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July 2016

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28/07/2016Human medicines European public assessment report (EPAR): Epclusa,

sofosbuvir / velpatasvir

Revision: 0, Authorised
28/07/2016Human medicines European public assessment report (EPAR): PecFent,

fentanyl

Revision: 10, Authorised
28/07/2016New vacancy: Temporary Agent, Solution Architect/Technical Lead
27/07/2016Human medicines European public assessment report (EPAR): Cotellic,

cobimetinib

Revision: 3, Authorised
27/07/2016Human medicines European public assessment report (EPAR): Osigraft,

eptotermin alfa

Revision: 13, Withdrawn
27/07/2016First European Medicines Agency - European Federation of Pharmaceutical Industries and Associations annual bilateral meeting , European Medicines Agency, London, UK, From: 16-Sep-2016, To: 16-Sep-2016
27/07/2016Human medicines European public assessment report (EPAR): Yondelis,

trabectedin

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

lumacaftor / ivacaftor

Revision: 3, Authorised
27/07/2016Opinion/decision on a Paediatric investigation plan (PIP): -,

Allantoin

Therapeutic area: Dermatology (updated)
27/07/2016Human medicines European public assessment report (EPAR): Entresto,

sacubitril / valsartan

Revision: 3, Authorised
27/07/2016Opinion/decision on a Paediatric investigation plan (PIP): -,

Selumetinib

Therapeutic area: Oncology (updated)
27/07/2016Human medicines European public assessment report (EPAR): Pegasys,

peginterferon alfa-2a

Revision: 29, Authorised
27/07/2016Opinion/decision on a Paediatric investigation plan (PIP): -,

Drospirenone

Therapeutic area: Endocrinology, -gynacology-fertility-metabolism (updated)
27/07/2016Opinion/decision on a Paediatric investigation plan (PIP): Wakix,

Pitolisant

Therapeutic area: Neurology (updated)
27/07/2016Opinion/decision on a Paediatric investigation plan (PIP): Cometriq,

Cabozantinib

Therapeutic area: Oncology (updated)
27/07/2016Human medicines European public assessment report (EPAR): Qtern,

saxagliptin / dapagliflozin

Revision: 0, Authorised
27/07/2016Opinion/decision on a Paediatric investigation plan (PIP): Lyxumia,

Lixisenatide

Therapeutic area: Endocrinology, -gynacology-fertility-metabolism (updated)
27/07/2016Opinions on safety variations/periodic safety update reports adopted at the CHMP meeting of 18-21 July 2016, adopted
27/07/2016Organisational matters: CHMP meeting 18-21 July 2016, adopted
27/07/2016Opinions on annual re-assessments, renewals of marketing authorisations and accelerated assessment procedures adopted at the CHMP meeting of 18-21 July 2016, adopted
27/07/2016Guidelines and concept papers adopted during the CHMP meeting 18-21 July 2016, adopted
27/07/2016Opinion/decision on a Paediatric investigation plan (PIP): Xgeva,

Denosumab

Therapeutic area: Immunology-Rheumatology-Transplantation/Oncology/Endocrinology, -gynacology-fertility-metabolism (updated)
27/07/2016Spinal muscular atrophy workshop (SMA), European Medicines Agency, London, From: 11-Nov-2016, To: 11-Nov-2016
27/07/2016Draft list of references supporting the assessment of Glycine max (L.) Merr., lecithin, draft
27/07/2016Herbal medicinal products: Glycine, Lecithinum ex soya, Glycine max (L.) Merr. (updated)
27/07/2016Draft European Union herbal monograph on Glycine max (L.) Merr., lecithin, draft
27/07/2016Draft assessment report on Glycine max (L.) Merr., lecithin, draft
27/07/2016Recommendations on eligibility to PRIME scheme - Adopted at the CHMP meeting of 18-21 July 2016, adopted
27/07/2016Current tenders for €135,000 or more (updated)
27/07/2016EMA Human Scientific Committees' Working Parties with Patients’ and Consumers’ Organisations (PCWP) and Healthcare Professionals’ Organisations (HCPWP) joint meeting: Workshop on social media, European Medicines Agency, London, UK, From: 19-Sep-2016, To: 19-Sep-2016
27/07/2016European Medicines Agency Human Scientific Committees' Working Parties with Patients’ and Consumers’ Organisations (PCWP) and Healthcare Professionals’ Organisations (HCPWP) joint meeting, European Medicines Agency, London, UK, From: 20-Sep-2016, To: 20-Sep-2016
27/07/2016Presubmission guidance: questions 1 to 11 (updated)
27/07/2016Scientific guideline: Updated advice on the use of colistin products in animals within the European Union: development of resistance and possible impact on human and animal health, adopted
27/07/2016Recommendations on the use of antibiotics in animals (updated)
27/07/2016News and press releases: Countries should reduce use of colistin in animals to decrease the risk of antimicrobial resistance
27/07/2016Overview of comments received on 'Updated advice on the use of colistin products in animals within the European Union: development of resistance and possible impact on human and animal health' (EMA/231573/2016)
27/07/2016List of medicinal products under additional monitoring (updated)
27/07/2016List of medicinal products under additional monitoring (updated)
27/07/2016List of medicines under additional monitoring (updated)
27/07/2016Use of herbal medicinal products containing pulegone and menthofuran (updated)
26/07/2016Plasma-master-file certifications (updated)
26/07/2016Regulatory and procedural guideline: Dates of 2017 Scientific Advice Working Party meetings and deadlines for submission of scientific advice, protocol assistance, qualification of biomarkers and parallel European Medicines Agency-health-technology-assessment requests
26/07/2016Orphan designation:

Recombinant humanised monoclonal IgG2 lambda antibody against human sclerostin

for the: Treatment of osteogenesis imperfecta
26/07/2016Orphan designation:

Recombinant protein derived from the saliva of the Ornithodoros moubata tick

for the: Treatment of Guillain-Barré syndrome
26/07/2016Human medicines European public assessment report (EPAR): Pemetrexed Fresenius Kabi,

pemetrexed

Revision: 0, Authorised
26/07/2016Orphan designation:

Cyclocreatine

for the: Treatment of creatine deficiency syndromes
26/07/2016Orphan designation:

Pyridoxine and L-pyroglutamic acid

for the: Treatment of fragile X syndrome
26/07/2016Orphan designation:

Modified mRNA encoding the UGT1A1 protein

for the: Treatment of Crigler-Najjar syndrome
26/07/2016Orphan designation:

Setmelanotide

for the: Treatment of Prader-Willi syndrome
26/07/2016Human medicines European public assessment report (EPAR): NovoRapid,

insulin aspart

Revision: 24, Authorised
26/07/2016Human medicines European public assessment report (EPAR): Xeloda,

capecitabine

Revision: 21, Authorised
26/07/2016Orphan designation:

3-(5-Amino-2-methyl-4-oxoquinazolin-3(4H)-yl)piperidine-2,6-dione hydrochloride-

for the: Treatment of diffuse large B-cell lymphoma
26/07/2016Orphan designation:

Humanised anti-IL-6 receptor monoclonal antibody

for the: Treatment of neuromyelitis optica spectrum disorders
26/07/2016Orphan designation:

2'-O-(2-Methoxyethyl) phosphorothioate antisense oligonucleotide targeting the growth hormone receptor

for the: Treatment of acromegaly
26/07/2016Orphan designation:

Eflornithine

for the: Treatment of glioma
26/07/2016Orphan designation:

Donor T lymphocytes depleted ex vivo of host alloreactive T cells using photodynamic treatment-

for the: Treatment in haematopoietic stem cell transplantation
26/07/2016Orphan designation:

Molgramostim

for the: Treatment of acute respiratory distress syndrome
26/07/2016Orphan designation:

Humanised monoclonal antibody targeting interleukin-15

for the: Treatment of eosinophilic oesophagitis
26/07/2016Orphan designation:

Diclofenamide

for the: Treatment of periodic paralysis
26/07/2016Orphan designation:

Teriparatide

for the: Treatment of hypoparathyroidism
26/07/2016Orphan designation:

Allogeneic donor-derived ex-vivo expanded T lymphocytes transduced with a retroviral vector containing inducible caspase 9 and truncated CD19

for the: Treatment in haematopoietic stem cell transplantation
26/07/2016Orphan designation:

Citric acid monohydrate

for the: Treatment of acute liver failure
26/07/2016Orphan designation:

Melatonin

for the: Treatment of neonatal sepsis
26/07/2016Human medicines European public assessment report (EPAR): Eviplera,

emtricitabine / rilpivirine / tenofovir disoproxil

Revision: 16, Authorised
26/07/2016Referral: Article 35, Benzathine benzylpenicillin intended for administration to food-producing species,

benzathine benzylpenicillin

(updated)
26/07/2016Regulatory and procedural guideline: European Medicines Agency guidance for companies requesting classification as minor uses minor species / limited markets, adopted (updated)
26/07/2016Scientific guideline: Guideline on the use of pharmacokinetics and pharmacodynamics in the development of antimicrobial medicinal products, adopted
25/07/2016Human medicines European public assessment report (EPAR): Dropcys,

