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December 2014

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Date Content
19/12/2014Clinical trials in human medicines
19/12/2014Human medicines European public assessment report (EPAR): Vfend,

voriconazole

Revision: 33, Authorised
19/12/2014Human medicines European public assessment report (EPAR): Trulicity,

dulaglutide

Revision: 0, Authorised
19/12/2014Human medicines European public assessment report (EPAR): Tadalafil Mylan,

tadalafil

Revision: 0, Authorised
19/12/2014Scientific guideline: Compilation of individual product-specific guidance on demonstration of bioequivalence
19/12/2014Human medicines European public assessment report (EPAR): Ipreziv,

azilsartan medoxomil

Revision: 4, Withdrawn
19/12/2014News and press releases: EMA Management Board: highlights of December 2014 meeting
19/12/2014Human medicines European public assessment report (EPAR): Nuwiq,

simoctocog alfa (rFVIII)

Revision: 0, Authorised
19/12/2014Questions and answers on level of detail in the regulatory submissions
19/12/2014Functional specifications for the EU portal and EU database to be audited
19/12/2014Answers to the requests for scientific advice on the impact on public health and animal health of the use of antibiotics in animals (updated)
19/12/2014News and press releases: Mitigating risks due to the use of antibiotics in animals
19/12/2014Regulatory and procedural guideline: Reflection paper on the use of heat treatment to inactivate retrovirus RD114 in live immunological veterinary medicinal products (IVMPs), draft: consultation open
19/12/2014Regulatory and procedural guideline: Reflection paper on the replacement of cell lines used for the production of immunological veterinary medicinal products (IVMPs), draft: consultation open
19/12/2014Regulatory 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)
19/12/2014News and press releases: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 15-18 December 2014
19/12/2014News and press releases: First stem-cell therapy recommended for approval in EU
19/12/2014News and press releases: Mysimba recommended for approval in weight management in adults
19/12/2014Overview of comments received on 'Answers to the request for scientific advice on the impact on public health and animal health of the use of antibiotics in animals' (updated)
19/12/2014Pending EC decision: Xiapex,

collagenase Clostridium histolyticum

Opinion date: 18-Dec-2014
19/12/2014Pending EC decision: Velcade,

bortezomib

Opinion date: 18-Dec-2014
19/12/2014Pending EC decision: Revlimid,

lenalidomide

Opinion date: 18-Dec-2014
19/12/2014Pending EC decision: Xydalba,

dalbavancin

Opinion date: 18-Dec-2014
19/12/2014Overview of invented names reviewed in Noveber 2014 by the Name Review Group (NRG), adopted
19/12/2014Use of antibiotics in animals: impact on public health and animal health (updated)
19/12/2014Pending EC decision: Tasermity,

sevelamer

Opinion date: 18-Dec-2014
19/12/2014Pending EC decision: Holoclar,

ex vivo autologous corneal epithelial cells including stem cells

Opinion date: 18-Dec-2014
19/12/2014Pending EC decision: Tresiba,

insulin degludec

Opinion date: 18-Dec-2014
19/12/2014Pending EC decision: Clopidogrel ratiopharm,

clopidogrel

Opinion date: 18-Dec-2014
19/12/2014Pending EC decision: Quinsair,

levofloxacin

Opinion date: 18-Dec-2014
19/12/2014European Medicines Agency Standard operating procedure (SOP): Standard operating procedure for steps involved in outsourcing of services (updated)
19/12/2014Pending EC decision: Xadago,

safinamide

Opinion date: 18-Dec-2014
19/12/2014Scientific advice and protocol assistance adopted during the CHMP meeting 15-18 December 2014, adopted
19/12/2014Guiding principles for international pharmacovigilance cluster teleconferences
18/12/2014Human medicines European public assessment report (EPAR): Galvus,

vildagliptin

Revision: 10, Authorised
18/12/2014Human medicines European public assessment report (EPAR): Bretaris Genuair,

aclidinium bromide

Revision: 8, Authorised
18/12/2014Human medicines European public assessment report (EPAR): Evoltra,

clofarabine

Revision: 20, Authorised
18/12/2014Human medicines European public assessment report (EPAR): Betmiga,

mirabegron

Revision: 4, Authorised
18/12/2014Type-IB variations: questions and answers (updated)
18/12/2014Type-IA variations: questions and answers (updated)
18/12/2014Submission of Article-46 paediatric studies: questions and answers (updated)
18/12/2014Withdrawn-product notification: questions and answers (updated)
18/12/2014Questions and answers relating to open tender 'Effectiveness and pharmacoepidemiology studies' – reference number EMA/2014/50/RE (updated)
18/12/2014European Medicines Agency practical guidance on the application form for centralised type IA and IB variations
18/12/2014Regulatory and procedural guideline: European Medicines Agency post-authorisation procedural advice for users of the centralised procedure: document with track changes (updated)
18/12/2014Regulatory and procedural guideline: European Medicines Agency post-authorisation procedural advice for users of the centralised procedure (updated)
18/12/2014Human medicines European public assessment report (EPAR): Telzir,

