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August 2018

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17/08/2018Human medicines European public assessment report (EPAR): Duavive,

oestrogens conjugated / bazedoxifene

Revision: 7, Authorised
17/08/2018Human medicines European public assessment report (EPAR): Emtricitabine/Tenofovir disoproxil Krka,

emtricitabine / tenofovir disoproxil

Revision: 3, Authorised
17/08/2018Procurement (updated)
17/08/2018Launch of the new EudraVigilance system: questions and answers from stakeholders (updated)
17/08/2018Human medicines European public assessment report (EPAR): Atosiban SUN,

atosiban

Revision: 4, Authorised
17/08/2018Scientific guideline: Draft guideline on clinical investigation of medicinal products in the treatment of epileptic disorders - Revision 3, draft: consultation open
17/08/2018Clinical investigation of medicinal products in the treatment of epileptic disorders (updated)
17/08/2018Human medicines European public assessment report (EPAR): Thalidomide Celgene (previously Thalidomide Pharmion),

thalidomide

Revision: 22, Authorised
17/08/2018Committee for Orphan Medicinal Products (COMP): 19-21 June 2018, European Medicines Agency, London, UK, From: 19-Jun-2018, To: 21-Jun-2018 (updated)
17/08/2018Committee for Orphan Medicinal Products (COMP): 22-24 May 2018, European Medicines Agency, London, UK, From: 22-May-2018, To: 24-May-2018 (updated)
17/08/2018Committee for Medicinal Products for Veterinary Use (CVMP): 17-19 July 2018, European Medicines Agency, London, UK, From: 17-Jul-2018, To: 19-Jul-2018 (updated)
17/08/2018Minutes of the COMP meeting of 22-24 May 2018
17/08/2018Minutes of the COMP meeting of 19-21 June 2018
17/08/2018Monthly report on application procedures guidelines and related documents for veterinary medicines: July 2018
17/08/2018Withdrawn application: Sutent,

sunitinib

Post-authorisation (updated)
16/08/2018Human medicines European public assessment report (EPAR): Entresto,

sacubitril / valsartan

Revision: 7, Authorised
16/08/2018Human medicines European public assessment report (EPAR): ReFacto AF,

moroctocog alfa

Revision: 35, Authorised
16/08/2018Adapalene / benzoyl peroxide: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00000059/201709 (updated)
16/08/2018Human medicines European public assessment report (EPAR): Cosentyx,

secukinumab

Revision: 9, Authorised
16/08/2018Human medicines European public assessment report (EPAR): Xeljanz,

tofacitinib

Revision: 4, Authorised
16/08/2018Herbal medicinal products: Polypodium , Polypodii rhizoma, Polypodium vulgare L. (updated)
15/08/2018Clinical data publication (updated)
15/08/2018Support for industry on clinical data publication (updated)
15/08/2018Quality of herbal medicinal products/traditional herbal medicinal products (updated)
15/08/2018Specifications: test procedures and acceptance criteria for herbal substances, herbal preparations and herbal medicinal products/traditional herbal medicinal products (updated)
15/08/2018Scientific guideline: Draft guideline on specifications: test procedures and acceptance criteria for herbal substances, herbal preparations and herbal medicinal products/traditional herbal medicinal products - Revision 3 , draft: consultation open
15/08/2018Scientific guideline: Draft guideline on quality of herbal medicinal products/traditional herbal medicinal products - Revision 3 , draft: consultation open
15/08/2018Human medicines European public assessment report (EPAR): Memantine ratiopharm,

memantine

Revision: 6, Authorised
15/08/2018Human medicines European public assessment report (EPAR): Opatanol,

olopatadine

Revision: 18, Authorised
15/08/2018HMPC monographs: Overview of recommendations for the uses of herbal medicinal products in the paediatric population (updated)
15/08/2018Human medicines European public assessment report (EPAR): Pregabalin Pfizer,

pregabalin

Revision: 12, Authorised
15/08/2018Human medicines European public assessment report (EPAR): Zoely,

