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March 2018

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29/03/2018Human medicines European public assessment report (EPAR): IDflu,

influenza vaccine (split virion, inactivated)

Revision: 13, Withdrawn
28/03/2018Human medicines European public assessment report (EPAR): Liprolog,

insulin lispro

Revision: 23, Authorised
28/03/2018Orphan designation:

Recombinant fusion protein linking coagulation factor VIIa with albumin

for the: Treatment of congenital factor VII deficiency (updated)
28/03/2018Orphan designation:

Alpha1-proteinase inhibitor (inhalation use)

for the: Treatment of cystic fibrosis (updated)
28/03/2018Orphan designation:

Human alpha1-proteinase inhibitor

for the: Treatment of emphysema secondary to congenital alpha1-antitrypsin deficiency (updated)
28/03/2018Orphan designation:

C1-esterase-inhibitor human

for the: Treatment in solid organ transplantation (updated)
28/03/2018Orphan designation:

Recombinant fusion protein linking human coagulation factor IX with human albumin

for the: Treatment of haemophilia B (updated)
28/03/2018Procedures for monograph and list entry establishment (updated)
28/03/2018Herbal medicinal products: , Salviae miltiorrhizae rhizoma, Salvia miltiorrhiza Bunge, radix et rhizoma
28/03/2018Herbal medicinal products: , Menyanthidis trifoliatae folium, Menyanthes trifoliata L., folium
28/03/2018Herbal medicinal products: Potentilla, Tormentillae rhizoma, Potentilla erecta (L.) Raeusch. (updated)
28/03/2018Call for scientific data for use in HMPC assessment work on Aloysia citriodora Paláu (syn. Aloysia triphylla (L’Hér.) Kuntze; Verbena triphylla L’Hér.; Lippia citriodora Kunth.), folium, draft: consultation open
28/03/2018Call for scientific data for use in HMPC assessment work on Herniariae glabra L.; Herniariae hirsuta L.; Herniariae incana LAM., herba, draft: consultation open
28/03/2018Call for scientific data for use in HMPC assessment work on Menyanthes trifoliata L., folium, draft: consultation open
28/03/2018Call for scientific data for the periodic review of the monograph on Quercus robur L.; Quercus petraea (Matt.) Liebl.; Quercus pubescens Willd., cortex, draft: consultation open
28/03/2018Call for scientific data for use in HMPC assessment work on Salvia miltiorrhiza Bunge, radix et rhizoma, draft: consultation open
28/03/2018Call for scientific data for the periodic review of the monograph on Solidago virgaurea L., herba, draft: consultation open
28/03/2018Call for scientific data for use in HMPC assessment work on Potenilla erecta (L.) Raeusch., rhizoma, draft: consultation open
28/03/2018Herbal medicinal products: Quercus, Quercus cortex, Quercus robur L.; Quercus petraea (Matt.) Liebl.; Quercus pubescens Willd. (updated)
28/03/2018Herbal medicinal products: Solidago, Solidaginis virgaureae herba, Solidago virgaurea L. (updated)
28/03/2018Herbal medicinal products: , Herniariae herba, Herniariae glabra L.; Herniariae hirsuta L.; Herniariae incana LAM., herba
28/03/2018Herbal medicinal products: , Aloysiae folium, Aloysia citriodora Paláu (syn. Aloysia triphylla (L’Hér.) Kuntze; Verbena triphylla ...
28/03/2018Launch of the new EudraVigilance system: questions and answers from stakeholders (updated)
28/03/2018Regulatory and procedural guideline: List of centrally authorised products requiring a notification of a change for update of annexes (updated)
28/03/2018Human medicines European public assessment report (EPAR): Tarceva,

erlotinib

Revision: 25, Authorised
28/03/2018Human medicines European public assessment report (EPAR): Leflunomide medac,

leflunomide

Revision: 14, Authorised
28/03/2018Human medicines European public assessment report (EPAR): Kinzalkomb,

telmisartan / hydrochlorothiazide

Revision: 32, Authorised
28/03/2018Human medicines European public assessment report (EPAR): Wakix,

pitolisant

Revision: 5, Authorised
28/03/2018Human medicines European public assessment report (EPAR): Ibrance,

palbociclib

Revision: 4, Authorised
28/03/2018Human medicines European public assessment report (EPAR): Erivedge,

vismodegib

Revision: 10, Authorised
28/03/2018PRIME: priority medicines (updated)
28/03/2018Human medicines European public assessment report (EPAR): Cotellic,

cobimetinib

Revision: 5, Authorised
28/03/2018Human medicines European public assessment report (EPAR): Shingrix,

herpes zoster vaccine (recombinant, adjuvanted)

Revision: 0, Authorised
28/03/2018Human medicines European public assessment report (EPAR): Avastin,

bevacizumab

Revision: 49, Authorised
28/03/2018Report: List of products granted eligibility to PRIME (updated)
28/03/2018Report: Recommendations on eligibility to PRIME scheme - Adopted at the CHMP meeting of 19-22 March 2018
28/03/2018List of medicines under additional monitoring (updated)
28/03/2018Annex I - List of cyproterone-acetate / ethinylestradiol-containing medicinal products in the European Union (updated)
28/03/2018List of medicinal products under additional monitoring (updated)
28/03/2018Annex I - List of cyproterone-acetate / ethinylestradiol-containing medicinal products in the European Union (updated)
28/03/2018List of medicinal products under additional monitoring (updated)
28/03/2018Second international awareness session for international regulators, academia and non-governmental organisations, European Medicines Agency, London, UK, From: 08-Mar-2018, To: 09-Mar-2018 (updated)
28/03/2018Human medicines European public assessment report (EPAR): Zinbryta,

daclizumab

Revision: 7, Suspended
28/03/2018News and press releases: Regulatory information – 1.7% increase of fees from 1 April 2018
28/03/2018Explanatory note on general fees payable to the European Medicines Agency as of 1 April 2018
28/03/2018Plasma-master-file certifications (updated)
28/03/2018Minutes of the CAT meeting 17 - 19 January 2018
28/03/2018Public statement: Public statement on IDflu: Withdrawal of the marketing authorisation in the European Union
28/03/2018Orphan designation:

Recombinant fusion protein linking human coagulation factor VIIa with human albumin

for the: Treatment of haemophilia B (updated)
28/03/2018Orphan designation:

Recombinant fusion protein linking human coagulation factor VIIa with human albumin

for the: Treatment of haemophilia A (updated)
27/03/2018Human medicines European public assessment report (EPAR): Zinforo,

ceftaroline fosamil

Revision: 15, Authorised
27/03/2018Withdrawn application: Balimek,

binimetinib

Initial authorisation (updated)
27/03/2018Human medicines European public assessment report (EPAR): Adenuric,

febuxostat

Revision: 16, Authorised
27/03/2018Human medicines European public assessment report (EPAR): Renvela,

sevelamer carbonate

Revision: 15, Authorised
27/03/2018Human medicines European public assessment report (EPAR): Kyprolis,

carfilzomib

Revision: 9, Authorised
27/03/2018Haemophilia registries workshop, European Medicines Agency, London, UK, From: 08-Jun-2018, To: 08-Jun-2018
27/03/2018Human medicines European public assessment report (EPAR): Tasermity,

sevelamer hydrochloride

Revision: 4, Withdrawn
27/03/2018Candesartan, candesartan / hydrochlorothiazide: CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00000527/201704 (updated)
27/03/2018Public statement: Public statement on Tasermity: Cessation of validity of the marketing authorisation in the European Union
27/03/2018Human medicines European public assessment report (EPAR): Axumin,

fluciclovine (18F)

Revision: 1, Authorised
27/03/2018News and press releases: European Medicines Agency closed 29 March to 2 April 2018
27/03/2018Human medicines European public assessment report (EPAR): Sirturo,

bedaquiline

Revision: 13, Authorised
27/03/2018Epirubicin: List of nationally authorised medicinal products - PSUSA/00001234/201706
27/03/2018Human medicines European public assessment report (EPAR): Pioglitazone Teva Pharma,

pioglitazone

Revision: 9, Authorised
27/03/2018List of European Union reference dates and frequency of submission of periodic safety update reports (updated)
26/03/2018Minutes of the COMP meeting of 16-18 January 2018
26/03/2018Agenda: Agenda - HMPC agenda of the 26-27 March 2018 meeting
26/03/2018Scientific advice and protocol assistance (March 2018), adopted
26/03/2018Human medicines European public assessment report (EPAR): Savene,

dexrazoxane

Revision: 12, Authorised
26/03/2018Orphan designation:

Tadekinig alfa

for the: Treatment of haemophagocytic lymphohistiocytosis (updated)
26/03/2018Human medicines European public assessment report (EPAR): NeoRecormon,

epoetin beta

Revision: 26, Authorised
26/03/2018Orphan designation:

4-[[(1S,4S)-5-[[4-[4-(oxazol-2-yl)phenoxy]phenyl]methyl]-2,5-diazabicyclo[2.2.1]hept-2-yl]methyl]benzoic acid

for the: Treatment of cystic fibrosis (updated)
26/03/2018Orphan designation:

Recombinant human interleukin-12

for the: Treatment of acute radiation syndrome (updated)
26/03/2018Orphan designation:

live attenuated Listeria monocytogenes bioengineered with a chimeric human epidermal growth factor receptor 2 fused to a truncated form of the Lm protein listeriolysin O

for the: Treatment of osteosarcoma (updated)
26/03/2018Orphan designation:

Volanesorsen sodium

for the: Treatment of familial partial lipodystrophy (updated)
26/03/2018Orphan designation:

(1E,6E)-1,7-bis(3,4-dimethoxyphenyl)-4-cyclobutylmethyl-1,6-heptadiene-3,5-dione

for the: Treatment of X-linked spinal and bulbar muscular atrophy (Kennedy’s disease) (updated)
26/03/2018Orphan designation:

6'-(R)-methyl-5-O-(5-amino-5,6-dideoxy-α-L-talofuranosyl)-paromamine sulfate

for the: Treatment of mucopolysaccharidosis type I (updated)
26/03/2018Orphan designation:

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

for the: Treatment of acromegaly (updated)
26/03/2018Human medicines European public assessment report (EPAR): Sevelamer carbonate Zentiva,

sevelamer carbonate

Revision: 9, Authorised
26/03/2018Human medicines European public assessment report (EPAR): Pegasys,

peginterferon alfa-2a

Revision: 36, Authorised
26/03/2018Monthly report on application procedures guidelines and related documents for veterinary medicines: February 2018
26/03/2018Inventory of herbal substances for assessment (updated)
26/03/2018Biologics Working Party (BWP) ad-hoc influenza working group: European Union recommendations for the seasonal influenza vaccine composition for the season 2018/2019
26/03/2018Regulatory and procedural guideline: Dossier requirements for submission of marketing authorisation and maximum residue limit (MRL) applications to the European Medicines Agency and to members of the Committee for Medicinal Products for Veterinary use (CVMP) (updated)
26/03/2018News and press releases: EU recommendations for 2018/2019 seasonal flu vaccine composition
26/03/2018Human medicines European public assessment report (EPAR): Symtuza,

darunavir / cobicistat / emtricitabine / tenofovir alafenamide

Revision: 2, Authorised
26/03/2018Human medicines European public assessment report (EPAR): Kadcyla,

trastuzumab emtansine

Revision: 9, Authorised
26/03/2018Human medicines European public assessment report (EPAR): Xeloda,

capecitabine

Revision: 22, Authorised
26/03/2018Orphan designation:

(S)-3'-(OH)-desazadesferrithiocin-polyether, magnesium salt (deferitazole)

for the: Treatment of chronic iron overload requiring chelation therapy (updated)
26/03/2018Human medicines European public assessment report (EPAR): CellCept,

mycophenolate mofetil

Revision: 29, Authorised
23/03/2018Human medicines European public assessment report (EPAR): Neulasta,

pegfilgrastim

Revision: 30, Authorised
23/03/2018Human medicines European public assessment report (EPAR): Yervoy,

ipilimumab

Revision: 21, Authorised
23/03/2018Human medicines European public assessment report (EPAR): Izba,

travoprost

Revision: 3, Authorised
23/03/2018Human medicines European public assessment report (EPAR): Prezista,

darunavir

Revision: 42, Authorised
23/03/2018Orphan designation:

(3S)-1-azabicyclo[2.2.2]oct-3-yl{2-[2-(4-fluorophenyl)-1,3-thiazol-4-yl]propan-2-yl}carbaNmate (venglustat)

for the: Treatment of Gaucher disease (updated)
23/03/2018Pending EC decision: Cabometyx ,

cabozantinib

Opinion date: 22-Mar-2018
23/03/2018Orphan designation:

(3S)-1-azabicyclo[2.2.2]oct-3-yl{2-[2-(4-fluorophenyl)-1,3-thiazol-4-yl]propan-2-yl}carbamate (venglustat)

for the: Treatment of Fabry disease (updated)
23/03/2018Human medicines European public assessment report (EPAR): Rezolsta,

darunavir / cobicistat

Revision: 5, Authorised
23/03/2018Human medicines European public assessment report (EPAR): Fortacin,

lidocaine / prilocaine

Revision: 6, Authorised
23/03/2018Substance and product data management services (updated)
23/03/2018Substance, product, organisation and referential (SPOR) master data (updated)
23/03/2018Minutes of the CVMP meeting of 13-15 February 2018
23/03/2018News and press releases: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 March 2018
23/03/2018News and press releases: New measures to avoid valproate exposure in pregnancy endorsed
23/03/2018News and press releases: Updated measures for pregnancy prevention during retinoid use
23/03/2018News and press releases: Withdrawal of pain medicine flupirtine endorsed
23/03/2018News and press releases: Colour change for insulin injection Fiasp to avoid mix ups with Tresiba
23/03/2018Pending EC decision: Zessly,

infliximab

Opinion date: 22-Mar-2018
23/03/2018Withdrawn application: Aranesp,

darbepoetin alfa

Post-authorisation
23/03/2018Pending EC decision: Rubraca,

rucaparib

Opinion date: 22-Mar-2018
23/03/2018Pending EC decision: Prasugrel Mylan,

prasugrel

Opinion date: 22-Mar-2018
23/03/2018Pending EC decision: Kanjinti,

trastuzumab

Opinion date: 22-Mar-2018
23/03/2018Pending EC decision: Ivemend,

fosaprepitant

Opinion date: 22-Mar-2018
23/03/2018Pending EC decision: Juluca,

dolutegravir / rilpivirine

Opinion date: 22-Mar-2018
23/03/2018Pending EC decision: Pemetrexed Krka,

pemetrexed

Opinion date: 22-Mar-2018
23/03/2018Pending EC decision: Repatha,

evolocumab

Opinion date: 22-Mar-2018
23/03/2018Pending EC decision: Dexxience,

betrixaban

Opinion date: 22-Mar-2018
23/03/2018Pending EC decision: Nerlynx,

neratinib

Opinion date: 22-Feb-2018 (updated)
23/03/2018Referral: Article 31 referrals, Omega-3 acid ethyl esters-containing medicinal products for oral in use in prevention after myocardial infarction,

Omega-3 fatty acid ethyl esters

23/03/2018Referral: Article 31 referrals, Retinoid-containing medicinal products,

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

(updated)
23/03/2018Referral: Article 31 referrals, Valproate and related substances,

sodium valproate, valproate magnesium, valproate semisodium, valproic acid, valpromide

(updated)
23/03/2018Pending EC decision: Timloze,

abaloparatide

Opinion date: 22-Mar-2018
23/03/2018Referral: Article 31 referrals, Flupirtine-containing medicinal products,

flupirtine

(updated)
22/03/2018Typhoid vaccine (live, attenuated): List of nationally authorised medicinal products - PSUSA/00003067/201707
22/03/2018Demeclocycline / triamcinolone: List of nationally authorised medicinal products - PSUSA/00010415/201707
22/03/2018Fluticasone propionate / formoterol fumarate dihydrate: List of nationally authorised medicinal products - PSUSA/00010339/201707
22/03/2018Pharmacovigilance (updated)
22/03/2018Newsletter: Public bulletin: Veterinary pharmacovigilance 2017
22/03/2018Report: Report on the operation of the Steering Group for the Joint EMA/HMA action plan on availability of veterinary vaccines 2016-2017
22/03/2018Availability of veterinary vaccines (updated)
22/03/2018Human medicines European public assessment report (EPAR): Bretaris Genuair,

aclidinium bromide

Revision: 14, Authorised
22/03/2018Human 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: 36, Authorised
22/03/2018Human medicines European public assessment report (EPAR): Fotivda,

tivozanib hydrochloride monohydrate

Revision: 1, Authorised
22/03/2018Work plan for Good Clinical Practice Inspectors Working Group 2018
22/03/2018Human medicines European public assessment report (EPAR): Qarziba (previously Dinutuximab beta EUSA and Dinutuximab beta Apeiron),

dinutuximab beta

Revision: 3, Authorised
22/03/2018Human medicines European public assessment report (EPAR): Sifrol,

pramipexole

Revision: 29, Authorised
22/03/2018Human medicines European public assessment report (EPAR): DuoTrav,

travoprost / timolol

Revision: 15, Authorised
22/03/2018Triamcinolone (topical and nasal formulations): List of nationally authorised medicinal products - PSUSA/00003017/201707
22/03/2018Core SmPC and package leaflet for sodium iodide (131 I) for therapeutic use
22/03/2018HMPC: overview of assessment work – priority list (updated)
21/03/2018Human medicines European public assessment report (EPAR): Taxotere,

docetaxel

Revision: 43, Authorised
21/03/2018Human medicines European public assessment report (EPAR): Brimica Genuair,

aclidinium / formoterol fumarate dihydrate

Revision: 9, Authorised
21/03/2018Human medicines European public assessment report (EPAR): Mircera,

methoxy polyethylene glycol-epoetin beta

Revision: 22, Authorised
21/03/2018Human medicines European public assessment report (EPAR): Corbilta (previously Levodopa/Carbidopa/Entacapone Sandoz),

levodopa / carbidopa / entacapone

Revision: 4, Authorised
21/03/2018Veterinary medicine European public assessment report (EPAR): Procox,

emodepside / toltrazuril

Revision: 13, Authorised
21/03/2018Human medicines European public assessment report (EPAR): Eklira Genuair,

aclidinium bromide

Revision: 14, Authorised
21/03/2018Human medicines European public assessment report (EPAR): Duaklir Genuair,

aclidinium bromide / formoterol

Revision: 9, Authorised
21/03/2018Human medicines European public assessment report (EPAR): Cyltezo,

adalimumab

Revision: 1, Authorised
21/03/2018Human medicines European public assessment report (EPAR): Reyataz,

atazanavir sulphate

Revision: 47, Authorised
21/03/2018Orphan designation:

(E)-(6-((N-methyl-((3-methylbenzofuran-2-yl)methyl)amino)-3-oxoprop-1-en-1-yl)-2-oxo-3,4-dihydro-1,8-naphthyridin-1(2H)-yl)methyl phosphate, bis ethanolamine salt (afabicin)

for the: Treatment of osteomyelitis (updated)
21/03/2018Orphan designation:

Allogeneic CD34+ cells expanded ex vivo with an aryl hydrocarbon receptor antagonist (spanlecortemlocel)

for the: Treatment of acute lymphoblastic leukaemia (updated)
21/03/2018Human medicines European public assessment report (EPAR): Imraldi,

adalimumab

Revision: 2, Authorised
21/03/2018Human medicines European public assessment report (EPAR): Humira,

adalimumab

Revision: 63, Authorised
21/03/2018Human medicines European public assessment report (EPAR): Docetaxel Winthrop,

docetaxel

Revision: 27, Authorised
21/03/2018Human medicines European public assessment report (EPAR): Samsca,

tolvaptan

Revision: 7, Authorised
21/03/2018Human medicines European public assessment report (EPAR): Flixabi,

infliximab

Revision: 4, Authorised
21/03/2018Scientific recommendation on classification of advanced therapy medicinal products: Allogeneic mesenchymal stem cells suspended in cell supernatant
21/03/2018Scientific recommendation on classification of advanced therapy medicinal products: Autologous dendritic cells, pulsed with allogeneic tumour cell lysate
21/03/2018Summaries of scientific recommendations on classification of advanced therapy medicinal products (updated)
21/03/2018Terms of reference 2018-2020: ESVAC sales Expert Advisory Group (updated)
21/03/2018Shortages catalogue (updated)
21/03/2018Work plan for the HMPC Quality Drafting Group (Q DG) 2018 (updated)
21/03/2018Arixtra (fondaparinux sodium) supply shortage (updated)
21/03/2018Information Technology Directors Group - List of nominated members (alphabetically by country) (updated)
21/03/2018Human medicines European public assessment report (EPAR): Xofigo,

radium Ra223 dichloride

Revision: 8, Authorised
21/03/2018Referral: Article 20 procedures, Xofigo,

radium Ra223 dichloride

(updated)
21/03/2018Human medicines European public assessment report (EPAR): Abasaglar (previously Abasria),

insulin glargine

Revision: 6, Authorised
20/03/2018COMP meeting report on the review of applications for orphan designation: March 2018
20/03/2018Human medicines European public assessment report (EPAR): Actrapid,

human insulin (rDNA)

