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September 2016

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27/09/2016Human medicines European public assessment report (EPAR): Tivicay,

dolutegravir

Revision: 8, Authorised
27/09/2016Human medicines European public assessment report (EPAR): Keytruda,

pembrolizumab

Revision: 4, Authorised
27/09/2016Human medicines European public assessment report (EPAR): Nimenrix,

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

Revision: 14, Authorised
26/09/2016Human medicines European public assessment report (EPAR): Xgeva,

denosumab

Revision: 8, Authorised
26/09/2016Agenda: Agenda - PRAC draft agenda of meeting 26-29 September 2016
26/09/2016Human medicines European public assessment report (EPAR): Bridion,

sugammadex

Revision: 12, Authorised
26/09/2016New product information wording: extracts from PRAC recommendations on signals adopted at the 30 August-2 September 2016 PRAC
26/09/2016List of signals discussed at the PRAC since September 2012 (updated)
26/09/2016PRAC recommendations on signals adopted at the PRAC meeting of 30 August-2 September 2016, adopted
26/09/2016Human medicines European public assessment report (EPAR): Prolia,

denosumab

Revision: 11, Authorised
26/09/2016Terms of reference for the European Medicines Agency (EMA) / Food and Drug Administration (FDA) cluster on rare diseases
26/09/2016News and press releases: EU-US collaboration to boost medicine development for rare diseases
26/09/2016Cluster activities (updated)
26/09/2016Human medicines European public assessment report (EPAR): Levetiracetam Actavis,

levetiracetam

Revision: 10, Authorised
26/09/2016Human medicines European public assessment report (EPAR): Caspofungin Accord,

caspofungin

Revision: 2, Authorised
26/09/2016Veterinary medicine European public assessment report (EPAR): Versican Plus Pi,

canine parainfluenza virus vaccine (live attenuated)

Revision: 1, Authorised
26/09/2016Human medicines European public assessment report (EPAR): Eurartesim,

piperaquine tetraphosphate / dihydroartemisinin

Revision: 6, Authorised
26/09/2016Veterinary medicine European public assessment report (EPAR): Versican Plus DHPPi,

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

Revision: 2, Authorised
26/09/2016Veterinary medicine European public assessment report (EPAR): Versican Plus Pi/L4,

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

Revision: 1, Authorised
26/09/2016Veterinary medicine European public assessment report (EPAR): Versican Plus L4,

Canine leptospirosis vaccine (inactivated)

Revision: 1, Authorised
26/09/2016Veterinary medicine European public assessment report (EPAR): Versican Plus DHPPi/L4,

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

Revision: 2, Authorised
26/09/2016EudraVigilance Information Day, European Medicines Agency, London, UK, From: 08-Nov-2016, To: 08-Nov-2016
23/09/2016Minutes of the 92nd meeting of the Management Board (updated)
23/09/2016Human medicines European public assessment report (EPAR): Zyprexa Velotab,

olanzapine

Revision: 26, Authorised
23/09/2016Organisational matters - CHMP meeting of 12-15 September 2016, adopted
23/09/2016Opinions on safety variations September 2016 adopted at the CHMP meeting of 12-15 September 2016, adopted
23/09/2016Opinions on annual re-assessments, renewals of marketing authorisations and accelerated assessment procedures Adopted at the CHMP meeting of 12-15 September 2016, adopted
23/09/2016Guidelines and concept papers adopted during the CHMP meeting 12-15 September 2016, adopted
23/09/2016Opinion/decision on a Paediatric investigation plan (PIP): -,

Caplacizumab

Therapeutic area: Haematology-Hemostaseology (updated)
23/09/2016Human medicines European public assessment report (EPAR): Xenical,

orlistat

Revision: 21, Authorised
23/09/2016Human medicines European public assessment report (EPAR): Lixiana,

edoxaban

Revision: 5, Authorised
23/09/2016Jardiance-H-C-PSUSA-00010388-201510 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisations
23/09/2016Human medicines European public assessment report (EPAR): Ameluz,

5-aminolevulinic acid hydrochloride

Revision: 7, Authorised
23/09/2016Human medicines European public assessment report (EPAR): Lamivudine Teva,

lamivudine

Revision: 7, Authorised
23/09/2016Opinion/decision on a Paediatric investigation plan (PIP): Dacogen,

decitabine

Therapeutic area: Oncology (updated)
23/09/2016Human medicines European public assessment report (EPAR): Plenadren,

hydrocortisone

Revision: 6, Authorised
23/09/2016Opinion/decision on a Paediatric investigation plan (PIP): -,

