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October 2014

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22/10/2014News and press releases: EMA ready to start assessment of Ebola vaccines and treatments as soon as data are made available
22/10/2014Press release: EMA ready to start assessment of Ebola vaccines and treatments as soon as data are made available
22/10/2014Human medicines European public assessment report (EPAR): ProQuad,

measles, mumps, rubella and varicella vaccine (live)

Revision: 16, Authorised
22/10/2014Work plan for Biostatistics Working Party 2014 (updated)
22/10/2014List of the recruitment agencies used by the European Medicines Agency for interim staff (updated)
22/10/2014Veterinary medicine European public assessment report (EPAR): Loxicom,

meloxicam

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

brimonidine

Revision: 1, Authorised
22/10/2014Human medicines European public assessment report (EPAR): Levetiracetam Actavis,

levetiracetam

Revision: 5, Authorised
22/10/2014Regulatory 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)
22/10/2014Veterinary medicine European public assessment report (EPAR): SevoFlo,

sevoflurane

Revision: 11, Authorised
22/10/2014Orphan designation:

Tasimelteon

for the: Treatment of non-24-hour sleep-wake disorder in blind people with no light perception (updated)
22/10/2014Human medicines European public assessment report (EPAR): Clopidogrel Apotex (previously Clopidogrel Mylan Pharma),

clopidogrel

Revision: 9, Authorised
21/10/2014Minutes of the PRAC meeting 8-11 September 2014
21/10/2014Human medicines European public assessment report (EPAR): Zoledronic Acid Hospira,

zoledronic acid

Revision: 2, Authorised
21/10/2014Human medicines European public assessment report (EPAR): NexoBrid,

concentrate of proteolytic enzymes enriched in bromelain

Revision: 4, Authorised
21/10/2014Report: Hearing the Association of the European Self-Medication Industry during the May 2014 Working Party on Community Monographs and Community List meeting
21/10/2014Public summary of the evaluation of the proposed product-specific waiver: Pacritinib for treatment of post-polycythaemia vera myelofibrosis and treatment of post-essential thrombocythaemia myelofibrosis
21/10/2014Public summary of the evaluation of the proposed product-specific waiver: Tirasemtiv for the treatment of amyotrophic lateral sclerosis
21/10/2014Public summary of the evaluation of the proposed paediatric investigation plan: (S)-Pyrrolidine-2-carboxylic acid compound with (2S,3R,4R,5S,6R)-2-(3-((2,3-dihydrobenzo[b][1,4]dioxin-6-yl)methyl)-4-ethylphenyl)-6-(hydroxymethyl)tetrahydro-2H-pyran-3,4,5-triol (2:1) for treatment of type-2 diabetes mellitus
21/10/2014Public summary of the evaluation of the proposed paediatric investigation plan: Recombinant parathyroid hormone for treatment of hypoparathyroidism
21/10/2014Public summary of the evaluation of the proposed paediatric investigation plan: Dupilumab for treatment of asthma
21/10/2014Public summary of the evaluation of the proposed paediatric investigation plan: Daclatasvir (dihydrochloride) / asunaprevir / (1ar,12bs)-8-Cyclohexyl-N-(dimethylsulfamoyl)-11-methoxy-1a-(((1R,5S)-3-methyl-3,8-diazabicyclo[3.2.1]oct-8-yl)carbonyl)-1,1a,2,12b-tetrahydrocyclopropa[d]indolo[2,1-a][2]benzazepine-5-carboxamide hydrochloride for the treatment of chronic hepatitis C
21/10/2014Agenda: Agenda - CAT agenda of the 16-17 October 2014 meeting
21/10/2014Public summary of the evaluation of the proposed paediatric investigation plan: N-[(1,3-dicyclohexyl-6-hydroxy-2,4-dioxo-1,2,3,4-tetrahydro-5-pyrimidinyl)carbonyl]glycine for treatment of anaemia due to chronic disorders
21/10/2014Report: Medicinal products for human use: Monthly figures - September 2014
21/10/2014Public summary of the evaluation of the proposed product-specific waiver: Human recombinant follicle-stimulating hormone (FE 999049) for treatment of female infertility and treatment of hypogonadotrophic hypogonadism
21/10/2014Public summary of the evaluation of the proposed paediatric investigation plan: Tofacitinib for treatment of ulcerative colitis
21/10/2014Public summary of the evaluation of the proposed paediatric investigation plan: Ranibizumab for treatment of retinopathy of prematurity
21/10/2014Public summary of the evaluation of the proposed product-specific waiver: Ranibizumab for treatment of choroidal neovascularisation and treatment of macular oedema
21/10/2014Public summary of the evaluation of the proposed paediatric investigation plan: Tobramycin for treatment of Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis
20/10/2014Agenda: Agenda - CHMP agenda of the 20-23 October 2014 meeting
20/10/2014Human medicines European public assessment report (EPAR): Macugen,

pegaptanib

Revision: 13, Authorised
20/10/2014Veterinary medicine European public assessment report (EPAR): Equilis StrepE,

live vaccine against Streptococcus equi

Revision: 9, Authorised
20/10/2014Veterinary medicine European public assessment report (EPAR): Fevaxyn Pentofel,

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

Revision: 16, Authorised
20/10/2014News and press releases: Speeding up development of Ebola treatments and vaccines
20/10/2014Agenda: Agenda - PDCO agenda of the 08-10 October 2014 meeting (updated)
20/10/2014Veterinary medicine European public assessment report (EPAR): Versican Plus DHPPi,

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

Revision: 0, Authorised
20/10/2014Veterinary medicine European public assessment report (EPAR): Versican Plus Pi/L4R,

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

Revision: 0, Authorised
20/10/2014Veterinary medicine European public assessment report (EPAR): Versican Plus L4,

Canine leptospirosis vaccine (inactivated)

Revision: 0, Authorised
20/10/2014Veterinary medicine European public assessment report (EPAR): Versican Plus Pi/L4,