fosamprenavir

Revision: 33, Authorised
18/12/2014Human medicines European public assessment report (EPAR): Mycophenolate mofetil Teva,

mycophenolate mofetil

Revision: 12, Authorised
18/12/2014Human medicines European public assessment report (EPAR): Humira,

adalimumab

Revision: 37, Authorised
18/12/2014Human medicines European public assessment report (EPAR): Plegridy,

peginterferon beta-1a

Revision: 2, Authorised
18/12/2014Human medicines European public assessment report (EPAR): Lamivudine/Zidovudine Teva,

lamivudine / zidovudine

Revision: 5, Authorised
18/12/2014Human medicines European public assessment report (EPAR): Comtan,

entacapone

Revision: 20, Authorised
18/12/2014Human medicines European public assessment report (EPAR): Cinryze,

C1 inhibitor (human)

Revision: 8, Authorised
18/12/2014Examples of prevalence sources previously considered in orphan medicinal product designation procedures
18/12/2014Regulatory and procedural guideline: Dossier requirements for referral procedures including centrally authorised products (CAPs) and nationally authorised products (NAPs) (updated)
18/12/2014Relevant sources for orphan disease prevalence data (updated)
17/12/2014Heads of Medicines Agencies (updated)
17/12/2014Monthly report on application procedures, guidelines and related documents for veterinary medicines: November 2014
17/12/2014Regulatory and procedural guideline: Procedure for reporting of pharmacovigilance inspections requested by the CVMP, adopted (updated)
17/12/2014Regulatory and procedural guideline: List of centrally authorised products requiring a notification of a change for update of annexes (updated)
17/12/2014Quality control of medicinal-product data submitted as per the legal requirement introduced by Article 57(2) of Regulation (EC) No 726/2004 (updated)
17/12/2014eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) bulk update manager (updated)
17/12/2014Certification evaluation report
17/12/2014Scientific recommendation on classification of advance therapy medicinal products (ATMP)
17/12/2014Peer review of the certification procedure
17/12/2014Electronic submission of medicinal product information by marketing-authorisation holders
17/12/2014List of medicinal products under additional monitoring (updated)
17/12/2014List of medicinal products under additional monitoring (updated)
17/12/2014The European Union regulatory network incident management plan for medicines for human use (updated)
17/12/2014Human medicines European public assessment report (EPAR): Maci,

matrix-applied characterised autologous cultured chondrocytes

Revision: 2, Suspended
17/12/2014Referral: Article 20 procedures, Maci,

matrix-applied characterised autologous cultured chondrocytes

(updated)
17/12/2014Human medicines European public assessment report (EPAR): Moventig,

naloxegol

Revision: 0, Authorised
16/12/2014Minutes of the 85th meeting of the Management Board
16/12/2014Agenda: Draft agenda for the 86th meeting of the Management Board
16/12/2014Scientific guideline: Guideline on quality of transdermal patches, adopted
16/12/2014Overview of comments received on 'Draft guideline on quality of transdermal patches'
16/12/2014Human medicines European public assessment report (EPAR): Signifor,

pasireotide

Revision: 4, Authorised
16/12/2014Human medicines European public assessment report (EPAR): Valdoxan,

agomelatine

Revision: 13, Authorised
16/12/2014Scientific guideline: Guideline on the use of phthalates as excipients in human medicinal products, adopted (updated)
16/12/2014Human medicines European public assessment report (EPAR): Vizamyl,

flutemetamol (18F)

Revision: 1, Authorised
16/12/2014Mandate, objectives and rules of procedure for the CVMP Ad Hoc Group on Veterinary Novel Therapies
16/12/2014News and press releases: Focus on innovative medicines for animals
16/12/2014Report: Assessment report for Article-5(3) procedure: Medicinal products under development for treatment of Ebola
16/12/2014Ebola (updated)
16/12/2014News and press releases: Experimental Ebola treatments still at early stage of development
16/12/2014Article-5(3) opinions (updated)
15/12/2014Scientific guideline: Guideline on the use of minimal residue disease as an endpoint in chronic lymphocytic leukaemia studies, draft: consultation open
15/12/2014Human medicines European public assessment report (EPAR): Cimzia,

certolizumab pegol

Revision: 12, Authorised
15/12/2014Human medicines European public assessment report (EPAR): Renagel,

sevelamer

Revision: 23, Authorised
15/12/2014Veterinary medicine European public assessment report (EPAR): Previcox,

firocoxib

Revision: 21, Authorised
15/12/2014Human medicines European public assessment report (EPAR): Toviaz,

fesoterodine

Revision: 16, Authorised
15/12/2014Human medicines European public assessment report (EPAR): Imatinib Teva,

imatinib

Revision: 3, Authorised
15/12/2014Minutes of the PRAC meeting 3-6 November 2014
15/12/2014Minutes of the CVMP meeting of 4-6 November 2014
15/12/2014Human medicines European public assessment report (EPAR): Bosulif,

bosutinib

Revision: 3, Authorised
15/12/2014Minutes - PDCO minutes of the 12-14 November 2014 meeting
15/12/2014Human medicines European public assessment report (EPAR): Lamivudine Teva Pharma B.V.,

