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April 2014

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23/04/2014Human medicines European public assessment report (EPAR): Removab,

catumaxomab

Revision: 5, Authorised
23/04/2014Human medicines European public assessment report (EPAR): Levitra,

vardenafil

Revision: 22, Authorised
23/04/2014Human medicines European public assessment report (EPAR): Xiapex,

collagenase Clostridium histolyticum

Revision: 7, Authorised
23/04/2014Pharmacovigilance in the paediatric population workshop, European Medicines Agency, London, UK, From: 28-Apr-2014, To: 28-Apr-2014
23/04/2014Human medicines European public assessment report (EPAR): Perjeta,

pertuzumab

Revision: 1, Authorised
23/04/2014Human medicines European public assessment report (EPAR): Esmya,

ulipristal

Revision: 6, Authorised
23/04/2014Human medicines European public assessment report (EPAR): Revlimid,

lenalidomide

Revision: 22, Authorised
23/04/2014Veterinary medicine European public assessment report (EPAR): Nobivac Myxo-RHD,

live myxoma-vectored rabbit-haemorrhagic-disease virus strain 009

Revision: 1, Authorised
23/04/2014Questions and answers: Good manufacturing practice (updated)
23/04/2014Scientific guideline: Reflection paper on anthelmintic resistance, draft: consultation open
23/04/2014Regulatory and procedural guideline: Substances considered as not falling within the scope of Regulation (EC) no 470/2009, with regard to residues of veterinary medicinal products in foodstuffs of animal origin, adopted (updated)
22/04/2014Veterinary medicine European public assessment report (EPAR): Econor,

valnemulin

Revision: 15, Authorised
22/04/2014Opinions on annual re-assessments, renewals of marketing authorisations and accelerated assessment procedures adopted at the CHMP meeting 17-20 February 2014 (updated)
22/04/2014News and press releases: EC/EMA-FDA bilateral - update
22/04/2014Quality of medicines questions and answers: Part 2 (updated)
22/04/2014Regulatory and procedural guideline: Initial notices for parallel distribution – March 2014
22/04/2014Veterinary medicine European public assessment report (EPAR): Certifect,

fipronil / amitraz / (S)-methoprene

Revision: 3, Authorised
22/04/2014Agenda: Agenda - CHMP agenda of the 22-25 April 2014 meeting
17/04/2014News and press releases: European Medicines Agency update on stolen vials of Herceptin
16/04/2014Agenda: Agenda - CAT agenda of the 15-16 April 2014 meeting
16/04/2014Regulatory and procedural guideline: European Medicines Agency guidance for companies requesting classification as minor uses minor species / limited markets, adopted (updated)
16/04/2014Orphan designation:

Cholic acid

for the: Treatment of inborn errors in primary bile acid synthesis responsive to treatment with cholic acid (updated)
16/04/2014Agenda: Agenda - PDCO agenda of the 23-25 April 2014 meeting
16/04/2014Questions and answers relating to open tender procedure – EMA/2014/01/PH Monitoring of scientific and medical literature and the entry of relevant information into EudraVigilance (updated)
16/04/2014Opinion/decision on a Paediatric Investigation Plan (PIP): Aranesp,

Darbepoetin alfa

Therapeutic area: Cardiovascular diseases/Oncology/Uro-nephrology (updated)
16/04/2014Opinion/decision on a Paediatric Investigation Plan (PIP): Baraclude,

Entecavir

Therapeutic area: Infectious diseases (updated)
16/04/2014Opinion/decision on a Paediatric Investigation Plan (PIP): Tamiflu,

Oseltamivir (phosphate)

Therapeutic area: Infectious diseases (updated)
16/04/2014Opinion/decision on a Paediatric Investigation Plan (PIP): -,

Anti-PD1 humanized monoclonal antibody of the IgG4/kappa class (MK-3475)

Therapeutic area: Oncology
16/04/2014Opinion/decision on a Paediatric Investigation Plan (PIP): -,

nivolumab

Therapeutic area: Oncology
16/04/2014Opinion/decision on a Paediatric Investigation Plan (PIP): -,

Glycopyrronium (bromide)

Therapeutic area: Neurology (updated)
16/04/2014Opinion/decision on a Paediatric Investigation Plan (PIP): Kalydeco,

Ivacaftor

Therapeutic area: Other (updated)
16/04/2014Opinion/decision on a Paediatric Investigation Plan (PIP): -,

Anti-human interleukin 23 p19 humanised IgG1/Ig kappa monoclonal antibody

Therapeutic area: Dermatology
16/04/2014Opinion/decision on a Paediatric Investigation Plan (PIP): Mimpara,