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

Revision: 0, Authorised
20/10/2014Veterinary medicine European public assessment report (EPAR): Versican Plus Pi,

canine parainfluenza virus vaccine (live attenuated)

Revision: 0, Authorised
17/10/2014Shortages catalogue (updated)
17/10/2014PDCO monthly report of opinions on paediatric investigation plans and other activities 8-10 October 2014
17/10/2014Xofigo (radium-223 dichloride) supply shortage
17/10/2014Newsletter: News bulletin for small and medium-sized enterprises - Issue 29
17/10/2014Veterinary medicine European public assessment report (EPAR): Suvaxyn PCV,

adjuvanted inactivated vaccine against porcine circovirus type 2 in piglets

Revision: 8, Authorised
17/10/2014Human medicines European public assessment report (EPAR): Doribax,

doripenem

Revision: 10, Withdrawn
17/10/2014Human medicines European public assessment report (EPAR): DuoPlavin,

clopidogrel / acetylsalicylic acid

Revision: 7, Authorised
17/10/2014Human medicines European public assessment report (EPAR): Revatio,

sildenafil

Revision: 24, Authorised
17/10/2014Veterinary medicine European public assessment report (EPAR): ProteqFlu-Te,

equine influenza and tetanus vaccine

Revision: 11, Authorised
17/10/2014Veterinary medicine European public assessment report (EPAR): ProteqFlu,

equine influenza vaccine

Revision: 11, Authorised
17/10/2014Veterinary medicine European public assessment report (EPAR): Zulvac 1 Bovis,

inactivated bluetongue virus, serotype 1

Revision: 4, Authorised
17/10/2014Veterinary medicine European public assessment report (EPAR): Zulvac 1 Ovis,

inactivated bluetongue virus, serotype-1

Revision: 4, Authorised
16/10/2014Prolia : EPAR - Summary for the public (updated)
16/10/2014Orphan designation:

Recombinant human monoclonal antibody of the IgG1 kappa class against prostate stem-cell antigen

for the: Treatment of pancreatic cancer (updated)
16/10/2014Orphan designation:

N-{2-Chloro-4-[(6,7-dimethoxy-4-quinolyl)oxy]phenyl}-N'-(5-methyl-3-isoxazolyl) urea hydrochloride monohydrate

for the: Treatment of renal-cell carcinoma (updated)
16/10/2014Orphan designation:

Lentiviral vector containing the human MYO7A gene

for the: Treatment of retinitis pigmentosa in Usher syndrome 1B (updated)
16/10/2014Orphan designation:

Ornithine phenylacetate

for the: Treatment of acute liver failure (updated)
16/10/2014Orphan designation:

Cholic acid

for the: Treatment of inborn errors in primary bile acid synthesis responsive to treatment with cholic acid (updated)
16/10/2014Orphan designation:

Human monoclonal antibody against Pseudomonas aeruginosa serotype O11

for the: Treatment of pneumonia caused by serotype O11 Pseudomonas aeruginosa (updated)
16/10/2014Orphan designation:

Progesterone

for the: Treatment of moderate and severe traumatic brain injury (updated)
16/10/2014Orphan designation:

Para-aminosalicylic acid

for the: Treatment of tuberculosis (updated)
16/10/2014Orphan designation:

Lentiviral vector containing the human ABCA4 gene

for the: Treatment of Stargardt’s disease (updated)
16/10/2014Orphan designation:

Pomalidomide

for the: Treatment of multiple myeloma (updated)
16/10/2014Orphan designation:

Glutathione

for the: Treatment of cystic fibrosis (updated)
16/10/2014Orphan designation:

Recombinant human interleukin-21

for the: Treatment of renal-cell carcinoma (updated)
16/10/2014Orphan designation:

Alvocidib

for the: Treatment of chronic lymphocytic leukaemia (updated)
16/10/2014Orphan designation:

Rilonacept

for the: Treatment of cryopirin-associated periodic syndromes (updated)
16/10/2014Orphan designation:

2-chloro-9-[2-deoxy-2-fluoro-ß-D-arabinofuranosyl]adenine

for the: Treatment of acute myeloid leukaemia (updated)
16/10/2014Orphan designation:

Amphotericin B (for inhalation use)

for the: Prevention of pulmonary fungal infection in patients deemed at risk (updated)
16/10/2014Orphan designation:

Octreotide chloride (lipid depot solution)

for the: Treatment of acromegaly (updated)
16/10/2014Orphan designation:

Adeno-associated viral vector serotype 5 containing the human ABCA4 gene

for the: Treatment of Stargardt's disease (updated)
16/10/2014Orphan designation:

Recombinant inhibitor of human plasma kallikrein

for the: Treatment of angioedema (updated)
16/10/2014Orphan designation:

Tobramycin (inhalation use)

for the: Treatment of Pseudomonas Aeruginosa lung infection in cystic fibrosis (updated)
16/10/2014Minutes - PDCO minutes of the 10-12 September 2014 meeting
16/10/2014COMP meeting report on the review of applications for orphan designation: October 2014
16/10/2014Human medicines European public assessment report (EPAR): M-M-RVAXPRO,

measles, mumps and rubella vaccine (live)

