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July 2016

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22/07/2016Human medicines European public assessment report (EPAR): Krystexxa,

pegloticase

Revision: 3, Withdrawn
22/07/2016Opinion/decision on a Paediatric investigation plan (PIP): Tecfidera,

Dimethyl fumarate

Therapeutic area: Neurology (updated)
22/07/2016Opinion/decision on a Paediatric investigation plan (PIP): -,

Vorapaxar

Therapeutic area: Cardiovascular diseases (updated)
22/07/2016Opinion/decision on a Paediatric investigation plan (PIP): Byetta, Bydureon,

Exenatide

Therapeutic area: Endocrinology, -gynacology-fertility-metabolism (updated)
22/07/2016Opinion/decision on a Paediatric investigation plan (PIP): Adcirca, Cialis,

Tadalafil

Therapeutic area: Cardiovascular diseases (updated)
22/07/2016Opinion/decision on a Paediatric investigation plan (PIP): Xarelto,

Rivaroxaban

Therapeutic area: Cardiovascular diseases (updated)
22/07/2016European Union (EU) International Organisation for Standardisation (ISO) identification of medical products (IDMP) task force meeting, European Medicines Agency, London, UK, From: 30-Jun-2016, To: 01-Jul-2016
22/07/2016Minutes of the CAT meeting 16-17 June 2016
22/07/2016Minutes of the HMPC 30-31 May 2016 meeting
22/07/2016COMP meeting report on the review of applications for orphan designation: July 2016
22/07/2016HMPC: overview of assessment work – priority list (updated)
22/07/2016Referral: Article 31 referrals, Vancomycin-containing medicines,

vancomycin

(updated)
22/07/2016News and press releases: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 18-21 July 2016
22/07/2016News and press releases: Two new medicines for advanced kidney cancer
22/07/2016News and press releases: First medicine for HIV pre-exposure prophylaxis recommended for approval in the EU
22/07/2016News and press releases: CHMP confirms recommendations for use of Zydelig
22/07/2016News and press releases: EMA recommends suspension of medicines over flawed studies at Semler Research Centre
22/07/2016Pending EC decision: Onivyde,

irinotecan

Opinion date: 21-Jul-2016
22/07/2016Referral: Article 31 referrals, Semler (updated)
22/07/2016Pending EC decision: Tenofovir disoproxil Zentiva,

tenofovir disoproxil

Opinion date: 21-Jul-2016
22/07/2016Pending EC decision: Xalkori,

crizotinib

Opinion date: 21-Jul-2016
22/07/2016Overview of invented names reviewed in July 2016 by the Name Review Group (NRG) adopted at the CHMP meeting of 18-21 July 2016, adopted
22/07/2016Semler - Marketing authorisations which are recommended for suspension and marketing authorisation applications which do not satisfy the criteria for authorisation as adopted by the CHMP on 21 July 2016
22/07/2016Semler - Marketing authorisations which are recommended for maintenance and marketing authorisation applications for which bioequivalence vis-à-vis the EU reference medicinal product has been established as adopted by the CHMP on 21 July 2016
22/07/2016Pending EC decision: Imbruvica,

ibrutinib

Opinion date: 21-Jul-2016
22/07/2016Pending EC decision: Thorinane,

enoxaparin sodium

Opinion date: 21-Jul-2016
22/07/2016Questions and answers on the withdrawal of the CPMP Note for guidance on preclinical pharmacological and toxicological testing of vaccines (CPMP/SWP/465)
22/07/2016Pending EC decision: Kisplyx,

lenvatinib

Opinion date: 21-Jul-2016
22/07/2016Withdrawn application: Begedina,

begelomab

Initial authorisation
22/07/2016Referral: Article 20 procedures, Zydelig,

idelalisib

(updated)
22/07/2016Pending EC decision: Sialanar,

glycopyrronium bromide

Opinion date: 21-Jul-2016 (updated)
22/07/2016Referral: Article 29(4) referrals, Diclofenac epolamine 50 mg tablets ,

diclofenac

22/07/2016Pending EC decision: Truberzi,

eluxadoline

Opinion date: 21-Jul-2016
22/07/2016Pending EC decision: Orencia,

abatacept

Opinion date: 21-Jul-2016
22/07/2016Pending EC decision: Cabometyx ,

cabozantinib

Opinion date: 21-Jul-2016
22/07/2016Referral: Article 30 referrals, Durogesic and associated names,

fentanyl

22/07/2016Pending EC decision: Ameluz,

5-aminolevulinic acid hydrochloride

Opinion date: 21-Jul-2016
22/07/2016Pending EC decision: Inhixa,

enoxaparin sodium

Opinion date: 21-Jul-2016
22/07/2016Preclinical pharmacological and toxicological testing of vaccines (updated)
22/07/2016Pending EC decision: Zydelig,

idelalisib

Opinion date: 21-Jul-2016 (updated)
22/07/2016Pending EC decision: Truvada,

emtricitabine / tenofovir disoproxil

Opinion date: 21-Jul-2016
22/07/2016Referral: Article 31 referrals, Pharmaceutics International Inc. (updated)
22/07/2016EMA response to Nordic Cochrane letter on human papillomavirus (HPV) vaccines - Conflict of interest issues of Executive Director
22/07/2016EMA response to Nordic Cochrane letter on EMA response to Nordic Cochrane letter on human papillomavirus (HPV) vaccines - Maladministration
22/07/2016Open letters (updated)
22/07/2016News and press releases: EMA website briefly unavailable on 25 July
21/07/2016Monthly report on application procedures guidelines and related documents for veterinary medicines: June 2016
21/07/2016Human medicines European public assessment report (EPAR): Imvanex,