Cinacalcet hydrochloride

Therapeutic area: Uro-nephrology (updated)
16/04/2014Opinion/decision on a Paediatric Investigation Plan (PIP): Incivo,

Telaprevir

Therapeutic area: Infectious diseases (updated)
16/04/2014Opinion/decision on a Paediatric Investigation Plan (PIP): Xeljanz,

Tofacitinib

Therapeutic area: Dermatology/Immunology-Rheumatology-Transplantation (updated)
16/04/2014Opinion/decision on a Paediatric Investigation Plan (PIP): -,

Lenvatinib

Therapeutic area: Oncology (updated)
16/04/2014Opinion/decision on a Paediatric Investigation Plan (PIP): -,

Recombinant human growth hormone modified by fusion with two hydrophilic polypeptide chains (VRS-317)

Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
16/04/2014Opinion/decision on a Paediatric Investigation Plan (PIP): Fosrenol in the RMS (Sweden) and associated name Foznol,

Lanthanum carbonate hydrate

Therapeutic area: Uro-nephrology (updated)
16/04/2014Opinion/decision on a Paediatric Investigation Plan (PIP): IXinity,

Trenonacog alfa

Therapeutic area: Haematology-Hemostaseology (updated)
16/04/2014Opinion/decision on a Paediatric Investigation Plan (PIP): -,

Dulaglutide

Therapeutic area: Endocrinology, -gynacology-fertility-metabolism (updated)
16/04/2014Opinion/decision on a Paediatric Investigation Plan (PIP): -,

idarucizumab

Therapeutic area: Other
16/04/2014Opinion/decision on a Paediatric Investigation Plan (PIP): BR/AM,

Amlodipine (besylate) / ramipril

Therapeutic area: Cardiovascular diseases
16/04/2014Opinion/decision on a Paediatric Investigation Plan (PIP): Humira,

adalimumab

Therapeutic area: Dermatology
16/04/2014Opinion/decision on a Paediatric Investigation Plan (PIP): Xeljanz,

Tofacitinib

Therapeutic area: Immunology-Rheumatology-Transplantation (updated)
16/04/2014Opinion/decision on a Paediatric Investigation Plan (PIP): -,

Glycerol phenylbutyrate

Therapeutic area: Endocrinology, -gynacology-fertility-metabolism (updated)
16/04/2014Opinion/decision on a Paediatric Investigation Plan (PIP): Trajenta,

Linagliptin

Therapeutic area: Endocrinology, -gynacology-fertility-metabolism (updated)
16/04/2014Opinion/decision on a Paediatric Investigation Plan (PIP): Dificlir,

Fidaxomicin

Therapeutic area: Infectious diseases (updated)
16/04/2014Opinion/decision on a Paediatric Investigation Plan (PIP): Allergovit Phleum,

Allergoid preparation of Phleum pratense pollen extract

Therapeutic area: Pneumology-allergology
16/04/2014Opinion/decision on a Paediatric Investigation Plan (PIP): Ruby-Fill (Rubidium Rb-82 Generator),

Rubidium (82Rb) chloride

Therapeutic area: Diagnostic (updated)
16/04/2014Veterinary medicine European public assessment report (EPAR): Previcox,

firocoxib

Revision: 19, Authorised
16/04/2014Veterinary medicine European public assessment report (EPAR): MS-H Vaccine,

Mycoplasma synoviae strain MS-H

Revision: 1, Authorised
16/04/2014Opinion/decision on a Paediatric Investigation Plan (PIP): -,

telmisartan / amlodipine (besylate)

Therapeutic area: Cardiovascular diseases
16/04/2014Opinion/decision on a Paediatric Investigation Plan (PIP): -,

Herpes simplex 1 virus thymidine kinase and truncated low affinity nerve growth factor receptor transfected donor lymphocytes

Therapeutic area: Oncology
16/04/2014Opinion/decision on a Paediatric Investigation Plan (PIP): Muscoplus,

diclofenac sodium / thiocolchicoside

Therapeutic area: Pain
16/04/2014Opinion/decision on a Paediatric Investigation Plan (PIP): -,

ertugliflozin / metformin

Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
16/04/2014Opinion/decision on a Paediatric Investigation Plan (PIP): -,

elobixibat

Therapeutic area: Gastroentology-Hepatology
16/04/2014News and press releases: European Medicines Agency alerts EU healthcare professionals after vials of falsified Herceptin identified
16/04/2014Opinion/decision on a Paediatric Investigation Plan (PIP): Easygol powder for oral solution,

Citric acid (as citric acid anhydrous) / sodium chloride / simeticone / macrogol 4000 / sodium citrate / sodium sulfate (as sodium sulfate anhydrous) / potassium chloride