Revision: 13, Authorised
16/10/2014HMPC meeting report on Community herbal monographs, guidelines and other activities - 29-30 September 2014
16/10/2014Minutes of the HMPC 30 June-1 July 2014 meeting
15/10/2014Scientific guideline: Concept paper on the need for revision of the points to consider on the clinical investigation of new medicinal products for the treatment of acute coronary syndrome, draft: consultation open
15/10/2014Agenda: Agenda and registration form - Medicines and Healthcare Products Regulatory Agency information day: Medical Dictionary for Regulatory Activities in the pharmacovigilance regulatory process
15/10/2014Medicines and Healthcare Products Regulatory Agency information day: Medical Dictionary for Regulatory Activities in the pharmacovigilance regulatory process, Holiday Inn Kensington Forum, London, UK, From: 08-Dec-2014, To: 08-Dec-2014
15/10/2014Human medicines European public assessment report (EPAR): Busulfan Fresenius Kabi,

busulfan

Revision: 0, Authorised
15/10/2014Lyxumia : EPAR - Summary for the public (updated)
15/10/2014Report: Sales of veterinary antimicrobial agents in 26 European Union / European Economic Area countries in 2012: Fourth European Surveillance of Veterinary Antimicrobial Consumption report
15/10/2014News and press releases: 15% decrease in sales of veterinary antibiotics in Europe
15/10/2014European Surveillance of Veterinary Antimicrobial Consumption (ESVAC) (updated)
15/10/2014Enyglid : EPAR - Summary for the public (updated)
15/10/2014Human medicines European public assessment report (EPAR): Arixtra,

fondaparinux sodium

Revision: 25, Authorised
15/10/2014Human medicines European public assessment report (EPAR): Triumeq,

abacavir sulfate / dolutegravir sodium / lamivudine

Revision: 0, Authorised
15/10/2014National experts on secondment application form (updated)
15/10/2014New vacancy: Temporary Agent , EMA/AD/364: Continuous Improvement Lead, Procedure Management Department, Procedure Management and Business Support Division (AD8) (updated)
14/10/2014Herbal Medicinal Products: Crataegus, Crataegi folium cum flore, Crataegus spp, folium cum flore (updated)
14/10/2014Human medicines European public assessment report (EPAR): Abasria,

insulin glargine

Revision: 0, Authorised
14/10/2014Human medicines European public assessment report (EPAR): Zydelig,

idelalisib

Revision: 0, Authorised
14/10/2014Regulatory and procedural guideline: European Medicines Agency guidance for applicants seeking scientific advice and protocol assistance (updated)
14/10/2014Human medicines European public assessment report (EPAR): Humira,

adalimumab

Revision: 36, Authorised
14/10/2014Regulatory and procedural guideline: Initial notices for parallel distribution – September 2014
14/10/2014Minutes of the CVMP meeting of 9-11 September 2014
14/10/2014European Union clinical trials portal and Union database: meeting with stakeholders, European Medicines Agency, London, UK, From: 21-Nov-2014, To: 21-Nov-2014 (updated)
14/10/2014Human medicines European public assessment report (EPAR): Zavesca,

miglustat

Revision: 21, Authorised
14/10/2014Technical specifications - Annex V response questionnaire: Procurement procedure EMA/2014/30/BD
14/10/2014Technical specifications - Annex III summary checklist of documents which tenderers must submit: Procurement procedure EMA/2014/30/BD
14/10/2014Technical specifications - Technical specifications for open invitation to tender: Procurement procedure EMA/2014/30/BD
14/10/2014Current tenders for €60,000 or more (updated)
14/10/2014Technical specifications - Annex IV draft framework service contract for outsourcing: Procurement procedure EMA/2014/30/BD
14/10/2014Technical specifications - Annex I costing sheet: Procurement procedure EMA/2014/30/BD
14/10/2014Technical specifications - Letter of invitation to tender: Procurement procedure EMA/2014/30/BD
14/10/2014Technical specifications - Annex II exclusion criteria declaration upon honour and detail of supporting documentation required: Procurement procedure EMA/2014/30/BD
13/10/2014Work instructions for managing EudraCT alerts, adopted
13/10/2014Human medicines European public assessment report (EPAR): Extavia,

interferon beta-1b

Revision: 14, Authorised
13/10/2014Monthly report on application procedures, guidelines and related documents for veterinary medicines: September 2014
13/10/2014Statement of expenses for candidates
13/10/2014Human medicines European public assessment report (EPAR): Velphoro,

mixture of polynuclear iron(III)-oxyhydroxide, sucrose and starches

Revision: 0, Authorised
13/10/2014Minutes of the CHMP meeting 21-24 July 2014
13/10/2014Organisational matters - CHMP meeting 22-25 September 2014, adopted
13/10/2014Opinions on safety variations / periodic safety update reports adopted during the CHMP meeting 22-25 September 2014, adopted
13/10/2014Opinions on annual re-assessments, renewals of marketing authorisations and accelerated assessment procedures adopted during the CHMP meeting 22-25 September 2014, adopted
13/10/2014Guidelines and concept papers adopted during the CHMP meeting 22-25 September 2014, adopted
13/10/2014Regulatory and procedural guideline: Dossier requirements for centrally authorised products (updated)
13/10/2014Healthcare professionals' organisations involved in the Agency's activities (updated)
13/10/2014Report: Applications for new human medicines under evaluation by the CHMP: October 2014
13/10/2014Technical specifications for open invitation to tender: Procurement procedure EMA/2014/27/RE
13/10/2014Technical specifications - Annex VI declaration on essential criteria: Procurement procedure EMA/2014/27/RE
13/10/2014Technical specifications - Annex V tenderer information form: Procurement procedure EMA/2014/27/RE
13/10/2014Technical specifications - Annex III summary checklist of documents which tenderers must submit: Procurement procedure EMA/2014/27/RE
13/10/2014Technical specifications - Annex II exclusion criteria declaration: Procurement procedure EMA/2014/27/RE
13/10/2014Technical specifications - Annex I costing sheet: : Procurement procedure EMA/2014/27/RE
13/10/2014Technical specifications - Letter of invitation to tender: Procurement procedure EMA/2014/27/RE
13/10/2014Technical specifications - Annex IV draft service contract: Procurement procedure EMA/2014/27/RE
10/10/2014Human medicines European public assessment report (EPAR): Fabrazyme,

agalsidase beta

Revision: 20, Authorised
10/10/2014Scientific guideline: Reflection paper on the requirements for selection and justification of starting materials for the manufacture of chemical active substances, adopted
10/10/2014Pending EC decision: Bovela,

modified live bovine virus diarrhoea 1 (strain ke-9) / modified live bovine virus diarrhoea 2 (strain ny-93)