modified vaccinia Ankara virus

Revision: 8, Authorised
21/07/2016Scientific guideline: Concept paper on the revision of the 'Guideline on strategies to identify and mitigate risks for first-in-human clinical trials with investigational medicinal products', draft: consultation open
21/07/2016News and press releases: Proposals to revise guidance on first-in-human clinical trials
21/07/2016Human medicines European public assessment report (EPAR): Jentadueto,

linagliptin / metformin hydrochloride

Revision: 10, Authorised
21/07/2016Human medicines European public assessment report (EPAR): Afinitor,

everolimus

Revision: 17, Authorised
20/07/2016Human medicines European public assessment report (EPAR): Sprycel,

dasatinib

Revision: 27, Authorised
20/07/2016Human medicines European public assessment report (EPAR): ATryn,

antithrombin alfa

Revision: 12, Authorised
20/07/2016Human medicines European public assessment report (EPAR): Fabrazyme,

agalsidase beta

Revision: 22, Authorised
20/07/2016Regulatory and procedural guideline: Procedure for the nomination and appointment of co-opted members of the Committee for Medicinal Products for Human / Veterinary Use and Committee on Herbal Medicinal Products (effective from 01/08/2016) (updated)
20/07/2016Veterinary medicine European public assessment report (EPAR): Bluevac BTV8,

bluetongue virus inactivated, serotype 8

Revision: 4, Authorised
20/07/2016Work instructions for handling of renewals for centrally authorised veterinary medicinal products, adopted
20/07/2016Work instructions for Handling of veterinary e-submissions, adopted
20/07/2016Human medicines European public assessment report (EPAR): Synjardy,

empagliflozin / metformin

Revision: 4, Authorised
20/07/2016Regulatory and procedural guideline: Dossier requirements for centrally authorised products (updated)
20/07/2016Human medicines European public assessment report (EPAR): Benlysta,

belimumab

Revision: 13, Authorised
20/07/2016Formatted table template to be inserted in each procedural submission cover letter (updated)
20/07/2016Minutes of the CVMP meeting of 14-16 June 2016
20/07/2016Human medicines European public assessment report (EPAR): Protopic,

tacrolimus

Revision: 21, Authorised
20/07/2016Veterinary medicine European public assessment report (EPAR): Zolvix,

monepantel

Revision: 10, Authorised
20/07/2016Human medicines European public assessment report (EPAR): Komboglyze,

saxagliptin / metformin hydrochloride

Revision: 11, Authorised
20/07/2016Agenda: Agenda - PDCO agenda of the 20-22 July 2016 meeting
20/07/2016Veterinary medicine European public assessment report (EPAR): Nobilis Influenza H5N2,

adjuvanted inactivated vaccine against avian influenza virus type A, subtype H5

Revision: 7, Authorised
20/07/2016Human medicines European public assessment report (EPAR): Mycamine,

micafungin

Revision: 11, Authorised
20/07/201610th anniversary of European Medicines Agency’s Patients' and Consumers' Working Party (PCWP), European Medicines Agency, London, UK, From: 14-Jun-2016, To: 14-Jun-2016 (updated)
20/07/2016Orphan designation:

Lenalidomide

for the: Treatment of mantle cell lymphoma (updated)
20/07/2016Human medicines European public assessment report (EPAR): Pramipexole Accord,

pramipexole

Revision: 4, Authorised
20/07/2016Veterinary medicine European public assessment report (EPAR): Suvaxyn Circo+MH RTU,

Porcine circovirus and porcine enzootic pneumonia vaccine (inactivated)

Revision: 1, Authorised
20/07/2016Veterinary medicine European public assessment report (EPAR): Nobilis IB 4-91,

live attenuated vaccine against avian infectious bronchitis

Revision: 11, Authorised
20/07/2016Veterinary medicine European public assessment report (EPAR): Nobilis IB Primo QX,

avian infectious bronchitis vaccine (live)

Revision: 1, Authorised
19/07/2016Human medicines European public assessment report (EPAR): Otezla,

apremilast

Revision: 2, Authorised
19/07/2016Human medicines European public assessment report (EPAR): Ibandronic acid Accord,

ibandronic acid

Revision: 5, Authorised
19/07/2016Human medicines European public assessment report (EPAR): Yondelis,

trabectedin

Revision: 17, Authorised
19/07/2016Referral: Article 33, CattleMarker IBR Inactivated,

Infectious bovine rhinotracheitis vaccine (inactivated)

