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August 2017

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31/08/2017Human medicines European public assessment report (EPAR): Halaven,

eribulin

Revision: 15, Authorised
31/08/2017Isotretinoin (oral formulations): List of nationally authorised medicinal products - PSUSA/00010488/201611
31/08/2017Isotretinoin (oral formulations): CMDh scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010488/201611
31/08/2017Human medicines European public assessment report (EPAR): Memantine Accord,

memantine

Revision: 3, Authorised
31/08/2017Human medicines European public assessment report (EPAR): Dificlir,

fidaxomicin

Revision: 9, Authorised
31/08/2017Human medicines European public assessment report (EPAR): Iscover,

clopidogrel

Revision: 37, Authorised
31/08/2017Human medicines European public assessment report (EPAR): Tovanor Breezhaler,

glycopyrronium bromide

Revision: 9, Authorised
31/08/2017Human medicines European public assessment report (EPAR): Cayston,

aztreonam

Revision: 15, Authorised
31/08/2017Human medicines European public assessment report (EPAR): Taxespira (previously Docetaxel Hospira UK Limited ),

docetaxel

Revision: 6, Authorised
31/08/2017Human medicines European public assessment report (EPAR): Kisqali,

ribociclib

Revision: 0, Authorised
31/08/2017Human medicines European public assessment report (EPAR): Ovaleap,

follitropin alfa

Revision: 5, Authorised
31/08/2017Human medicines European public assessment report (EPAR): Signifor,

pasireotide

Revision: 9, Authorised
31/08/2017Human medicines European public assessment report (EPAR): Rivastigmine Actavis,

rivastigmine

Revision: 12, Authorised
31/08/2017Human medicines European public assessment report (EPAR): Busilvex,

busulfan

Revision: 16, Authorised
31/08/2017Human medicines European public assessment report (EPAR): Zykadia,

ceritinib

Revision: 7, Authorised
31/08/2017Human medicines European public assessment report (EPAR): Imraldi,

adalimumab

Revision: 0, Authorised
31/08/2017Referral: Article 31 referrals, Quinolone- and fluoroquinolone-containing medicinal products,

nalidixic acid, pipemidic acid, cinoxacin, enoxacin, pefloxacin, lomefloxacin, ciprofloxacin, levofloxacin, ofloxacin, moxifloxacin, norfloxacin, prulifloxacin, rufloxacin, flumequin

(updated)
31/08/2017Scientific guideline: Draft ICH E9 (R1) addendum on estimands and sensitivity analysis in clinical trials to the guideline on statistical principles for clinical trials, step 2b - Revision 1, draft: consultation open
31/08/2017Scientific guideline: Draft ICH S5 (R3) guideline on reproductive toxicology: detection of toxicity to reproduction for human pharmaceuticals, step 2b - Revision 3, draft: consultation open
31/08/2017ICH E9 statistical principles for clinical trials (updated)
31/08/2017ICH S5 (R2) reproductive toxicology: detection of toxicity to reproduction for human pharmaceuticals (updated)
30/08/2017Human medicines European public assessment report (EPAR): Darzalex,

daratumumab

Revision: 3, Authorised
30/08/2017Human medicines European public assessment report (EPAR): Dacogen,

decitabine

Revision: 10, Authorised
30/08/2017Human medicines European public assessment report (EPAR): Blincyto,

blinatumomab

Revision: 4, Authorised
30/08/2017Human medicines European public assessment report (EPAR): Filgrastim Hexal,

filgrastim

Revision: 12, Authorised
30/08/2017Human medicines European public assessment report (EPAR): Alli (previously Orlistat GSK),

orlistat

Revision: 15, Authorised
30/08/2017Human medicines European public assessment report (EPAR): Imnovid (previously Pomalidomide Celgene),

pomalidomide

Revision: 10, Authorised
30/08/2017Human medicines European public assessment report (EPAR): Thyrogen,

thyrotropin alfa

Revision: 21, Authorised
30/08/2017EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) pharmaceutical dose forms (updated)
30/08/2017EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) substances (updated)
30/08/2017EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) organisations (updated)
30/08/2017EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) routes of administration (updated)
30/08/2017Human medicines European public assessment report (EPAR): Constella,

linaclotide

Revision: 13, Authorised
30/08/2017Human medicines European public assessment report (EPAR): Siklos,

hydroxycarbamide

Revision: 12, Authorised
30/08/2017Annual renewal of conditional marketing authorisations: questions and answers (updated)
30/08/2017Renewals: questions and answers (updated)
30/08/2017Pre-authorisation guidance (updated)
30/08/2017Post-authorisation measures: questions and answers (updated)
30/08/2017Classification of changes: questions and answers (updated)
30/08/2017Annual re-assessment: questions and answers (updated)
30/08/2017Extensions of marketing authorisations: questions and answers (updated)
30/08/2017Periodic safety update reports: questions and answers (updated)
30/08/2017Regulatory and procedural guideline: European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure: document with tracked changes (updated)
30/08/2017Regulatory and procedural guideline: European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure (updated)
30/08/2017Regulatory and procedural guideline: European Medicines Agency post-authorisation procedural advice for users of the centralised procedure (updated)
30/08/2017Regulatory and procedural guideline: European Medicines Agency post-authorisation procedural advice for users of the centralised procedure - track changes (updated)
30/08/2017Human medicines European public assessment report (EPAR): Caprelsa,