Revision: 15, Authorised
20/03/2018Human medicines European public assessment report (EPAR): Insulatard,

insulin human (rDNA)

Revision: 17, Authorised
20/03/2018Human medicines European public assessment report (EPAR): Nimenrix,

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

Revision: 21, Authorised
20/03/2018Human medicines European public assessment report (EPAR): Epclusa,

sofosbuvir / velpatasvir

Revision: 4, Authorised
20/03/2018Human medicines European public assessment report (EPAR): Mixtard,

insulin human (rDNA)

Revision: 16, Authorised
20/03/2018Human medicines European public assessment report (EPAR): Actraphane,

insulin human (rDNA)

Revision: 16, Authorised
20/03/2018Human medicines European public assessment report (EPAR): Protaphane,

insulin human (rDNA)

Revision: 15, Authorised
20/03/2018Agenda: Agenda - PDCO agenda of the 20-23 March 2018 meeting
20/03/2018Human medicines European public assessment report (EPAR): Sycrest,

asenapine

Revision: 15, Authorised
20/03/2018Human medicines European public assessment report (EPAR): Sutent,

sunitinib

Revision: 32, Authorised
20/03/2018Human medicines European public assessment report (EPAR): Odefsey,

emtricitabine / rilpivirine / tenofovir alafenamide

Revision: 10, Authorised
20/03/2018Human medicines European public assessment report (EPAR): Oprymea,

pramipexole

Revision: 18, Authorised
20/03/2018Procurement (updated)
19/03/2018Human medicines European public assessment report (EPAR): Fanaptum,

iloperidone

Revision: 0, Refused
19/03/2018Regulatory and procedural guideline: EudraVigilance release notes v.1.10 (updated)
19/03/2018Human medicines European public assessment report (EPAR): Capecitabine Teva,

capecitabine

Revision: 9, Authorised
19/03/2018Good pharmacogenomic practice (updated)
19/03/2018Scientific guideline: Guideline on good pharmacogenomic practice - First version, adopted
19/03/2018Overview of comments received on 'Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues' (EMEA/CHMP/BMWP/42832/2005 Rev. 1)
19/03/2018Multiannual work programme 2018-2020
19/03/2018News and press releases: Workshop on Paediatric Regulation – stakeholders to discuss how to boost development of medicines for children
19/03/2018Orphan designation:

Synthetic 12 amino acid peptide designed after subcommissural organ-spondin

for the: Treatment of spinal cord injury (updated)
16/03/2018Pharmacovigilance Risk Assessment Committee (PRAC): Work Plan 2018
16/03/2018News and press releases: Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 13-15 March 2018
16/03/2018Pending EC decision: Semintra,

telmisartan

Opinion date: 15-Mar-2018
16/03/2018Pending EC decision: Activyl Tick Plus,

indoxacarb / permethrin

Opinion date: 15-Mar-2018
16/03/2018Pending EC decision: Onsior,

robenacoxib

Opinion date: 15-Mar-2018
16/03/2018Pending EC decision: Bravecto Plus, Opinion date: 15-Mar-2018
16/03/2018Article-30(3) opinions (updated)
16/03/2018MRL pending EC decision: Isoflurane - Summary opinion of the CVMP on the establishment of maximum residue limits
16/03/2018MRL pending EC decision: Diflubenzuron - Summary opinion of the CVMP on the establishment of maximum residue limits AA
16/03/2018Scientific guideline: Public consultation concerning a request for CVMP opinion under Article 30(3) of Regulation (EC) No 726/2004 on the risk for the consumer resulting from the use of diethanolamine as an excipient in veterinary medicinal products for food-producing species (EMEA/V/A/127), draft: consultation open
16/03/2018Human medicines European public assessment report (EPAR): PritorPlus,

telmisartan / hydrochlorothiazide

Revision: 31, Authorised
16/03/2018Human medicines European public assessment report (EPAR): Opdivo,

nivolumab

Revision: 17, Authorised
16/03/2018Report: 8th annual report veterinary – Minor use / minor species and limited market (2017)
16/03/2018Report: 2017 Annual Report on EudraVigilance for the European Parliament, the Council and the Commission - reporting period: 1 January to 31 December 2017
16/03/2018Outcome of written procedures during the period 21 November 2017 to 21 February
16/03/2018Rules for the implementation of Council Regulation (EC) No 297/95 on fees payable to the European Medicines Agency and other measures: revised implementing rules to the Fee Regulation as of 1 April 2018
16/03/2018Summary of transfers of appropriations in budgets 2017 and 2018
16/03/2018Trimetazidine: List of nationally authorised medicinal products - PSUSA/00003043/201708
16/03/2018Enalapril / hydrochlorothiazide: List of nationally authorised medicinal products - PSUSA/00001212/201707
16/03/2018Clinical Trial Regulation (updated)
16/03/2018News and press releases: EMA Management Board: highlights of March 2018 meeting
15/03/2018Management Board meeting: 15 March 2018, European Medicines Agency, London, UK, From: 15-Mar-2018, To: 15-Mar-2018 (updated)
15/03/2018Agenda: Agenda for the 99th meeting of the Management Board (updated)
15/03/2018Ceftibuten: List of nationally authorised medicinal products - PSUSA/00000611/201707
15/03/2018Decision of the Executive Director on rules governing the secondment of national experts to the European Medicines Agency (updated)
15/03/2018European Medicines Agency veterinary medicines innovation day, European Medicines Agency, London, UK, From: 19-Apr-2018, To: 19-Apr-2018 (updated)
15/03/2018Agenda: Agenda - European Medicines Agency veterinary medicines innovation day (updated)
15/03/2018Aluvia H-W-764 (updated)
15/03/2018Human medicines European public assessment report (EPAR): Nucala,