19/07/2016Human medicines European public assessment report (EPAR): Avastin,

bevacizumab

Revision: 44, Authorised
19/07/2016Human medicines European public assessment report (EPAR): Imnovid (previously Pomalidomide Celgene),

pomalidomide

Revision: 7, Authorised
19/07/2016Human medicines European public assessment report (EPAR): Zinbryta,

daclizumab

Revision: 0, Authorised
19/07/2016Human medicines European public assessment report (EPAR): Opdivo,

nivolumab

Revision: 5, Authorised
19/07/2016New vacancy: Temporary Agent, Master Data Management Architect (updated)
19/07/2016Agenda: Agenda - CHMP agenda of the 18-21 July 2016 meeting
19/07/2016Human medicines European public assessment report (EPAR): Remicade,

infliximab

Revision: 46, Authorised
19/07/2016Human medicines European public assessment report (EPAR): Eylea,

aflibercept

Revision: 8, Authorised
19/07/2016Human medicines European public assessment report (EPAR): BeneFIX,

nonacog alfa

Revision: 33, Authorised
18/07/2016Human medicines European public assessment report (EPAR): Revlimid,

lenalidomide

Revision: 27, Authorised
18/07/2016Human medicines European public assessment report (EPAR): Xydalba,

dalbavancin

Revision: 3, Authorised
18/07/2016Human medicines European public assessment report (EPAR): Relistor,

methylnaltrexone bromide

Revision: 13, Authorised
18/07/2016Human medicines European public assessment report (EPAR): Irbesartan Zentiva (previously Irbesartan Winthrop),

irbesartan

Revision: 18, Authorised
18/07/2016Human medicines European public assessment report (EPAR): Xeplion,

paliperidone

Revision: 9, Authorised
18/07/2016Human medicines European public assessment report (EPAR): DuoResp Spiromax,

budesonide / formoterol

Revision: 3, Authorised
18/07/2016Human medicines European public assessment report (EPAR): Humira,

adalimumab

Revision: 47, Authorised
18/07/201617 beta-estradiol / etonogestrel - Notification of discontinuation of a paediatric development which is covered by an agreed paediatric-investigation-plan decision
18/07/2016Opinion/decision on a Paediatric investigation plan (PIP): -,

KEOC liquid extract ethanolic 30 per cent (w/w) of Allium cepa L. (fresh bulb) and Citrus lemon (L.) Burm. (fresh fruit) / Paullinia cupana Kunth / Theobroma cacao L.

Therapeutic area: Dermatology
18/07/2016Opinion/decision on a Paediatric investigation plan (PIP): -,

Anti-respiratory syncytial virus human IgG1κ monoclonal antibody (MEDI8897)

Therapeutic area: Infectious diseases
18/07/2016Opinion/decision on a Paediatric investigation plan (PIP): -,

Doravirine

Therapeutic area: Infectious diseases
18/07/2016Opinion/decision on a Paediatric investigation plan (PIP): -,

Darunavir, cobicistat, emtricitabine, tenofovir alafenamide

Therapeutic area: Infectious diseases
18/07/2016Opinion/decision on a Paediatric investigation plan (PIP): -,

Human recombinant IgG1 monoclonal antibody targeting fibroblast growth factor 23 (KRN23)

Therapeutic area: Other
18/07/2016Opinion/decision on a Paediatric investigation plan (PIP): -,

Recombinant humanized anti-MMP9 monoclonal antibody IgG4 (GS-5745)

Therapeutic area: Gastroentology-Hepatology
18/07/2016Opinion/decision on a Paediatric investigation plan (PIP): -,

Diclofenac (sodium) / capsaicin

Therapeutic area: Pain
18/07/2016Opinion/decision on a Paediatric investigation plan (PIP): -,

Hydrogen Peroxide

Therapeutic area: Dermatology
18/07/2016Opinion/decision on a Paediatric investigation plan (PIP): -,

Doravirine

Therapeutic area: Infectious diseases
18/07/2016Template letter of intent for request of scientific advice - veterinary (updated)
18/07/2016Regulatory and procedural guideline: European Medicines Agency guidance for companies requesting scientific advice (veterinary) (updated)
18/07/2016Regulatory and procedural guideline: European Medicines Agency guidance for companies requesting classification as minor uses minor species / limited markets, adopted (updated)
15/07/2016EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) substances (updated)
15/07/2016EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) organisations (updated)
15/07/2016EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) pharmaceutical dose forms (updated)
15/07/2016Human medicines European public assessment report (EPAR): Voriconazole Accord,

voriconazole

Revision: 6, Authorised
15/07/2016List of nationally authorised medicinal products: sultamicillin PSUSA/00002829/201511
15/07/2016Human medicines European public assessment report (EPAR): DaTSCAN,

ioflupane (123l)

Revision: 18, Authorised
15/07/2016Human medicines European public assessment report (EPAR): Aprovel,

irbesartan

Revision: 35, Authorised
15/07/2016News and press releases: EMA recommends suspending the veterinary medicine Velactis used in dairy cows at the time of drying off
15/07/2016News and press releases: Committee for Medicinal Products for Veterinary Use (CVMP) Meeting of 12-14 July 2016
15/07/2016Pending EC decision: Eravac,

Rabbit haemorrhagic disease type 2 virus (RHDV2), inactivated

Opinion date: 14-Jul-2016
15/07/2016Press release: Committee for Medicinal Products for Veterinary Use (CVMP) Meeting of 12-14 July 2016
15/07/2016Human medicines European public assessment report (EPAR): Topotecan Hospira,

topotecan

Revision: 8, Authorised
15/07/2016Referral: Article 31 referrals, Inhaled corticosteroids containing medicinal products indicated in the treatment of chronic obstructive pulmonary disease,

beclomethasone, budesonide, flunisolide, fluticasone propionate, fluticasone furoate