Opinion date: 09-Oct-2014
10/10/2014Regulatory and procedural guideline: Draft functional specifications for the European Union portal and European Union database to be audited, draft: consultation open
10/10/2014News and press releases: Committee for Medicinal Products for Veterinary Use (CVMP)
10/10/2014Human medicines European public assessment report (EPAR): Optisulin,

insulin glargine

Revision: 17, Authorised
10/10/2014Human medicines European public assessment report (EPAR): Xigduo,

dapagliflozin / metformin

Revision: 1, Authorised
10/10/2014News and press releases: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 6-9 October 2014
10/10/2014News and press releases: PRAC recommends strengthening the restrictions on the use of valproate in women and girls
10/10/2014News and press releases: PRAC review does not confirm increase in heart problems with testosterone medicines
10/10/2014News and press releases: PRAC recommends further measures to minimise risk of blood vessel blockage with Iclusig
10/10/2014Referral: Article 31 referrals, Testosterone-containing medicines,

testosterone

(updated)
10/10/2014Referral: Article 31 referrals, Valproate and related substances,

sodium valproate, valproic acid, valproate semisodium, valpromide

(updated)
10/10/2014Referral: Article 20 procedures, Iclusig,

ponatinib

(updated)
10/10/2014Herbal Medicinal Products: Fucus, Fucus vesiculosus, thallus, Fucus vesiculosus L. (updated)
10/10/2014Herbal Medicinal Products: Juglans, Juglandis folium, Juglans regia L. (updated)
10/10/2014Herbal Medicinal Products: Marrubium, Marrubii herba, Marrubium vulgare L. (updated)
10/10/2014Herbal Medicinal Products: Panax, Ginseng radix, Panax ginseng C. A. Meyer. (updated)
10/10/2014Herbal Medicinal Products: Origanum, Origani dictamni herba, Origanum dictamnus L. (updated)
10/10/2014Referral: Article 31 referrals, Ibuprofen- and dexibuprofen-containing medicines,

ibuprofen and dexibuprofen

(updated)
09/10/2014Herbal Medicinal Products: Humulus, Lupuli flos, Humulus lupulus L. (updated)
09/10/2014How to submit a scientific advice or protocol assistance request (updated)
09/10/2014Human medicines European public assessment report (EPAR): Isentress,

raltegravir

Revision: 23, Authorised
09/10/2014Human medicines European public assessment report (EPAR): Silodyx,

silodosin

Revision: 10, Authorised
09/10/2014Human medicines European public assessment report (EPAR): Trizivir,

abacavir (as sulfate) / lamivudine / zidovudine

Revision: 22, Authorised
09/10/2014Human medicines European public assessment report (EPAR): Brilique,

ticagrelor

Revision: 6, Authorised
09/10/2014Human medicines European public assessment report (EPAR): Brinavess,

vernakalant hydrochloride

Revision: 6, Authorised
09/10/2014Human medicines European public assessment report (EPAR): Mozobil,

plerixafor

Revision: 9, Authorised
09/10/2014Opinion/decision on a Paediatric Investigation Plan (PIP): -,

Glycopyrronium (bromide)

Therapeutic area: Neurology (updated)
09/10/2014Opinion/decision on a Paediatric Investigation Plan (PIP): Brintellix,

Vortioxetine

Therapeutic area: Psychiatry (updated)
09/10/2014Opinion/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)
09/10/2014Opinion/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)
09/10/2014Inspections and Human Medicines Pharmacovigilance (updated)
09/10/2014Opinion/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)
09/10/2014Opinion/decision on a Paediatric Investigation Plan (PIP): -,

Brodalumab

Therapeutic area: Dermatology
09/10/2014Human medicines European public assessment report (EPAR): Onbrez Breezhaler,

indacaterol

Revision: 8, Authorised
09/10/2014Regulatory and procedural guideline: List of active substances subject to worksharing for signal management (updated)
08/10/2014Human medicines European public assessment report (EPAR): Jevtana,

cabazitaxel

Revision: 9, Authorised
08/10/2014Human medicines European public assessment report (EPAR): Zalasta,

olanzapine

Revision: 12, Authorised
08/10/2014Human medicines European public assessment report (EPAR): Urorec,

silodosin

Revision: 10, Authorised
08/10/2014Human medicines European public assessment report (EPAR): HBVaxPro,

hepatitis-B vaccine (rDNA)

Revision: 19, Authorised
08/10/2014Human medicines European public assessment report (EPAR): Lojuxta,

lomitapide

Revision: 2, Authorised
08/10/2014Human medicines European public assessment report (EPAR): Deltyba,

delamanid

Revision: 2, Authorised
08/10/2014Human medicines European public assessment report (EPAR): Hirobriz Breezhaler,

indacaterol

Revision: 8, Authorised
08/10/2014Human medicines European public assessment report (EPAR): Ebixa,

memantine

Revision: 23, Authorised
08/10/2014Human medicines European public assessment report (EPAR): Elonva,

corifollitropin alfa

Revision: 6, Authorised
08/10/2014Report: European Medicines Agency mid-year report 2014 from the Executive Director
08/10/2014Rules for the implementation of the financial regulation applicable to the budget of the European Medicines Agency (updated)
08/10/2014Outcome of written procedures finalised during the period from 13 May 2014 to 1 September 2014
08/10/2014Report: Annual report on European Medicines Agency’s interaction with patients, consumers, healthcare professionals and their organisations (2013)
08/10/2014Report: EudraVigilance status report 2009 (veterinary) (updated)
08/10/2014Summary of transfer of appropriations in the budget 2014 - October 2014
08/10/2014Referral: 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)
08/10/2014Draft inventory of paediatric therapeutic needs: Paediatric oncology
08/10/2014Orphan designation:

Metreleptin

for the: Treatment of Berardinelli-Seip syndrome (updated)
08/10/2014Orphan designation:

Allopurinol sodium

for the: Treatment of perinatal asphyxia (updated)
08/10/2014Orphan designation:

Metreleptin

for the: Treatment of Lawrence syndrome (updated)
08/10/2014Orphan designation:

Metreleptin

for the: Treatment of familial partial lipodystrophy (updated)
08/10/2014Orphan designation:

Metreleptin

for the: Treatment of Barraquer-Simons syndrome (updated)
08/10/2014Orphan designation:

Liposomal combination of cytarabine and daunorubicin

for the: Treatment of acute myeloid leukaemia (updated)
08/10/2014Orphan designation:

Lipopolysaccharide of Ochrobactrum intermedium

for the: Prevention of sepsis in at-risk premature infants of less than or equal to 32 weeks (updated)
08/10/2014Orphan designation:

Amikacin sulfate

for the: Treatment of nontuberculous mycobacterial lung disease (updated)
08/10/2014Orphan designation:

Beloranib

for the: Treatment of Prader-Willi syndrome (updated)
08/10/2014Orphan designation:

Allogeneic human dendritic cells derived from a CD34+ progenitor cell line

for the: Treatment of acute myeloid leukaemia (updated)
08/10/2014Regulatory and procedural guideline: European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure: document with track changes (updated)
08/10/2014Regulatory and procedural guideline: European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure (updated)
08/10/2014Presubmission guidance: questions 11 to 20 (updated)
08/10/2014Presubmission guidance: questions 41 to 50 (updated)
08/10/2014Human medicines European public assessment report (EPAR): Xarelto,

rivaroxaban

Revision: 12, Authorised
08/10/2014Pandemrix-H-C-832-II-0069 : EPAR - Assessment Report - Variation, adopted
07/10/2014Orphan designation:

Donor lymphocyte preparation depleted of functional alloreactive T-cells

for the: Prevention of Graft-versus-Host Disease (updated)
07/10/2014Human medicines European public assessment report (EPAR): Mircera,

methoxy polyethylene glycol-epoetin beta

Revision: 16, Authorised
07/10/2014Orphan designation:

2-[[3-({4-[(5-{2-[(3-Fluorophenyl)amino]-2-oxoethyl}-1H-pyrazol-3-yl)amino]-quinazolin-7-yl}oxy)propyl](ethyl)amino]ethyl dihydrogen phosphate trihydrate

for the: Treatment of acute myeloid leukaemia (updated)
07/10/2014Orphan designation:

Trientine dihydrochloride

for the: Treatment of Wilson's disease (updated)
07/10/2014Orphan designation:

Skin equivalent graft genetically corrected with a COL7A1-encoding SIN retroviral vector

for the: Treatment of dystrophic epidermolysis bullosa (updated)
07/10/2014Human medicines European public assessment report (EPAR): Levetiracetam ratiopharm,

levetiracetam

Revision: 4, Authorised
07/10/2014Orphan designation:

Peptides mimicking antigen receptors on autoimmune B cells and autoimmune T cells associated with myasthenia gravis

for the: Treatment of myasthenia gravis (updated)
07/10/2014Human medicines European public assessment report (EPAR): Zutectra,

human hepatitis-B immunoglobulin

Revision: 8, Authorised
07/10/2014Orphan designation:

Olaparib

for the: Treatment of ovarian cancer (updated)
07/10/2014Human medicines European public assessment report (EPAR): DuoCover,

clopidogrel / acetylsalicylic acid

Revision: 9, Authorised
07/10/2014Newsletter: Human medicines highlights - September 2014
07/10/2014Minutes of the COMP meeting 8-10 July 2014
07/10/2014Agenda: Agenda - CVMP agenda of the 7-9 October 2014 meeting
07/10/2014Extended EudraVigilance Medicinal Product Dictionary e-learning course presentations (updated)
07/10/2014eXtended EudraVigilance medicinal product dictionary data-entry tool user manual (updated)
07/10/2014Veterinary medicine European public assessment report (EPAR): Aftovaxpur DOE,

one to three inactivated, purified foot-and-mouth-disease viruses out of a set of seven (multistrain)

Revision: 1, Authorised
07/10/2014Agenda: Agenda - Regulatory workshop on clinical trials designs in neuromyelitis optica (NMO) and spectrum disorders (updated)
07/10/2014Regulatory workshop on clinical trials designs in neuromyelitis optica (NMO) and spectrum disorders, European Medicines Agency, London, UK, From: 10-Oct-2014, To: 10-Oct-2014 (updated)
06/10/2014Agenda: Agenda - PRAC draft agenda of meeting 6-9 October 2014
06/10/2014Human medicines European public assessment report (EPAR): Evarrest,

human fibrinogen / human thrombin

Revision: 1, Authorised
06/10/2014Human medicines European public assessment report (EPAR): Levetiracetam Accord,

levetiracetam

Revision: 4, Authorised
06/10/2014Human medicines European public assessment report (EPAR): Fasturtec,

rasburicase

Revision: 17, Authorised
06/10/2014Herbal Medicinal Products: Eleutherococcus , Eleutherococci radix, Eleutherococcus senticosus (Rupr. et Maxim.) Maxim. (updated)
06/10/2014Human medicines European public assessment report (EPAR): Fareston,

toremifene

Revision: 16, Authorised
06/10/2014Human medicines European public assessment report (EPAR): Cetrotide,

cetrorelix

Revision: 18, Authorised
06/10/2014Human medicines European public assessment report (EPAR): Pixuvri,

pixantrone dimaleate

Revision: 9, Authorised
06/10/2014Human medicines European public assessment report (EPAR): Lamivudine Teva Pharma B.V.,

lamivudine

Revision: 3, Authorised
06/10/2014Human medicines European public assessment report (EPAR): Lamivudine Teva,

lamivudine

Revision: 4, Authorised
06/10/2014Human medicines European public assessment report (EPAR): Tybost,

cobicistat

Revision: 2, Authorised
06/10/2014Human medicines European public assessment report (EPAR): Kogenate Bayer,

octocog alfa

Revision: 26, Authorised
06/10/2014Human medicines European public assessment report (EPAR): Cervarix,