nomegestrol / estradiol

Revision: 15, Authorised
15/08/2018News and press releases: How are new medicines approved by EMA?
15/08/2018HMPC meeting report on European Union herbal monographs, guidelines and other activities - 23-24 July 2018
15/08/2018Report: Medicinal products for human use: monthly figures - July 2018
15/08/2018Human medicines European public assessment report (EPAR): Torisel,

temsirolimus

Revision: 28, Authorised
15/08/2018Biosimilar medicinal products containing recombinant granulocyte-colony stimulating factor (Annex to guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues) (updated)
15/08/2018Scientific guideline: Draft guideline on similar biological medicinal products containing recombinant granulocyte-colony stimulating factor (rG-CSF) - Revision 1, draft: consultation open
15/08/2018Formatted table template to be inserted in each procedural submission cover letter (updated)
15/08/2018Veterinary medicine European public assessment report (EPAR): Pexion,

imepitoin

Revision: 6, Authorised
15/08/2018Scientific publications (updated)
15/08/2018Human medicines European public assessment report (EPAR): Mylotarg,

gemtuzumab ozogamicin

Revision: 1, Authorised
15/08/2018Organisation chart: Information Management (updated)
14/08/2018Human medicines European public assessment report (EPAR): Galafold,

migalastat

Revision: 6, Authorised
14/08/2018Human medicines European public assessment report (EPAR): Inlyta,

axitinib

Revision: 8, Authorised
14/08/2018Veterinary medicine European public assessment report (EPAR): Ubac,

Streptococcus uberis vaccine (inactivated)

Revision: 0, Authorised
14/08/2018Human medicines European public assessment report (EPAR): Darunavir Mylan,

darunavir

Revision: 2, Authorised
14/08/2018Epinastine: List of nationally authorised medicinal products - PSUSA/00001231/201710
14/08/2018Epinastine: CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00001231/201710
14/08/2018Regulatory and procedural guideline: European Medicines Agency post-authorisation procedural advice for users of the centralised procedure (updated)
14/08/2018Regulatory and procedural guideline: European Medicines Agency post-authorisation procedural advice for users of the centralised procedure - track changes (updated)
14/08/2018Dutasteride, dutasteride / tamsulosine: List of nationally authorised medicinal products - PSUSA/00010506/201711
14/08/2018Extensions of marketing authorisations: questions and answers (updated)
14/08/2018Human medicines European public assessment report (EPAR): Brintellix,

vortioxetine

Revision: 11, Authorised
14/08/2018Post-authorisation measures: questions and answers (updated)
14/08/2018Type-II variations: questions and answers (updated)
14/08/2018Antithrombin iii: List of nationally authorised medicinal products - PSUSA/00003159/201712 (updated)
14/08/2018Glatiramer: List of nationally authorised medicinal products - PSUSA/00001529/201711
14/08/2018Alfuzosin: List of nationally authorised medicinal products -
14/08/2018Overview of comments received on 'Procedure for the review and revision of European Union herbal monographs and European Union list entries' - Revision 2
14/08/2018Procedure for the systematic review of European Union herbal monographs and/or European Union list entries
14/08/2018Scientific guideline: Procedure for the review and revision of European Union herbal monographs and European Union list entries - Revision 2, adopted
14/08/2018Deoxycholic acid: CMDh scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010525/201710
14/08/2018Deoxycholic acid: List of nationally authorised products - PSUSA/00010525/201710
14/08/2018Herbal medicinal products: Echinacea, Echinaceae pallidae radix, Echinacea pallida (Nutt.) Nutt. (updated)
14/08/2018Veterinary medicine European public assessment report (EPAR): Suvaxyn PRRS MLV,

Porcine respiratory and reproductive syndrome virus vaccine (live)