mepolizumab

Revision: 6, Authorised
15/03/2018Minutes of the HMPC 20-21 November 2017 meeting
15/03/2018Regulatory and procedural guideline: Quick Response (QR) codes in the labelling and/or package leaflet of veterinary medicinal products authorised via the centralised (CP), mutual recognition (MRP), decentralised procedures (DCP) and national procedures (updated)
15/03/2018Agenda: Agenda - CAT agenda of the 14-16 March 2018 meeting
15/03/2018Committee for Advanced Therapies (CAT): 14-16 March 2018, European Medicines Agency, London, UK, From: 14-Mar-2018, To: 16-Mar-2018 (updated)
15/03/2018Lidocaine hydrochloride / phenylephrine hydrochloride / tropicamide: List of nationally authorised medicinal products - PSUSA/00010390/201707
15/03/2018Caffeine (apnea): List of nationally authorised medicinal products - PSUSA/00000482/201707
15/03/2018Report: Annual report on the use of the special contribution for orphan medicinal products - 2017
15/03/2018Human medicines European public assessment report (EPAR): Humalog,

insulin lispro

Revision: 28, Authorised
15/03/2018Human medicines European public assessment report (EPAR): Mvasi,

bevacizumab

Revision: 1, Authorised
14/03/2018Human medicines European public assessment report (EPAR): Movymia,

teriparatide

Revision: 3, Authorised
14/03/2018Support for industry on clinical data publication (updated)
14/03/2018Human medicines European public assessment report (EPAR): Stalevo,

levodopa / carbidopa / entacapone

Revision: 23, Authorised
14/03/2018PDCO meeting dates for 2016, 2017 and 2018 (updated)
14/03/2018PDCO meeting dates for 2019, 2020 and 2021 (updated)
14/03/2018Theophylline: List of nationally authorised medicinal products - PSUSA/00002921/201706
14/03/2018Human medicines European public assessment report (EPAR): Isentress,

raltegravir

Revision: 31, Authorised
14/03/2018Referral: Article 20 procedures, Zinbryta,

daclizumab

(updated)
14/03/2018Human medicines European public assessment report (EPAR): Kengrexal,

cangrelor

Revision: 5, Authorised
14/03/2018Thirteenth industry stakeholder platform - operation of EU pharmacovigilance , European Medicines Agency, London, UK, From: 20-Mar-2018, To: 20-Mar-2018
14/03/2018Human medicines European public assessment report (EPAR): Latuda,

lurasidone

Revision: 12, Authorised
14/03/2018Report: Medicinal products for human use: monthly figures - February 2018
14/03/2018Scientific publications (updated)
14/03/2018Regulatory and procedural guideline: How to register with EudraVigilance and EVDAS - Training module EV-M1 (updated)
14/03/2018QRD PSUR annex IV template (updated)
14/03/2018User registration steps for EU QPPVs or trusted deputies (for the purpose of the EudraVigilance registration process) - Annex I (updated)
14/03/2018Veterinary medicine European public assessment report (EPAR): Profender,

emodepside / praziquantel

Revision: 16, Authorised
14/03/2018Human medicines European public assessment report (EPAR): Xeplion,

paliperidone

Revision: 11, Authorised
14/03/2018Human medicines European public assessment report (EPAR): Tolura,

telmisartan

Revision: 7, Authorised
14/03/2018Orphan designation:

Allogeneic umbilical cord blood CD34+ cells cultured ex vivo with Notch ligand Delta1

for the: Treatment in haematopoietic stem cell transplantation
14/03/2018Orphan designation:

Sirolimus

for the: Treatment of sickle cell disease
14/03/2018Orphan designation:

Ciclopirox

for the: Treatment of congenital erythropoietic porphyria
14/03/2018Human medicines European public assessment report (EPAR): Truvada,

emtricitabine / tenofovir disoproxil

Revision: 37, Authorised
13/03/2018Orphan designation:

Gilteritinib

for the: Treatment of acute myeloid leukaemia
13/03/2018Orphan designation:

Itacitinib

for the: Treatment of graft-versus-host disease
13/03/2018Orphan designation:

N-[2,6-bis(1-methylethyl)phenyl]-N'-[[1-[4-(dimethylamino)phenyl]cyclopentyl]methyl]urea, hydrochloride salt

for the: Treatment of congenital adrenal hyperplasia
13/03/2018Orphan designation:

Recombinant adeno-associated viral vector serotype 2/1 encoding human beta-hexosaminidase alpha and beta subunits

for the: Treatment of GM2 gangliosidosis
13/03/2018Quilizumab - Notification of discontinuation of a paediatric development which is covered by an agreed paediatric-investigation-plan decision
13/03/2018Opinion/decision on a Paediatric investigation plan (PIP): -,

Quilizumab

Therapeutic area: Pneumology-allergology (updated)
13/03/2018Veterinary medicine European public assessment report (EPAR): Oxybee,

oxalic acid dehydrate

Revision: 0, Authorised
13/03/2018Human medicines European public assessment report (EPAR): Neparvis,

sacubitril / valsartan

Revision: 5, Authorised
13/03/2018Agenda: Agenda - CVMP agenda of the 13-15 March 2018 meeting
13/03/2018Human medicines European public assessment report (EPAR): Insuman,

insulin human

Revision: 25, Authorised
13/03/2018Human medicines European public assessment report (EPAR): Ifirmacombi,

irbesartan / hydrochlorothiazide

Revision: 6, Authorised
13/03/2018Octreotide : List of nationally authorised medicinal products - PSUSA/00002201/201706, adopted
13/03/2018Flecainide: List of nationally authorised medicinal products - PSUSA/00001396/201706, adopted
13/03/2018Nulojix (belatacept) supply shortage (updated)
13/03/2018Orphan designation:

Adeno-associated viral vector serotype 2/6 encoding zinc-finger nucleases and the human iduronate 2-sulfatase gene

for the: Treatment of mucopolysaccharidosis type II (Hunter's syndrome)
13/03/2018Human medicines European public assessment report (EPAR): Menveo,

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

Revision: 20, Authorised
13/03/2018Important medical event terms list version 21.0 (IME-List) (updated)
13/03/2018EudraVigilance - Inclusion/exclusion criteria for the 'Important medical events' list (updated)
13/03/2018Herbal medicinal products: Ribes , Ribis nigri folium, Ribes nigrum L. (updated)
12/03/2018Orphan designation:

Adeno-associated viral vector serotype 2/6 encoding zinc-finger nucleases and the human alpha L-iduronidase gene

for the: Treatment of mucopolysaccharidosis type I
12/03/2018Orphan designation:

N-(bromoacetyl)-3,3-dinitroazetidine

for the: Treatment of small cell lung cancer
12/03/2018Human medicines European public assessment report (EPAR): Mirapexin,

pramipexole

Revision: 31, Authorised
12/03/2018Hydrochlorothiazide moexipril: List of nationally authorised medicinal products - PSUSA/00002082/201706
12/03/2018Public hearings (updated)
12/03/2018Amorolfine: List of nationally authorised medicinal products - PSUSA/00000185/201706
12/03/2018Veterinary medicine European public assessment report (EPAR): Advocate,

imidacloprid / moxidectin

Revision: 19, Authorised
12/03/2018Agenda: Agenda - COMP agenda of the 13-15 March 2018 meeting
12/03/2018Orphan designation:

Recombinant human monoclonal IgG1 antibody for fibroblast growth factor 23 (burosumab)

for the: Treatment of X-linked hypophosphataemia (updated)
12/03/2018Human medicines European public assessment report (EPAR): Crysvita,

burosumab

Revision: 0, Authorised
12/03/2018Orphan designation:

Vatiquinone

for the: Treatment of RARS2 syndrome
12/03/2018Orphan designation:

Humanised Fc-engineered monoclonal antibody against CD19

for the: Treatment of IgG4-related disease
12/03/2018Orphan designation:

Adeno-associated viral vector serotype 5 encoding a microRNA targeted to human huntingtin gene

for the: Treatment of Huntington's disease
12/03/2018Orphan designation:

Cannabidiol

for the: Treatment of tuberous sclerosis
12/03/2018Orphan designation:

Pyrazolo[1,5-a]pyrimidine, 3-[4-chloro-2-(4-morpholinyl)-5-thiazolyl]-7-(1-ethylpropyl)-2,5-dimethyl-pyrazolo[1,3-a]pyrimidine

for the: Treatment of congenital adrenal hyperplasia
12/03/2018Orphan designation:

Metformin and L-citrulline

for the: Treatment of Duchenne muscular dystrophy
12/03/2018List of active substances involved in the pilot on signal detection in EudraVigilance by marketing authorisation holders (updated)
12/03/2018Veterinary medicine European public assessment report (EPAR): Meloxidyl,

meloxicam

Revision: 13, Authorised
12/03/2018Human medicines European public assessment report (EPAR): Tolucombi,

telmisartan / hydrochlorothiazide

Revision: 6, Authorised
12/03/2018Orphan designation:

Siponimod

for the: Treatment of dermatomyositis (updated)
12/03/2018Orphan designation:

Siponimod

for the: Treatment of polymyositis (updated)
12/03/2018Orphan designation:

Human plasmin

for the: Treatment of acute peripheral arterial occlusion (updated)
12/03/2018Human medicines European public assessment report (EPAR): Aripiprazole Mylan Pharma (previously Aripiprazole Pharmathen),

aripiprazole

Revision: 6, Authorised
12/03/2018Human medicines European public assessment report (EPAR): Emselex,

darifenacin hydrobromide

Revision: 21, Authorised
09/03/2018Landiolol: List of nationally authorised medicinal products - PSUSA/00010570/201708
09/03/2018Agenda: CHMP ORGAM minutes for the meeting on 12 February 2018
09/03/2018European Union BFC conversion v.2.8 (updated)
09/03/2018Regulatory and procedural guideline: EU Individual Case Safety Report (ICSR) implementation guide business rules spreadsheets (updated)
09/03/2018Committee for Medicinal Products for Human Use (CHMP): 19-22 February 2018, European Medicines Agency, London, UK, From: 19-Feb-2018, To: 22-Feb-2018 (updated)
09/03/2018COMP meeting report on the review of applications for orphan designation: February 2018
09/03/2018Misoprostol (gynaecological indication - termination of pregnancy): List of nationally authorised medicinal products - PSUSA/00010354/201705
09/03/2018Misoprostol (gynaecological indication - termination of pregnancy): CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010354/201705
09/03/2018Work plan for the Working Party on European Union Monographs and List (MLWP) 2018 (updated)
09/03/2018Work plan for the Organisational Matters Drafting Group (ORGAM DG) 2018 (updated)
09/03/2018Mandate, objectives and rules of procedure for the HMPC Working Party on Community Monographs and Community List (MLWP) (updated)
09/03/2018Report: Applications for new human medicines under evaluation by the CHMP: March 2018
09/03/2018News and press releases: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 5-8 March 2018
09/03/2018Newsletter: Human medicines highlights - March 2018
09/03/2018News and press releases: Prostate cancer medicine Xofigo must not be used with Zytiga and prednisone/prednisolone
09/03/2018Almotriptan: List of nationally authorised medicinal products - PSUSA/00000101/201706
09/03/2018Ketotifen (ophtalmic formulations): List of nationally authorised medicinal products - PSUSA/00001812/201706
09/03/2018Ketorolac (systemic formulations): List of nationally authorised medicinal products - PSUSA/00001811/201707
09/03/2018Carbetocin: List of nationally authorised medicinal products - PSUSA/00000546/201706
09/03/2018Ketorolac (ophtalmic formulations): List of nationally authorised medicinal products - PSUSA/00001810/201707
08/03/2018Human medicines European public assessment report (EPAR): NeuroBloc,

botulinum toxin type B

Revision: 28, Authorised
08/03/2018Human medicines European public assessment report (EPAR): Evoltra,

clofarabine

Revision: 25, Authorised
08/03/2018Regulatory and procedural guideline: List of substances and products subject to worksharing for signal management (updated)
08/03/2018Magnesium sulphate / sodium sulphate / potassium sulphate: List of nationally authorised medicinal products - PSUSA/00010239/201708
08/03/2018Human medicines European public assessment report (EPAR): Topotecan Teva,

topotecan

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

telmisartan

Revision: 27, Authorised
08/03/2018Human medicines European public assessment report (EPAR): Fasenra,

benralizumab

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

pentosan polysulfate sodium

Revision: 2, Authorised
08/03/2018Human medicines European public assessment report (EPAR): Aripiprazole Accord,

aripiprazole

Revision: 5, Authorised
08/03/2018Human medicines European public assessment report (EPAR): Xermelo,

telotristat ethyl

Revision: 1, Authorised
08/03/2018Minutes of the CHMP meeting 22-25 January 2018
08/03/2018Human medicines European public assessment report (EPAR): Aripiprazole Sandoz,

aripiprazole

Revision: 5, Authorised
08/03/2018CAT monthly report of application procedures, guidelines and related documents on advanced therapies: February 2018
08/03/2018Human medicines European public assessment report (EPAR): Zyclara,

imiquimod

Revision: 7, Authorised
08/03/2018Mifepristone / misoprostol: CMDh scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010378/201705
08/03/2018Mifepristone / misoprostol: List of nationally authorised medicinal products - PSUSA/00010378/201705
08/03/2018Human medicines European public assessment report (EPAR): Palonosetron Hospira,

palonosetron

Revision: 3, Authorised
08/03/2018Veterinary medicine European public assessment report (EPAR): Sileo,

dexmedetomidine

Revision: 5, Authorised
08/03/2018Herbal medicinal products: Hypericum, Hyperici herba, Hypericum perforatum L. (updated)
08/03/2018Draft European Union herbal monograph on Hypericum perforatum L., herba (traditional use) - Revision 1, draft: consultation open
08/03/2018Herbal medicinal products: Ruscus , Rusci aculeati rhizoma, Ruscus aculeatus L. (updated)
08/03/2018Draft European Union herbal monograph on Ruscus aculeatus L. rhizoma- Revision 1, draft: consultation open
07/03/2018Tramadol: List of nationally authorised medicinal products - PSUSA/00003002/201705
07/03/2018Tramadol: CMDh scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00003002/201705
07/03/2018Human medicines European public assessment report (EPAR): Synflorix,

pneumococcal polysaccharide conjugate vaccine (adsorbed)