lamivudine

Revision: 4, Authorised
15/12/2014Call for scientific data for the systematic review of the monograph on <i>Centaurium erythraea</i> Rafn., herba., draft: consultation open
15/12/2014Call for scientific data for the systematic review of the monograph on <i>Fragaria vesca</i> L., folium, draft: consultation open
15/12/2014Call for scientific data for the systematic review of the monograph on <i>Salvia officinalis</i> L., folium, draft: consultation open
15/12/2014Herbal Medicinal Products: Centaurium, Centaurii herba, Centaurium erythraea Rafn (updated)
15/12/2014Call for scientific data for the systematic review of the monograph on <i>Althaea officinalis</i> L., radix., draft: consultation open
15/12/2014Herbal Medicinal Products: Salvia, Salviae officinalis folium, Salvia officinalis L. (updated)
15/12/2014Human medicines European public assessment report (EPAR): DuoPlavin,

clopidogrel / acetylsalicylic acid

Revision: 8, Authorised
15/12/2014News and press releases: Adaptive pathways: a future approach to bring new medicines to patients?
15/12/2014Adaptive pathways (updated)
15/12/2014Human medicines European public assessment report (EPAR): Elaprase,

idursulfase

Revision: 10, Authorised
15/12/2014Agenda: Agenda - CHMP agenda of the 15-18 December 2014 meeting
15/12/2014Herbal Medicinal Products: Althaea, Althaeae radix, Althaea officinalis L. (updated)
12/12/2014News and press releases: Diclofenac use in animals poses a risk to European vultures
12/12/2014Report: CVMP assessment report under Article 30(3) of Regulation (EC) No 726/2004 on the risk to vultures and other necrophagous bird populations in the European Union in connection with the use of veterinary medicinal products containing the substance diclofenac
12/12/2014News and press releases: Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 9-11 December 2014
12/12/2014Overview of comments received on public consultation regarding the request to the European Medicines Agency from the European Commission for a scientific opinion regarding the risks to vultures and other necrophagous bird populations in the Union in connection with the use of veterinary medicinal products containing the substance diclofenac
12/12/2014Pending EC decision: Suvaxyn CSF Marker,

live recombinant E2 gene deleted Bovine Viral Diarrhoea Virus containing Classical Swine Fever E2 (CP7_E2alf)

Opinion date: 11-Dec-2014
12/12/2014Pending EC decision: Zulvac SBV,

inactivated schmallenberg virus

Opinion date: 11-Dec-2014
12/12/2014Careers (updated)
12/12/2014Human medicines European public assessment report (EPAR): Rezolsta,

darunavir / cobicistat

Revision: 0, Authorised
12/12/2014Type-IA variations: questions and answers (updated)
12/12/2014Pre-notification check for type IA variations: ensuring the quality of veterinary type IA variation submissions
12/12/2014Human medicines European public assessment report (EPAR): Cyanokit,

hydroxocobalamin

Revision: 7, Authorised
12/12/2014Opinion/decision on a Paediatric Investigation Plan (PIP): Zostavax,

Varicella-zoster virus (live, attenuated)

Therapeutic area: Vaccines
12/12/2014Human medicines European public assessment report (EPAR): Pegasys,

peginterferon alfa-2a

Revision: 26, Authorised
12/12/2014Opinion/decision on a Paediatric Investigation Plan (PIP): -,

Pandemic live attenuated influenza virus (H5N1)

Therapeutic area: Vaccines
12/12/2014Opinion/decision on a Paediatric Investigation Plan (PIP): -,

Diclofenac sodium / thiocolchicoside

Therapeutic area: Pain
12/12/2014Newsletter: Human medicines highlights - November 2014
12/12/2014Opinion/decision on a Paediatric Investigation Plan (PIP): -,

Abaloparatide

Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
12/12/2014Opinion/decision on a Paediatric Investigation Plan (PIP): -,

Macrogol 3350

Therapeutic area: Gastroentology-Hepatology
12/12/2014HMPC monographs: Overview of recommendations for the uses of herbal medicinal products in the paediatric population (updated)
12/12/2014Opinion/decision on a Paediatric Investigation Plan (PIP): -,

naloxone (hydrochloride)

Therapeutic area: Pain/Gastroentology-Hepatology
12/12/2014Opinion/decision on a Paediatric Investigation Plan (PIP): -,

Purified adenylate cyclase recombinant protein carrying subfragments of the early protein E7 antigen from human papillomavirus strain 16 (recombinant CyaA-HPV16E7) / purified adenylate cyclase recombinant protein carrying subfragments of the early protein E7 antigen from human papillomavirus strain 18 (recombinant CyaA-HPV18E7)

Therapeutic area: Vaccines
12/12/2014Opinion/decision on a Paediatric Investigation Plan (PIP): -,

cannabidiol / delta-9-tetrahydrocannabinol

Therapeutic area: Neurology
12/12/2014Opinion/decision on a Paediatric Investigation Plan (PIP): -,

inotuzumab ozogamicin

Therapeutic area: Haematology-Hemostaseology
12/12/2014Opinion/decision on a Paediatric Investigation Plan (PIP): -,