(3-((4-Benzoyl-1-piperazinyl)(oxo)acetyl)-4-methoxy-7-(3-methyl-1H-1,2,4-triazol-1-yl)-1H-pyrrolo[2,3-c]pyridin-1-yl)methyl dihydrogen phosphate, 2-amino-2-(hydroxymethyl)-1,3-propanediol (1:1) (BMS-663068)

Therapeutic area: Infectious diseases (updated)
23/09/2016Human medicines European public assessment report (EPAR): Blincyto,

blinatumomab

Revision: 2, Authorised
23/09/2016Human medicines European public assessment report (EPAR): Constella,

linaclotide

Revision: 12, Authorised
23/09/2016Minutes of the CHMP meeting 18-21 July 2016
23/09/2016Human medicines European public assessment report (EPAR): Abilify,

aripiprazole

Revision: 37, Authorised
23/09/2016The EU clinical trial portal and database
23/09/2016Opinion/decision on a Paediatric investigation plan (PIP): Benlysta,

belimumab

Therapeutic area: Immunology-Rheumatology-Transplantation (updated)
23/09/2016Human medicines European public assessment report (EPAR): Raloxifene Teva,

raloxifene

Revision: 7, Authorised
23/09/2016Human medicines European public assessment report (EPAR): Caprelsa,

vandetanib

Revision: 7, Authorised
23/09/2016Human medicines European public assessment report (EPAR): Sovaldi,

sofosbuvir

Revision: 9, Authorised
23/09/2016Opinion/decision on a Paediatric investigation plan (PIP): -,

Recombinant dimer of 6 kD early secretory antigenic target / recombinant 10 kD culture filtrate protein

Therapeutic area: Diagnostic (updated)
23/09/2016Human medicines European public assessment report (EPAR): Vizamyl,

flutemetamol (18F)

Revision: 5, Authorised
23/09/2016Opinion/decision on a Paediatric investigation plan (PIP): -,

1-(2,2-difluoro-1,3-benzodioxol-5-yl)-N-{1-[(2R)-2,3-dihydroxypropyl]-6-fluoro-2-(1-hydroxy-2-methylpropan-2-yl)-1H-indol-5-yl}cyclopropanecarboxamide (VX-661) / ivacaftor

Therapeutic area: Pneumology-allergology (updated)
23/09/2016Human medicines European public assessment report (EPAR): Tandemact,

pioglitazone / glimepiride

Revision: 14, Authorised
23/09/2016Veterinary medicine European public assessment report (EPAR): Pirsue,

pirlimycin

Revision: 12, Authorised
23/09/2016Human medicines European public assessment report (EPAR): Zoledronic acid Actavis,

zoledronic acid

Revision: 9, Authorised
22/09/2016Opinion/decision on a Paediatric investigation plan (PIP): -,

Quizartinib

Therapeutic area: Oncology
22/09/2016Opinion/decision on a Paediatric investigation plan (PIP): -,

Eculizumab

Therapeutic area: Immunology-Rheumatology-Transplantation
22/09/2016Veterinary medicine European public assessment report (EPAR): Rheumocam,

meloxicam

Revision: 10, Authorised
22/09/2016Opinion/decision on a Paediatric investigation plan (PIP): -,

Recombinant human beta-glucuronidase (rhGUS, UX003)

Therapeutic area: Endocrinology, -gynacology-fertility-metabolism (updated)
22/09/2016Opinion/decision on a Paediatric investigation plan (PIP): -,

Andexanet alfa

Therapeutic area: Other
22/09/2016Opinion/decision on a Paediatric investigation plan (PIP): -,

Emicizumab

Therapeutic area: Haematology-Hemostaseology
22/09/2016Opinion/decision on a Paediatric investigation plan (PIP): Stivarga,

Regorafenib

Therapeutic area: Oncology (updated)
22/09/2016Opinion/decision on a Paediatric investigation plan (PIP): Valdoxan, Thymanax,

Agomelatine

Therapeutic area: Psychiatry (updated)
22/09/2016Opinion/decision on a Paediatric investigation plan (PIP): Revolade,

Eltrombopag (olamine)

Therapeutic area: Gastroentology-Hepatology
22/09/2016Opinion/decision on a Paediatric investigation plan (PIP): -,

brivaracetam

Therapeutic area: Neurology (updated)
22/09/2016Opinion/decision on a Paediatric investigation plan (PIP): Humira,

Adalimumab

Therapeutic area: Dermatology/Immunology-Rheumatology-Transplantation/Ophthalmology/Gastroentology-Hepatology (updated)
22/09/2016Opinion/decision on a Paediatric investigation plan (PIP): -,