Therapeutic area: Gastroentology-Hepatology
16/04/2014Medication Errors - Follow-up Actions from Workshop: Implementation Plan 2014-2015
16/04/2014Medication errors (updated)
16/04/2014News and press releases: EMA and EU national competent authorities agree on action plan to address medication errors
16/04/2014Opinion/decision on a Paediatric Investigation Plan (PIP): -,

Enalapril (maleate)

Therapeutic area: Cardiovascular diseases
16/04/2014Current tenders for €60,000 or more (updated)
16/04/2014Opinion/decision on a Paediatric Investigation Plan (PIP): Jetrea,

Ocriplasmin

Therapeutic area: Ophthalmology
16/04/2014Opinion/decision on a Paediatric Investigation Plan (PIP): Stelara,

Ustekinumab

Therapeutic area: Immunology-Rheumatology-Transplantation/Gastroentology-Hepatology
16/04/2014Opinion/decision on a Paediatric Investigation Plan (PIP): Otoken,

Fluocinolone acetonide

Therapeutic area: Oto-rhino-laryngology
16/04/2014Opinion/decision on a Paediatric Investigation Plan (PIP): -,

Human normal immunoglobulin

Therapeutic area: Immunology-Rheumatology-Transplantation
15/04/2014Scientific guideline: Interim guidance on enhanced safety surveillance for seasonal influenza vaccines in the EU, adopted
15/04/2014SME workshop for micro, small and medium-sized enterprises: Focus on quality for medicines containing chemical entities, European Medicines Agency, London, UK, From: 04-Apr-2014, To: 04-Apr-2014 (updated)
15/04/2014News and press releases: European Medicines Agency closed 17-21 April 2014
15/04/2014Data quality control methodology for data submitted under Article 57(2) of Regulation (EC) No.726/2004
15/04/2014Minutes of the CVMP meeting of 11-13 March 2014
15/04/2014Call for scientific data for use in HMPC assessment work on Glycine max, lecithin, draft: consultation open (updated)
15/04/2014Human medicines European public assessment report (EPAR): Cholic Acid FGK,

cholic acid

Revision: 0, Authorised
14/04/2014Appendix V - Adverse-drug-reaction reporting details (updated)
14/04/2014Veterinary medicine European public assessment report (EPAR): Porcilis ColiClos,

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

Revision: 1, Authorised
14/04/2014Veterinary medicine European public assessment report (EPAR): Zuprevo,

tildipirosin

Revision: 2, Authorised
14/04/2014Veterinary medicine European public assessment report (EPAR): Porcilis Porcoli Diluvac Forte (previously Porcilis Porcoli),

vaccine to provide passive immunity to the progeny against E. coli in pigs

Revision: 7, Authorised
14/04/2014COMP meeting report on the review of applications for orphan designation: April 2014
14/04/2014Veterinary medicine European public assessment report (EPAR): Meloxidyl,

meloxicam

Revision: 11, Authorised
14/04/2014Veterinary medicine European public assessment report (EPAR): BTVPUR Alsap 8,

adjuvanted bluetongue virus vaccine

Revision: 5, Authorised
14/04/2014News and press releases: Update on infringement procedure against Roche Registration Ltd.
14/04/2014Human medicines European public assessment report (EPAR): Rivastigmine 3M Health Care Ltd,

rivastigmine

Revision: 0, Authorised
14/04/2014Veterinary medicine European public assessment report (EPAR): Nobilis IB 4-91,

live attenuated vaccine against avian infectious bronchitis

Revision: 8, Authorised
14/04/2014Human medicines European public assessment report (EPAR): Effentora,

fentanyl

Revision: 13, Authorised
14/04/2014Human medicines European public assessment report (EPAR): Instanyl,

fentanyl

Revision: 8, Authorised
14/04/2014Human medicines European public assessment report (EPAR): Memantine Accord,

memantine

Revision: 1, Authorised
14/04/2014Human medicines European public assessment report (EPAR): PecFent,

fentanyl

Revision: 6, Authorised
14/04/2014Opinion of the CVMP on the establishment of maximum residue limits: Tildipirosin
14/04/2014Opinion of the CVMP on the establishment of maximum residue limits: Triptorelin acetate
14/04/2014Human medicines European public assessment report (EPAR): Twinrix Paediatric,