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

Revision: 16, Authorised
06/10/2014Human medicines European public assessment report (EPAR): Truvada,

emtricitabine / tenofovir disoproxil

Revision: 25, Authorised
06/10/2014Human medicines European public assessment report (EPAR): Eviplera,

emtricitabine / rilpivirine / tenofovir disoproxil

Revision: 9, Authorised
06/10/2014List of Union reference dates and frequency of submission of periodic safety update reports (PSURs) (updated)
06/10/2014Human medicines European public assessment report (EPAR): Leflunomide ratiopharm,

leflunomide

Revision: 7, Authorised
06/10/2014Human medicines European public assessment report (EPAR): Pregabalin Pfizer,

pregabalin

Revision: 1, Authorised
06/10/2014Human medicines European public assessment report (EPAR): Temozolomide Sandoz,

temozolomide

Revision: 10, Authorised
06/10/2014Human medicines European public assessment report (EPAR): Exjade,

deferasirox

Revision: 20, Authorised
06/10/2014Human medicines European public assessment report (EPAR): Pheburane,

sodium phenylbutyrate

Revision: 1, Authorised
06/10/2014News and press releases: Information on suspected side effects of nationally authorised medicines now available through a single website
06/10/2014Did you know? You can report side effects yourself
06/10/2014Human medicines European public assessment report (EPAR): Topotecan Hospira,

topotecan

Revision: 3, Authorised
06/10/2014Human medicines European public assessment report (EPAR): Tobi Podhaler,

tobramycin

Revision: 4, Authorised
06/10/2014News and press releases: EMA Management Board: highlights of October 2014 meeting
06/10/2014Human medicines European public assessment report (EPAR): Plegridy,

peginterferon beta-1a

Revision: 1, Authorised
06/10/2014Human medicines European public assessment report (EPAR): Lantus,

insulin glargine

Revision: 23, Authorised
06/10/2014Human medicines European public assessment report (EPAR): Pramipexole Teva,

pramipexole

Revision: 12, Authorised
06/10/2014Human medicines European public assessment report (EPAR): Thalidomide Celgene (previously Thalidomide Pharmion),

thalidomide

Revision: 16, Authorised
06/10/2014Human medicines European public assessment report (EPAR): Eperzan,

albiglutide

Revision: 1, Authorised
06/10/2014Human medicines European public assessment report (EPAR): Tepadina,

thiotepa

Revision: 4, Authorised
06/10/2014Human medicines European public assessment report (EPAR): Myocet,

doxorubicin

Revision: 18, Authorised
06/10/2014Human medicines European public assessment report (EPAR): Kolbam (previously Cholic Acid FGK),

Revision: 2, Authorised
06/10/2014Human medicines European public assessment report (EPAR): Neoclarityn,

desloratadine

Revision: 29, Authorised
06/10/2014Human medicines European public assessment report (EPAR): Lyrica,

pregabalin

Revision: 26, Authorised
06/10/2014Human medicines European public assessment report (EPAR): Neulasta,

pegfilgrastim

Revision: 26, Authorised
06/10/2014Human medicines European public assessment report (EPAR): Ketek,

telithromycin

Revision: 22, Authorised
06/10/2014Human medicines European public assessment report (EPAR): Zoledronic acid Teva Generics,

zoledronic acid

Revision: 1, Authorised
06/10/2014Human medicines European public assessment report (EPAR): Temomedac,

temozolomide

Revision: 8, Authorised
03/10/2014Human medicines European public assessment report (EPAR): Ovaleap,

follitropin alfa

Revision: 2, Authorised
03/10/2014Human medicines European public assessment report (EPAR): Osigraft,

eptotermin alfa

Revision: 12, Authorised
03/10/2014Minutes of the CAT meeting 17-18 July 2014
03/10/2014Human medicines European public assessment report (EPAR): Zoledronic acid Actavis,

zoledronic acid

Revision: 4, Authorised
03/10/2014Human medicines European public assessment report (EPAR): Optimark,

gadoversetamide

Revision: 8, Authorised
03/10/2014Template for information exchange for the preparation of the assessment report supporting the establishment of Community monographs and Community list entries (updated)
03/10/2014Annual report on a designated orphan-medicinal-product (updated)
03/10/2014Human medicines European public assessment report (EPAR): Synflorix,

pneumococcal polysaccharide conjugate vaccine (adsorbed)

Revision: 10, Authorised
03/10/2014Scientific guideline: Draft guideline on regulatory acceptance of 3R (replacement, reduction, refinement) testing approaches, draft: consultation open
03/10/2014Human medicines European public assessment report (EPAR): Sutent,

sunitinib

Revision: 24, Authorised
03/10/2014Human medicines European public assessment report (EPAR): Twynsta,

telmisartan / amlodipine

Revision: 4, Authorised
03/10/2014Human medicines European public assessment report (EPAR): Kinzalkomb,

telmisartan / hydrochlorothiazide

Revision: 27, Authorised
03/10/2014Human medicines European public assessment report (EPAR): Kinzalmono (previously Telmisartan Boehringer Ingelheim Pharma KG),

telmisartan

Revision: 23, Authorised
03/10/2014Human medicines European public assessment report (EPAR): Temodal,

temozolomide

Revision: 27, Authorised
03/10/2014Human medicines European public assessment report (EPAR): Tandemact,

pioglitazone / glimepiride

Revision: 11, Authorised
03/10/2014Veterinary medicine European public assessment report (EPAR): Eryseng Parvo,

porcine parvovirosis and swine erysipelas vaccine (inactivated)