vandetanib

Revision: 9, Authorised
29/08/2017Agenda: Agenda - PRAC draft agenda of meeting 29 August-1 September 2017
29/08/2017PSUR roadmap: joint industry/assessor training, European Medicines Agency, London, UK, From: 22-Sep-2017, To: 22-Sep-2017
29/08/2017Human medicines European public assessment report (EPAR): Tyverb,

lapatinib

Revision: 24, Authorised
29/08/2017Organisation chart: Human Medicines Evaluation (updated)
29/08/2017Human medicines European public assessment report (EPAR): Xarelto,

rivaroxaban

Revision: 22, Authorised
29/08/2017Human medicines European public assessment report (EPAR): Aranesp,

darbepoetin alfa

Revision: 37, Authorised
29/08/2017Tixocortol, chlorhexidine gluconate / tixocortol pivalate : List of nationally authorised medicinal products - PSUSA/00010333/201611
29/08/2017Tixocortol, chlorhexidine gluconate / tixocortol pivalate : CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00010333/201611
25/08/2017Human medicines European public assessment report (EPAR): Temomedac,

temozolomide

Revision: 10, Authorised
25/08/2017Agenda: Agenda – Eleventh stakeholder forum on the pharmacovigilance legislation
25/08/2017Eleventh stakeholder forum on the pharmacovigilance legislation, European Medicines Agency, London, UK, From: 21-Sep-2017, To: 21-Sep-2017
25/08/2017Human medicines European public assessment report (EPAR): Prolia,

denosumab

Revision: 16, Authorised
25/08/2017Human medicines European public assessment report (EPAR): Soliris,

eculizumab

Revision: 22, Authorised
25/08/2017Lenograstim: CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00001839/201610
25/08/2017Lenograstim: List of nationally authorised medicinal products - PSUSA/00001839/201610
24/08/2017Regulatory and procedural guideline: List of centrally authorised products requiring a notification of a change for update of annexes (updated)
24/08/2017Human medicines European public assessment report (EPAR): SonoVue,

sulphur hexafluoride

Revision: 15, Authorised
24/08/2017Veterinary medicine European public assessment report (EPAR): Quadrisol,

vedaprofen

Revision: 18, Authorised
24/08/2017Human medicines European public assessment report (EPAR): Xofigo,

radium Ra223 dichloride

Revision: 7, Authorised
24/08/2017Human medicines European public assessment report (EPAR): Ristfor,

sitagliptin / metformin hydrochloride

Revision: 15, Authorised
24/08/2017Human medicines European public assessment report (EPAR): Inhixa,

enoxaparin sodium

Revision: 3, Authorised
23/08/2017Human medicines European public assessment report (EPAR): Revolade,

eltrombopag

Revision: 18, Authorised
23/08/2017Human medicines European public assessment report (EPAR): Forxiga,

dapagliflozin

Revision: 11, Authorised
23/08/2017Human medicines European public assessment report (EPAR): Fampyra,

fampridine

Revision: 11, Authorised
23/08/2017Human medicines European public assessment report (EPAR): PegIntron,

peginterferon alfa-2b

Revision: 35, Authorised
23/08/2017Human medicines European public assessment report (EPAR): Ristaben,

sitagliptin

Revision: 16, Authorised
23/08/2017News and press releases: Strengthening EU-US cooperation in medicine inspections
23/08/2017Statement of authority and confidentiality commitment from the United States Food and drug Administration (FDA) not publicly disclose non-public information shared by the European Commission's Directorate-General for Health and Food Safety and the European Medicines Agency (EMA)
23/08/2017Statement of authority and confidentiality commitment from the European Comission's Directorate-General for Health and Food Safety and the European Medicines Agency (EMA) not to publicy disclose non-public information shared by the United States Food and Drug Administration (FDA)
23/08/2017United States (updated)
22/08/2017Human medicines European public assessment report (EPAR): Spectrila,

asparaginase

Revision: 1, Authorised
22/08/2017Human medicines European public assessment report (EPAR): Olysio,

simeprevir

Revision: 11, Authorised
22/08/2017Human medicines European public assessment report (EPAR): Odefsey,

emtricitabine / rilpivirine / tenofovir alafenamide

Revision: 7, Authorised
22/08/2017Human medicines European public assessment report (EPAR): Genvoya,

elvitegravir / cobicistat / emtricitabine / tenofovir alafenamide

Revision: 10, Authorised
22/08/2017Non-clinical documentation for herbal medicinal products in applications for marketing authorization (updated)
22/08/2017Scientific guideline: Draft guideline on non-clinical documentation in applications for marketing authorisation/registration of well-established and traditional herbal medicinal products - Revision 1, draft: consultation open
22/08/2017Human medicines European public assessment report (EPAR): Temozolomide Sun,

temozolomide

Revision: 10, Authorised
22/08/2017Human medicines European public assessment report (EPAR): Xalkori,

crizotinib

Revision: 17, Authorised
22/08/2017Human medicines European public assessment report (EPAR): Travatan,

travoprost

Revision: 26, Authorised
22/08/2017Human medicines European public assessment report (EPAR): Emend,

aprepitant

Revision: 22, Authorised
22/08/2017Human medicines European public assessment report (EPAR): Edistride,

dapagliflozin

Revision: 6, Authorised
22/08/2017Human medicines European public assessment report (EPAR): Chenodeoxycholic acid Leadiant (previously known as Chenodeoxycholic acid sigma-tau),

chenodeoxycholic acid

Revision: 2, Authorised
22/08/2017Human medicines European public assessment report (EPAR): Ammonaps,

sodium phenylbutyrate

Revision: 15, Authorised
22/08/2017Human medicines European public assessment report (EPAR): Perjeta,