(updated)
15/07/2016Human medicines European public assessment report (EPAR): Revinty Ellipta,

fluticasone furoate / vilanterol

Revision: 6, Authorised
15/07/2016Human medicines European public assessment report (EPAR): Budesonide/Formoterol Teva,

budesonide / formoterol

Revision: 2, Authorised
15/07/2016Human medicines European public assessment report (EPAR): Relvar Ellipta,

fluticasone furoate / vilanterol

Revision: 8, Authorised
15/07/2016Human medicines European public assessment report (EPAR): BiResp Spiromax,

budesonide / formoterol

Revision: 3, Authorised
15/07/2016Human medicines European public assessment report (EPAR): Vylaer Spiromax,

budesonide / formoterol

Revision: 3, Authorised
15/07/2016Herbal medicinal products: Polypodium , Polypodii rhizoma, Polypodium vulgare L. (updated)
15/07/2016Herbal medicinal products: Trigonella, Trigonellae foenugraeci semen, Trigonella foenum-graecum L. (updated)
15/07/2016Call for scientific data for the systematic review of the monograph on Trigonella foenum-graecum L., semen, draft: consultation open
15/07/2016Call for scientific data for the systematic review of the monograph on Polypodium vulgare L., rhizoma, draft: consultation open
15/07/2016Call for scientific data for the systematic review of the monograph on Oenothera biennis L.; Oenothera lamarckiana L., oleum, draft: consultation open
15/07/2016Call for scientific data for the systematic review of the monograph on Commiphora molmol Engler, gummi-resina, draft: consultation open
15/07/2016Herbal medicinal products: Commiphora, Myrrha, gummi-resina, Commiphora molmol Engler (updated)
15/07/2016Press release: EMA recommends suspending the veterinary medicine Velactis used in dairy cows at the time of drying off
14/07/2016Report: Medicinal products for human use: monthly figures - June 2016
14/07/2016Human medicines European public assessment report (EPAR): Sancuso,

granisetron

Revision: 8, Authorised
14/07/2016Human medicines European public assessment report (EPAR): ReFacto AF,

moroctocog alfa

Revision: 31, Authorised
14/07/2016European Medicines Agency meeting and holiday dates 2017
14/07/2016European Medicines Agency meeting and holiday dates 2016 (updated)
14/07/2016Agenda: Agenda - CAT agenda of the 13-15 July 2016 meeting
14/07/2016Human medicines European public assessment report (EPAR): Imatinib Teva,

imatinib

Revision: 7, Authorised
14/07/2016Human medicines European public assessment report (EPAR): Opgenra,

eptotermin alfa

Revision: 9, Withdrawn
14/07/2016Human medicines European public assessment report (EPAR): Norvir,

ritonavir

Revision: 54, Authorised
14/07/2016Human medicines European public assessment report (EPAR): Micardis,

telmisartan

Revision: 22, Authorised
14/07/2016Human medicines European public assessment report (EPAR): Ferriprox,

deferiprone

Revision: 20, Authorised
14/07/2016Imatinib Teva : EPAR - Product Information (updated)
14/07/2016Human medicines European public assessment report (EPAR): Pheburane,

sodium phenylbutyrate

Revision: 2, Authorised
14/07/2016Clinical Trial Regulation (updated)
14/07/2016Human medicines European public assessment report (EPAR): Matever,

levetiracetam

Revision: 13, Authorised
14/07/2016Human medicines European public assessment report (EPAR): Reyataz,

atazanavir sulphate

Revision: 42, Authorised
14/07/2016Human medicines European public assessment report (EPAR): Zavicefta,

ceftazidime / avibactam

Revision: 0, Authorised
14/07/2016Human medicines European public assessment report (EPAR): Iclusig,

ponatinib

Revision: 12, Authorised
14/07/2016Human medicines European public assessment report (EPAR): EndolucinBeta,

lutetium (177 Lu) chloride

Revision: 0, Authorised
13/07/2016Scientific guideline: Draft concept paper on guidance for the collection of data on antimicrobial consumption by species from national data collection systems, draft: consultation open
13/07/2016Human medicines European public assessment report (EPAR): Taxespira (previously Docetaxel Hospira UK Limited ),

docetaxel

Revision: 4, Authorised
13/07/2016Insuman Basal and Comb 25 (insulin human) supply shortage (updated)
13/07/2016List of nationally authorised medicinal products: clevidipine PSUSA/00010288/201511
13/07/2016Research projects (updated)
12/07/2016Human medicines European public assessment report (EPAR): Soliris,

eculizumab

Revision: 19, Authorised
12/07/2016Human medicines European public assessment report (EPAR): Nplate,

romiplostim

Revision: 15, Authorised
12/07/2016Human medicines European public assessment report (EPAR): Victoza,

liraglutide

Revision: 15, Authorised
12/07/2016Human medicines European public assessment report (EPAR): Tractocile,

atosiban

Revision: 21, Authorised
12/07/2016Human medicines European public assessment report (EPAR): Daklinza,

daclatasvir

Revision: 7, Authorised
12/07/2016Human medicines European public assessment report (EPAR): Hexacima,

diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and Haemophilus influenzae type-b conjugate vaccine (adsorbed)