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

Revision: 15, Authorised
14/04/2014Best practice guide for staff leaving the European Medicines Agency
14/04/2014Human medicines European public assessment report (EPAR): Ribavirin Teva Pharma B.V.,

ribavirin

Revision: 9, Authorised
11/04/2014Human medicines European public assessment report (EPAR): Ribavirin Teva,

ribavirin

Revision: 9, Authorised
11/04/2014News and press releases: Registration opens for EMA workshop on the clinical investigation of medicines for the treatment of Alzheimer’s disease
11/04/2014EMA workshop on the clinical investigation of medicines for the treatment of Alzheimer’s disease, European Medicines Agency, London, UK, From: 24-Nov-2014, To: 25-Nov-2014
11/04/2014Human medicines European public assessment report (EPAR): Sutent,

sunitinib

Revision: 22, Authorised
11/04/2014Human medicines European public assessment report (EPAR): Soliris,

eculizumab

Revision: 13, Authorised
11/04/2014Human medicines European public assessment report (EPAR): Velcade,

bortezomib

Revision: 34, Authorised
11/04/2014MRL pending EC decision: Barium selenate - Summary opinion of the CVMP on the estabilishment of maximum residue limits
11/04/2014Pending EC decision: Vectra Felis,

pyriproxyfen / dinotefuran

Opinion date: 10-Apr-2014
11/04/2014News and press releases: Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 8-10 April 2014
11/04/2014Regulatory and procedural guideline: European Medicines Agency certificates of medicinal products - instructions on how to fill in the application form, adopted (updated)
11/04/2014News and press releases: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 7-10 April 2014
11/04/2014News and press releases: PRAC recommends against combined use of medicines affecting the renin-angiotensin (RAS) system
11/04/2014News and press releases: Start of review of ambroxol and bromhexine
11/04/2014News and press releases: Start of review of codeine-containing medicines when used for cough and cold in children
11/04/2014News and press releases: Review of oral methadone medicines containing povidone started
11/04/2014News and press releases: Review of testosterone-containing medicines started
11/04/2014Referral: Article 31 referrals, Testosterone-containing medicines,

testosterone

11/04/2014Referral: Article 31 referrals, Ambroxol and bromhexine-containing medicines,

ambroxol and bromhexine

11/04/2014Referral: Article 107i procedures, Methadone medicinal products for oral use containing povidone
11/04/2014Referral: Article 31 referrals, Codeine containing medicinal products for the treatment of cough or cold in paediatric patients,

codeine

11/04/2014News and press releases: Specifications for additional efficacy studies for medicines published in the Official Journal of the EU
11/04/2014Human medicines European public assessment report (EPAR): Victrelis,

boceprevir

Revision: 14, Authorised
11/04/2014Human medicines European public assessment report (EPAR): Xalkori,

crizotinib

Revision: 5, Authorised
11/04/2014Human medicines European public assessment report (EPAR): Herceptin,

trastuzumab

Revision: 22, Authorised
10/04/2014Human medicines European public assessment report (EPAR): Neuraceq,

florbetaben (18F)

Revision: 1, Authorised
10/04/2014Human medicines European public assessment report (EPAR): Ceplene,

histamine dihydrochloride

Revision: 8, Authorised
10/04/2014Human medicines European public assessment report (EPAR): Bosulif,

bosutinib

Revision: 1, Authorised
10/04/2014Human medicines European public assessment report (EPAR): Docetaxel Teva,

docetaxel

Revision: 8, Authorised
10/04/2014Human medicines European public assessment report (EPAR): Docetaxel Kabi,

docetaxel

Revision: 4, Authorised
10/04/2014Human medicines European public assessment report (EPAR): Eperzan,

albiglutide

Revision: 0, Authorised
10/04/2014Human medicines European public assessment report (EPAR): Docetaxel Accord,

docetaxel

Revision: 4, Authorised
10/04/2014Human medicines European public assessment report (EPAR): Clopidogrel Acino,

clopidogrel

Revision: 2, Authorised
10/04/2014Human medicines European public assessment report (EPAR): Tafinlar,

dabrafenib

Revision: 1, Authorised
10/04/2014Human medicines European public assessment report (EPAR): Adempas,

riociguat

Revision: 0, Authorised
10/04/2014Human medicines European public assessment report (EPAR): Fluenz Tetra,

influenza vaccine (live attenuated, nasal)

Revision: 1, Authorised
10/04/2014Referral: Article 31 referrals, Renin-angiotensin-system (RAS)-acting agents,

captopril, imidapril, zofenopril, candesartan, delapril, telmisartan, aliskiren, moexipril, enalapril, valsartan, fosinopril, irbesartan, perindopril, quinapril, ramipril, eprosartan, olmesartan, trandolapril, losartan, azilsartan, lisinopril, spirapril, benazepril, cilazapril