Solithromycin

Therapeutic area: Infectious diseases (updated)
22/09/2016Opinion/decision on a Paediatric investigation plan (PIP): Elonva,

Corifollitropin alfa

Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
22/09/2016List of European Union reference dates and frequency of submission of periodic safety update reports (updated)
22/09/2016Opinion/decision on a Paediatric investigation plan (PIP): -,

Levamisole (hydrochloride)

Therapeutic area: Uro-nephrology (updated)
22/09/2016Opinion/decision on a Paediatric investigation plan (PIP): -,

baricitinib

Therapeutic area: Immunology-Rheumatology-Transplantation (updated)
22/09/2016Opinion/decision on a Paediatric investigation plan (PIP): -,

Indacaterol (acetate) / Glycopyrronium (bromide) / Mometasone (furoate) (QVM149)

Therapeutic area: Pneumology-allergology
22/09/2016Opinion/decision on a Paediatric investigation plan (PIP): Soliris,

Eculizumab

Therapeutic area: Immunology-Rheumatology-Transplantation (updated)
21/09/2016Human medicines European public assessment report (EPAR): Efavirenz Teva,

efavirenz

Revision: 7, Authorised
21/09/2016Plasma-master-file certifications (updated)
21/09/2016News and press releases: Healthcare professionals’ working party elects co-chair
21/09/2016Report: Annual report of the Good Manufacturing and Distribution Practice Inspectors Working Group 2015 (updated)
21/09/2016Human medicines European public assessment report (EPAR): Inflectra,

infliximab

Revision: 12, Authorised
21/09/2016Recommendations on eligibility to PRIME scheme - Adopted at the CHMP meeting of 12-15 September 2016, adopted
21/09/2016PRIME: priority medicines (updated)
21/09/2016Report: Biologics Working Party report on viral safety of plasma-derived and urine-derived medicinal products with respect to Zika virus
21/09/2016News and press releases: Zika virus infection: plasma- and urine-derived medicines safe to use
21/09/2016Human medicines European public assessment report (EPAR): Cervarix,

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

Revision: 26, Authorised
21/09/2016Human medicines European public assessment report (EPAR): Granupas (previously Para-aminosalicylic acid Lucane),

para-aminosalicylic acid

Revision: 3, Authorised
21/09/2016News and press releases: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 September 2016 (corrected)
21/09/2016Opinion of the Committee for Medicinal Products for Veterinary Use on the establishment of maximum residue limits: Hydrocortisone aceponate, adopted
21/09/2016Training on electronic reporting of individual case safety reports (ICSRs) to EudraVigilance in the European Economic Area, Eurosites, Paris, France, From: 05-Oct-2016, To: 07-Oct-2016
20/09/2016MRL report: Hydrocortisone aceponate: European public maximum-residue-limit assessment report (EPMAR) - CVMP
20/09/2016Ninth industry stakeholder platform - operation of EU pharmacovigilance, European Medicines Agency, UK, From: 21-Sep-2016, To: 21-Sep-2016
20/09/2016Human medicines European public assessment report (EPAR): Mysimba,

naltrexone / bupropion

Revision: 3, Authorised
20/09/2016Task force for the implementation of International Standards on Identification of medicinal products in the EU (i.e. EU ISO IDMP task force) (updated)
20/09/2016Questions and answers relating to service concession: meeting and training organisation (EMA/2016/43/RS) (updated)
20/09/2016Current tenders for €135,000 or more (updated)
19/09/2016Mandate, objectives and rules of procedure of the Scientific Advice Working Party (SAWP) (updated)
19/09/2016Taxotere (docetaxel) supply shortage (updated)
19/09/2016Opinion/decision on a Paediatric investigation plan (PIP): -,

Metreleptin

Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
19/09/2016Opinion/decision on a Paediatric investigation plan (PIP): -,

Cadazolid

Therapeutic area: Infectious diseases
19/09/2016Opinion/decision on a Paediatric investigation plan (PIP): -,

Eleclazine

Therapeutic area: Cardiovascular diseases
19/09/2016Opinion/decision on a Paediatric investigation plan (PIP): -,

Eleclazine

Therapeutic area: Cardiovascular diseases
19/09/2016Notices of calls for tender - 2015 (updated)
19/09/2016CVMP: Agendas, minutes and reports (updated)
19/09/2016Agenda: Agenda - Patient registries workshop (updated)
19/09/2016Ex ante publicity of a negotiated procedure – EMA/2016/51/COM – Evidence-based database
19/09/2016Calls for tender €15,000 - €135,000 (updated)
19/09/2016Agenda: Agenda - HMPC agenda of the 19-20 September 2016 meeting
19/09/2016COMP meeting report on the review of applications for orphan designation: September 2016
19/09/2016Human medicines European public assessment report (EPAR): Benlysta,

belimumab

Revision: 14, Authorised
19/09/2016Regulatory and procedural guideline: List of centrally authorised products requiring a notification of a change for update of annexes (updated)
16/09/2016Referral: Article 31 referrals, Symbioflor 2,