Fluticasone propionate / formoterol fumarate

Therapeutic area: Pneumology-allergology (updated)
12/12/2014Public summary of the evaluation of a proposed paediatric investigation plan: Macrogol 3350 for treatment of constipation
12/12/2014Opinion/decision on a Paediatric Investigation Plan (PIP): Sycrest,

Asenapine (maleate)

Therapeutic area: Psychiatry (updated)
12/12/2014Opinion/decision on a Paediatric Investigation Plan (PIP): -,

Heterologous human adult liver-derived progenitor cells (HHALPC)

Therapeutic area: Gastroentology-Hepatology (updated)
12/12/2014Opinion/decision on a Paediatric Investigation Plan (PIP): -,

L-asparaginase encapsulated in erythrocytes

Therapeutic area: Oncology (updated)
12/12/2014Public summary of the evaluation of a proposed paediatric investigation plan: Inotuzumab ozogamicin for treatment of acute lymphoblastic leukaemia
12/12/2014Opinion/decision on a Paediatric Investigation Plan (PIP): Fycompa,

Perampanel

Therapeutic area: Neurology (updated)
12/12/2014Public summary of the evaluation of a proposed paediatric investigation plan: Diclofenac sodium/thiocolchicoside for treatment of musculoskeletal and connective tissue pain
12/12/2014Opinion/decision on a Paediatric Investigation Plan (PIP): -,

Recombinant fusion protein consisting of human coagulation factor IX attached to the Fc domain of human IgG1 (rFIXFc)

Therapeutic area: Haematology-Hemostaseology (updated)
12/12/2014Public summary of the evaluation of a proposed paediatric investigation plan: Pandemic live attenuated influenza virus (H5N1) for prevention of influenza infection
12/12/2014Public summary of the evaluation of a proposed paediatric investigation plan: Naloxone (hydrochloride) for treatment of opioid-induced constipation
12/12/2014Public summary of the evaluation of a proposed paediatric investigation plan: Purified adenylate cyclase recombinant protein carrying subfragments of the early protein E7 antigen from human papillomavirus strain 16 (recombinant CyaA-HPV16E7) / purified adenylate cyclase recombinant protein carrying subfragments of the early protein E7 antigen...
12/12/2014Opinion/decision on a Paediatric Investigation Plan (PIP): Forxiga,

Dapagliflozin

Therapeutic area: Endocrinology, -gynacology-fertility-metabolism (updated)
12/12/2014Public summary of the evaluation of a proposed paediatric investigation plan: Varicella-zoster virus (live, attenuated) for prevention of varicella-zoster-virus reactivation
12/12/2014Opinion/decision on a Paediatric Investigation Plan (PIP): Benlysta,

belimumab

Therapeutic area: Immunology-Rheumatology-Transplantation (updated)
12/12/2014Opinion/decision on a Paediatric Investigation Plan (PIP): Lojuxta,

Lomitapide

Therapeutic area: Other (updated)
12/12/2014Human medicines European public assessment report (EPAR): Norvir,

ritonavir

Revision: 48, Authorised
12/12/2014Human medicines European public assessment report (EPAR): Abraxane,

paclitaxel

Revision: 16, Authorised
12/12/2014HMPC meeting report on Community herbal monographs, guidelines and other activities - 24 November 2014
12/12/2014Human medicines European public assessment report (EPAR): Hycamtin,

topotecan

Revision: 23, Authorised
11/12/2014Newsletter: News bulletin for pharmacovigilance programme update - Issue 2
11/12/2014Current tenders for €60,000 or more (updated)
11/12/2014Human medicines European public assessment report (EPAR): Avonex,

interferon beta-1a

Revision: 22, Authorised
11/12/2014Overview of comments on 'Reflection paper on clinical aspects related to tissue engineered products'
11/12/2014Scientific guideline: Reflection paper on clinical aspects related to tissue engineered products, adopted
11/12/2014Report: Applications for new human medicines under evaluation by the CHMP: December 2014
11/12/2014Report: Medicinal products for human use: Monthly figures - November 2014
11/12/2014Regulatory and procedural guideline: Compilation of Community procedures on inspections and exchange of information, adopted (updated)
11/12/2014Human medicines European public assessment report (EPAR): Aranesp,

darbepoetin alfa

Revision: 33, Authorised
11/12/2014Human medicines European public assessment report (EPAR): Inovelon,