pertuzumab

Revision: 11, Authorised
22/08/2017PSUR Assessment Report template for use by the European Medicines Agency (updated)
22/08/2017Human medicines European public assessment report (EPAR): Silapo,

epoetin zeta

Revision: 12, Authorised
22/08/2017Human medicines European public assessment report (EPAR): Arzerra,

ofatumumab

Revision: 16, Authorised
22/08/2017PSUR Assessment Report template for use by Member States (updated)
21/08/2017Human medicines European public assessment report (EPAR): Sirturo,

bedaquiline

Revision: 12, Authorised
21/08/2017Human medicines European public assessment report (EPAR): ViraferonPeg,

peginterferon alfa-2b

Revision: 35, Authorised
21/08/2017Human medicines European public assessment report (EPAR): Descovy,

emtricitabine / tenofovir alafenamide

Revision: 7, Authorised
21/08/2017Human medicines European public assessment report (EPAR): Ebymect,

dapagliflozin / metformin

Revision: 6, Authorised
21/08/2017Notices of calls for tender - 2017 (updated)
21/08/2017Healthy animals, healthy people - leaflet
21/08/2017News and press releases: Better veterinary medicines for healthier animals and people
18/08/2017Referral: Article 29(4) referrals, Paracetamol/Ibuprofen 500 mg/150 mg film-coated tablets,

paracetamol-ibuprofen

(updated)
18/08/2017Agenda: Agenda and registration form - EudraVigilance information day on 19 September 2017 (updated)
18/08/2017Human medicines European public assessment report (EPAR): Norvir,

ritonavir

Revision: 57, Authorised
18/08/2017Human medicines European public assessment report (EPAR): IntronA,

interferon alfa-2b

Revision: 28, Authorised
18/08/2017EU Telematics (updated)
18/08/2017The joint European Union Telematics governance model (updated)
18/08/2017EU Telematics systems in operation
18/08/2017Report: Annual report of the Good Clinical Practice Inspectors Working Group 2016
18/08/2017Report: Scientific recommendation on classification of advanced therapy medicinal products: Allogeneic human mesenchymal stem cells derived from Wharton’s jelly tissue of umbilical cord
18/08/2017Report: Scientific recommendation on classification of advanced therapy medicinal products: Autologous adipose derived mesenchymal stem cells, freshly isolated
18/08/2017Report: Scientific recommendation on classification of advanced therapy medicinal products: Cultured allogenic Wharton’s jelly derived mesenchymal stem cells
18/08/2017Report: Scientific recommendation on classification of advanced therapy medicinal products: Cultured autologous adipose derived mesenchymal stem cells
18/08/2017Report: Scientific recommendation on classification of advanced therapy medicinal products: Cultured autologous adipose derived regenerative mesenchymal stem cells
18/08/2017Report: Scientific recommendation on classification of advanced therapy medicinal products: Cultured autologous Wharton’s jelly derived mesenchymal stem cells
18/08/2017Summaries of scientific recommendations on classification of advanced therapy medicinal products (updated)
18/08/2017Report: Scientific recommendation on classification of advanced therapy medicinal products: Replication incompetent adenoviral vector encoding Interleukin 12 with activator ligand
18/08/2017Report: Scientific recommendation on classification of advanced therapy medicinal products: Autologous human adipose perivascular stromal cells genetically modified to secrete soluble TRAIL ligand
18/08/2017Report: Scientific recommendation on classification of advanced therapy medicinal products: Allogeneic haptenized, stimulated and irradiated non-proliferative colorectal tumour whole cells derived from 3 colorectal cell lines
18/08/2017Report: Scientific recommendation on classification of advanced therapy medicinal products: Resorbable, viscoelastic matrix
18/08/2017Report: Scientific recommendation on classification of advanced therapy medicinal products: Human cultured dermal fibroblasts and human epidermal keratinocytes
18/08/2017Report: Scientific recommendation on classification of advanced therapy medicinal products: Human autologous adipose-derived stromal/stem Cells (ADSCs)
18/08/2017Report: Scientific recommendation on classification of advanced therapy medicinal products: Human autologous stromal vascular fraction (SVF)
18/08/2017Report: Scientific recommendation on classification of advanced therapy medicinal products: Recombinant adeno-associated virus (AAV) pseudotyped with viral capsid from serotype 5 which holds a construct that contains two guide ribonucleic acids (gRNAs) sequences (CEP290-64 and CEP290-323) driven by human U6 promoter elements and the clustered regularly interspaced
18/08/2017Report: Scientific recommendation on classification of advanced therapy medicinal products: Allogeneic suspension of unexpanded and uncultured human amniotic fluid-derived cells
18/08/2017Human medicines European public assessment report (EPAR): Intelence,

etravirine

Revision: 21, Authorised
18/08/2017Human medicines European public assessment report (EPAR): Odomzo,

sonidegib

Revision: 4, Authorised
18/08/2017Human medicines European public assessment report (EPAR): Tafinlar,

dabrafenib

Revision: 12, Authorised
17/08/2017Human medicines European public assessment report (EPAR): Maviret, Revision: 0, Authorised
17/08/2017Herbal medicinal products: Echinacea, Echinaceae purpureae radix, Echinacea purpurea (L.) Moench. (updated)
17/08/2017Human medicines European public assessment report (EPAR): Strimvelis,

autologous CD34+ enriched cell fraction that contains CD34+ cells transduced with retroviral vector that encodes for the human ADA cDNA sequence