Escherichia coli bacteria (cells and autolysate)

(updated)
16/09/2016Human medicines European public assessment report (EPAR): Pixuvri,

pixantrone dimaleate

Revision: 13, Authorised
16/09/2016Human medicines European public assessment report (EPAR): Yellox,

bromfenac

Revision: 6, Authorised
16/09/2016News and press releases: Paediatric Committee re-elects chair
16/09/2016Referral: Article 35, Veterinary medicinal products containing a combination of lincomycin and spectinomycin to be administered orally to pigs and, or poultry,

lincomycin and spectinomycin

16/09/2016News and press releases: New treatment for patients with soft tissue sarcoma
16/09/2016News and press releases: New treatment for breast cancer
16/09/2016Pending EC decision: Glyxambi,

empagliflozin / linagliptin

Opinion date: 15-Sep-2016
16/09/2016Referral: Article 30 referrals, Clenil and associated names,

beclometasone dipropionate

16/09/2016Withdrawn application: Cokiera,

dasabuvir / ombitasvir / paritaprevir / ritonavir

Initial authorisation
16/09/2016Pending EC decision: Granpidam,

sildenafil

Opinion date: 15-Sep-2016
16/09/2016Pending EC decision: NovoRapid,

insulin aspart

Opinion date: 15-Sep-2016
16/09/2016Pending EC decision: Ninlaro,

ixazomib

Opinion date: 15-Sep-2016 (updated)
16/09/2016Pending EC decision: Chenodeoxycholic acid sigma-tau,

chenodeoxycholic acid

Opinion date: 15-Sep-2016
16/09/2016Pending EC decision: Lartruvo,

olaratumab

Opinion date: 15-Sep-2016
16/09/2016Withdrawn application: Adempas,

riociguat

Post-authorisation
16/09/2016Pending EC decision: Ibrance,

palbociclib

Opinion date: 15-Sep-2016
16/09/2016Pending EC decision: Emtricitabine/Tenofovir disoproxil Zentiva,

emtricitabine / tenofovir disoproxil

Opinion date: 15-Sep-2016
16/09/2016Referral: Article 31 referrals, Pharmaceutics International Inc. (updated)
16/09/2016News and press releases: Pharmaceutics International Inc., US: supply of non-critical medicines to EU to be stopped due to manufacturing failings
16/09/2016Pending EC decision: Parsabiv,

etelcalcetide

Opinion date: 15-Sep-2016
16/09/2016Pending EC decision: Ivabradine Zentiva,

ivabradine

Opinion date: 15-Sep-2016
16/09/2016Pending EC decision: Ivabradine JensonR,

ivabradine

Opinion date: 15-Sep-2016
16/09/2016Human medicines European public assessment report (EPAR): Kengrexal,

cangrelor

Revision: 2, Authorised
16/09/2016Human medicines European public assessment report (EPAR): Iclusig,

ponatinib

Revision: 13, Authorised
15/09/2016Human medicines European public assessment report (EPAR): Kyprolis,

carfilzomib

Revision: 4, Authorised
15/09/2016News and press releases: EMA survey on initial marketing authorisation application 2016
15/09/2016Human medicines European public assessment report (EPAR): Levitra,

vardenafil

Revision: 24, Authorised
15/09/2016Ex ante publicity of a negotiated procedure – EMA/2016/60/COM – Pharmaceutical eBooks
15/09/2016Human medicines European public assessment report (EPAR): Zoledronic acid medac,

zoledronic acid

Revision: 8, Authorised
14/09/2016Human medicines European public assessment report (EPAR): Pegasys,

peginterferon alfa-2a

Revision: 30, Authorised
14/09/2016Human medicines European public assessment report (EPAR): Kivexa,

abacavir / lamivudine

Revision: 27, Authorised
14/09/2016Human medicines European public assessment report (EPAR): Fortacin,

lidocaine / prilocaine

Revision: 3, Authorised
14/09/2016Agenda: Agenda - PDCO agenda of the 14-16 September 2016 meeting
14/09/2016Human medicines European public assessment report (EPAR): Brintellix,

vortioxetine

Revision: 7, Authorised
14/09/2016Human medicines European public assessment report (EPAR): Levetiracetam Hospira,