Revision: 2, Authorised
14/08/2018Veterinary medicine European public assessment report (EPAR): Sileo,

dexmedetomidine

Revision: 6, Authorised
14/08/2018Human medicines European public assessment report (EPAR): Otezla,

apremilast

Revision: 5, Authorised
13/08/2018Human medicines European public assessment report (EPAR): Stocrin,

efavirenz

Revision: 39, Authorised
13/08/2018Human medicines European public assessment report (EPAR): Exjade,

deferasirox

Revision: 40, Authorised
13/08/2018Human medicines European public assessment report (EPAR): Aldara,

imiquimod

Revision: 24, Authorised
13/08/2018Veterinary medicine European public assessment report (EPAR): Onsior,

robenacoxib

Revision: 11, Authorised
13/08/2018Regulatory and procedural guideline: EU Individual Case Safety Report (ICSR) implementation guide business rules spreadsheets (updated)
13/08/2018Atorvastatin: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010347/201710
13/08/2018Atorvastatin: List of nationally authorised medicinal products - PSUSA/00010347/201710
13/08/2018Human medicines European public assessment report (EPAR): Sivextro,

tedizolid phosphate

Revision: 9, Authorised
13/08/2018Scientific guideline: Guideline on core summary for product characteristics for human albumin solution - Revision 3, adopted
13/08/2018Core summary for product characteristics for human albumin solution (updated)
13/08/2018Human medicines European public assessment report (EPAR): Tybost,

cobicistat

Revision: 11, Authorised
13/08/2018Scientific guideline: Guideline on the clinical investigation of recombinant and human plasma-derived factor VIII products - Revision 2, adopted
13/08/2018Scientific guideline: Guideline on core SmPC for human plasma derived and recombinant coagulation factor VIII products - Revision 3, adopted
13/08/2018Clinical investigation of recombinant and human plasma-derived factor VIII products (updated)
13/08/2018Core summary of product characteristics for human plasma-derived and recombinant coagulation factor VIII products (updated)
13/08/2018Human medicines European public assessment report (EPAR): PecFent,

fentanyl

Revision: 17, Authorised
13/08/2018Herbal medicinal products: Hedera, Hederae helicis folium, Hedera helix L. (updated)
13/08/2018Human medicines European public assessment report (EPAR): Gilenya,

fingolimod

Revision: 20, Authorised
10/08/2018PDCO monthly report of opinions on paediatric investigation plans and other activities 24-27 July 2018
10/08/2018Human medicines European public assessment report (EPAR): Tysabri,

natalizumab

Revision: 27, Authorised
10/08/2018Human medicines European public assessment report (EPAR): Sevelamer carbonate Zentiva,

sevelamer carbonate

Revision: 10, Authorised
10/08/2018Human medicines European public assessment report (EPAR): GONAL-f,

follitropin alfa

Revision: 22, Authorised
10/08/2018Report: Applications for new human medicines under evaluation by the Committee for Medicinal Products for Human Use: August 2018
10/08/2018Human medicines European public assessment report (EPAR): Bosulif,

bosutinib

Revision: 16, Authorised
10/08/2018CVMP meeting dates 2019, 2020 and 2021
10/08/2018News and press releases: Update on review of valsartan medicines due to detection of NDMA
10/08/2018Human medicines European public assessment report (EPAR): Exforge HCT,

amlodipine besylate / valsartan / hydrochlorothiazide

Revision: 13, Authorised
10/08/2018Human medicines European public assessment report (EPAR): Eylea,

aflibercept

Revision: 13, Authorised
10/08/2018Pharmacovigilance Risk Assessment Committee (PRAC): 11-14 June 2018, European Medicines Agency, London, UK, From: 11-Jun-2018, To: 14-Jun-2018 (updated)
10/08/2018Minutes of the PRAC meeting 11-14 June 2018
10/08/2018Human medicines European public assessment report (EPAR): Riximyo,

rituximab

Revision: 2, Authorised
10/08/2018Human medicines European public assessment report (EPAR): Genvoya,

elvitegravir / cobicistat / emtricitabine / tenofovir alafenamide

Revision: 16, Authorised
10/08/2018Human medicines European public assessment report (EPAR): Mysimba,

naltrexone / bupropion

Revision: 10, Authorised
09/08/2018Newsletter: News bulletin for small and medium-sized enterprises - Issue 44
09/08/2018Human medicines European public assessment report (EPAR): Numient,