(updated)
10/04/2014Referral: Article 35, Veterinary medicines containing enrofloxacin to be administered via the drinking water to chickens and/or turkeys,

enrofloxacin

10/04/2014Hemoprostol H-W-2652
10/04/2014Human medicines European public assessment report (EPAR): Rivastigmine Sandoz,

rivastigmine

Revision: 6, Authorised
10/04/2014Human medicines European public assessment report (EPAR): Docetaxel Mylan,

docetaxel

Revision: 4, Authorised
10/04/2014Submission of scientific data (updated)
10/04/2014Human medicines European public assessment report (EPAR): Vfend,

voriconazole

Revision: 30, Authorised
10/04/2014Second periodic safety update report information day, European Medicines Agency, London, UK, From: 29-Apr-2014, To: 29-Apr-2014
09/04/2014Monthly report on application procedures, guidelines and related documents for veterinary medicines: March 2014
09/04/2014Scientific guideline: Draft concept paper on the establishment of a guideline on the selection of sterilisation processes for drug products, draft: consultation open
09/04/2014Overview of comments received on 'Guideline on stability testing for applications for variations to a marketing authorisation'
09/04/2014Scientific guideline: Guideline on stability testing for applications for variations to a marketing authorisation, adopted
09/04/2014Human medicines European public assessment report (EPAR): Lamivudine Teva,

lamivudine

Revision: 2, Authorised
09/04/2014Human medicines European public assessment report (EPAR): Cholib,

fenofibrate / simvastatin

Revision: 1, Authorised
09/04/2014Human medicines European public assessment report (EPAR): Rivastigmine Hexal,

rivastigmine

Revision: 6, Authorised
09/04/2014Referral: Article 20 procedures, Kogenate Bayer and Helixate NexGen,

octocog alfa

(updated)
09/04/2014Lamivudine Teva : EPAR - All Authorised presentations (updated)
08/04/2014News and press releases: EMA announces final steps for its clinical-trial data policy
08/04/2014Human medicines European public assessment report (EPAR): Hirobriz Breezhaler,

indacaterol

Revision: 7, Authorised
08/04/2014Human medicines European public assessment report (EPAR): Onbrez Breezhaler,

indacaterol

Revision: 7, Authorised
08/04/2014Human medicines European public assessment report (EPAR): Avastin,

bevacizumab

Revision: 35, Authorised
08/04/2014Human medicines European public assessment report (EPAR): Evra,

norelgestromin / ethinyl estradiol

Revision: 15, Authorised
08/04/2014Human medicines European public assessment report (EPAR): Ioa,

nomegestrol acetate / estradiol

Revision: 3, Authorised
08/04/2014Human medicines European public assessment report (EPAR): Temozolomide Hexal,

temozolomide

Revision: 8, Authorised
08/04/2014Human medicines European public assessment report (EPAR): Latuda,

lurasidone

Revision: 0, Authorised
08/04/2014Human medicines European public assessment report (EPAR): Zoely,

nomegestrol / estradiol

Revision: 4, Authorised
08/04/2014Human medicines European public assessment report (EPAR): Evoltra,

clofarabine

Revision: 18, Authorised
08/04/2014Healthcare professionals' organisations involved in the Agency's activities (updated)
08/04/2014HMPC meeting report on Community herbal monographs, guidelines and other activities - 24-25 March 2014
08/04/2014Human medicines European public assessment report (EPAR): Olanzapine Cipla (previously Olanzapine Neopharma),

olanzapine

Revision: 10, Authorised
08/04/2014Human medicines European public assessment report (EPAR): Olanzapine Glenmark Europe,

olanzapine

Revision: 7, Authorised
08/04/2014Publications (updated)
08/04/2014Human medicines European public assessment report (EPAR): Olanzapine Teva,

olanzapine

Revision: 12, Authorised
08/04/2014Human medicines European public assessment report (EPAR): Adasuve,

loxapine

Revision: 2, Authorised
08/04/2014Human medicines European public assessment report (EPAR): Olanzapine Glenmark,

olanzapine

Revision: 8, Authorised
08/04/2014Human medicines European public assessment report (EPAR): Abilify Maintena,

aripiprazole

Revision: 1, Authorised
08/04/2014Referral: Article 29(4) referrals, Tibolona Aristo and Tibocina and associated names,

