetiracetam

Revision: 9, Authorised
10/01/2017Human medicines European public assessment report (EPAR): Capecitabine Medac,

capecitabine

Revision: 6, Authorised
09/01/2017Human medicines European public assessment report (EPAR): Nonafact,

human coagulation factor IX

Revision: 9, Authorised
09/01/2017Orphan designation:

68Ga-DOTA-pABzA-DIG-dPhe-Gln-Trp-Ala-Val-Gly-His-NHCH[(CH2-CH(CH3)2]2

for the: Diagnosis of gastrointestinal stromal tumours
09/01/2017Orphan designation:

Dantrolene sodium

for the: Treatment of Wolfram syndrome
09/01/2017Orphan designation:

Ivosidenib

for the: Treatment of acute myeloid leukaemia
09/01/2017Orphan designation:

Recombinant self-complementary adeno-associated viral vector serotype 9 containing the human CLN3 gene

for the: Treatment of neuronal ceroid lipofuscinosis
09/01/2017Multi-stakeholder paediatric oncology strategy workshop (cancers with anaplastic lymphoma kinase aberrations), European Medicines Agency, London, UK, From: 30-Jan-2017, To: 31-Jan-2017
09/01/2017Setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities (updated)
09/01/2017Questions and answers on implementation of risk based prevention of cross contamination in production and ‘Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities’ (EMA/CHMP/CVMP/SWP/169430/2012)
09/01/2017Agenda: Agenda - PRAC draft agenda of meeting 9-12 January 2017
09/01/2017Orphan designation:

Pegylated recombinant human interleukin-10

for the: Treatment of pancreatic cancer
09/01/2017ICMRA - Mapping of the bilateral arrangements between the ICMRA members
09/01/2017ICMRA - Mapping of supply chain/anticounterfeiting initiatives
09/01/2017ICMRA - Mapping of pharmacovigilance initiatives
09/01/2017ICMRA - Mapping of multinational project initiatives
09/01/2017ICMRA - Mapping of IT initiatives as a support to global medicines regulation
09/01/2017ICMRA - Mapping of GMP inspection initiatives
09/01/2017ICMRA - Mapping of generic initiatives
09/01/2017Connecting the dots - Towards global knowledge of the international medicine regulatory landscape: mapping of international initiatives (updated)
09/01/2017ICMRA - Mapping of crisis management initiatives
09/01/2017Orphan designation:

Ibudilast

for the: Treatment of amyotrophic lateral sclerosis
09/01/2017Human medicines European public assessment report (EPAR): Synjardy,

empagliflozin / metformin

Revision: 7, Authorised
09/01/2017Orphan designation:

Propranolol

for the: Treatment of soft tissue sarcoma
09/01/2017Orphan designation:

Metformin

for the: Treatment of progressive myoclonic epilepsy type 2 (Lafora disease)
09/01/2017Orphan designation:

Avelumab

for the: Treatment of gastric cancer
09/01/2017Orphan designation:

Cabiralizumab

for the: Treatment of tenosynovial giant cell tumour, localised and diffuse type
09/01/2017Orphan designation:

Adeno-associated viral vector serotype 8 encoding engineered rhodopsin DNA-binding repressor and human rhodopsin expression cassettes

for the: Treatment of retinitis pigmentosa
09/01/2017Dorzolamide: CMDh scientific conclusions and grounds for the variation to the terms of the Marketing Authorisation - PSUSA/00003168/201602 (updated)
09/01/2017Orphan designation:

3-(3-Methanesulfonyl-phenyl)-1-propyl-piperidine hydrochloride

for the: Treatment of narcolepsy
09/01/2017Veterinary medicine European public assessment report (EPAR): Broadline,

eprinomectin, fipronil, praziquantel, (S)-methoprene

Revision: 4, Authorised
06/01/2017Human medicines European public assessment report (EPAR): Levetiracetam Accord,

levetiracetam

Revision: 7, Authorised
06/01/2017Human medicines European public assessment report (EPAR): Keppra,

levetiracetam

Revision: 39, Authorised
06/01/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Humanised chimeric antibody with a humanised H chain and a chimeric (mouse V-domain, human C-domain) L chain against epidermal growth factor receptor conjugated to maleimidocaproyl monomethylauristatin F (ABT-414)
L chain against epidermal growth factor receptor conjugated to maleimidocaproyl
monomethylauristatin F (ABT-414)