levodopa / carbidopa

Revision: 3, Authorised
09/08/2018Human medicines European public assessment report (EPAR): Fampyra,

fampridine

Revision: 12, Authorised
09/08/2018Human medicines European public assessment report (EPAR): Truxima,

rituximab

Revision: 6, Authorised
09/08/2018Human medicines European public assessment report (EPAR): Dynastat,

parecoxib

Revision: 26, Authorised
09/08/2018Human medicines European public assessment report (EPAR): Rituzena (previously Tuxella),

rituximab

Revision: 5, Authorised
09/08/2018Human medicines European public assessment report (EPAR): Ritemvia,

rituximab

Revision: 4, Authorised
09/08/2018Prulifloxacin: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002569/201710
09/08/2018Prulifloxacin: List of nationally authorised medicinal products - PSUSA/00002569/201710
09/08/2018Human medicines European public assessment report (EPAR): Zonisamide Mylan,

zonisamide

Revision: 2, Authorised
09/08/2018Human medicines European public assessment report (EPAR): ATryn,

antithrombin alfa

Revision: 15, Authorised
09/08/2018Human medicines European public assessment report (EPAR): Nityr,

nitisinone

Revision: 0, Authorised
08/08/2018Human medicines European public assessment report (EPAR): Aimovig,

erenumab

Revision: 0, Authorised
08/08/2018News and press releases: EMA: working for every patient in Europe
08/08/2018Human medicines European public assessment report (EPAR): Rapamune,

sirolimus

Revision: 36, Authorised
08/08/2018Human medicines European public assessment report (EPAR): Tarceva,

erlotinib

Revision: 27, Authorised
08/08/2018Human medicines European public assessment report (EPAR): Zometa,

zoledronic acid

Revision: 32, Authorised
08/08/2018Human medicines European public assessment report (EPAR): Mavenclad,

cladribine

Revision: 2, Authorised
08/08/2018News and press releases: Esmya: new measures to minimise risk of rare but serious liver injury
08/08/2018Human medicines European public assessment report (EPAR): Firdapse (previously Zenas),

amifampridine

Revision: 15, Authorised
08/08/2018Human medicines European public assessment report (EPAR): Esmya,

ulipristal

Revision: 13, Authorised
08/08/2018Referral: Article 20 procedures, Esmya,

ulipristal acetate

(updated)
07/08/2018Human medicines European public assessment report (EPAR): NovoEight,

turoctocog alfa

Revision: 6, Authorised
07/08/2018Human medicines European public assessment report (EPAR): Ariclaim,

duloxetine

Revision: 26, Withdrawn
07/08/2018Human medicines European public assessment report (EPAR): Champix,

varenicline

Revision: 32, Authorised
07/08/2018Human medicines European public assessment report (EPAR): Samsca,

tolvaptan

Revision: 9, Authorised
07/08/2018Human medicines European public assessment report (EPAR): Axumin,

fluciclovine (18F)

Revision: 3, Authorised
07/08/2018Human medicines European public assessment report (EPAR): Invokana,

canagliflozin

Revision: 11, Authorised
07/08/2018Human medicines European public assessment report (EPAR): Alkindi,

hydrocortisone

Revision: 2, Authorised
07/08/2018Referral: Article 30 referrals, Scandonest and associated names,

mepivacaine

(updated)
07/08/2018Human medicines European public assessment report (EPAR): DuoResp Spiromax,

budesonide / formoterol

Revision: 6, Authorised
07/08/2018Human medicines European public assessment report (EPAR): Cerdelga,

eliglustat

Revision: 8, Authorised
07/08/2018Human medicines European public assessment report (EPAR): Tygacil,