Revision: 1, Authorised
17/08/2017Human medicines European public assessment report (EPAR): Cosentyx,

secukinumab

Revision: 7, Authorised
17/08/2017Human medicines European public assessment report (EPAR): Relvar Ellipta,

fluticasone furoate / vilanterol

Revision: 10, Authorised
17/08/2017Human medicines European public assessment report (EPAR): Janumet,

sitagliptin / metformin

Revision: 20, Authorised
17/08/2017Human medicines European public assessment report (EPAR): Fycompa,

perampanel

Revision: 12, Authorised
17/08/2017Baclofen (oral): CMDh scientific conclusions and grounds for the variation, amendments to the product information, and timetable for the implementation - PSUSA/00000294/201609 (updated)
17/08/2017Baclofen (oral): List of nationally authorised medicinal products - PSUSA/00000294/201609 (updated)
17/08/2017News and press releases: Tick and flea control agent Bravecto continues to be acceptably safe to use
17/08/2017Human medicines European public assessment report (EPAR): Blitzima,

rituximab

Revision: 0, Authorised
16/08/2017Referentials and organisations management services (updated)
16/08/2017Human medicines European public assessment report (EPAR): Empliciti,

elotuzumab

Revision: 2, Authorised
16/08/2017Human medicines European public assessment report (EPAR): Picato,

ingenol mebutate

Revision: 7, Authorised
16/08/2017Orphan designation:

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

for the: Treatment of choroideremia (updated)
16/08/2017Orphan designation:

Recombinant humanised monoclonal IgG2 lambda antibody against human sclerostin

for the: Treatment of osteogenesis imperfecta (updated)
16/08/2017Orphan designation:

adenovirus associated viral vector serotype 5 containing the human pde6β gene

for the: Treatment of retinitis pigmentosa (updated)
16/08/2017Agenda: Agenda - PDCO agenda of the 15-18 August 2017 meeting
16/08/2017Orphan designation:

Humanised IgG4 monoclonal antibody against extracellular tau

for the: Treatment of progressive supranuclear palsy (updated)
16/08/2017Orphan designation:

Ciclosporin (inhalation use)

for the: Treatment of graft rejection after lung transplantation (updated)
16/08/2017Orphan designation:

Ciclosporin (inhalation use)

for the: Prevention of graft rejection after lung transplantation (updated)
16/08/2017Orphan designation:

Autologous CD34+ cells transduced with a lentiviral vector containing the human SGSH gene

for the: Treatment of mucopolysaccharidosis IIIA (Sanfilippo A syndrome) (updated)
16/08/2017Orphan designation:

Adenovirus associated viral vector serotype 4 containing the human RPE65 gene

for the: Treatment of retinitis pigmentosa (updated)
16/08/2017Orphan designation:

Adenovirus associated viral vector serotype 4 containing the human RPE65 gene

for the: Treatment of leber's congenital amaurosis (updated)
16/08/2017Orphan designation:

Methoxsalen

for the: Treatment of graft-versus-host disease (updated)
16/08/2017Orphan designation:

Emeramide

for the: Prevention of mercury toxicity (updated)
16/08/2017Orphan designation:

N,N'-bis(2-mercaptoethyl)isophthalamide (emeramide)

for the: Treatment of mercury toxicity (updated)
16/08/2017Human medicines European public assessment report (EPAR): Anoro,

umeclidinium bromide / vilanterol

Revision: 7, Authorised
16/08/2017Human medicines European public assessment report (EPAR): Ninlaro,

ixazomib

Revision: 1, Authorised
16/08/2017Human medicines European public assessment report (EPAR): Efficib,

sitagliptin / metformin

Revision: 21, Authorised
16/08/2017Human medicines European public assessment report (EPAR): Humira,

adalimumab

Revision: 59, Authorised
16/08/2017Orphan designation:

Synthetic hepcidin

for the: Treatment of beta thalassaemia intermedia and major (updated)
16/08/2017Orphan designation:

synthetic human hepcidin

for the: treatment of sickle cell disease (updated)
16/08/2017Orphan designation:

Fluocinolone acetonide

for the: Treatment of non-infectious uveitis (updated)
16/08/2017Orphan designation:

4-[(2E)-1-oxo-3-(2,6,6-trimethyl-1-cyclohexen-1-yl)-2-propen-1-yl]-1-piperazinecarboxamide

for the: Treatment of retinitis pigmentosa (updated)
16/08/2017Orphan designation:

Pyr-His-Trp-Ser-Tyr-D-Lys(doxorubicinylglutarate)-Leu-Arg-Pro-Gly-NH2, acetate salt

for the: Treatment of ovarian cancer (updated)
16/08/2017Minutes of the HMPC 29-30 May 2017 meeting
16/08/2017Orphan designation:

Desipramine chlorhydrate

for the: Treatment of Rett syndrome (updated)
16/08/2017Orphan designation:

(2-aminoethyl) carbamic acid (2R,5S,8S,11S,14R,17S,19aS)-11-(4-aminobutyl)-5-benzyl-8-(4-benzyloxy benzyl)-14-(1H-indol-3-ylmethyl)-4,7,10,13,16,19-hexaoxo-17-phenyloctadecahydro-3a,6,9,12,15,18-hexaazacyclopentacyclooctadecen-2-yl ester, di[(S)-2-aminosu (pasireotide)

for the: Treatment of functional gastro-entero-pancreatic endocrine tumours (updated)
16/08/2017Orphan designation:

Polyphenyl(disodium 3-O-sulfo-beta-D-glucopyranuronate)-(1->3)-beta-D-galactopyranoside

for the: Treatment of anti-MAG neuropathy
15/08/2017Inductos (dibotermin alfa) - Supply shortage
15/08/2017Dissolution specification for generic oral immediate release products (updated)
15/08/2017Scientific guideline: Reflection paper on the dissolution specification for generic solid oral immediate release products with systemic action - First version
15/08/2017Scientific guideline: Overview of comments received on 'Draft reflection paper on the dissolution specification for generic solid oral immediate release products with systemic action' - First version
15/08/2017Human medicines European public assessment report (EPAR): Cyanokit,

hydroxocobalamin

Revision: 9, Authorised
15/08/2017Orphan designation:

Oxymetazoline hydrochloride gel

for the: Treatment of spinal cord injury
15/08/2017Human medicines European public assessment report (EPAR): Rituzena (previously Tuxella),

rituximab

Revision: 0, Authorised
15/08/2017Orphan designation:

Bacillus subtilis oxalate decarboxylase

for the: Treatment of primary hyperoxaluria
15/08/2017Orphan designation:

Retinol

for the: Prevention of retinopathy of prematurity
15/08/2017Human medicines European public assessment report (EPAR): Giotrif,

afatinib

Revision: 9, Authorised
15/08/2017Withdrawn application: Qinprezo,

vosaroxin

Initial authorisation (updated)
15/08/2017Human medicines European public assessment report (EPAR): Ritemvia,

rituximab

Revision: 0, Authorised
15/08/2017Launch of the new EudraVigilance system: questions and answers from stakeholders (updated)
14/08/2017Human medicines European public assessment report (EPAR): Uptravi,

selexipag

Revision: 4, Authorised
14/08/2017Human medicines European public assessment report (EPAR): Adcetris,

brentuximab vedotin

Revision: 19, Authorised
14/08/2017Orphan designation:

Autologous CD4+ and CD8+ T cells expressing a CD19-specific chimeric antigen receptor

for the: Treatment of diffuse large B-cell lymphoma
14/08/2017Human medicines European public assessment report (EPAR): Nivestim,

filgrastim

Revision: 15, Authorised
14/08/2017Orphan designation:

5(S)-(2'-hydroxy ethoxy)-20(S)-Camptothecin

for the: Treatment of osteosarcoma (updated)
14/08/2017Orphan designation:

Tirapazamine

for the: Treatment of hepatocellular carcinoma
14/08/2017Orphan designation:

Recombinant human heat-shock protein 70

for the: Treatment of Niemann-Pick’s disease, type C (updated)
14/08/2017Orphan designation:

Recombinant human antibody directed against misfolded human superoxide dismutase 1

for the: Treatment of amyotrophic lateral sclerosis
14/08/2017Orphan designation:

Sirolimus

for the: Treatment of pachyonychia congenita
14/08/2017Human medicines European public assessment report (EPAR): Inflectra,

infliximab

Revision: 15, Authorised
14/08/2017Agenda: Agenda - CHMP agenda of the 14-17 August 2017 written procedure
14/08/2017Referral: Article 35, Zinc oxide
14/08/2017Human medicines European public assessment report (EPAR): Temozolomide Hexal,

temozolomide

Revision: 13, Authorised
14/08/2017Scientific guideline: Guideline on manufacture of the finished dosage form - Revision 1, adopted
14/08/2017Manufacture of the finished dosage form (updated)
14/08/2017Human medicines European public assessment report (EPAR): Benepali,

etanercept

Revision: 5, Authorised
11/08/2017Agenda: Agenda - CAT agenda for the written procedure - 7-11 August 2017
11/08/2017Report: CAT monthly report of application procedures, guidelines and related documents on advanced therapies: July 2017
11/08/2017Report: Medicinal products for human use: monthly figures - July 2017
11/08/2017New vacancy: Temporary Agent (AD6), Database Administrator (updated)
10/08/2017Orphan designation:

N-carboxymethyl-glycyl-L-threonyl-L-histidyl-L-3,3-diphenylalanyl-L-piperidincarboxy-3-yl-L-arginyl-L-S-methylthio-cystyl-L-arginyl-L-tryptophyl-aminohexanyl-N-carboxamidomethyl-glycine N-hexadecylamide

for the: Treatment of beta thalassaemia intermedia and major (updated)
10/08/2017Orphan designation:

{2-amino-8-[4-(pyrrolidinylcarbonyl)phenyl]-(3H-benzo[f]azepin-4-yl)}-N,N-dipropylcarboxamide

for the: Treatment of ovarian cancer (updated)
10/08/2017Human medicines European public assessment report (EPAR): Ebilfumin,

oseltamivir

Revision: 6, Authorised
10/08/2017Human medicines European public assessment report (EPAR): Infanrix Hexa,