rufinamide

Revision: 12, Authorised
11/12/2014Public summary of the evaluation of a proposed paediatric investigation plan: Sotagliflozin for treatment of type-2 diabetes mellitus
11/12/2014Public summary of the evaluation of a proposed paediatric investigation plan: Molidustat for the treatment of anaemia due to chronic disorders
11/12/2014Public summary of the evaluation of a proposed paediatric investigation plan: Cholera vaccine, live attenuated, oral (strain CVD 103-HgR) for prevention of disease caused by V. cholerae serogroup O1
11/12/2014Public summary of the evaluation of a proposed paediatric investigation plan: (3S,11aR)-N-[(2,4-Difluorophenyl)methyl]-6-hydroxy-3-methyl-5,7-dioxo-2,3,5,7,11,11a-hexahydro[1,3]oxazolo[3,2-a]pyrido [1,2-d]pyrazine-8-carboxamide (GSK1265744) for treatment of human immunodeficiency virus (HIV-1) infection
11/12/2014Public summary of the evaluation of a proposed paediatric investigation plan: Belimumab for treatment of systemic lupus erythematosus
11/12/2014Regulatory and procedural guideline: Initial notices for parallel distribution – November 2014
10/12/2014Dossier requirements for pre-submission procedure: Advanced-therapy medicinal products (ATMP) certification - Submission of application dossiers to the European Medicines Agency and members of the Committee for Advanced Therapies (CAT)
10/12/2014Certification procedure for SMEs (updated)
10/12/2014Appendix V - Adverse-drug-reaction reporting details (updated)
10/12/2014Human medicines European public assessment report (EPAR): Pioglitazone Accord,

pioglitazone

Revision: 2, Authorised
10/12/2014Human medicines European public assessment report (EPAR): Pandemic Influenza Vaccine H5N1 Baxter AG,

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

Revision: 3, Authorised
10/12/2014Opinion/decision on a Paediatric Investigation Plan (PIP): Stivarga,

Regorafenib

Therapeutic area: Oncology (updated)
10/12/2014Human medicines European public assessment report (EPAR): Javlor,

vinflunine

Revision: 7, Authorised
10/12/2014Opinion/decision on a Paediatric Investigation Plan (PIP): -,

Turoctocog alfa pegol

Therapeutic area: Haematology-Hemostaseology (updated)
10/12/2014New vacancy: Contract Agent, long-term (FG IV), Legal Officer
10/12/2014New vacancy: Temporary Agent (AD6), Quality of Medicines Specialist
10/12/2014Human medicines European public assessment report (EPAR): Visudyne,

verteporfin

Revision: 26, Authorised
10/12/2014Human medicines European public assessment report (EPAR): Sonata,

zaleplon

Revision: 17, Authorised
10/12/2014Opinion/decision on a Paediatric Investigation Plan (PIP): -,

Lenvatinib

Therapeutic area: Oncology (updated)
10/12/2014Opinion/decision on a Paediatric Investigation Plan (PIP): Deltyba,

Delamanid

Therapeutic area: Infectious diseases (updated)
10/12/2014Referral: Article 35, Baytril injectable and generics,

enrofloxacin

10/12/2014Referral: Article 34, Baytril injectable,

enrofloxacin

10/12/2014Technical specifications - Annex I costing sheet: Procurement procedure EMA/2014/49/AUD
10/12/2014Technical specifications for open invitation to tender: Procurement procedure EMA/2014/49/AUD
10/12/2014Letter of invitation to tender - Procurement procedure EMA/2014/49/AUD
10/12/2014Technical specifications - Annex IV draft service contract: Procurement procedure EMA/2014/49/AUD
09/12/2014Opinion/decision on a Paediatric Investigation Plan (PIP): -,

Recombinant fusion protein linking human coagulation factor IX with human albumin

Therapeutic area: Haematology-Hemostaseology (updated)
09/12/2014Opinion/decision on a Paediatric Investigation Plan (PIP): -,

MAGE-A3 recombinant protein

Therapeutic area: Oncology (updated)
09/12/2014Opinion/decision on a Paediatric Investigation Plan (PIP): -,

Fibrinogen / thrombin / aprotinin / calcium chloride

Therapeutic area: Other (updated)
09/12/2014Opinion/decision on a Paediatric Investigation Plan (PIP): -,

Neisseria meningitidis serogroup B recombinant lipoprotein (rLP2086; subfamily A; Escherichia coli) / Neisseria meningitidis serogroup B recombinant lipoprotein (rLP2086; subfamily B; Escherichia coli) (rLP2086)

Therapeutic area: Vaccines (updated)
09/12/2014Agenda: Agenda - CVMP agenda of the 9-11 December 2014 meeting
09/12/2014Human medicines European public assessment report (EPAR): Fampyra,

fampridine

Revision: 5, Authorised
09/12/2014Opinion/decision on a Paediatric Investigation Plan (PIP): Lumigan and associated names,

Bimatoprost

Therapeutic area: Ophthalmology/Dermatology (updated)
09/12/2014Human medicines European public assessment report (EPAR): Xaluprine (previously Mercaptopurine Nova Laboratories),

mercaptopurine

Revision: 4, Authorised
09/12/2014Opinion/decision on a Paediatric Investigation Plan (PIP): HyQvia,