tigecycline

Revision: 27, Authorised
07/08/2018Detailed guidance on the electronic submission of information on medicinal products for human use by marketing authorisation holders to the European Medicines Agency in accordance with Article 57(2), second subparagraph of Regulation (EC) No. 726/2004: Chapter 2: Electronic submission of information on medicinal products by marketing authorisation holders (updated)
07/08/2018Detailed guidance on the electronic submission of information on medicinal products for human use by marketing-authorisation holders to the European Medicines Agency in accordance with Article 57(2), second subparagraph of Regulation (EC) No. 726/2004: Chapter 3.II: Extended EudraVigilance product report message (XEVPRM) user guidance (updated)
07/08/2018Electronic submission of Article 57(2) data: questions and answers (updated)
07/08/2018Detailed guidance on the electronic submission of information on medicinal products for human use by marketing-authorisation holders to the European Medicines Agency in accordance with Article 57(2), second subparagraph of Regulation (EC) No. 726/2004: Chapter 3.II: Extended EudraVigilance product report message (XEVPRM) user guidance (updated)
07/08/2018Presentation - eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) e-learning - Session 1.2: Registration with EudraVigilance (updated)
07/08/2018Detailed guidance on the electronic submission of information on medicinal products for human use by marketing authorisation holders to the European Medicines Agency in accordance with Article 57(2), second subparagraph of Regulation (EC) No. 726/2004: Chapter 2: Electronic submission of information on medicinal products by marketing authorisation holders (updated)
07/08/2018Human medicines European public assessment report (EPAR): Taxespira (previously Docetaxel Hospira UK Limited ),

docetaxel

Revision: 8, Authorised
07/08/2018Human medicines European public assessment report (EPAR): Tyverb,

lapatinib

Revision: 27, Authorised
07/08/2018Human medicines European public assessment report (EPAR): Rixathon,

rituximab

Revision: 2, Authorised
07/08/2018Human medicines European public assessment report (EPAR): Lusduna,

insulin glargine

Revision: 2, Authorised
07/08/2018Human medicines European public assessment report (EPAR): Azomyr,

desloratadine

Revision: 42, Authorised
07/08/2018Human medicines European public assessment report (EPAR): Levetiracetam Sun,

levetiracetam

Revision: 10, Authorised
07/08/2018Human medicines European public assessment report (EPAR): Viread,

tenofovir disoproxil

Revision: 47, Authorised
07/08/2018Human medicines European public assessment report (EPAR): Toviaz,

fesoterodine

Revision: 20, Authorised
06/08/2018Human medicines European public assessment report (EPAR): Tegsedi,

inotersen

Revision: 0, Authorised
06/08/2018Newsletter: Human medicines highlights - August 2018
06/08/2018Guideline on the use of minimal residual disease as a clinical endpoint in multiple myeloma studies
06/08/2018Scientific guideline: Draft guideline on the use of minimal residual disease as a clinical endpoint in multiple myeloma studies, draft: consultation open
06/08/2018Orphan designation:

Metreleptin

for the: Treatment of Lawrence syndrome (updated)
06/08/2018Orphan designation:

Metreleptin

for the: Treatment of Berardinelli-Seip syndrome (updated)
06/08/2018Orphan designation:

Metreleptin

for the: Treatment of Barraquer-Simons syndrome (updated)
06/08/2018Orphan designation:

Metreleptin

for the: Treatment of familial partial lipodystrophy (updated)
06/08/2018Human medicines European public assessment report (EPAR): Hefiya,

adalimumab

Revision: 0, Authorised
06/08/2018ICH M9 on biopharmaceutics classification system based biowaivers
06/08/2018Scientific guideline: ICH M9 on biopharmaceutics classification system based biowaivers - Step 2b - First version, draft: consultation open
06/08/2018Human medicines European public assessment report (EPAR): Naglazyme,

galsulfase

Revision: 13, Authorised
06/08/2018Human medicines European public assessment report (EPAR): Levetiracetam Accord,

levetiracetam

Revision: 8, Authorised
06/08/2018Mosquirix H-W-2300 (updated)
06/08/2018Human medicines European public assessment report (EPAR): Emtriva,

emtricitabine

Revision: 27, Authorised
06/08/2018Myalepta: Educational material for patients and healthcare professionals to ensure Myalepta is used correctly
06/08/2018Human medicines European public assessment report (EPAR): Myalepta,