levetiracetam

Revision: 4, Authorised
14/09/2016News and press releases: Progress made in the operation of EU pharmacovigilance legislation
14/09/2016Tenth stakeholder forum on the pharmacovigilance legislation, European Medicines Agency, UK, From: 21-Sep-2016, To: 21-Sep-2016
14/09/2016Agenda: Agenda – Tenth Stakeholder forum on the Pharmacovigilance legislation
14/09/2016Human medicines European public assessment report (EPAR): Atosiban SUN,

atosiban

Revision: 2, Authorised
14/09/2016Human medicines European public assessment report (EPAR): Truvada,

emtricitabine / tenofovir disoproxil

Revision: 33, Authorised
13/09/2016Human medicines European public assessment report (EPAR): Tracleer,

bosentan

Revision: 27, Authorised
13/09/2016Human medicines European public assessment report (EPAR): Ilaris,

canakinumab

Revision: 15, Authorised
13/09/2016Human medicines European public assessment report (EPAR): Genvoya,

elvitegravir / cobicistat / emtricitabine / tenofovir alafenamide

Revision: 3, Authorised
13/09/2016CMDh Scientific conclusions and grounds for the variation, amendments to the Product Information and timetable for the implementation: minoxidil (topical formulation) PSUSA/00002067/201510 (updated)
13/09/2016Human medicines European public assessment report (EPAR): Trizivir,

abacavir (as sulfate) / lamivudine / zidovudine

Revision: 30, Authorised
13/09/2016List of nationally authorised medicinal products: lubiprostone PSUSA/00010290/201601
13/09/2016List of nationally authorised medicinal products: magnesium sulphate/sodium sulphate/potassium sulphate PSUSA/00010239/201602
13/09/2016Human medicines European public assessment report (EPAR): Zavesca,

miglustat

Revision: 24, Authorised
13/09/2016List of nationally authorised medicinal products: alendronate PSUSA/00000078/201601
12/09/2016Agenda: Agenda - CHMP agenda of the 12-15 September 2016
12/09/2016Human medicines European public assessment report (EPAR): Lamivudine/Zidovudine Teva,

lamivudine / zidovudine

Revision: 8, Authorised
12/09/2016Veterinary medicine European public assessment report (EPAR): Procox,

emodepside / toltrazuril

Revision: 10, Authorised
12/09/2016Human medicines European public assessment report (EPAR): Noxafil,

posaconazole

Revision: 20, Authorised
12/09/2016Human medicines European public assessment report (EPAR): Bondronat,

ibandronic acid

Revision: 24, Authorised
12/09/2016Human medicines European public assessment report (EPAR): Rivastigmine 1 A Pharma,

rivastigmine

Revision: 8, Authorised
12/09/2016Human medicines European public assessment report (EPAR): Elaprase,

idursulfase

Revision: 15, Authorised
12/09/2016Application form for the involvement of industry stakeholder organisations in the activities of the European Medicines Agency (EMA)
12/09/2016List of nationally authorised medicinal products: valaciclovir PSUSA/00003086/201512
12/09/2016List of nationally authorised medicinal products: minoxidil (non topical formulations) PSUSA/0002066/201510
12/09/2016List of nationally authorised medicinal products: flumazenil PSUSA/00001413/201512
12/09/2016List of nationally authorised medicinal products: lidocaine hydrochloride / phenylephrine hydrochloride / tropicamide PSUSA/00010390/201601
12/09/2016Human medicines European public assessment report (EPAR): Tasermity,

sevelamer hydrochloride

Revision: 3, Authorised
12/09/2016Veterinary medicine European public assessment report (EPAR): Metacam,

meloxicam

Revision: 20, Authorised
12/09/2016Veterinary medicine European public assessment report (EPAR): Sedadex,

dexmedetomidine

Revision: 0, Authorised
09/09/2016Committee for Advanced Therapies (CAT): 8-9 September 2016, European Medicines Agency, London, UK, From: 08-Sep-2016, To: 09-Sep-2016 (updated)
09/09/2016Agenda: Agenda - CAT agenda of the 8-9 September 2016 meeting
09/09/2016Human medicines European public assessment report (EPAR): Nevanac,

nepafenac

Revision: 12, Authorised
09/09/2016List of nationally authorised medicinal products: alizapride PSUSA/00000091/201601
09/09/2016List of nationally authorised medicinal products: exemestane PSUSA/00001345/201512
09/09/2016News and press releases: Committee for Medicinal Products for Veterinary Use (CVMP) Meeting of 6-8 September 2016
09/09/2016Human medicines European public assessment report (EPAR): Vivanza,