Revision: 11, Authorised
12/07/2016Human medicines European public assessment report (EPAR): Nivestim,

filgrastim

Revision: 11, Authorised
12/07/2016Overview of comments received on 'Guideline on the clinical development of medicinal products for the treatment of HIV infection'
12/07/2016Human medicines European public assessment report (EPAR): Viagra,

sildenafil

Revision: 30, Authorised
12/07/2016Human medicines European public assessment report (EPAR): Imatinib Actavis,

imatinib

Revision: 6, Authorised
12/07/2016List of nationally authorised medicinal products: diacerein PSUSA/0001026/201512
12/07/2016List of nationally authorised medicinal products: treprostinil PSUSA/00003013/201511
12/07/2016Human medicines European public assessment report (EPAR): Erivedge,

vismodegib

Revision: 7, Authorised
12/07/2016Agenda: Agenda - CVMP agenda of the 12-14 July 2016 meeting
12/07/2016Human medicines European public assessment report (EPAR): Tecfidera,

dimethyl fumarate

Revision: 7, Authorised
12/07/2016Scientific guideline: Draft implementation strategy of ICH Q3D guideline, draft: consultation open
12/07/2016Human medicines European public assessment report (EPAR): Omnitrope,

somatropin

Revision: 12, Authorised
12/07/2016Implementation of the ISO IDMP standards (updated)
12/07/2016Human medicines European public assessment report (EPAR): Flixabi,

infliximab

Revision: 1, Authorised
12/07/2016Report: Annual activity report 2015
12/07/2016Human medicines European public assessment report (EPAR): SonoVue,

sulphur hexafluoride

Revision: 14, Authorised
11/07/2016List of nationally authorised medicinal products: atomoxetine PSUSA/00000262/201511
11/07/2016List of nationally authorised medicinal products: salmeterol PSUSA/00002681/201510
11/07/2016Information Technology Directors Group - List of nominated members (alphabetically by country) (updated)
11/07/2016Nominations to the European Union Telematics governance bodies (updated)
11/07/2016Opinion/decision on a Paediatric investigation plan (PIP): Betmiga,

Mirabegron

Therapeutic area: Uro-nephrology (updated)
11/07/2016Opinion/decision on a Paediatric investigation plan (PIP): -,

recombinant parathyroid hormone

Therapeutic area: Endocrinology, -gynacology-fertility-metabolism (updated)
11/07/2016Opinion/decision on a Paediatric investigation plan (PIP): Forxiga,

Dapagliflozin

Therapeutic area: Endocrinology, -gynacology-fertility-metabolism (updated)
11/07/2016Opinion/decision on a Paediatric investigation plan (PIP): -,

Peanut allergen extract

Therapeutic area: Pneumology-allergology (updated)
11/07/2016Opinion/decision on a Paediatric investigation plan (PIP): -,

Grazoprevir

Therapeutic area: Infectious diseases (updated)
11/07/2016Opinion/decision on a Paediatric investigation plan (PIP): -,

Grazoprevir / Elbasvir

Therapeutic area: Infectious diseases (updated)
11/07/2016Human medicines European public assessment report (EPAR): Pritor,

telmisartan

Revision: 25, Authorised
11/07/2016Public summary of the evaluation of a proposed paediatric investigation plan: Fluciclovine (18F) for diagnosis of amino acid metabolism in solid malignant tumours
11/07/2016Opinion/decision on a Paediatric investigation plan (PIP): -,

Human normal immunoglobulin

Therapeutic area: Immunology-Rheumatology-Transplantation (updated)
11/07/2016Opinion/decision on a Paediatric investigation plan (PIP): Truvada,

Emtricitabine / tenofovir disoproxil fumarate

Therapeutic area: Infectious diseases (updated)
11/07/2016Public summary of the evaluation of a proposed paediatric investigation plan: Osilodrostat for the treatment of adrenal cortical hyperfunction
11/07/2016Public summary of the evaluation of a proposed paediatric investigation plan: Nintedanib for the treatment of systemic sclerosis
11/07/2016Public summary of the evaluation of a proposed paediatric investigation plan: Emtricitabine / tenofovir disoproxil fumarate (Truvada) for the treatment of human immunodeficiency virus (HIV-1) infection and for the prevention of human immunodeficiency virus (HIV-1) infection
11/07/2016Public summary of the evaluation of a proposed paediatric investigation plan: Dupilumab for treatment of nasal polyposis
11/07/2016Public summary of the evaluation of a proposed paediatric investigation plan: (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) for the treatment of human immunodeficiency virus (HIV-1) infection
11/07/2016Public summary of the evaluation of a proposed paediatric investigation plan: Human normal immunoglobulin for treatment of primary immunodeficiency
11/07/2016Opinion/decision on a Paediatric investigation plan (PIP): -,

Osilodrostat

Therapeutic area: Endocrinology, -gynacology-fertility-metabolism (updated)
11/07/2016Opinion/decision on a Paediatric investigation plan (PIP): Ofev,

Nintedanib

Therapeutic area: Immunology-Rheumatology-Transplantation/Pneumology-allergology (updated)
11/07/2016Opinion/decision on a Paediatric investigation plan (PIP): -,

Fluciclovine (18F)

Therapeutic area: Diagnostic/Oncology (updated)
11/07/2016Opinion/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)
11/07/2016Referral: Article 20 procedures, Direct-acting antivirals indicated for treatment of hepatitis C (interferon-free),

daclatasvir / dasabuvir / sofosbuvir / ledipasvir / simeprevir / ombitasvir/paritaprevir / ritonavir