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

Revision: 34, Authorised
10/08/2017Human medicines European public assessment report (EPAR): Thorinane,

enoxaparin sodium

Revision: 1, Authorised
10/08/2017Enabling science that works for patients – leaflet
10/08/2017News and press releases: Science and innovation for better medicines
10/08/2017Monthly report on application procedures guidelines and related documents for veterinary medicines: July 2017
10/08/2017Human medicines European public assessment report (EPAR): Januvia,

sitagliptin

Revision: 21, Authorised
10/08/2017Human medicines European public assessment report (EPAR): Ferriprox,

deferiprone

Revision: 22, Authorised
09/08/2017Human medicines European public assessment report (EPAR): Trimbow,

beclometasone / formoterol / glycopyrronium bromide

Revision: 0, Authorised
09/08/2017European Medicines Agency meeting and holiday dates 2018 (updated)
09/08/2017Newsletter: Human medicines highlights - August 2017
09/08/2017Human medicines European public assessment report (EPAR): Pregabalin Pfizer,

pregabalin

Revision: 10, Authorised
09/08/2017Newsletter: What's new in pharmacovigilance - QPPV Update - Issue 2 - 2017
09/08/2017The European Union regulatory network incident management plan for medicines for human use (updated)
09/08/2017Veterinary medicine European public assessment report (EPAR): Equioxx,

firocoxib

Revision: 7, Authorised
09/08/2017Agenda: Programme and registration form - Joint European Medicines Agency / Drug Information Association information day on measuring the impact of pharmacovigilance activities, 14 November 2017 (updated)
09/08/2017Human medicines European public assessment report (EPAR): Orencia,

abatacept

Revision: 25, Authorised
09/08/2017Minutes of the CAT meeting 10-12 May 2017
08/08/2017Regulatory and procedural guideline: Guide for rapporteurs and coordinators on the multinational assessment teams
08/08/2017Human medicines European public assessment report (EPAR): Temozolomide Teva,

temozolomide

Revision: 16, Authorised
08/08/2017Human medicines European public assessment report (EPAR): Xeplion,

paliperidone

Revision: 10, Authorised
08/08/2017Annual report of the Pharmacovigilance Inspectors Working Group for 2016
08/08/2017Human medicines European public assessment report (EPAR): Leflunomide Winthrop,

leflunomide

Revision: 13, Authorised
08/08/2017Referral: Article 31 referrals, Medicinal products containing lactose of bovine origin for IV/IM use in acute allergic reactions,

methylprednisolone

(updated)
08/08/2017European medicines agency Standard operating procedure (SOP): Standard operating procedure for management of periodic safety update reports (PSURs) for centrally authorised veterinary medicinal products: Annex I – contact details of national competent authorities (NCAs) for PSUR submission (updated)
08/08/2017News and press releases: EMA supports regulatory harmonisation in East Africa
08/08/2017List of withdrawn medicinal products in accordance with Art. 123(4) of the Directive (31/07/2017) (updated)
07/08/2017Human medicines European public assessment report (EPAR): Arava,

leflunomide

Revision: 33, Authorised
07/08/2017Human medicines European public assessment report (EPAR): Zinforo,

ceftaroline fosamil

Revision: 14, Authorised
07/08/2017PRAC recommendations on signals adopted at the 3-6 July 2017 PRAC meeting, adopted
07/08/2017List of signals discussed at the PRAC since September 2012 (updated)
07/08/2017New product information wording: extracts from PRAC recommendations on signals adopted at the 3-6 July 2017 PRAC
07/08/2017Human medicines European public assessment report (EPAR): Vizarsin,

sildenafil

Revision: 13, Authorised
07/08/2017Human medicines European public assessment report (EPAR): Xelevia,

sitagliptin

Revision: 23, Authorised
07/08/2017Human medicines European public assessment report (EPAR): Tesavel,

sitagliptin

Revision: 17, Authorised
07/08/2017Human medicines European public assessment report (EPAR): DepoCyte,

cytarabine

Revision: 15, Authorised
07/08/2017The new EudraVigilance system – Public communications plan for European Medicines Agency and National Competent Authorities in the European Economic Area: overview of the planned public communication milestones
07/08/2017Human medicines European public assessment report (EPAR): Torisel,

temsirolimus

Revision: 26, Authorised
07/08/2017EudraVigilance change management (updated)
07/08/2017Human medicines European public assessment report (EPAR): Temozolomide Accord,

temozolomide

Revision: 15, Authorised
07/08/2017Report: Applications for new human medicines under evaluation by the CHMP: August 2017
04/08/2017Human medicines European public assessment report (EPAR): Eperzan,

albiglutide

Revision: 7, Authorised
04/08/2017Human medicines European public assessment report (EPAR): Feraccru,

ferric maltol

Revision: 4, Authorised
04/08/2017Carbidopa / levodopa (except for centrally authorised product): CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00000548/201610
04/08/2017Carbidopa / levodopa (except for centrally authorised product): List of nationally authorised medicinal products - PSUSA/00000548/201610
04/08/2017Draft European Union herbal monograph on Cimicifuga racemosa (L.) Nutt., rhizome - Revision 1, draft: consultation open
04/08/2017Veterinary medicine European public assessment report (EPAR): Broadline,

eprinomectin, fipronil, praziquantel, (S)-methoprene

Revision: 5, Authorised
04/08/2017Herbal medicinal products: Cimicifuga, Cimicifugae rhizoma, Cimicifuga racemosa (L.) Nutt. (updated)
04/08/2017Human medicines European public assessment report (EPAR): Velmetia,

sitagliptin / metformin

Revision: 22, Authorised
04/08/2017Human medicines European public assessment report (EPAR): Seebri Breezhaler,

glycopyrronium bromide

Revision: 6, Authorised
04/08/2017CHMP ORGAM minutes for the meeting on 12 June 2017
04/08/2017CHMP ORGAM minutes for the meeting on 10 July 2017
04/08/2017Workshop on generation and use of Health Based Exposure Limits (HBEL), European Medicines Agency, London, UK, From: 20-Jun-2017, To: 21-Jun-2017 (updated)
04/08/2017Human medicines European public assessment report (EPAR): Enurev Breezhaler,