vardenafil

Revision: 21, Authorised
09/09/2016Pending EC decision: Draxxin,

tulathromycin

Opinion date: 08-Sep-2016
09/09/2016News and press releases: Head of International Affairs, Emer Cooke, to leave European Medicines Agency
09/09/2016Agenda: Agenda - Workshops for micro, small and medium-sized enterprises: focus on non-clinical aspects (updated)
08/09/2016Declaration of interests: Hans-Georg Eichler (updated)
08/09/2016List of nationally authorised medicinal products: rupatadine PSUSA/00002673/201512
08/09/2016List of nationally authorised medicinal products: caffeine/ergotamine PSUSA/00000485/201511
08/09/2016List of nationally authorised medicinal products: flunitrazepam PSUSA/00001418/201601
08/09/2016List of nationally authorised medicinal products: sertindole PSUSA/00002695/201601
08/09/2016List of nationally authorised medicinal products: gaxilose PSUSA/00010283/201601
08/09/2016List of nationally authorised medicinal products: allopurinol PSUSA/00000095/201512
08/09/2016List of nationally authorised medicinal products: ciclosporin (systemic use)PSUSA/00000745/201512
08/09/2016List of nationally authorised medicinal products: acipimox PSUSA/00000050/201512
08/09/2016List of nationally authorised medicinal products: carboprost PSUSA/00000560/201601
08/09/2016List of nationally authorised medicinal products: ketamine PSUSA/00001804/201512
08/09/2016List of nationally authorised medicinal products: bisoprolol / hydrochlorothiazide PSUSA/00000420/201511
08/09/2016List of nationally authorised medicinal products: cefotaxime PSUSA/00000599/201512
08/09/2016Newsletter: Human medicines highlights - August 2016
08/09/2016Human medicines European public assessment report (EPAR): PecFent,

fentanyl

Revision: 11, Authorised
08/09/2016Human medicines European public assessment report (EPAR): Pramipexole Teva,

pramipexole

Revision: 15, Authorised
08/09/2016Referral: Article 35, Altrenogest,

n/a

08/09/2016Human medicines European public assessment report (EPAR): Fareston,

toremifene

Revision: 19, Authorised
07/09/2016News and press releases: Fighting antimicrobial resistance globally
07/09/2016Human medicines European public assessment report (EPAR): Tysabri,

natalizumab

Revision: 23, Authorised
07/09/2016News and press releases: Workshop on adaptive pathways - discussing a concept for development of medicines addressing unmet medical needs
07/09/2016Tripartite meeting held between EMA, FDA and PMDA at EMA, London, on 1-2 September 2016 to discuss regulatory approaches for the evaluation of antibacterial agents
07/09/2016Adaptive pathways workshop, European Medicines Agency, UK, From: 08-Dec-2016, To: 08-Dec-2016
07/09/2016Human medicines European public assessment report (EPAR): Rivastigmine Sandoz,

rivastigmine

Revision: 10, Authorised
07/09/2016Human medicines European public assessment report (EPAR): Lumark,

lutetium, isotope of mass 177

Revision: 1, Authorised
07/09/2016Second annual scientific workshop at EMA: Applying regulatory science to neonates , European Medicines Agency, London, UK, From: 12-Sep-2016, To: 13-Sep-2016 (updated)
07/09/2016Human medicines European public assessment report (EPAR): Mircera,

methoxy polyethylene glycol-epoetin beta

Revision: 19, Authorised
07/09/2016Veterinary medicine European public assessment report (EPAR): Letifend,

canine leishmaniasis vaccine (recombinant protein)

Revision: 1, Authorised
07/09/2016Veterinary medicine European public assessment report (EPAR): Advocate,

imidacloprid / moxidectin

Revision: 16, Authorised
07/09/2016Human medicines European public assessment report (EPAR): Imlygic,

talimogene laherparepvec

Revision: 1, Authorised
07/09/2016Human medicines European public assessment report (EPAR): Neuraceq,

florbetaben (18F)

Revision: 10, Authorised
07/09/2016Human medicines European public assessment report (EPAR): Praxbind,

idarucizumab

Revision: 1, Authorised
06/09/2016Human medicines European public assessment report (EPAR): Nevirapine Teva,

nevirapine

Revision: 8, Authorised
06/09/2016Signal detection and management information day, European Medicines Agency, UK, From: 02-Dec-2016, To: 02-Dec-2016
06/09/2016Agenda: Agenda - COMP agenda of the 6-8 September 2016
06/09/2016Human medicines European public assessment report (EPAR): Sivextro,

tedizolid phosphate

Revision: 4, Authorised
06/09/2016Veterinary medicine European public assessment report (EPAR): Velactis,

cabergoline

Revision: 1, Suspended
06/09/2016Orphan designation:

Sodium hypochlorite

for the: Treatment of partial deep dermal and full thickness burns
06/09/2016Orphan designation:

Brincidofovir

for the: Treatment of adenovirus infection in immunocompromised patients
06/09/2016Orphan designation:

Mifamurtide

for the: Treatment of echinococcosis
06/09/2016Orphan designation:

Mifamurtide

for the: Treatment of hepatocellular carcinoma
06/09/2016Orphan designation:

Triheptanoin

for the: Treatment of McArdle’s disease
06/09/2016Orphan designation:

Autologous Epstein-Barr virus specific T cells derived from peripheral blood mononuclear cells, expanded ex vivo-

for the: Treatment of extranodal NK/T-cell lymphoma, nasal type
06/09/2016Orphan designation:

Autologous Epstein-Barr virus specific T cells derived from peripheral blood mononuclear cells, expanded ex vivo

for the: Treatment of post-transplant lymphoproliferative disorder
06/09/2016Orphan designation:

Volanesorsen sodium

for the: Treatment of familial partial lipodystrophy
06/09/2016Orphan designation:

2-[4-(1-methyl-4-pyridin-4-yl-1H-pyrazol-3-yl)-phenoxymethyl]-quinoline succinic acid

for the: Treatment of Huntington's disease
06/09/2016Orphan designation:

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

for the: Treatment of soft tissue sarcoma
06/09/2016Orphan designation:

Dimethyl fumarate

for the: Treatment of bullous pemphigoid
06/09/2016Orphan designation:

Adeno-associated viral vector serotype 2.7m8 containing the ChrimsonR-tdTomato gene

for the: Treatment of retinitis pigmentosa
06/09/2016Orphan designation:

Sodium benzoate

for the: Treatment of hyperargininaemia
06/09/2016Orphan designation:

autologous CD4+ and CD8+ T cells transduced with lentiviral vector containing an affinity-enhanced T-cell receptor targeting the New York esophageal antigen-1

for the: Treatment of soft tissue sarcoma
06/09/2016Orphan designation:

Poly(oxy-1,2-ethanediyl), alpha-(carboxymethyl)-omega-methoxy-, amide with arginase 1 [cobalt cofactor] (synthetic human) (1:10), trimer

for the: Treatment of hyperargininaemia
06/09/2016Orphan designation:

Recombinant human monoclonal antibody to insulin receptor

for the: Treatment of congenital hyperinsulinism
06/09/2016Veterinary medicine European public assessment report (EPAR): Panacur AquaSol,

fenbendazole

Revision: 5, Authorised
06/09/2016Orphan designation:

Sodium benzoate

for the: Treatment of citrullinaemia type 1
06/09/2016Orphan designation:

Sodium benzoate

for the: Treatment of carbamoyl-phosphate synthase-1 deficiency
06/09/2016Orphan designation:

Setmelanotide

for the: Treatment of pro-opiomelanocortin deficiency
06/09/2016Orphan designation:

3-[4-(1H-imidazol-1-ylmethyl)phenyl]-5-(2-methylpropyl)thiophene-2-[(N-butyloxylcarbamate)-sulphonamide] sodium salt

for the: Treatment of idiopathic pulmonary fibrosis
06/09/2016Orphan designation:

Sirolimus

for the: Treatment of sporadic lymphangioleiomyomatosis
06/09/2016Orphan designation:

Sodium benzoate

for the: Treatment of ornithine transcarbamylase deficiency
06/09/2016Human medicines European public assessment report (EPAR): Rivastigmine Hexal,

rivastigmine

Revision: 9, Authorised
06/09/2016Veterinary medicine European public assessment report (EPAR): SevoFlo,

sevoflurane

Revision: 13, Authorised
06/09/2016Withdrawn application: Kyndrisa,

drisapersen

Initial authorisation (updated)
06/09/2016Annex II - Concession specification: costing sheet (EMA/2016/43/RS) (updated)
06/09/2016CMDh Scientific conclusions and grounds for the variation, amendments to the Product Information and timetable for the implementation: technetium (99mtc) mebrofenin PSUSA/00002861/201511
06/09/2016List of nationally authorised medicinal products: technetium (99mtc) mebrofenin PSUSA/00002861/201511
05/09/2016Human medicines European public assessment report (EPAR): Zalmoxis,

allogeneic T cells genetically modified with a retroviral vector encoding for a truncated form of the human low affinity nerve growth factor receptor (ΔLNGFR) and the herpes simplex I virus thymidine kinase (HSV-TK Mut2)