(updated)
11/07/2016Scientific guideline: Guideline on the clinical development of medicinal products for the treatment of HIV infection, adopted
11/07/2016Work programme of the European Medicines Agency 2016 (updated)
11/07/2016List of participants - Developing a framework of collaboration between EMA and academia
11/07/2016Human medicines European public assessment report (EPAR): Clopidogrel BGR (previously Zylagren),

clopidogrel

Revision: 11, Authorised
11/07/2016List of nationally authorised medicinal products: alendronate / alfacalcidol PSUSA/00010308/201512
11/07/2016List of nationally authorised medicinal products: naltrexone PSUSA/00002117/201511
11/07/2016List of nationally authorised medicinal products: indapamide PSUSA/00001731/201511
11/07/2016List of nationally authorised medicinal products: Terazosin PSUSA/00002895/201511
11/07/2016Human medicines European public assessment report (EPAR): Feraccru,

ferric maltol

Revision: 1, Authorised
08/07/2016Human medicines European public assessment report (EPAR): Odefsey,

emtricitabine / rilpivirine / tenofovir alafenamide

Revision: 0, Authorised
08/07/2016Agenda: Agenda - HMPC agenda of the 11-12 July 2016 meeting
08/07/2016Register of deadlines to put a medicinal product on the market in accordance with Article 33 of the Paediatric Regulation (updated)
08/07/2016Human medicines European public assessment report (EPAR): Aripiprazole Mylan Pharma (previously Aripiprazole Pharmathen),

aripiprazole

Revision: 2, Authorised
08/07/2016News and press releases: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 4-8 July 2016
08/07/2016News and press releases: PRAC concludes review of Zydelig and issues updated recommendations for use
08/07/2016Referral: Article 31 referrals, Paracetamol-modified release,

paracetamol

08/07/2016Referral: Article 31 referrals, Factor VIII
08/07/2016Getting involved (updated)
08/07/2016Referral: Article 20 procedures, SGLT2 inhibitors (previously Canagliflozin),

canagliflozin, empagliflozin, dapagliflozin, canagliflozin / metformin, empagliflozin / metformin, dapagliflozin / metformin

(updated)
08/07/2016Referral: Article 31 referrals, Retinoid-containing medicinal products,

acitretin, adapalene, alitretinoin, bexarotene, isotretinoin, tretinoin, tazarotene

08/07/2016Human medicines European public assessment report (EPAR): Zytiga,

abiraterone

Revision: 14, Authorised
08/07/2016Human medicines European public assessment report (EPAR): Retacrit,

epoetin zeta

Revision: 17, Authorised
08/07/2016Human medicines European public assessment report (EPAR): Iblias,

octocog alfa

Revision: 1, Authorised
08/07/2016Human medicines European public assessment report (EPAR): Inflectra,

infliximab

Revision: 11, Authorised
08/07/2016Human medicines European public assessment report (EPAR): Lixiana,

edoxaban

Revision: 4, Authorised
08/07/2016Human medicines European public assessment report (EPAR): Kolbam ,

cholic acid

Revision: 11, Authorised
08/07/2016Human medicines European public assessment report (EPAR): Sildenafil Actavis,

sildenafil

Revision: 10, Authorised
08/07/2016Human medicines European public assessment report (EPAR): Vfend,

voriconazole

Revision: 39, Authorised
08/07/2016Human medicines European public assessment report (EPAR): Lopinavir/Ritonavir Mylan,

lopinavir/ritonavir

Revision: 1, Authorised
08/07/2016Human medicines European public assessment report (EPAR): Repatha,

evolocumab

Revision: 2, Authorised
08/07/2016List of nationally authorised medicinal products: diclofenac (systemic formulations) PSUSA/00001048/201509
08/07/2016CMDh Scientific conclusions and grounds for the variation, amendments to the Product Information and timetable for the implementation: diclofenac (systemic formulations) PSUSA/00001048/201509
08/07/2016Overview of comments received on 'Guideline on clinical evaluation of medicinal products used in weight control'
08/07/2016Overview of comments received on ''Guideline on clinical investigation of medicinal products in the treatment of hypertension'
08/07/2016Clinical investigation on medicinal products in the treatment of hypertension (updated)
08/07/2016Clinical investigation of medicinal products in the treatment of lipid disorders (updated)
08/07/2016Clinical evaluation of medicinal products used in weight control (updated)
08/07/2016Scientific guideline: Guideline on clinical evaluation of medicinal products used in weight management, adopted
08/07/2016Scientific guideline: Guideline on clinical investigation of medicinal products in the treatment of lipid disorders, adopted
08/07/2016Scientific guideline: Guideline on clinical investigation of medicinal products in the treatment of hypertension, adopted
08/07/2016Report: Applications for new human medicines under evaluation by the CHMP: July 2016
08/07/2016Newsletter: Human medicines highlights - June 2016
08/07/2016Joint DIA/EFGCP/EMA better medicines for children conference 2016 on optimisiation of drug development for the benefit of children, European Medicines Agency, London, UK, From: 10-Oct-2016, To: 11-Oct-2016
07/07/2016Minutes of the CAT meeting 18-20 May 2016
07/07/2016European medicines agency Standard operating procedure (SOP): Standard operating procedure for micro, small and medium-sized enterprises (SME) conditional fee exemptions
07/07/2016Work instructions for publication of web content on www.ema.europa.eu, adopted (updated)
07/07/2016List of nationally authorised medicinal products: glycopyrronium bromide (all indications except for chronic obstructive pulmonary disease) PSUSA/00001556/201509
07/07/2016CMDh Scientific conclusions and grounds for the variation, amendments to the Product Information, and timetable for the implementation (all EU languages included): glycopyrronium bromide (all indications except for chronic obstructive pulmonary disease) PSUSA/00001556/201509
07/07/2016Human medicines European public assessment report (EPAR): Levetiracetam Hospira,