glycopyrronium bromide

Revision: 6, Authorised
04/08/2017Summary of discussions - Workshop on generation and use of Health Based Exposure Limits (HBEL)
04/08/2017Templates for assessors (updated)
04/08/2017One year of additional market protection for new indication assessment report template
04/08/2017Renewal assessment report template
04/08/2017 Risk management plan (RMP) assessment report sub-template for type II variations and periodic safety update reports (PSURs)
04/08/2017Annual re-assessment assessment report template
04/08/2017Annual renewal assessment report template
04/08/2017Non-imposed post-authorisation safety study (PASS) final results assessment report sub-template for type II variations
04/08/2017Post-authorisation efficacy studies (PAES) assessment report sub-template for type II variations
04/08/2017PRAC advice template
04/08/2017One year extension of data protection for legal status switch assessment report template
04/08/2017One year extension of data protection for new indication of well-established use product assessment report template
04/08/2017Human medicines European public assessment report (EPAR): Temozolomide Sandoz,

temozolomide

Revision: 14, Authorised
04/08/2017Referral: Article 35, Methylprednisolone injection for cattle
03/08/2017Tadalafil product-specific bioequivalence guidance (updated)
03/08/2017Scientific guideline: Draft tadalafil film-coated tablets 2.5 mg, 5 mg, 10 mg and 20 mg product-specific bioequivalence guidance - Revision 1, draft: consultation open
03/08/2017Prasugrel product-specific bioequivalence guidance (updated)
03/08/2017Scientific guideline: Draft prasugrel hydrochloride film-coated tablets 5 mg and 10 mg product-specific bioequivalence guidance - Revision 1, draft: consultation open
03/08/2017Human medicines European public assessment report (EPAR): Cinryze,

C1 inhibitor (human)

Revision: 14, Authorised
03/08/2017Human medicines European public assessment report (EPAR): Kyntheum,

brodalumab

Revision: 0, Authorised
03/08/2017Scientific guideline: Draft dimethyl fumarate gastro-resistant capsules 120 mg and 240 mg product-specific bioequivalence guidance, draft: consultation open
03/08/2017Dimethyl fumarate gastro-resistant capsules 120 mg and 240 mg product-specific bioequivalence guidance
03/08/2017Minutes - PDCO minutes of the 20-23 June 2017 meeting
03/08/2017Ibuprofen 200 - 800 mg oral use, immediate release formulations product-specific bioequivalence guidance
03/08/2017Scientific guideline: Addendum to the guideline on the evaluation of medicinal products indicated for treatment of bacterial infections to address the clinical development of new agents to treat pulmonary disease due to Mycobacterium tuberculosis - Revision 1, adopted
03/08/2017Addendum to the note for guidance on evaluation of medicinal products indicated for treatment of bacterial infections to specifically address the clinical development of new agents to treat disease due to Mycobacterium Tuberculosis (updated)
03/08/2017Minutes of the COMP meeting 13-15 June 2017
03/08/2017Human medicines European public assessment report (EPAR): Insuman,

insulin human

Revision: 24, Authorised
03/08/2017Human medicines European public assessment report (EPAR): Tadalafil Mylan,

tadalafil

Revision: 5, Authorised
03/08/2017Orphan designation:

Pegylated recombinant human factor IX (nonacog beta pegol)

for the: Treatment of haemophilia B (updated)
03/08/2017Maximum Residue Limits (MRL) (updated)
03/08/2017Human medicines European public assessment report (EPAR): Jardiance,

empagliflozin

Revision: 13, Authorised
03/08/2017Human medicines European public assessment report (EPAR): Synjardy,

empagliflozin / metformin

Revision: 10, Authorised
02/08/2017Human medicines European public assessment report (EPAR): Leflunomide medac,

leflunomide

Revision: 13, Authorised
02/08/2017Human medicines European public assessment report (EPAR): Xultophy,

insulin degludec / liraglutide

Revision: 7, Authorised
02/08/2017Human medicines European public assessment report (EPAR): Xgeva,

denosumab

Revision: 12, Authorised
02/08/2017Human medicines European public assessment report (EPAR): Parsabiv,

etelcalcetide

Revision: 1, Authorised
02/08/2017Human medicines European public assessment report (EPAR): Clopidogrel BGR (previously Zylagren),

clopidogrel

Revision: 12, Authorised
02/08/2017Human medicines European public assessment report (EPAR): Truxima,

rituximab

Revision: 3, Authorised
02/08/2017Human medicines European public assessment report (EPAR): Refixia,

nonacog beta pegol

Revision: 0, Authorised
02/08/2017Marketing authorisation holder electronic reaction monitoring report example
02/08/2017Presentation - EudraVigilance reporting process for users: Create and send individual case safety reports (ICSRs) using EVWEB - Training Module EV-M3d - Part II
02/08/2017EudraVigilance: electronic reporting (updated)
02/08/2017European Union E2B (R3) testing files (updated)
02/08/2017European Union example instances - E2B(R3) testing files (updated)
02/08/2017European Union reference instances (updated)
02/08/2017Human medicines European public assessment report (EPAR): Vedrop,

tocofersolan

Revision: 10, Authorised
02/08/2017Human medicines European public assessment report (EPAR): Praxbind,

idarucizumab

Revision: 3, Authorised
02/08/2017Human medicines European public assessment report (EPAR): Bemfola,

follitropin alfa

Revision: 4, Authorised
02/08/2017Human medicines European public assessment report (EPAR): Keytruda,

pembrolizumab

Revision: 9, Authorised
02/08/2017Human medicines European public assessment report (EPAR): Plegridy,