metreleptin

Revision: 0, Authorised
06/08/2018Cinryze (C1 inhibitor, human) supply shortage 222
06/08/2018Report: Annual report of the Good Manufacturing and Distribution Practice Inspectors Working Group 2017
06/08/2018Minutes - PDCO minutes of the 26-29 June 2018 meeting
06/08/2018Human medicines European public assessment report (EPAR): Revatio,

sildenafil

Revision: 36, Authorised
06/08/2018PRAC recommendations on signals adopted at the 5-8 February 2018 PRAC meeting, adopted (updated)
06/08/2018PRAC recommendations on signals adopted at the 9-12 July 2018 PRAC meeting, adopted
06/08/2018New product information wording: extracts from PRAC recommendations on signals adopted at the 9-12 July 2018 PRAC
06/08/2018List of signals discussed at the PRAC since September 2012 (updated)
06/08/2018Withdrawn application: Restaysis,

ciclosporin

Initial authorisation (updated)
06/08/2018Human medicines European public assessment report (EPAR): Cetrotide,

cetrorelix

Revision: 23, Authorised
06/08/2018Human medicines European public assessment report (EPAR): Emtricitabine/Tenofovir disoproxil Krka d.d.,

emtricitabine / tenofovir disoproxil

Revision: 3, Authorised
03/08/2018Human medicines European public assessment report (EPAR): Firmagon,

degarelix

Revision: 13, Authorised
03/08/2018Human medicines European public assessment report (EPAR): Ilaris,

canakinumab

Revision: 20, Authorised
03/08/2018Human medicines European public assessment report (EPAR): Jentadueto,

linagliptin / metformin hydrochloride

Revision: 14, Authorised
03/08/2018Human medicines European public assessment report (EPAR): Ameluz,

5-aminolevulinic acid hydrochloride

Revision: 12, Authorised
03/08/2018Human medicines European public assessment report (EPAR): Metalyse,

tenecteplase

Revision: 17, Authorised
03/08/2018Human medicines European public assessment report (EPAR): Cystadane,

betaine anhydrous

Revision: 11, Authorised
03/08/2018Human medicines European public assessment report (EPAR): Inflectra,

infliximab

Revision: 18, Authorised
03/08/2018Human medicines European public assessment report (EPAR): Iclusig,

ponatinib

Revision: 18, Authorised
03/08/2018Human medicines European public assessment report (EPAR): Lixiana,

edoxaban

Revision: 7, Authorised
03/08/2018Human medicines European public assessment report (EPAR): Adcetris,

brentuximab vedotin

Revision: 23, Authorised
03/08/2018Human medicines European public assessment report (EPAR): Carbaglu,

carglumic acid

Revision: 16, Authorised
03/08/2018Human medicines European public assessment report (EPAR): Ristfor,

sitagliptin / metformin hydrochloride

Revision: 18, Authorised
03/08/2018Antimicrobial resistance in veterinary medicine (updated)
03/08/2018Human medicines European public assessment report (EPAR): Vargatef,

nintedanib

Revision: 9, Authorised
03/08/2018Human medicines European public assessment report (EPAR): Visudyne,

verteporfin

Revision: 31, Authorised
03/08/2018Pharmaceutical industry (updated)
03/08/2018Report: European Medicines Agency’s interaction with industry stakeholders - Annual report 2017
03/08/2018Morphine morphine-cyclizine: CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00010549/201710 (updated)
03/08/2018Morphine morphine-cyclizine: List of nationally authorised medicinal products - PSUSA/00010549/201710 (updated)
03/08/2018Scientific guideline: Posaconazole gastro-resistant tablet 100 mg product-specific bioequivalence guidance, adopted
03/08/2018Scientific guideline: Agomelatine tablet 25 mg product-specific bioequivalence guidance, adopted
03/08/2018Ledipasvir/sofosbuvir film-coated tablet 90 mg/400 mg product-specific bioequivalence guidance (updated)
03/08/2018Scientific guideline: Ledipasvir/sofosbuvir film-coated tablet 90 mg/400 mg product-specific bioequivalence guidance, adopted
03/08/2018Human medicines European public assessment report (EPAR): Halimatoz,