Revision: 0, Authorised
03/10/2014Report: Questions and answers on the European Medicines Agency policy on publication of clinical data for medicinal products for human use (updated)
03/10/2014Human medicines European public assessment report (EPAR): Xolair,

omalizumab

Revision: 15, Authorised
03/10/2014Human medicines European public assessment report (EPAR): Tafinlar,

dabrafenib

Revision: 3, Authorised
03/10/2014Human medicines European public assessment report (EPAR): Xenical,

orlistat

Revision: 19, Authorised
03/10/2014Human medicines European public assessment report (EPAR): Xiapex,

collagenase Clostridium histolyticum

Revision: 10, Authorised
03/10/2014Human medicines European public assessment report (EPAR): Xalkori,

crizotinib

Revision: 7, Authorised
02/10/2014Comments received on "Policy 0070 on publication and access to clinical-trial data"
02/10/2014News and press releases: Publication of clinical reports
02/10/2014Publication and access to clinical data: an inclusive development process (updated)
02/10/2014Publication and access to clinical-trial data - Comments received from public consultation (July - September 2013)
02/10/2014Overview of comments received on 'Publication and access to clinical-trial data' (EMA/240810/2013) - from stakeholder 01 to 88
02/10/2014Overview of comments received on 'Publication and access to clinical-trial data' (EMA/240810/2013) - from stakeholder 109 to 126
02/10/2014Overview of comments received on 'Publication and access to clinical-trial data' (EMA/240810/2013) - from stakeholder 127 to 156
02/10/2014Scientific guideline: List of changes to combined Veterinary Dictionary for Drug Related Affairs list of clinical terms for reporting suspected adverse reactions in animal and humans to veterinary medicinal products for 2014, adopted (updated)
02/10/2014Overview of comments received on 'Publication and access to clinical-trial data' (EMA/240810/2013) - from stakeholder 157 to 169
02/10/2014European Medicines Agency policy on publication of clinical data for medicinal products for human use
02/10/2014Press release: Publication of clinical reports
02/10/2014Veterinary Dictionary for Drug Related Affairs (VeDDRA) V11 dataload friendly file including deprecated terms
02/10/2014Non-current Veterinary Dictionary for Drug Related Affairs (VeDDRA) low level terms (LLT) and codes (updated)
02/10/2014Scientific guideline: Combined Veterinary Dictionary for Drug Related Affairs list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products, adopted (updated)
02/10/2014Scientific guideline: Combined Veterinary Dictionary for Drug Related Affairs list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products, adopted (updated)
02/10/2014Report: Finalisation of the EMA policy on publication of and access to clinical trial data – Targeted consultation with key stakeholders - Summary report
02/10/2014Overview of comments received on 'Publication and access to clinical-trial data' (EMA/240810/2013) - from stakeholder 89 to 108
02/10/2014Release of data from clinical trials (updated)
02/10/2014Human medicines European public assessment report (EPAR): Eporatio,

epoetin theta

Revision: 5, Authorised
02/10/2014Human medicines European public assessment report (EPAR): Opsumit,

macitentan

Revision: 1, Authorised
02/10/2014Human medicines European public assessment report (EPAR): Karvezide,

irbesartan / hydrochlorothiazide

Revision: 31, Authorised
02/10/2014Orphan designation:

Lentiviral vector containing the human liver and erythroid pyruvate kinase (PKLR) gene

for the: Treatment of pyruvate kinase deficiency
02/10/2014Human medicines European public assessment report (EPAR): Opgenra,

eptotermin alfa

Revision: 9, Authorised
02/10/2014Human medicines European public assessment report (EPAR): Olanzapine Teva,

olanzapine

Revision: 13, Authorised
02/10/2014Orphan designation:

Variant of recombinant human fibroblast growth factor 19

for the: Treatment of primary biliary cirrhosis
02/10/2014Orphan designation:

4-{[(2R,3S,4R,5S)-4-(4-chloro-2-fluoro-phenyl)-3-(3-chloro-2-fluoro-phenyl)-4-cyano-5-(2,2-dimethyl-propyl)-pyrrolidine-2-carbonyl]-amino}-3-methoxy-benzoic acid

for the: Treatment of acute myeloid leukaemia
02/10/2014Orphan designation:

S3,S13-cyclo(D-tyrolsyl-L-isoleucyl-L-cysteinyl-L-valyl-1-methyl-L-tryptophyl-L-glutaminyl-L-aspartyl-L-tryptophyl-N-methyl-L-glycyl-L-alanyl-L-histidyl-L-arginyl-L-cysteinyl-N-methyl-L-isoleucinamide)

for the: Treatment of paroxysmal nocturnal haemoglobinuria
02/10/2014Human medicines European public assessment report (EPAR): Stayveer,

bosentan monohydrate

Revision: 1, Authorised
02/10/2014Human medicines European public assessment report (EPAR): Abilify,

aripiprazole

Revision: 29, Authorised
02/10/2014Human medicines European public assessment report (EPAR): Karvea,

irbesartan

Revision: 31, Authorised
02/10/2014Human medicines European public assessment report (EPAR): Irbesartan/Hydrochlorothiazide Teva,

irbesartan / hydrochlorothiazide

Revision: 7, Authorised
02/10/2014Human medicines European public assessment report (EPAR): Irbesartan Zentiva (previously Irbesartan Winthrop),

irbesartan

Revision: 15, Authorised
02/10/2014Human medicines European public assessment report (EPAR): Rasilez HCT,

aliskiren / hydrochlorothiazide

Revision: 6, Authorised
02/10/2014Human medicines European public assessment report (EPAR): Ecansya (previously Capecitabine Krka),

capecitabine

Revision: 4, Authorised
02/10/2014Veterinary medicine European public assessment report (EPAR): Eryseng,

swine erysipelas vaccine (inactivated)

Revision: 0, Authorised
02/10/2014Human medicines European public assessment report (EPAR): Nevirapine Teva,

nevirapine

Revision: 4, Authorised
02/10/2014Human medicines European public assessment report (EPAR): Olanzapine Apotex,

olanzapine

Revision: 4, Authorised
02/10/2014Human medicines European public assessment report (EPAR): Clopidogrel BGR (previously Zylagren),

clopidogrel

Revision: 6, Authorised
02/10/2014Human medicines European public assessment report (EPAR): DuoTrav,

travoprost / timolol

Revision: 12, Authorised
02/10/2014Orphan designation:

Vector based on an adeno-associated virus serotype 2 backbone, pseudo-serotyped with a type 8 capsid, which carries the coding sequence of the human TYMP gene under the control of the human thyroxine binding globulin promoter

for the: Treatment of mitochondrial neurogastrointestinal encephalomyopathy
02/10/2014Agenda: Agenda for the 85th meeting of the Management Board
02/10/2014Orphan designation:

Obinutuzumab

for the: Treatment of diffuse large B-cell lymphoma
02/10/2014Human medicines European public assessment report (EPAR): NovoMix,

insulin aspart

Revision: 23, Authorised
02/10/2014Human medicines European public assessment report (EPAR): Nimenrix,

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

Revision: 5, Authorised
02/10/2014Orphan designation:

Macromolecular conjugate of heparin sodium on a polymer backbone

for the: Prevention of ischaemia/reperfusion injury associated with solid organ transplantation
02/10/2014Human medicines European public assessment report (EPAR): Ibandronic acid Accord,

ibandronic acid

Revision: 2, Authorised
02/10/2014Human medicines European public assessment report (EPAR): Rasilez,

aliskiren

Revision: 12, Authorised
02/10/2014Human medicines European public assessment report (EPAR): DuoResp Spiromax,

budesonide / formoterol

Revision: 1, Authorised
02/10/2014Human medicines European public assessment report (EPAR): Simulect,

basiliximab

Revision: 17, Authorised
02/10/2014Orphan designation:

2-(2-methyl-5-nitro-1H-imidazol-1-yl)ethylsulfamide

for the: Treatment of small cell lung cancer
02/10/2014Orphan designation:

[5-Amino-1-(4-fluoro-phenyl)-1H-pyrazol-4-yl]-[3-(2,3-dihydroxy-propoxy)-phenyl]-methanone

for the: Treatment of pancreatic cancer
01/10/2014Orphan designation:

Humanised IgG1 monoclonal antibody against human KIR3DL2

for the: Treatment of cutaneous T-cell lymphoma
01/10/2014Orphan designation:

Adeno-associated viral vector serotype 8 containing the human UGT1A1 gene

for the: Treatment of Crigler-Najjar syndrome
01/10/2014Human medicines European public assessment report (EPAR): Exforge,

amlodipine / valsartan

Revision: 15, Authorised
01/10/2014Human medicines European public assessment report (EPAR): Dafiro,

amlodipine / valsartan

Revision: 16, Authorised
01/10/2014Human medicines European public assessment report (EPAR): Edarbi,

azilsartan medoxomil

Revision: 3, Authorised
01/10/2014Human medicines European public assessment report (EPAR): Dafiro HCT,

amlodipine besylate / valsartan / hydrochlorothiazide

Revision: 7, Authorised
01/10/2014Human medicines European public assessment report (EPAR): Exforge HCT,

amlodipine besylate / valsartan / hydrochlorothiazide

Revision: 7, Authorised
01/10/2014Orphan designation:

Recombinant human diamine oxidase

for the: Treatment of mastocytosis
01/10/2014Orphan designation:

Recombinant factor VIIa modified with three terminal repeats derived from the β chain of human chorionic gonadotropin

for the: Treatment of haemophilia B
01/10/2014Orphan designation:

Ulinastatin

for the: Treatment of acute pancreatitis
01/10/2014Orphan designation:

(Z)-3-(3-(3,5-bis(trifluoromethyl)phenyl)-1H-1,2,4-triazol-1-yl)-N'-(pyrazin-2-yl)acrylohydrazide

for the: Treatment of diffuse large B-cell lymphoma
01/10/2014Orphan designation:

Recombinant factor VIIa modified with three terminal repeats derived from the β chain of human chorionic gonadotropin

for the: Treatment of haemophilia A
01/10/2014Orphan designation:

Recombinant human apolipoprotein A-I in a complex with phospholipids

for the: Treatment of apolipoprotein A-I deficiency
01/10/2014Scientific guideline: Draft concept paper on the revision of the guideline on the development of new medicinal products for the treatment of ulcerative colitis, draft: consultation open
01/10/2014Scientific guideline: Draft concept paper on the revision of the guideline on the development of new medicinal products for the treatment of Crohn’s disease, draft: consultation open
01/10/2014Scientific guideline: Draft guideline on core summary of product characteristics for human plasma-derived and recombinant coagulation factor-IX products, draft: consultation open
01/10/2014Human medicines European public assessment report (EPAR): Viramune,

nevirapine

Revision: 33, Authorised
01/10/2014Guidebook for tenderers: Submitting a tender in response to a procurement procedure organised by European Medicines Agency (September 2014) (updated)
01/10/2014Human medicines European public assessment report (EPAR): Copalia HCT,

amlodipine / valsartan / hydrochlorothiazide

Revision: 7, Authorised
01/10/2014Human medicines European public assessment report (EPAR): Copalia,

amlodipine / valsartan

Revision: 16, Authorised
01/10/2014Human medicines European public assessment report (EPAR): Aprovel,

irbesartan

Revision: 32, Authorised
01/10/2014Human medicines European public assessment report (EPAR): CoAprovel,

irbesartan / hydrochlorothiazide

Revision: 30, Authorised
01/10/2014Orphan designation:

17α,21-dihydroxy-16α-methyl-pregna-1,4,9(11)-triene-3,20-dione

for the: Treatment of Duchenne muscular dystrophy
01/10/2014Human medicines European public assessment report (EPAR): Ilaris,

canakinumab

Revision: 9, Authorised
01/10/2014Human medicines European public assessment report (EPAR): Irbesartan Teva,

irbesartan

Revision: 6, Authorised