Revision: 0, Authorised
05/09/2016Important medical event terms list (MedDRA version 19.1) (updated)
05/09/2016Agenda: Agenda - CVMP agenda of the 6-8 September 2016 meeting
05/09/2016Human medicines European public assessment report (EPAR): Dificlir,

fidaxomicin

Revision: 8, Authorised
05/09/2016Human medicines European public assessment report (EPAR): Airexar Spiromax,

salmeterol xinafoate / fluticasone propionate

Revision: 0, Authorised
05/09/2016Human medicines European public assessment report (EPAR): Gardasil 9,

human papillomavirus 9-valent vaccine (recombinant, adsorbed)

Revision: 4, Authorised
05/09/2016Human medicines European public assessment report (EPAR): Humira,

adalimumab

Revision: 49, Authorised
05/09/2016Human medicines European public assessment report (EPAR): Fluenz Tetra,

influenza vaccine (live attenuated, nasal)

Revision: 9, Authorised
05/09/2016List of nationally authorised medicinal products: niflumic PSUSA/00002157/201512
05/09/2016List of nationally authorised medicinal products: zafirlukast PSUSA/00003138/201512
05/09/2016List of nationally authorised medicinal products: minoxidil (topical formulation) PSUSA/00002067/201510
02/09/2016Human medicines European public assessment report (EPAR): Zurampic,

lesinurad

Revision: 1, Authorised
02/09/2016Human medicines European public assessment report (EPAR): Bonviva,

ibandronic acid

Revision: 22, Authorised
02/09/2016Human medicines European public assessment report (EPAR): Signifor,

pasireotide

Revision: 7, Authorised
02/09/2016Human medicines European public assessment report (EPAR): Aerivio Spiromax,

salmeterol / fluticasone propionate

Revision: 0, Authorised
02/09/2016Human medicines European public assessment report (EPAR): Levetiracetam Accord,

levetiracetam

Revision: 6, Authorised
02/09/2016Human medicines European public assessment report (EPAR): Toviaz,

fesoterodine

Revision: 18, Authorised
02/09/2016Human medicines European public assessment report (EPAR): Renagel,

sevelamer

Revision: 28, Authorised
02/09/2016News and press releases: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 30 August - 2 September 2016
02/09/2016Report: Highlights from the European Medicines Agency industry platform meeting held on 21 April 2016 on the operation of the centralised procedure for human medicinal products
02/09/2016Human medicines European public assessment report (EPAR): Cinqaero,

reslizumab

Revision: 0, Authorised
02/09/2016Human medicines European public assessment report (EPAR): Grastofil,

filgrastim

Revision: 7, Authorised
02/09/2016Scientific guideline: Concept paper on the revision of the 'Guideline on non-clinical documentation for herbal medicinal products in applications for marketing authorisation (bibliographical and mixed applications) and in applications for simplified registration', draft: consultation open
02/09/2016Human medicines European public assessment report (EPAR): Fuzeon,

enfuvirtide

Revision: 18, Authorised
01/09/2016Human medicines European public assessment report (EPAR): Accofil,

filgrastim

Revision: 5, Authorised
01/09/2016Scientific guideline: Draft guideline on the assessment of clinical safety and efficacy in the preparation of European Union herbal monographs for well-established and traditional herbal medicinal products, draft: consultation open
01/09/2016Human medicines European public assessment report (EPAR): Zoledronic Acid Accord,

zoledronic acid

Revision: 3, Authorised
01/09/2016Human medicines European public assessment report (EPAR): NeoRecormon,

epoetin beta

Revision: 23, Authorised
01/09/2016Agenda: Agenda - EMA Human Scientific Committees' Working Parties with Patients’ and Consumers’ Organisations (PCWP) and Healthcare Professionals’ Organisations (HCPWP) joint meeting - Workshop on social media
01/09/2016Agenda: Draft Agenda - EMA Human Scientific Committees' Working Parties with Patients’ and Consumers’ Organisations (PCWP) and Healthcare Professionals’ Organisations (HCPWP) joint meeting
01/09/2016Human medicines European public assessment report (EPAR): CellCept,

mycophenolate mofetil

Revision: 26, Authorised
01/09/2016Human medicines European public assessment report (EPAR): Opsumit,

macitentan

Revision: 6, Authorised
01/09/2016PDCO monthly report of opinions on paediatric investigation plans and other activities 17-19 August 2016
01/09/2016Deputy Executive Director and support services
01/09/2016Inspections, Human Medicines Pharmacovigilance and Committees (updated)
01/09/2016Information Management (updated)
01/09/2016Administration and Corporate Management (updated)
01/09/2016Advisory functions (updated)
01/09/2016Human Medicines Evaluation (updated)
01/09/2016Stakeholders and Communication (updated)