levetiracetam

Revision: 3, Authorised
07/07/2016Human medicines European public assessment report (EPAR): Pemetrexed Hospira,

pemetrexed

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

oseltamivir

Revision: 28, Authorised
07/07/2016Human medicines European public assessment report (EPAR): Lyrica,

pregabalin

Revision: 34, Authorised
07/07/2016Human medicines European public assessment report (EPAR): Zoledronic Acid Hospira,

zoledronic acid

Revision: 7, Authorised
07/07/2016Human medicines European public assessment report (EPAR): Xaluprine (previously Mercaptopurine Nova Laboratories),

mercaptopurine

Revision: 5, Authorised
07/07/2016Report: Summary of Product Characteristics Advisory Group 2010-2015 activity report
07/07/2016Human medicines European public assessment report (EPAR): Incruse,

umeclidinium bromide

Revision: 4, Authorised
07/07/2016Pharmacovigilance fees: questions and answers (updated)
07/07/2016Pharmacovigilance fees: questions and answers (updated)
07/07/2016Scientific guideline: Draft guideline on the clinical evaluation of direct acting antivirals for the treatment of chronic hepatitis, draft: consultation open
07/07/2016Human medicines European public assessment report (EPAR): Briviact,

brivaracetam

Revision: 2, Authorised
07/07/2016List of nationally authorised medicinal products: glycopyrronium / neostigmine PSUSA/00001557/201509
07/07/2016CMDh Scientific conclusions and grounds for the variation, amendments to the Product Information and timetable for the implementation: glycopyrronium / neostigmine PSUSA/00001557/201509
07/07/2016Human medicines European public assessment report (EPAR): Lemtrada,

alemtuzumab

Revision: 3, Authorised
07/07/2016Agenda: Agenda - COMP agenda of the 11-13 July 2016 meeting
07/07/2016List of nationally authorised medicinal products: mycophenolic acid (apart from mycophenolate mofetil) PSUSA/00010243/201510
07/07/2016Opinion of the Committee for Medicinal Products for Veterinary Use on the establishment of maximum residue limits: Eprinomectin, adopted
06/07/2016Human medicines European public assessment report (EPAR): Pregabalin Pfizer,

pregabalin

Revision: 7, Authorised
06/07/2016Human medicines European public assessment report (EPAR): Tasigna,

nilotinib

Revision: 30, Authorised
06/07/2016News and press releases: Statement on the outcome of the UK referendum
06/07/2016Questions and answers: Article 13 referral procedures
06/07/2016Questions and answers: Article 30 referral procedures
06/07/2016Regulatory and procedural guideline: Questions and answers on Article 20 non-pharmacovigilance procedures
06/07/2016Questions and answers: Article 31 non-pharmacovigilance referrals
06/07/2016Questions and answers: Article 20 non-pharmacovigilance procedures
06/07/2016List of nationally authorised medicinal products: iodine (131i) iobenguane PSUSA/00001764/201505 (updated)
06/07/2016CMDh Scientific conclusions and grounds for the variation, amendments to the Product Information and timetable for the implementation: iodine (131i) iobenguane PSUSA/00001764/201505 (updated)
06/07/2016Regulatory and procedural guideline: Questions and answers on Article 29(4) referral procedures
06/07/2016Regulatory and procedural guideline: Questions and answers on Article 13 referral procedures
06/07/2016Regulatory and procedural guideline: Questions and answers on Article 30 referral procedures
06/07/2016Regulatory and procedural guideline: Questions and answers on Article 31 non-pharmacovigilance referrals
06/07/2016Questions and answers: Article 29(4) referral procedures
06/07/2016Human medicines European public assessment report (EPAR): Inlyta,

axitinib

Revision: 6, Authorised
06/07/2016Human medicines European public assessment report (EPAR): Hexyon,

diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and Haemophilus influenzae type-b conjugate vaccine (adsorbed)

Revision: 11, Authorised
06/07/2016Minutes - PDCO minutes of the 25-27 May 2016 meeting
06/07/2016Human medicines European public assessment report (EPAR): Prolia,

denosumab

Revision: 10, Authorised
06/07/2016Human medicines European public assessment report (EPAR): Cancidas (previously Caspofungin MSD),

caspofungin

Revision: 20, Authorised
06/07/2016Human medicines European public assessment report (EPAR): Ixiaro,

Japanese-encephalitis vaccine (inactivated, adsorbed)