adalimumab

Revision: 0, Authorised
03/08/2018Human medicines European public assessment report (EPAR): Forsteo,

teriparatide

Revision: 20, Authorised
03/08/2018Human medicines European public assessment report (EPAR): Deltyba,

delamanid

Revision: 9, Authorised
03/08/2018Human medicines European public assessment report (EPAR): Matever,

levetiracetam

Revision: 17, Authorised
03/08/2018Human medicines European public assessment report (EPAR): Zydelig,

idelalisib

Revision: 14, Authorised
03/08/2018Human medicines European public assessment report (EPAR): Taltz,

ixekizumab

Revision: 6, Authorised
03/08/2018Vismodegib hard capsule 150 mg product-specific bioequivalence guidance (updated)
03/08/2018Scientific guideline: Vismodegib hard capsule 150 mg product-specific bioequivalence guidance, adopted
03/08/2018Overview of comments received on 'Vismodegib hard capsule 150 mg product-specific bioequivalence guidance'
03/08/2018Scientific guideline: Cholic acid capsules 50 mg and 250 mg product-specific bioequivalence guidance, adopted
03/08/2018Overview of comments received on 'Cholic acid capsules 50 mg and 250 mg product-specific bioequivalence guidance’
03/08/2018Cholic acid capsules 50 mg and 250 mg product-specific bioequivalence guidance (updated)
02/08/2018CAT monthly report of application procedures, guidelines and related documents on advanced therapies: July 2018
02/08/2018HMPC: overview of assessment work – priority list (updated)
02/08/2018Treprostinil: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00003013/201711
02/08/2018Treprostinil: List of nationally authorised medicinal products - PSUSA/00003013/201711
02/08/2018Orphan designation:

Lenalidomide

for the: Treatment of chronic lymphocytic leukaemia (updated)
02/08/2018Orphan designation:

Lenalidomide

for the: Treatment of diffuse large B-cell lymphoma (updated)
02/08/2018Orphan designation:

Pomalidomide

for the: Treatment of multiple myeloma (updated)
02/08/2018Report: Medicinal products for human use: monthly figures - June 2018
02/08/2018Outcome of public consultation on 'Questions and Answers on implementation of risk-based prevention of cross contamination in production 'and ‘Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities’
02/08/2018Overview of comments received on 'Questions and answers on implementation of risk based prevention of cross contamination in production' and ‘Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities’
02/08/2018Orphan designation:

Lenalidomide

for the: Treatment of follicular lymphoma (updated)
02/08/2018Orphan designation:

Autologous CD34+ haematopoietic stem cells transduced with lentiviral vector encoding the human betaA-T87Q-globin gene

for the: Treatment of beta thalassaemia intermedia and major (updated)
02/08/2018Orphan designation:

Autologous haematopoietic stem cells transduced with lentiviral vector Lenti-D encoding the human ABCD1 cDNA

for the: Treatment of adrenoleukodystrophy (updated)
02/08/2018Orphan designation:

Autologous CD34+ haematopoietic stem cells transduced with lentiviral vector encoding the human beta A-T87Q-globin gene for the treatment of sickle cell disease

for the: The treatment of sickle cell disease (updated)
02/08/2018Orphan designation:

Lenalidomide

for the: Treatment of marginal zone lymphoma (updated)
02/08/2018News and press releases: Update on review of recalled valsartan medicines
02/08/2018Human medicines European public assessment report (EPAR): Hyrimoz,

adalimumab

Revision: 0, Authorised
02/08/2018Human medicines European public assessment report (EPAR): Lenvima,

lenvatinib

Revision: 4, Authorised
02/08/2018Human medicines European public assessment report (EPAR): Xagrid,

anagrelide

Revision: 32, Authorised
02/08/2018Human medicines European public assessment report (EPAR): Kisplyx,

lenvatinib

Revision: 5, Authorised
02/08/2018Plasma-master-file certifications (updated)
02/08/2018Human medicines European public assessment report (EPAR): BiResp Spiromax,