Human normal immunoglobulin

Therapeutic area: Immunology-Rheumatology-Transplantation (updated)
09/12/2014Agenda: Agenda - PDCO agenda of the 10-12 December 2014 meeting
09/12/2014The first conference for medicines regulatory authorities in Sudan and neighbouring countries, Khartoum, Sudan, From: 06-Dec-2014, To: 08-Dec-2014
09/12/2014Human medicines European public assessment report (EPAR): Ventavis,

iloprost

Revision: 22, Authorised
09/12/2014Human medicines European public assessment report (EPAR): Instanyl,

fentanyl

Revision: 11, Authorised
09/12/2014Human medicines European public assessment report (EPAR): Cayston,

aztreonam

Revision: 9, Authorised
09/12/2014Human medicines European public assessment report (EPAR): Onglyza,

saxagliptin

Revision: 10, Authorised
09/12/2014Human medicines European public assessment report (EPAR): Thymanax,

agomelatine

Revision: 11, Authorised
09/12/2014Human medicines European public assessment report (EPAR): Neupro,

rotigotine

Revision: 18, Authorised
08/12/2014Human medicines European public assessment report (EPAR): Incresync,

alogliptin / pioglitazone

Revision: 3, Authorised
08/12/2014Innovative Medicines Initiative WEB-RADR workshop, European Medicines Agency, London, UK, From: 10-Dec-2014, To: 10-Dec-2014
08/12/2014Referral: Article 31 referrals, Bromocriptine-containing medicines indicated in the prevention or suppression of physiological lactation post-partum,

bromocriptine

(updated)
08/12/2014Classification and analysis of the good clinical practice (GCP) inspection findings of GCP inspections conducted at the request of CHMP
08/12/2014Workshop summary - Benefit-risk communication to medicines users: How can regulators best meet the information needs of patients and healthcare professionals?
08/12/2014Report: Workshop report - Benefit-risk communication to medicines users: How can regulators best meet the information needs of patients and healthcare professionals?
08/12/2014Agenda: Agenda - European Medicines Agency Human Scientific Committees' Working Parties with Patients’ and Consumers’ Organisations (PCWP) and Healthcare Professionals’ Organisations (HCPWP) joint meeting Workshop on benefit-risk communication (updated)
08/12/2014European Medicines Agency Human Scientific Committees' Working Parties with Patients’ and Consumers’ Organisations (PCWP) and Healthcare Professionals’ Organisations (HCPWP) joint meeting - Workshop on benefit-risk communication, European Medicines Agency, London, UK, From: 17-Sep-2014, To: 17-Sep-2014 (updated)
08/12/2014Human medicines European public assessment report (EPAR): Fortacin,

lidocaine / prilocaine

Revision: 1, Authorised
08/12/2014Advisory functions, Corporate Governance and Programme Management Office (updated)
08/12/2014Procedure Management and Business Support (updated)
08/12/2014Human medicines European public assessment report (EPAR): Dukoral,

cholera vaccine (inactivated, oral)

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

pneumococcal polysaccharide conjugate vaccine (adsorbed)

Revision: 11, Authorised
08/12/2014Human medicines European public assessment report (EPAR): Orgalutran,

ganirelix

Revision: 14, Authorised
08/12/2014Human medicines European public assessment report (EPAR): Altargo,

retapamulin

Revision: 13, Authorised
08/12/2014Public declaration of interests and confidentiality undertaking of European Medicines Agency scientific committee members and experts - prefilled sample form (version 2)
05/12/2014News and press releases: GVK Biosciences review: some Member States suspend marketing authorisations for concerned medicines
05/12/2014Human medicines European public assessment report (EPAR): Arzerra,

ofatumumab

Revision: 8, Authorised
05/12/2014Referral: Article 31 referrals, Ambroxol and bromhexine-containing medicines,

ambroxol and bromhexine

(updated)
05/12/2014Human medicines European public assessment report (EPAR): Aclasta,

zoledronic acid

Revision: 17, Authorised
05/12/2014Human medicines European public assessment report (EPAR): Adasuve,

loxapine

Revision: 5, Authorised
05/12/2014Opinion/decision on a Paediatric Investigation Plan (PIP): Tygacil,

Tigecycline

Therapeutic area: Other (updated)
05/12/2014Opinion/decision on a Paediatric Investigation Plan (PIP): Voncento,

Human coagulation factor VIII / von Willebrand factor

Therapeutic area: Haematology-Hemostaseology (updated)
05/12/2014Opinion/decision on a Paediatric Investigation Plan (PIP): Vimpat,

Lacosamide

Therapeutic area: Neurology (updated)
05/12/2014Opinion/decision on a Paediatric Investigation Plan (PIP): Relvar Ellipta and associated names,

Fluticasone furoate / vilanterol

Therapeutic area: Pneumology-allergology (updated)
05/12/2014Opinion/decision on a Paediatric Investigation Plan (PIP): Brilique,

Ticagrelor

Therapeutic area: Cardiovascular diseases (updated)
05/12/2014Human medicines European public assessment report (EPAR): Epivir,

lamivudine

Revision: 30, Authorised
05/12/2014Human medicines European public assessment report (EPAR): Caprelsa,

vandetanib

Revision: 3, Authorised
05/12/2014Human medicines European public assessment report (EPAR): Trajenta,

linagliptin

Revision: 4, Authorised
05/12/2014Opinion/decision on a Paediatric Investigation Plan (PIP): Inovelon,