Tibolone

(updated)
08/04/2014Human medicines European public assessment report (EPAR): Oslif Breezhaler,

indacaterol

Revision: 7, Authorised
07/04/2014Human medicines European public assessment report (EPAR): Peyona (previously Nymusa),

caffeine

Revision: 5, Authorised
07/04/2014Agenda: Agenda - PRAC draft agenda of meeting 7-10 April 2014
07/04/2014Human medicines European public assessment report (EPAR): Vedrop,

d-alpha-tocopherol

Revision: 6, Authorised
07/04/2014Agenda: Agenda - CVMP agenda of the 8-10 April 2014 meeting
07/04/2014Human medicines European public assessment report (EPAR): Jevtana,

cabazitaxel

Revision: 8, Authorised
07/04/2014Human medicines European public assessment report (EPAR): Zelboraf,

vemurafenib

Revision: 7, Authorised
07/04/2014Human medicines European public assessment report (EPAR): Kalydeco,

ivacaftor

Revision: 2, Authorised
07/04/2014Detailed 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 5: Extended EudraVigilance product report acknowledgement message (updated)
07/04/2014Detailed 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 5: Extended EudraVigilance product report acknowledgement message (updated)
07/04/2014Detailed 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.I: Extended EudraVigilance product report message (XEVPRM) technical specifications (updated)
07/04/2014Detailed 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.I: Extended EudraVigilance product report message (XEVPRM) technical specifications (updated)
07/04/2014Human medicines European public assessment report (EPAR): Nexium Control,

esomeprazole

Revision: 3, Authorised
07/04/2014News and press releases: EMA and Australian regulator strengthen collaboration in the area of orphan medicines
04/04/2014Human medicines European public assessment report (EPAR): Cerezyme,

imiglucerase

Revision: 18, Authorised
04/04/2014News and press releases: World Health Day 2014: focus on diseases transmitted by vectors
04/04/2014Human medicines European public assessment report (EPAR): Nimenrix,

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

Revision: 3, Authorised
04/04/2014Newsletter: Human medicines highlights - March 2014
04/04/2014Human medicines European public assessment report (EPAR): Invanz,

ertapenem

Revision: 16, Authorised
04/04/2014Human medicines European public assessment report (EPAR): Baraclude,

entecavir

Revision: 17, Authorised
04/04/2014Human medicines European public assessment report (EPAR): Eviplera,

emtricitabine / rilpivirine / tenofovir disoproxil

Revision: 6, Authorised
04/04/2014EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) organisations (updated)
04/04/2014Presubmission request form (updated)
04/04/2014Regulatory and procedural guideline: Dossier requirements for centrally authorised products (updated)
04/04/2014EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) pharmaceutical dose forms (updated)
04/04/2014EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) routes of administration (updated)
04/04/2014Human medicines European public assessment report (EPAR): Privigen,

human normal immunoglobulin (IVIg)

Revision: 16, Authorised
04/04/2014List of European Union reference dates and frequency of submission of periodic safety update reports (updated)
03/04/2014News and press releases: EMA confirms withdrawal of two court cases concerning access to clinical-trial data
03/04/2014Human medicines European public assessment report (EPAR): Champix,

varenicline

Revision: 22, Authorised
03/04/2014Orphan designation:

Vascular endothelial growth factor-D gene in an adenoviral vector for use with a collagen collar

for the: Prevention of stenosis in synthetic grafts used in haemodialysis (updated)
03/04/2014Orphan designation:

Trabedersen

for the: Treatment of pancreatic cancer (updated)
03/04/2014Human medicines European public assessment report (EPAR): Aptivus,

tipranavir

Revision: 29, Authorised
03/04/2014Joint European Medicines Agency (EMA), US Food and Drug Administration (FDA), and Japanese Ministry of Health, Labour and Welfare (MHLW) and Pharmaceuticals and Medical Devices Agency (PMDA) orphan medicinal product workshop, European Medicines Agency, London, UK, From: 10-Mar-2014, To: 10-Mar-2014 (updated)
03/04/2014Orphan designation:

TGF-ß2-specific phosphorothioate antisense oligodeoxynucleotide

for the: Treatment of high-grade glioma (updated)
03/04/2014Orphan designation:

Sacrosidase

for the: Treatment of congenital sucrase-isomaltase deficiency (updated)
03/04/2014Orphan designation:

Recombinant human serum amyloid P

for the: Prevention of scarring post glaucoma filtration surgery (updated)
03/04/2014Member States involved in the EMA-EU MSs-FDA initiative on inspections for generic applications (updated)
03/04/2014Human medicines European public assessment report (EPAR): Xolair,

omalizumab

Revision: 14, Authorised
03/04/2014Orphan designation:

Phosphorothioate oligonucleotide targeted to apolipoprotein C-III

for the: Treatment of familial chylomicronaemia syndrome
03/04/2014Minutes of the HMPC 27-28 January 2014 meeting
03/04/2014Orphan designation:

N-({Carbamoylmethyl-[3-(2-oxo-pyrrolidin-1-yl)-propyl]-carbamoyl}-methyl)-2-[2-(2-fluoro-phenyl)-ethylamino]-N-isobutyl-acetamide

for the: Treatment of optic neuritis
03/04/2014Consultation meeting with stakeholders: Request from the European Commission for advice on the impact on public and animal health of the use of antibiotics in animals, European Medicines Agency, London, UK, From: 28-Feb-2014, To: 28-Feb-2014 (updated)
02/04/2014Orphan designation:

Autologous dendritic cells pulsed with tumour antigen-derived synthetic peptides (MAGE-1, HER-2, AIM-2, TRP-2, gp-100, and interleukin-13 receptor alpha)

for the: Treatment of glioma
02/04/2014Orphan designation:

68Ga-2,2'-(7-(4-((S)-1-((4S,7S,10S,13R,16S,19R)-4-((R)-1-amino-3-(4-hydroxyphenyl)-1-oxopropan-2-ylcarbamoyl)-10-(4-aminobutyl)-16-(4-((S)-2,6-dioxohexahydropyrimidine-4-carboxamido)benzyl)-7-((R)-1-hydroxyethyl)-6,9,12,15,18-pentaoxo-13-(4-ureidobenzyl)-1,2-dithia-5,8,11,14,17-pentaazacycloicosan-19-ylamino)-3-(4-chlorophenyl)-1-oxopropan-2-ylamino)-1-carboxy-4-oxobutyl)-1,4,7-triazonane-1,4-diyl)diacetic acid

for the: Diagnosis of gastro-entero-pancreatic neuroendocrine tumours
02/04/2014Orphan designation:

Pioglitazone

for the: Treatment of adrenoleukodystrophy
02/04/2014Human medicines European public assessment report (EPAR): Isentress,

raltegravir

Revision: 21, Authorised
02/04/2014Orphan designation:

Ruxolitinib

for the: Treatment of polycythaemia vera
02/04/2014Human medicines European public assessment report (EPAR): Crixivan,

indinavir

Revision: 34, Authorised
02/04/2014Human medicines European public assessment report (EPAR): Onduarp,

telmisartan / amlodipine

Revision: 2, Withdrawn
02/04/2014Orphan designation:

Recombinant human acid ceramidase

for the: Treatment of Farber disease
02/04/2014Orphan designation:

3-Chloro-4-fluorophenyl-[4-fluoro-4-{[(5-methylpyrimidin-2-ylmethyl) amino]methyl}piperidin-1-yl]methanone

for the: Treatment of Rett syndrome
02/04/2014Minutes - PDCO minutes of the 12-14 February 2014 meeting
02/04/2014Conditions of use, conditions for distribution and patients targeted and conditions for safety monitoring adressed to member states for Sofosbuvir available for compassionate use
02/04/2014Summary on compassionate use for Ledipasvir/Sofosbuvir
02/04/2014New vacancy: Contract Agent, long-term, FG III, Data Officer(s), Product Database Management, Business Data and Support Department
02/04/2014New vacancy: Temporary Agent (AD8), Continuous Improvement Lead, Procedure Management Department
02/04/2014New vacancy: Temporary Agent (AD12), Head of Administration Division
02/04/2014Pending EC decision: Vokanamet,

canagliflozin / metformin

Opinion date: 20-Feb-2014 (updated)
02/04/2014Pending EC decision: Jardiance,

empagliflozin

Opinion date: 20-Mar-2014 (updated)
01/04/2014Regulatory and procedural guideline: The revised checking process of mock-ups and specimens of outer/immediate labelling and package leaflets in the centralised procedure for veterinary medicinal products, adopted (updated)
01/04/2014Q&A: Mock-ups (updated)
01/04/2014Q&A: 1-20 (updated)
01/04/2014Q&A: Extension applications (updated)
01/04/2014Regulatory and procedural guideline: Mock-ups checklist - Guidance for checking mock-ups
01/04/2014Orphan designation:

Recombinant homodimer of the human annexin V

for the: Prevention of ischaemia / reperfusion injury associated with solid-organ transplantation (updated)
01/04/2014Orphan designation:

Picoplatin

for the: Treatment of small cell lung cancer (updated)
01/04/2014Orphan designation:

Macitentan

for the: Treatment of pulmonary arterial hypertension (updated)
01/04/2014Orphan designation:

Lestaurtinib

for the: Treatment of acute myeloid leukaemia (updated)
01/04/2014Orphan designation:

Human dermal fibroblasts cultured on a bioresorbable polyglactin mesh

for the: Treatment of epidermolysis bullosa (updated)
01/04/2014News and press releases: European Medicines Agency introduces new fee incentives for SMEs for post-authorisation activities
01/04/2014Veterinary medicine European public assessment report (EPAR): Activyl,

indoxacarb

Revision: 4, Authorised
01/04/2014Orphan designation:

Ascorbic acid

for the: Treatment of Charcot-Marie-Tooth disease type 1A (updated)
01/04/2014Orphan designation:

Adenovirus-mediated herpes-simplex-virus thymidine-kinase (HKSV-tk) gene

for the: Treatment of high-grade glioma with subsequent use of ganciclovir sodium (updated)
01/04/2014Orphan designation:

16-base single-stranded PNA oligonucleotide linked to a 7-aminoacid peptide

for the: Treatment of neuroblastoma (updated)
01/04/2014Orphan designation:

16-Base single-stranded peptide nucleic acid oligonucleotide linked to a 7-amino acid peptide

for the: Treatment of medulloblastoma (updated)
01/04/2014Rules for the implementation of the financial regulation applicable to the budget of the European Medicines Agency (updated)
01/04/2014Explanatory note on fees payable to the European Medicines Agency
01/04/2014Commission Regulation (EU) No 272/2014 of 17 March 2014 amending Council Regulation (EC) No 297/95 as regards the adjustment of the fees of the European Medicines Agency to the inflation rate
01/04/2014News and press releases: Increased fees coming into effect on 1 April 2014
01/04/2014Questions and answers relating to open procurement procedure EMA/2014/05/COM – Information resources
01/04/2014Orphan designation:

16-base single-stranded peptide nucleic acid oligonucleotide linked to 7-amino acid peptide

for the: Treatment of neuroblastoma (updated)
01/04/2014Electronic submission of veterinary dossiers: Questions and answers (updated)
01/04/2014Use of eSubmission Gateway / Web Client extended to new procedure types from 1st of April 2014
01/04/2014Orphan designation:

(1R,2S) 6-bromo-alpha-[2-(dimethylamino)ethyl]-2-methoxy-alpha-(1-naphthyl)-beta-phenyl-3-quinolineethanol

for the: Treatment of tuberculosis (updated)
01/04/2014Orphan designation:

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

for the: Treatment of Duchenne muscular dystrophy
01/04/2014Human medicines European public assessment report (EPAR): Tyverb,

lapatinib

Revision: 19, Authorised
01/04/2014Orphan designation:

Cysteamine

for the: Treatment of cystic fibrosis
01/04/2014Human medicines European public assessment report (EPAR): Gilenya,

fingolimod

Revision: 5, Authorised
01/04/2014Human medicines European public assessment report (EPAR): Zalasta,

olanzapine

Revision: 11, Authorised
01/04/2014Orphan designation:

11-(4-Dimethylamino-3-hydroxy-6-methyl-tetrahydro-pyran-2-yloxy)-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-1-oxa-6-aza-cyclopentadecane-13,15-dione

for the: Treatment of cystic fibrosis
01/04/2014Orphan designation:

Eculizumab

for the: Prevention of delayed graft function after solid organ transplantation
01/04/2014Orphan designation:

Gallium [Ga-68]-N-[(4,7,10-Tricarboxymethyl-1,4,7,10-tetraazacyclododec-1-yl)acetyl]-D-phenylalanyl-L-cysteinyl-L-tyrosyl-D-tryptophanyl-L-lysyl-L-threoninyl-Lcysteinyl-L-threonine-cyclic(2-7)disulfide

for the: Diagnosis of gastro-entero-pancreatic neuroendocrine tumours
01/04/2014Human medicines European public assessment report (EPAR): Tysabri,

natalizumab

Revision: 16, Authorised
01/04/2014CHMP Blood Products Working Party work programme 2014 (updated)
01/04/2014News and press releases: SME workshop on quality of medicines takes place this Friday
01/04/2014Transfer of marketing authorisation: questions and answers (updated)
01/04/2014Type-II variations: questions and answers (updated)
01/04/2014Periodic safety update reports: questions and answers (updated)
01/04/2014Type-IB variations: questions and answers (updated)
01/04/2014Article-61(3) notifications: questions and answers (updated)
01/04/2014Regulatory and procedural guideline: European Medicines Agency post-authorisation procedural advice for users of the centralised procedure: document with track changes (updated)
01/04/2014Type-IA variations: questions and answers (updated)
01/04/2014Regulatory and procedural guideline: European Medicines Agency post-authorisation procedural advice for users of the centralised procedure (updated)
01/04/2014Human medicines European public assessment report (EPAR): Avonex,

interferon beta-1a

Revision: 19, Authorised
01/04/2014Orphan designation:

Mixture of recombinant human IgG1 monoclonal antibodies against human cytomegalovirus envelope glycoproteins

for the: Prevention of congenital cytomegalovirus infection following primary cytomegalovirus infection