Revision: 12, Authorised
06/07/2016News and press releases: Procedural information – EMA goes electronic for PDCO opinions and subsequent EMA decisions
06/07/2016European Medicines Agency (EMA) Human Scientific Committees' Working Parties with Patients’ and Consumers’ Organisations (PCWP) and Healthcare Professionals’ Organisations (HCPWP) joint meeting: Session on communication and information on medicines, European Medicines Agency, London, UK, From: 08-Mar-2016, To: 08-Mar-2016 (updated)
06/07/2016Veterinary medicine European public assessment report (EPAR): Sevocalm,

sevoflurane

Revision: 0, Authorised
06/07/2016Paediatric investigation plans: questions and answers (updated)
06/07/2016Human medicines European public assessment report (EPAR): DuoPlavin,

clopidogrel / acetylsalicylic acid

Revision: 14, Authorised
05/07/2016Human medicines European public assessment report (EPAR): Tobi Podhaler,

tobramycin

Revision: 11, Authorised
05/07/2016Veterinary medicine European public assessment report (EPAR): Aivlosin,

tylvalosin

Revision: 25, Authorised
05/07/2016Human medicines European public assessment report (EPAR): Myozyme,

alglucosidase alfa

Revision: 13, Authorised
05/07/2016Second annual scientific workshop at EMA: Applying regulatory science to neonates , European Medicines Agency, London, UK, From: 12-Sep-2016, To: 13-Sep-2016
05/07/2016Human medicines European public assessment report (EPAR): Cubicin,

daptomycin

Revision: 21, Authorised
05/07/2016Human medicines European public assessment report (EPAR): Menveo,

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

Revision: 18, Authorised
05/07/2016Environmental impact assessment for veterinary medicinal products in support of the VICH guidelines GL6 and GL38 (updated)
05/07/2016Scientific guideline: Guideline on environmental impact assessment for veterinary medicinal products in support of the VICH guidelines GL6 and GL38, adopted (updated)
05/07/2016Mandate, objectives and rules of procedure for the CVMP Pharmacovigilance Working Party (PhVWP-V) (updated)
05/07/2016Careers (updated)
05/07/2016Referral: Article 30 referrals, Novantrone and associated names,

mitoxantrone

(updated)
04/07/2016Pharmacovigilance Risk Assessment Committee (PRAC): 4-8 July 2016, European Medicines Agency, London, UK, From: 04-Jul-2016, To: 08-Jul-2016 (updated)
04/07/2016Agenda: Agenda - PRAC draft agenda of meeting 4-8 July 2016
04/07/2016Human medicines European public assessment report (EPAR): Genvoya,

elvitegravir / cobicistat / emtricitabine / tenofovir alafenamide

Revision: 2, Authorised
04/07/2016Exceptions to the VNeeS format (updated)
04/07/2016PDCO monthly report of opinions on paediatric investigation plans and other activities 22-24 June 2016
04/07/2016Human medicines European public assessment report (EPAR): NovoThirteen,

catridecacog

Revision: 3, Authorised
04/07/2016Workshop on immunogenicity assessment of biotechnology-derived therapeutic proteins - Workshop summary
04/07/2016Human medicines European public assessment report (EPAR): Ecalta,

anidulafungin

Revision: 15, Authorised
04/07/2016European Union agencies (updated)
04/07/2016PRAC recommendations on signals adopted at the PRAC meeting of 6-9 June 2016, adopted
04/07/2016New product information wording: extracts from PRAC recommendations on signals adopted at the 6-9 June 2016 PRAC
04/07/2016News and press releases: Infringement procedure against Roche – EMA update
04/07/2016List of signals discussed at the PRAC since September 2012 (updated)
04/07/2016Biologicals: finished product (updated)
01/07/2016CAT monthly report of application procedures, guidelines and related documents on advanced therapies: June 2016
01/07/2016Minutes of the PRAC meeting 10-13 May 2016
01/07/2016MRL report: Eprinomectin: European public maximum-residue-limit assessment report (EPMAR) - CVMP
01/07/2016Human medicines European public assessment report (EPAR): Forsteo,

teriparatide

Revision: 17, Authorised
01/07/2016Human medicines European public assessment report (EPAR): Ongentys,

opicapone

Revision: 0, Authorised
01/07/2016Human medicines European public assessment report (EPAR): Vpriv,

velaglucerase alfa

Revision: 9, Authorised
01/07/2016Human medicines European public assessment report (EPAR): Karvea,

irbesartan

Revision: 34, Authorised
01/07/2016Umbipro H-W-3799 (updated)
01/07/2016Pharmacovigilance fees payable to the European Medicines Agency (updated)
01/07/2016Orphan designation:

Hydrocortisone (modified-release tablet)

for the: Treatment of adrenal insufficiency (updated)
01/07/2016Explanatory note on pharmacovigilance fees payable to the European Medicines Agency (updated)
01/07/2016Human medicines European public assessment report (EPAR): Granupas (previously Para-aminosalicylic acid Lucane),

para-aminosalicylic acid

Revision: 2, Authorised
01/07/2016Human medicines European public assessment report (EPAR): Neuraceq,

florbetaben (18F)

Revision: 9, Authorised
01/07/2016Clinical investigation of medicinal products for the treatment of ankylosing spondylitis (updated)
01/07/2016Scientific guideline: Draft guideline on the clinical investigation of medicinal products for the treatment of axial spondyloarthritis - Revision 1, draft: consultation open
01/07/2016Herbal medicinal products: Salvia, Salviae fruticosae folium, Salvia fruticosa, Mill. (Salvia triloba L.) (updated)
01/07/2016Scientific guideline: Draft guideline on the requirements for quality documentation concerning biological investigational medicinal products in clinical trials, draft: consultation open