Therapeutic area:
06/01/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Allogeneic Mesenchymal Precursor Cells (rexlemestrocel-L)

Therapeutic area: Other
06/01/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Sirukumab

Therapeutic area: Immunology-Rheumatology-Transplantation
06/01/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Immunoglobulin G2, anti-(human α-calcitonin gene-related peptide/β-calcitonin gene-related peptide) (human-Mus musculus monoclonal TEV-48125 heavy chain), disulphide with human-Mus musculus monoclonal TEV-48125 light chain, dimer (TEV-48125)

Therapeutic area: Neurology
06/01/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Monoclonal IgG1 anti-influenza A antibody

Therapeutic area: Infectious diseases
06/01/2017Opinion/decision on a Paediatric investigation plan (PIP): -,

Peramivir

Therapeutic area: Infectious diseases
06/01/2017EudraVigilance training (updated)
06/01/2017Presentation - EV Reporting process for users: EV Gateway, WEB-Trader, EV-Post functions - Training Module EV-M3a
06/01/2017Presentation - EV Reporting process for users: Introduction to EVWEB - Training Module EV-M3b
06/01/2017Presentation - EV Reporting process for users: Export functions in EVWEB - Training Module EV-M3c
06/01/2017Presentation - EV Reporting process for users: Create and send ICSRs using EVWEB - Training Module EV-M3d
06/01/2017Presentation - EVDAS training for Marketing Authorisation Holders - Training module EV-M5b
06/01/2017Presentation - ADRreports.eu portal - Training module EV-M6
06/01/2017Presentation - ISO ICSR standard implementation for IT system developers - Training module IT-M1
06/01/2017Presentation - EudraVigilance Data Analysis System (EVDAS) training for National Competent Authorities - Training module EV-M5a
06/01/2017EudraVigilance change management (updated)
06/01/2017European Union BFC conversion (v.2.1) (updated)
06/01/2017Regulatory and procedural guideline: EudraVigilance auditable requirement project - EudraVigilance training plan, adopted (updated)
06/01/2017Herbal medicinal products: questions and answers (updated)
06/01/2017Regulatory questions and answers on herbal medicinal products (updated)
06/01/2017Antimicrobial resistance (updated)
06/01/2017Monitoring of medical literature and the entry of relevant information into the EudraVigilance database by the European Medicines Agency - Description of the Journal/Reference databases used (updated)
05/01/2017Human medicines European public assessment report (EPAR): Docetaxel Winthrop,

docetaxel

Revision: 23, Authorised
05/01/2017Human medicines European public assessment report (EPAR): Truberzi,

eluxadoline

Revision: 1, Authorised
05/01/2017Human medicines European public assessment report (EPAR): Mepact,

mifamurtide

Revision: 13, Authorised
05/01/2017Human medicines European public assessment report (EPAR): Raplixa,

human fibrinogen / human thrombin

Revision: 4, Authorised
05/01/2017Human medicines European public assessment report (EPAR): Cystadane,

betaine anhydrous

Revision: 9, Authorised
05/01/2017Monitoring of medical literature and the entry of relevant information into the EudraVigilance database by the European Medicines Agency: Questions and answers (updated)
05/01/2017Monitoring of medical literature and the entry of relevant information into the EudraVigilance database by the European Medicines Agency - Inclusion and exclusion criteria for processing of Individual Case Safety Reports (updated)
05/01/2017Work instructions for organisation of CVMP Working Party meetings, adopted
05/01/2017Human medicines European public assessment report (EPAR): Kolbam ,

cholic acid

Revision: 12, Authorised
05/01/2017Human medicines European public assessment report (EPAR): Viread,

tenofovir disoproxil

Revision: 44, Authorised
05/01/2017Human medicines European public assessment report (EPAR): Aripiprazole Accord,

aripiprazole

Revision: 3, Authorised
05/01/2017Human medicines European public assessment report (EPAR): Eperzan,

albiglutide

Revision: 6, Authorised
05/01/2017Human medicines European public assessment report (EPAR): Somac Control,

pantoprazole

Revision: 9, Authorised
05/01/2017Human medicines European public assessment report (EPAR): Xydalba,

dalbavancin

Revision: 4, Authorised
05/01/2017Human medicines European public assessment report (EPAR): Plenadren,

hydrocortisone

Revision: 8, Authorised
05/01/2017Human medicines European public assessment report (EPAR): Yervoy,

ipilimumab

Revision: 14, Authorised
05/01/2017Human medicines European public assessment report (EPAR): Controloc Control,

pantoprazole

Revision: 8, Authorised
05/01/2017Orphan designation:

Recombinant human dyskerin

for the: Treatment of dyskeratosis congenita (updated)
05/01/2017Human medicines European public assessment report (EPAR): Pixuvri,

pixantrone dimaleate

Revision: 14, Authorised
05/01/2017Report: Summary report of the European Medicines Agency-EuropaBio information day - 22 November 2016
05/01/2017Minutes of the CAT meeting 3-4 November 2016
05/01/2017CAT monthly report of application procedures, guidelines and related documents on advanced therapies: December 2016
05/01/2017Human medicines European public assessment report (EPAR): Odomzo,

sonidegib

Revision: 2, Authorised
05/01/2017Human medicines European public assessment report (EPAR): Aripiprazole Zentiva,

aripiprazole

Revision: 3, Authorised
05/01/2017Human medicines European public assessment report (EPAR): Cubicin,

daptomycin

Revision: 23, Authorised
04/01/2017EudraVigilance training on electronic reporting of ICSRs in the EEA, European Medicines Agency, London, UK, From: 24-Apr-2017, To: 26-Apr-2017
04/01/2017EudraVigilance training on electronic reporting of ICSRs in the EEA, European Medicines Agency, London, UK, From: 15-May-2017, To: 17-May-2017
04/01/2017EudraVigilance training on electronic reporting of Individual case safety reportd in the European Economic Area, European Medicines Agency, London, UK, From: 23-Jan-2017, To: 25-Jan-2017
04/01/2017EudraVigilance training on electronic reporting of ICSRs in the EEA, European Medicines Agency, London, UK, From: 27-Feb-2017, To: 01-Mar-2017
04/01/2017Agenda: Agenda and registration form - EudraVigilance training on electronic reporting of ICSRs in the EEA
04/01/2017Evofosfamide - Notification of discontinuation of a paediatric development which is covered by an agreed paediatric-investigation-plan decision
04/01/2017Enpr-EMA awareness webinar, European Medicines Agency, London, UK, From: 01-Dec-2016, To: 01-Dec-2016 (updated)
04/01/2017Newsletter: European network of paediatric research at the European Medicines Agency newsletter: December 2016
04/01/2017Workshop on identifying opportunities for ‘big data’ in medicines development and regulatory science, CCT Venue Plus, London, UK, From: 14-Nov-2016, To: 15-Nov-2016 (updated)
04/01/2017Veterinary medicine European public assessment report (EPAR): Aivlosin,

tylvalosin

Revision: 27, Authorised
04/01/2017Human medicines European public assessment report (EPAR): Libertek,