mercaptamine

Revision: 0, Refused
25/07/2016HMPC meeting report on European Union herbal monographs, guidelines and other activities - 11-12 July 2016
25/07/2016Report: Workshop report - Demonstrating significant benefit of orphan medicines: concepts, methodology and impact on access
25/07/2016Draft European Union herbal monograph on Allium sativum L., bulbus, draft: consultation open
25/07/2016Herbal medicinal products: Allium, Allii sativi bulbus, Allium sativum L. (updated)
25/07/2016Scientific guideline: Questions and answers on mentioning solvents in the product information of veterinary medicinal products authorised via the centralised procedure, adopted (updated)
25/07/2016Scientific guideline: Draft guideline on the higher-tier testing of veterinary medicinal products to dung fauna, draft: consultation open
25/07/2016Scientific guideline: Draft guideline on approach towards harmonisation of withdrawal periods, draft: consultation open
25/07/2016Scientific guideline: Guideline for testing and evaluation of the efficacy of antiparasitic substances for the treatment and prevention of tick and flea infestations in dogs and cats, adopted
25/07/2016Overview of comments received on 'Guideline for the testing and evaluation of the efficacy of antiparasitic substances for the treatment and prevention of tick and flea infestation in dogs and cats' (EMEA/CVMP/EWP/005/2000 Rev. 3)
25/07/2016Draft European Union herbal monograph on Glycine max (L.) Merr., oleum, draft: consultation open
25/07/2016Herbal medicinal products: Glycine, Soiae oleum raffinatum, Glycine max (L.) Merr. (updated)
25/07/2016Questions and answers on how to express the frequency of adverse reactions within the product information
25/07/2016Questions and answers: implementation of the CVMP guideline on environmental impact assessment for veterinary medicinal products in support of the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH) guidelines GL6 (phase I) and GL38 (phase II) (updated)
25/07/2016Stem cell-based products for veterinary use: specific questions on tumorigenicity to be addressed by Ad Hoc Expert Group on Veterinary Novel Therapies (ADVENT)
25/07/2016Scientific guideline: Draft stem cell-based products for veterinary use: specific questions on target animal safety to be addressed by Ad Hoc Expert Group on Veterinary Novel Therapies (ADVENT), draft: consultation open
25/07/2016Scientific guideline: Draft stem cell-based products for veterinary use: specific questions on tumorigenicity to be addressed by Ad Hoc Expert Group on Veterinary Novel Therapies (ADVENT), draft: consultation open
25/07/2016Stem cell-based products for veterinary use: specific questions on target animal safety to be addressed by the Ad Hoc Expert Group on Veterinary Novel Therapies (ADVENT)
25/07/2016Scientific guideline: Concept paper for the revision of the guideline on anticoccidials used for the therapy of coccidiosis in chickens, turkeys and geese, draft: consultation open
25/07/2016Scientific guideline: Concept paper on revision of the current guideline on the summary of product characteristics for antimicrobial products, draft: consultation open
22/07/2016Opinion/decision on a Paediatric investigation plan (PIP): Tecfidera,

Dimethyl fumarate

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

pegloticase

Revision: 3, Withdrawn
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
22/07/2016HMPC: overview of assessment work – priority list (updated)
22/07/2016COMP meeting report on the review of applications for orphan designation: July 2016
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
22/07/2016Preclinical pharmacological and toxicological testing of vaccines (updated)
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
22/07/2016Pending 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
19/07/2016Referral: Article 33, CattleMarker IBR Inactivated,

Infectious bovine rhinotracheitis vaccine (inactivated)

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

pancreas powder

Revision: 0, Authorised
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
19/07/2016Agenda: Agenda - CHMP agenda of the 18-21 July 2016 meeting
19/07/2016New vacancy: Temporary Agent, Master Data Management Architect (updated)
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
18/07/201617 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): -,

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

Therapeutic area: Gastroentology-Hepatology
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): -,

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): -,

Diclofenac (sodium) / capsaicin

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

Hydrogen Peroxide

Therapeutic area: Dermatology
18/07/2016Regulatory and procedural guideline: European Medicines Agency guidance for companies requesting scientific advice (veterinary) (updated)
18/07/2016Template letter of intent for request of scientific advice - veterinary (updated)
15/07/2016EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) pharmaceutical dose forms (updated)
15/07/2016EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) organisations (updated)
15/07/2016EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) substances (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
15/07/2016Press release: Committee for Medicinal Products for Veterinary Use (CVMP) Meeting of 12-14 July 2016
15/07/2016News and press releases: Committee for Medicinal Products for Veterinary Use (CVMP) Meeting of 12-14 July 2016
15/07/2016News and press releases: EMA recommends suspending the veterinary medicine Velactis used in dairy cows at the time of drying off
15/07/2016Pending EC decision: Eravac,