peginterferon beta-1a

Revision: 11, Authorised
02/08/2017Human medicines European public assessment report (EPAR): Retacrit,

epoetin zeta

Revision: 20, Authorised
02/08/2017Questions and answers on production of water for injections by non-distillation methods – reverse osmosis and biofilms and control strategies - Final
02/08/2017Questions and answers on production of water for injections by non-distillation methods – reverse osmosis and biofilms and control strategies - Final
02/08/2017Regulatory and procedural guideline: Guideline on good pharmacovigilance practices (GVP) - Product- or population-specific considerations IV: paediatric population, draft: consultation open
02/08/2017Regulatory and procedural guideline: Comments received from public consultation on good pharmacovigilance practices (GVP) - GVP Module VI – Management and reporting of adverse reactions to medicinal products (EMA/873138/2011 Rev. 2)
02/08/2017Regulatory and procedural guideline: Guideline on good pharmacovigilance practices (GVP) - Module VI Addendum I – Duplicate management of suspected adverse reaction reports, adopted (updated)
02/08/2017Regulatory and procedural guideline: Guideline on good pharmacovigilance practices (GVP) - Module VI – Collection, management and submission of reports of suspected adverse reactions to medicinal products (Rev. 2) - post public consultation with track changes, adopted
02/08/2017Regulatory and procedural guideline: Guidelines on good pharmacovigilance practices (GVP) - Introductory cover note, last updated with revision 2 of module VI on ICSRs finalised post-public consultation, its new addendum on duplicate management and the considerations chapter IV on the paediatric population for public consultation
02/08/2017Regulatory and procedural guideline: Guideline on good pharmacovigilance practices (GVP) - Module VI – Collection, management and submission of reports of suspected adverse reactions to medicinal products (Rev. 2), adopted (updated)
02/08/2017Submission of comments on GVP product- or population-specific considerations IV: Paediatric population
02/08/2017Human medicines European public assessment report (EPAR): Komboglyze,

saxagliptin / metformin hydrochloride

Revision: 13, Authorised
02/08/2017Good pharmacovigilance practices (updated)
01/08/2017EudraVigilance training and support (updated)
01/08/2017United Kingdom’s withdrawal from the European Union ('Brexit') (updated)
01/08/2017News and press releases: EMA prepares for Brexit
01/08/2017Human medicines European public assessment report (EPAR): Dinutuximab beta Apeiron,

dinutuximab beta

Revision: 1, Authorised
01/08/2017Human medicines European public assessment report (EPAR): Lyrica,

pregabalin

Revision: 37, Authorised
01/08/2017Human medicines European public assessment report (EPAR): Cuprymina,

copper (64Cu) chloride

Revision: 5, Authorised
01/08/2017PDCO monthly report of opinions on paediatric investigation plans and other activities 18-21 July 2017
01/08/2017Agenda: CHMP ORGAM agenda for the meeting on 10 July 2017
01/08/2017Floseal haemostatic matrix (Floseal VH S/D) - Procedural steps and scientific information after initial consultation
01/08/2017Minutes - PDCO minutes of the 16-19 May 2017 meeting
01/08/2017Timetable: Initial (full) marketing authorisation application (updated)
01/08/2017Timetable initial (full) marketing authorisation application - Accelerated assessment (updated)
01/08/2017Timetable: Initial (Full) marketing authorisation application - ATMP (updated)
01/08/2017CooperSurgical Inc ART Media - Procedural steps and scientific information after initial consultation
01/08/2017COOK IVF cell media - Procedural steps and scientific information after initial consultation
01/08/2017Gems Medium Suite - Procedural steps and scientific information after initial consultation
01/08/2017IVF Media G5 - Procedural steps and scientific information after initial consultation
01/08/2017FertiPro N.V. HSA-containing ART media - Procedural steps and scientific information after initial consultation
01/08/2017Steen solution - Procedural steps and scientific information after initial consultation
01/08/2017Irvine Scientific Reproductive Media - Procedural steps and scientific information after initial consultation
01/08/2017CHMP opinions on consultation procedures (updated)
01/08/2017Surgiflo haemostatic matrix kit - Ferrosan - Procedural steps and scientific information after initial consultation
01/08/2017Hemoblast - Procedural steps and scientific information after initial consultation
01/08/2017Origio - Procedural steps and scientific information after initial consultation
01/08/2017Minutes of the CHMP meeting 19-22 June 2017
01/08/2017Human medicines European public assessment report (EPAR): Leganto,

rotigotine

Revision: 12, Authorised
01/08/2017News and press releases: CMDh confirms that methylprednisolone injections containing lactose must not be given to patients allergic to cow's milk proteins
01/08/2017Medicines for older people (updated)
01/08/2017Scientific guideline: Reflection paper on the pharmaceutical development of medicines for use in the older population - First version, draft: consultation open
01/08/2017News and press releases: EMA encourages tailored development of medicines for older people
01/08/2017Pharmaceutical development of medicines for use in the older population (updated)
01/08/2017Development of guidance on the non-clinical evaluation of radiopharmaceuticals
01/08/2017Scientific guideline: Concept paper on the development of guidance on the non-clinical evaluation of radiopharmaceuticals - First version, draft: consultation open
01/08/2017Human medicines European public assessment report (EPAR): Cimzia,

certolizumab pegol

Revision: 20, Authorised
01/08/2017Minutes of the 96th meeting of the Management Board: 14-15 June 2017
01/08/2017Human medicines European public assessment report (EPAR): Veltassa,

patiromer

Revision: 0, Authorised