roflumilast

Revision: 10, Authorised
03/01/2017Safety and residue data requirements for veterinary medicinal products intended for minor use or minor species (MUMS)/limited market (updated)
03/01/2017Scientific guideline: Guideline on safety and residue data requirements for pharmaceutical veterinary medicinal products intended for minor use or minor species (MUMS)/limited market, adopted
03/01/2017Overview of comments received on 'Guideline on safety and residue data requirements for veterinary medicinal products intended for minor use or minor species (MUMS)/limited market'
03/01/2017Quality data requirements for veterinary medicinal products intended for minor use or minor species (MUMS)/limited market (updated)
03/01/2017Scientific guideline: Guideline on quality data requirements for veterinary medicinal products intended for minor use or minor species (MUMS)/limited market, adopted
03/01/2017Overview of comments received on ‘Guideline on quality data requirements for veterinary medicinal products intended for minor use or minor species (MUMS)/limited market’
03/01/2017Agenda: Agenda - European Medicines Agency and Association of the European Self-Medication Industry (AESGP) annual bilateral meeting
03/01/2017European 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
03/01/2017Efficacy and target animal safety data requirements for veterinary medicinal products intended for minor uses or minor species (updated)
03/01/2017Overview of comments received on 'Guideline on efficacy and target animal safety data requirements for veterinary medicinal products intended for minor use or minor species (MUMS)/limited market'
03/01/2017Scientific guideline: Guideline on efficacy and target animal safety data requirements for veterinary medicinal products intended for minor use or minor species (MUMS)/limited market, adopted
03/01/2017Levodopa/carbidopa/entacapone product-specific bioequivalence guidance (updated)
03/01/2017Scientific guideline: Levodopa/Carbidopa/Entacapone film-coated tablet 200 mg/50 mg/200 mg, 175 mg/43.75 mg/200 mg, 150 mg/37.5 mg/200 mg, 125 mg/31.25 mg/200 mg, 100 mg/25 mg/200 mg, 75 mg/18.75 mg/200 mg and 50 mg/12.5 mg/200 mg product-specific bioequivalence guidance, adopted
03/01/2017Overview of comments received on Levodopa/Carbidopa/Entacapone film-coated tablet 200 mg/50 mg/200 mg, 175 mg/43.75 mg/200 mg, 150 mg/37.5 mg/200 mg, 125 mg/31.25 mg/200 mg, 100 mg/25 mg/200 mg, 75 mg/18.75 mg/200 mg and 50 mg/12.5 mg/200 mg product-specific bioequivalence guidance’
03/01/2017Pazopanib product-specific bioequivalence guidance (updated)
03/01/2017Overview of comments received on Pazopanib film-coated tablet 200 mg and 400 mg product-specific bioequivalence guidance
03/01/2017Scientific guideline: Pazopanib film-coated tablet 200 mg and 400 mg product-specific bioequivalence guidance, adopted
03/01/2017New product information wording: extracts from PRAC recommendations on signals adopted at the 28 November-1 December 2016 PRAC
03/01/2017PRAC recommendations on signals adopted at the PRAC meeting of 28 November-1 December 2016, adopted
03/01/2017List of signals discussed at the PRAC since September 2012 (updated)
03/01/2017Paliperidone product-specific bioequivalence guidance (updated)
03/01/2017Scientific guideline: Paliperidone prolonged-release tablet 1.5 mg, 3 mg, 6 mg, 9 mg and 12 mg product-specific bioequivalence guidance, adopted
03/01/2017Fingolimod product-specific bioequivalence guidance (updated)
03/01/2017Overview of comments received on 'Fingolimod capsules 0.5 mg product-specific bioequivalence guidance'
03/01/2017Scientific guideline: Fingolimod capsules 0.5 mg product-specific bioequivalence guidance, adopted
03/01/2017Everolimus product-specific bioequivalence guidance (updated)
03/01/2017Scientific guideline: Everolimus tablets 0.25 mg, 0.5 mg, 0.75 mg and 1 mg; 2.5 mg, 5 mg and 10 mg, dispersible tablets 0.1 mg and 0.25 mg; 2 mg, 3 mg and 5 mg product-specific bioequivalence guidance, adopted
03/01/2017Overview of comments received on ‘Everolimus tablets 0.25 mg, 0.5 mg, 0.75 mg and 1 mg; 2.5 mg, 5 mg and 10 mg, dispersible tablets 0.1 mg and 0.25 mg; 2 mg, 3 mg and 5 mg product-specific bioequivalence guidance’
03/01/2017European Medicines Agency Human Scientific Committees' Working Parties with Patients’ and Consumers’ Organisations (PCWP) and Healthcare Professionals’ Organisations (HCPWP) joint meeting, European Medicines Agency, London, UK, From: 20-Sep-2016, To: 20-Sep-2016 (updated)
03/01/2017Current tenders for €135,000 or more (updated)
03/01/2017Organisation chart: Deputy Executive Director support services (updated)
03/01/2017Organisation chart: Human Medicines Research and Development Support (updated)
03/01/2017Organisation chart of the European Medicines Agency (updated)
03/01/2017Organisation chart: Stakeholders and Communication (updated)
03/01/2017Inventory of herbal substances for assessment (updated)
03/01/2017Stakeholder focus group meeting on availability of lumpy skin disease (LSD) vaccines authorised to European Union (EU) standards, European Medicines Agency, London, UK, From: 31-Jan-2017, To: 31-Jan-2017
03/01/2017Human medicines European public assessment report (EPAR): Zomarist,

vildagliptin / metformin

Revision: 14, Authorised
03/01/2017Human medicines European public assessment report (EPAR): Icandra (previously Vildagliptin / metformin hydrochloride Novartis),

vildagliptin / metformin

Revision: 14, Authorised