Rufinamide

Therapeutic area: Neurology (updated)
05/12/2014Nomination form for European experts (updated)
05/12/2014Opinion/decision on a Paediatric Investigation Plan (PIP): -,

Midostaurin

Therapeutic area: Oncology (updated)
05/12/2014Human medicines European public assessment report (EPAR): Duaklir Genuair,

aclidinium bromide / formoterol fumarate dihydrate

Revision: 0, Authorised
05/12/2014Opinion/decision on a Paediatric Investigation Plan (PIP): -,

Tabalumab

Therapeutic area: Immunology-Rheumatology-Transplantation (updated)
05/12/2014Human medicines European public assessment report (EPAR): Vylaer Spiromax,

budesonide / formoterol

Revision: 0, Authorised
05/12/2014Regulatory and procedural guideline: Recommendations for the implementation of the exemptions to the labelling and package-leaflet obligations in the centralised procedure (updated)
05/12/2014List of details of national competent authority to contact for requests of translation exemption falling under Article 63(3) of Directive 2001/83/EC and cases of shortages (updated)
05/12/2014News and press releases: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 1-4 December 2014
05/12/2014Human medicines European public assessment report (EPAR): Brimica Genuair,

aclidinium / formoterol fumarate dihydrate

Revision: 0, Authorised
05/12/2014Referral: Article 31 referrals, Testosterone-containing medicines,

testosterone

(updated)
05/12/2014Human medicines European public assessment report (EPAR): Infanrix Hexa,

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

Revision: 21, Authorised
05/12/2014Human medicines European public assessment report (EPAR): Puregon,

follitropin beta

Revision: 22, Authorised
05/12/2014Human medicines European public assessment report (EPAR): Byetta,

exenatide

Revision: 15, Authorised
05/12/2014Questions and answers relating to open procurement procedure EMA/2014/48/PH - Monitoring of scientific and medical literature and the entry of relevant information into EudraVigilance (updated)
05/12/2014Request to consult information on the areas of expertise of European experts
05/12/2014Guidance for submission and validation of electronic declaration of interests and electronic curriculum vitae
05/12/2014Human medicines European public assessment report (EPAR): Budesonide/Formoterol Teva Pharma B.V.,

budesonide / formoterol fumarate dihydrate

Revision: 0, Authorised
05/12/2014Confidentiality undertaking for observers (updated)
04/12/2014Opinion/decision on a Paediatric Investigation Plan (PIP): -,

Human fibrinogen / human thrombin

Therapeutic area: Other
04/12/2014Opinion/decision on a Paediatric Investigation Plan (PIP): -,

Molidustat (sodium)

Therapeutic area: Haematology-Hemostaseology
04/12/2014Opinion/decision on a Paediatric Investigation Plan (PIP): -,

(3S,11aR)-N-[(2,4-Difluorophenyl)methyl]-6-hydroxy-3-methyl-5,7-dioxo-2,3,5,7,11,11a-hexahydro[1,3]oxazolo[3,2-a]pyrido [1,2-d]pyrazine-8-carboxamide (GSK1265744)

Therapeutic area: Infectious diseases
04/12/2014Opinion/decision on a Paediatric Investigation Plan (PIP): -,

Sotagliflozin

Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
04/12/2014Opinion/decision on a Paediatric Investigation Plan (PIP): -,

Cholera vaccine, live attenuated, oral (strain CVD 103-HgR)

Therapeutic area: Vaccines
04/12/2014Opinion/decision on a Paediatric Investigation Plan (PIP): -,

4-((2R,3S,4R,5S)-3-(3-Chloro-2-fluorophenyl)-4-(4-chloro-2-fluorophenyl)-4-cyano-5-neopentylpyrrolidine-2-carboxamido)-3-methoxybenzoic acid (RO5503781)

Therapeutic area:
04/12/2014Human medicines European public assessment report (EPAR): Budesonide/Formoterol Teva,

budesonide / formoterol

Revision: 0, Authorised
04/12/2014Opinion/decision on a Paediatric Investigation Plan (PIP): -,

Ibrutinib

Therapeutic area: Oncology
04/12/2014Opinion/decision on a Paediatric Investigation Plan (PIP): -,

Landiolol (hydrochloride)

Therapeutic area: Cardiovascular diseases
04/12/2014Opinion/decision on a Paediatric Investigation Plan (PIP): Benlysta,

Belimumab

Therapeutic area: Immunology-Rheumatology-Transplantation
04/12/2014Human medicines European public assessment report (EPAR): Zaltrap,

aflibercept

Revision: 2, Authorised
04/12/2014Human medicines European public assessment report (EPAR): Harvoni,

sofosbuvir / ledipasvir

Revision: 0, Authorised
03/12/2014News and press releases: No evidence that Fluad vaccine caused deaths in Italy
03/12/2014Human medicines European public assessment report (EPAR): Evicel,

human fibrinogen / human thrombin

Revision: 10, Authorised
03/12/2014Human medicines European public assessment report (EPAR): Fluenz,

influenza vaccine (intranasal, live attenuated)