Rabbit haemorrhagic disease type 2 virus (RHDV2), inactivated

Opinion date: 14-Jul-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): BiResp Spiromax,

budesonide / formoterol

Revision: 3, 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): Budesonide/Formoterol Teva,

budesonide / formoterol

Revision: 2, Authorised
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): Vylaer Spiromax,

budesonide / formoterol

Revision: 3, Authorised
15/07/2016Herbal medicinal products: Commiphora, Myrrha, gummi-resina, Commiphora molmol Engler (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: Polypodium , Polypodii rhizoma, Polypodium vulgare L. (updated)
15/07/2016Herbal medicinal products: Trigonella, Trigonellae foenugraeci semen, Trigonella foenum-graecum L. (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): Micardis,

telmisartan

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

ritonavir

Revision: 54, 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): Nplate,

romiplostim

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

eculizumab

Revision: 19, 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): Nivestim,

filgrastim

Revision: 11, 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): Daklinza,

daclatasvir

Revision: 7, 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: salmeterol PSUSA/00002681/201510
11/07/2016List of nationally authorised medicinal products: atomoxetine PSUSA/00000262/201511
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): -,

recombinant parathyroid hormone

Therapeutic area: Endocrinology, -gynacology-fertility-metabolism (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): -,

Grazoprevir

Therapeutic area: Infectious diseases (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 / Elbasvir

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

telmisartan

Revision: 25, Authorised
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): -,

(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)
11/07/2016Opinion/decision on a Paediatric investigation plan (PIP): -,

Fluciclovine (18F)

Therapeutic area: Diagnostic/Oncology (updated)
11/07/2016Opinion/decision on a Paediatric investigation plan (PIP): Ofev,

Nintedanib

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

Osilodrostat

Therapeutic area: Endocrinology, -gynacology-fertility-metabolism (updated)
11/07/2016Public summary of the evaluation of a proposed paediatric investigation plan: Human normal immunoglobulin for treatment of primary immunodeficiency
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
11/07/2016Public 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: 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: Nintedanib for the treatment of systemic sclerosis
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: (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
11/07/2016Opinion/decision on a Paediatric investigation plan (PIP): Truvada,

Emtricitabine / tenofovir disoproxil fumarate

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, Retinoid-containing medicinal products,

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

08/07/2016Referral: Article 31 referrals, Factor VIII
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, Paracetamol-modified release,

paracetamol

08/07/2016Getting involved (updated)
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): 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): Inflectra,

infliximab

Revision: 11, 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
08/07/2016CMDh Scientific conclusions and grounds for the variation, amendments to the Product Information and timetable for the implementation: diclofenac (systemic formulations) PSUSA/00001048/201509
08/07/2016List of nationally authorised medicinal products: diclofenac (systemic formulations) PSUSA/00001048/201509
08/07/2016Clinical evaluation of medicinal products used in weight control (updated)
08/07/2016Clinical investigation on medicinal products in the treatment of hypertension (updated)
08/07/2016Overview of comments received on 'Guideline on clinical evaluation of medicinal products used in weight control'
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 hypertension, adopted
08/07/2016Clinical investigation of medicinal products in the treatment of lipid disorders (updated)
08/07/2016Overview of comments received on ''Guideline on clinical investigation of medicinal products in the treatment of hypertension'
08/07/2016Scientific guideline: Guideline on clinical investigation of medicinal products in the treatment of lipid disorders, 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
07/07/2016Work instructions for publication of web content on www.ema.europa.eu, adopted (updated)
07/07/2016European medicines agency Standard operating procedure (SOP): Standard operating procedure for micro, small and medium-sized enterprises (SME) conditional fee exemptions
07/07/2016CMDh 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
07/07/2016List of nationally authorised medicinal products: 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
07/07/2016Implementing ISO IDMP: introduction to SPOR data services, European Medicines Agency, London, UK, From: 04-Aug-2016, To: 04-Aug-2016
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
06/07/2016CMDh Scientific conclusions and grounds for the variation, amendments to the Product Information and timetable for the implementation: iodine (131i) iobenguane PSUSA/00001764/201505 (updated)
06/07/2016Questions and answers: Article 30 referral procedures
06/07/2016Questions and answers: Article 13 referral procedures
06/07/2016Questions and answers: Article 29(4) referral procedures
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 31 non-pharmacovigilance referrals
06/07/2016Questions and answers: Article 20 non-pharmacovigilance procedures
06/07/2016Regulatory and procedural guideline: Questions and answers on Article 20 non-pharmacovigilance procedures
06/07/2016Regulatory and procedural guideline: Questions and answers on Article 13 referral procedures
06/07/2016List of nationally authorised medicinal products: iodine (131i) iobenguane PSUSA/00001764/201505 (updated)
06/07/2016Questions and answers: Article 31 non-pharmacovigilance referrals
06/07/2016Regulatory and procedural guideline: Questions and answers on Article 30 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