budesonide / formoterol

Revision: 6, Authorised
02/08/2018Human medicines European public assessment report (EPAR): Kentera (previously Oxybutynin Nicobrand),

oxybutynin

Revision: 15, Authorised
02/08/2018Human medicines European public assessment report (EPAR): Ofev,

nintedanib

Revision: 8, Authorised
02/08/2018EudraVigilance Veterinary (updated)
02/08/2018Human medicines European public assessment report (EPAR): Ribavirin Teva Pharma B.V.,

ribavirin

Revision: 13, Authorised
02/08/2018Human medicines European public assessment report (EPAR): Repatha,

evolocumab

Revision: 8, Authorised
01/08/2018Human medicines European public assessment report (EPAR): Aplidin,

plitidepsin

Revision: 0, Refused
01/08/2018Human medicines European public assessment report (EPAR): Docetaxel Teva,

docetaxel

Revision: 16, Authorised
01/08/2018Data Monitoring Committees issues
01/08/2018Scientific guideline: Draft questions and answers on Data Monitoring Committees issues, draft: consultation open
01/08/2018Human medicines European public assessment report (EPAR): Flixabi,

infliximab

Revision: 5, Authorised
01/08/2018Human medicines European public assessment report (EPAR): Bavencio,

avelumab

Revision: 2, Authorised
01/08/2018Human medicines European public assessment report (EPAR): Ceplene,

histamine dihydrochloride

Revision: 12, Authorised
01/08/2018Human medicines European public assessment report (EPAR): Xalkori,

crizotinib

Revision: 22, Authorised
01/08/2018Human medicines European public assessment report (EPAR): NexoBrid,

concentrate of proteolytic enzymes enriched in bromelain

Revision: 6, Authorised
01/08/2018Human medicines European public assessment report (EPAR): Eliquis,

apixaban

Revision: 15, Authorised
01/08/2018Human medicines European public assessment report (EPAR): Procysbi,

mercaptamine

Revision: 9, Authorised
01/08/2018News and press releases: Brexit preparedness: EMA to further temporarily scale back and suspend activities
01/08/2018Veterinary medicine European public assessment report (EPAR): Apoquel,

oclacitinib maleate

Revision: 4, Authorised
01/08/2018Human medicines European public assessment report (EPAR): Janumet,

sitagliptin / metformin

Revision: 23, Authorised
01/08/2018MRL report: Eprinomectin (Fin fish; extrapolation to horses and rabbits): European public maximum-residue-limit assessment report (EPMAR) - CVMP
01/08/2018MRL report: Porcine prolactin (porcine species): European public maximum-residue-limit assessment report (EPMAR) - CVMP
01/08/2018Human medicines European public assessment report (EPAR): Darzalex,

daratumumab

Revision: 5, Authorised
01/08/2018Report: List of products granted eligibility to PRIME (updated)
01/08/2018Referral: Article 30 referrals, Septanest and associated names,

articaine (hydrochloride)/ adrenaline (tartrate)

(updated)
01/08/2018Report: Recommendations on eligibility to PRIME scheme - Adopted at the CHMP meeting of 23-26 July 2018
01/08/2018Human medicines European public assessment report (EPAR): Vosevi,

sofosbuvir / velpatasvir / voxilaprevi

Revision: 2, Authorised
01/08/2018Human medicines European public assessment report (EPAR): Clopidogrel HCS,

clopidogrel

Revision: 8, Authorised
01/08/2018Human Medicines Evaluation (updated)
01/08/2018Organisation chart: Inspections, Human Medicines Pharmacovigilance and Committees Division (updated)
01/08/2018Organisation chart: Human Medicines Evaluation (updated)
01/08/2018Inspections, Human Medicines Pharmacovigilance and Committees (updated)
01/08/2018Human medicines European public assessment report (EPAR): Zinplava,

bezlotoxumab

Revision: 4, Authorised
01/08/2018Human medicines European public assessment report (EPAR): Ryzodeg,

insulin degludec / insulin aspart

Revision: 10, Authorised