Revision: 4, Withdrawn
03/12/2014Human medicines European public assessment report (EPAR): Temozolomide Hexal,

temozolomide

Revision: 11, Authorised
03/12/2014Human medicines European public assessment report (EPAR): Voncento,

human coagulation factor VIII / von Willebrand factor

Revision: 2, Authorised
03/12/2014Human medicines European public assessment report (EPAR): Sebivo,

telbivudine

Revision: 16, Authorised
03/12/2014Human medicines European public assessment report (EPAR): Riluzole Zentiva,

riluzole

Revision: 4, Authorised
03/12/2014Human medicines European public assessment report (EPAR): Kadcyla,

trastuzumab emtansine

Revision: 1, Authorised
03/12/2014Human medicines European public assessment report (EPAR): Vimizim,

elosulfase alfa

Revision: 2, Authorised
03/12/2014Human medicines European public assessment report (EPAR): Lojuxta,

lomitapide

Revision: 3, Authorised
03/12/2014Minutes of the HMPC 29-30 September 2014 meeting
02/12/2014Agenda: Agenda - Expert meeting on the clinical investigation of medicines for the treatment of paediatric hepatitis C
02/12/2014Expert meeting on the clinical investigation of medicines for the treatment of paediatric hepatitis C, European Medicines Agency, London, UK, From: 09-Dec-2014, To: 09-Dec-2014
02/12/2014Minutes of the CAT meeting 18-19 September 2014
02/12/2014Minutes of the CAT meeting 16-17 October 2014
02/12/2014Referral: Article 31 referrals, GVK Biosciences (updated)
02/12/2014Human medicines European public assessment report (EPAR): Myclausen,

mycophenolate mofetil

Revision: 5, Authorised
02/12/2014Human medicines European public assessment report (EPAR): ellaOne,

ulipristal acetate

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

saxagliptin / metformin hydrochloride

Revision: 6, Authorised
02/12/2014Human medicines European public assessment report (EPAR): Zoledronic acid Teva,

zoledronic acid

Revision: 3, Authorised
02/12/2014Human medicines European public assessment report (EPAR): Tybost,

cobicistat

Revision: 3, Authorised
02/12/2014Overview of comments received on draft guideline on similar biological medicinal products
01/12/2014Scientific guideline: Draft questions and answers on cyclodextrins in the context of the revision of the guideline on ‘Excipients in the label and package leaflet of medicinal products for human use', draft: consultation open
01/12/2014Report: Background review for the excipient propylene glycol: In the context of the revision of the guideline on ‘Excipients in the label and package leaflet of medicinal products for human use’ - Draft report
01/12/2014Report: Background review for cyclodextrins used as excipients: In the context of the revision of the guideline on ‘Excipients in the label and package leaflet of medicinal products for human use’ - Draft report
01/12/2014Scientific guideline: Draft questions and answers on propylene glycol and esters in the context of the revision of the guideline on ‘Excipients in the label and package leaflet of medicinal products for human use’, draft: consultation open
01/12/2014Agenda: Agenda - PRAC draft agenda of meeting 1-4 December 2014
01/12/2014Introductory cover note to the list of European Union reference dates and frequency of submission of periodic safety update reports (updated)
01/12/2014List of Union reference dates and frequency of submission of periodic safety update reports (PSURs) (updated)
01/12/2014Agenda: Agenda - COMP agenda of the 9-11 December 2014 meeting
01/12/2014Human medicines European public assessment report (EPAR): Krystexxa,

pegloticase

Revision: 1, Authorised
01/12/2014Organisation chart: Information Technology (updated)
01/12/2014Declaration of interests: Pedro Pina Ferreira
01/12/2014Information Technology (updated)
01/12/2014Veterinary medicine European public assessment report (EPAR): Zulvac 8 Ovis,

inactivated bluetongue virus, serotype 8

Revision: 7, Authorised
01/12/2014Veterinary medicine European public assessment report (EPAR): Zulvac 8 Bovis,

inactivated bluetongue virus, serotype 8

Revision: 6, Authorised
01/12/2014Human medicines European public assessment report (EPAR): Vibativ,

telavancin

Revision: 5, Authorised
01/12/2014Orphan designation:

1-[(3R)-3-[4-amino-3-(4-phenoxyphenyl)-1H-pyrazolo[3,4 d]pyrimidin-1-yl]-1-piperidinyl]-2-propen-1-one

for the: Treatment of mantle-cell lymphoma (updated)
01/12/2014Orphan designation:

1-[(3R)-3-[4-amino-3-(4-phenoxyphenyl)-1H-pyrazolo[3,4 d]pyrimidin-1-yl]-1-piperidinyl]-2-propen-1-one

for the: Treatment of chronic lymphocytic leukaemia (updated)
01/12/2014European Medicines Agency 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 (updated)
01/12/2014Human medicines European public assessment report (EPAR): Ketek,

telithromycin

Revision: 23, Authorised
01/12/2014Prezista-H-C-707-II-63 : EPAR - Assessment Report - Variation , adopted