Revision: 30, Authorised
07/03/2018Human medicines European public assessment report (EPAR): Epivir,

lamivudine

Revision: 39, Authorised
07/03/2018Opinion/decision on a Paediatric investigation plan (PIP): Zinplava,

Bezlotoxumab

Therapeutic area: Infectious diseases (updated)
07/03/2018Opinion/decision on a Paediatric investigation plan (PIP): Truberzi,

Eluxadoline

Therapeutic area: Gastroentology-Hepatology (updated)
07/03/2018PDCO monthly report of opinions on paediatric investigation plans and other activities 20-23 February 2018
07/03/2018European Union Telematics Management Board - Terms of reference (updated)
07/03/2018Alteplase: List of nationally authorised medicinal products - PSUSA/00000112/201705
07/03/2018Alteplase: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00000112/201705
07/03/2018Human medicines European public assessment report (EPAR): Olanzapine Teva,

olanzapine

Revision: 23, Authorised
07/03/2018Veterinary medicine European public assessment report (EPAR): Zactran,

gamithromycin

Revision: 10, Authorised
07/03/2018Human medicines European public assessment report (EPAR): Aripiprazole Zentiva,

aripiprazole

Revision: 5, Authorised
07/03/2018EMA tracking tool: relocation to Amsterdam - Main milestones (updated)
07/03/2018Human medicines European public assessment report (EPAR): Pregabalin Accord,

pregabalin

Revision: 5, Authorised
07/03/2018Opinion/decision on a Paediatric investigation plan (PIP): -,

Synthetic double-stranded small interfering RNA (siRNA) oligonucleotide specific to the mRNA of the caspase 2 gene

Therapeutic area: Ophthalmology
07/03/2018Opinion/decision on a Paediatric investigation plan (PIP): -,

Sirolimus

Therapeutic area: Other
07/03/2018Human medicines European public assessment report (EPAR): Ristempa,

pegfilgrastim

Revision: 3, Withdrawn
07/03/2018Public statement: Public statement on Ristempa: Withdrawal of the marketing authorisation in the European Union
07/03/2018Opinion/decision on a Paediatric investigation plan (PIP): -,

Resminostat

Therapeutic area: Oncology
07/03/2018Using Organisations Management Services (OMS) and Referentials Management Service (RMS) data in electronic application forms (eAF): SPOR webinar, European Medicines Agency, London, UK, From: 28-Nov-2017, To: 28-Nov-2017
07/03/2018Opinion/decision on a Paediatric investigation plan (PIP): -,

Atorvastatin / ezetimibe

Therapeutic area: Cardiovascular diseases
07/03/2018Opinion/decision on a Paediatric investigation plan (PIP): -,

Soluble human T cell receptor (TCR) directed against the glycoprotein 100 (gp100) melanoma antigen, linked to the single-chain variable fragment (ScFv) domain of the anti-cluster of differentiation 3 (CD3) antibody

Therapeutic area: Oncology
07/03/2018Opinion/decision on a Paediatric investigation plan (PIP): -,

Vonapanitase

Therapeutic area: Cardiovascular diseases
07/03/2018Human medicines European public assessment report (EPAR): Dasselta,

desloratadine

Revision: 9, Authorised
07/03/2018Opinion/decision on a Paediatric investigation plan (PIP): -,

Human Neutrophil Elastase Inhibitor (CHF6333)

Therapeutic area: Pneumology-allergology
07/03/2018Methyl salicylate / levomenthol: CMDh scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010241/201704
07/03/2018Methyl salicylate / levomenthol: List of nationally authorised medicinal products - PSUSA/00010241/201704
07/03/2018News and press releases: EMA recommends immediate suspension and recall of multiple sclerosis medicine Zinbryta
06/03/2018Human medicines European public assessment report (EPAR): Javlor,

vinflunine

Revision: 8, Authorised
06/03/2018Human medicines European public assessment report (EPAR): Zubsolv,

buprenorphine / naloxone

Revision: 1, Authorised
06/03/2018Human medicines European public assessment report (EPAR): Buccolam,

midazolam

Revision: 7, Authorised
06/03/2018Bismuth subcitrate potassium / metronidazole / tetracycline: List of nationally authorised medicinal products - PSUSA/00010199/201705
06/03/2018Bismuth subcitrate potassium / metronidazole / tetracycline: CMDh scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010199/201705
06/03/2018SPOR data services: questions and answers webinar with industry, European Medicines Agency, London, UK, From: 07-Dec-2017, To: 07-Dec-2017
06/03/2018Human medicines European public assessment report (EPAR): Kinzalmono (previously Telmisartan Boehringer Ingelheim Pharma KG),

telmisartan

Revision: 28, Authorised
06/03/2018Timetable: Marketing authorisation renewal application - ATMP (updated)
06/03/2018Timetable: Marketing authorisation renewal application (updated)
06/03/2018Opinion/decision on a Paediatric investigation plan (PIP): -,

Monoclonal IgG1 anti-influenza A antibody

Therapeutic area: Infectious diseases (updated)
06/03/2018Monoclonal IgG1 anti-influenza A antibody - Notification of discontinuation of a paediatric development which is covered by an agreed paediatric-investigation-plan decision
06/03/2018Human fibrinogen / human thrombin - Notification of discontinuation of a paediatric development which is covered by an agreed paediatric-investigation-plan decision
06/03/2018Opinion/decision on a Paediatric investigation plan (PIP): -,

Human fibrinogen / human thrombin

Therapeutic area: Haematology-Hemostaseology (updated)
06/03/2018Candesartan, candesartan / hydrochlorothiazide: List of nationally authorised medicinal products - PSUSA/00000527/201704
06/03/2018Irinotecan (except for liposomal formulations): CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00001783/201705
06/03/2018Amikacin: List of nationally authorised medicinal products - PSUSA/00000143/201706
06/03/2018Irinotecan (except for liposomal formulations): List of nationally authorised medicinal products - PSUSA/00001783/201705
06/03/2018Hepatitis a (inactivated) / typhoid polysaccharide vaccine (adsorbed): List of nationally authorised medicinal products - PSUSA/00001594/201706
06/03/2018Folic acid: List of nationally authorised medicinal products - PSUSA/00001459/201706
06/03/2018Folic acid: CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00001459/201706
06/03/2018Human medicines European public assessment report (EPAR): Elocta,

efmoroctocog alfa

Revision: 4, Authorised
06/03/2018Veterinary medicine European public assessment report (EPAR): Bluevac BTV8,

bluetongue virus inactivated, serotype 8

Revision: 6, Authorised
06/03/2018Human medicines European public assessment report (EPAR): NutropinAq,

somatropin

Revision: 15, Authorised
06/03/2018Elocta : EPAR - Procedural steps taken and scientific information after authorisation (updated)
06/03/2018Orphan designation:

Carbetocin

for the: Treatment of Prader-Willi syndrome (updated)
06/03/2018CHMP post-authorisation summary of positive opinion for Isentress, adopted (updated)
06/03/2018Human medicines European public assessment report (EPAR): Omnitrope,

somatropin

Revision: 14, Authorised
06/03/2018Timetable: Annual reassessment - ATMP (updated)
06/03/2018Timetable: Annual renewal application of conditional marketing authorisation (updated)
06/03/2018Timetable: Annual renewal application of conditional marketing authorisation - ATMP (updated)
06/03/2018Timetable: Annual reassessment (updated)
06/03/2018Orphan designation:

Choline tetrathiomolybdate

for the: Treatment of Wilson’s disease (updated)
06/03/2018Methyl salicylate / levomenthol / DL-camphor: CMDh scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010117/201704
06/03/2018Methyl salicylate / levomenthol / DL-camphor: List of nationally authorised medicinal products - PSUSA/00010117/201704
05/03/2018Human medicines European public assessment report (EPAR): Jakavi,

ruxolitinib

Revision: 15, Authorised
05/03/2018Human medicines European public assessment report (EPAR): Tresiba,

insulin degludec

Revision: 9, Authorised
05/03/2018Opinion/decision on a Paediatric investigation plan (PIP): Palexia and associated names; Yantil and associated names; Tapentadol and associated names,

Tapentadol (hydrochloride)

Therapeutic area: Pain (updated)
05/03/2018Opinion/decision on a Paediatric investigation plan (PIP): Revatio,

Sildenafil

Therapeutic area: Other (updated)
05/03/2018Opinion/decision on a Paediatric investigation plan (PIP): -,

Aluminium hydroxide adsorbed, depigmented glutaraldehyde polymerised, allergic extract of equal amounts of Phleum pratense, Dactylis glomerata, Festuca elatior, Lolium perenne and Poa pratensis pollen (Grasses-Mix) and Secale cereale (cultivated rye) pollen (50/50)

Therapeutic area: Pneumology-allergology (updated)
05/03/2018Opinion/decision on a Paediatric investigation plan (PIP): -,

Aluminium hydroxide adsorbed, depigmented glutaraldehyde polymerised, allergic extract of equal amounts of Phleum pratense, Dactylis glomerata, Festuca elatior, Lolium perenne and Poa pratensis pollen (Grasses-Mix) (1/5) each

Therapeutic area: Pneumology-allergology (updated)
05/03/2018Opinion/decision on a Paediatric investigation plan (PIP): -,

Aluminium hydroxide adsorbed, depigmented glutaraldehyde polymerised, allergic extract of Phleum pratense pollen

Therapeutic area: Pneumology-allergology (updated)
05/03/2018Opinion/decision on a Paediatric investigation plan (PIP): Soliris,

Eculizumab

Therapeutic area: Neurology (updated)
05/03/2018Opinion/decision on a Paediatric investigation plan (PIP): -,

Fc- and CDR-modified humanised monoclonal antibody against C5

Therapeutic area: Haematology-Hemostaseology
05/03/2018Opinion/decision on a Paediatric investigation plan (PIP): Coagadex,

Human coagulation factor X

Therapeutic area: Haematology-Hemostaseology (updated)
05/03/2018Opinion/decision on a Paediatric investigation plan (PIP): -,

Budesonide

Therapeutic area: Pneumology-allergology
05/03/2018Opinion/decision on a Paediatric investigation plan (PIP): -,

Cemilimab

Therapeutic area: Oncology
05/03/2018Opinion/decision on a Paediatric investigation plan (PIP): -,

Vosoritide (BMN 111)

Therapeutic area: Other
05/03/2018Opinion/decision on a Paediatric investigation plan (PIP): -,

Emapalumab

Therapeutic area: Immunology-Rheumatology-Transplantation
05/03/2018Opinion/decision on a Paediatric investigation plan (PIP): Vibativ,

Telavancin (hydrochloride)

Therapeutic area: Infectious diseases (updated)
05/03/2018Opinion/decision on a Paediatric investigation plan (PIP): Translarna,

Ataluren

Therapeutic area: Neurology (updated)
05/03/2018Opinion/decision on a Paediatric investigation plan (PIP): Betmiga,

Mirabegron

Therapeutic area: Uro-nephrology (updated)
05/03/2018Opinion/decision on a Paediatric investigation plan (PIP): -,

Recombinant human glutamic acid decarboxylase (rhGAD65)

Therapeutic area: Endocrinology, -gynacology-fertility-metabolism (updated)
05/03/2018Opinion/decision on a Paediatric investigation plan (PIP): Blincyto,

Blinatumomab

Therapeutic area: Oncology (updated)
05/03/2018Opinion/decision on a Paediatric investigation plan (PIP): Revestive,

Teduglutide

Therapeutic area: Gastroentology-Hepatology (updated)
05/03/2018Opinion/decision on a Paediatric investigation plan (PIP): Cosentyx,

Secukinumab

Therapeutic area: Immunology-Rheumatology-Transplantation (updated)
05/03/2018Opinion/decision on a Paediatric investigation plan (PIP): Amitiza,

Lubiprostone

Therapeutic area: Gastroentology-Hepatology (updated)
05/03/2018Opinion/decision on a Paediatric investigation plan (PIP): -,

Neisseria meningitidis serogroup A polysaccharide conjugated to tetanus toxoid / N. meningitidis serogroup C polysaccharide conjugated to tetanus toxoid / N. meningitidis serogroup Y polysaccharide conjugated to tetanus toxoid / N. meningitidis serogroup W polysaccharide conjugated to tetanus toxoid (MenACYW)

Therapeutic area: Vaccines
05/03/2018Opinion/decision on a Paediatric investigation plan (PIP): -,

Brazikumab

Therapeutic area: Gastroentology-Hepatology
05/03/2018Opinion/decision on a Paediatric investigation plan (PIP): -,

Opicinumab

Therapeutic area: Neurology
05/03/2018Opinion/decision on a Paediatric investigation plan (PIP): -,

Tolonium chloride

Therapeutic area: Other
05/03/2018Opinion/decision on a Paediatric investigation plan (PIP): Trittico and associated names,

Trazodone (hydrochloride)

Therapeutic area: Neurology
05/03/2018Opinion/decision on a Paediatric investigation plan (PIP): -,

Fremanezumab

Therapeutic area: Neurology
05/03/2018Opinion/decision on a Paediatric investigation plan (PIP): -,

Omega-3-carboxylic acids

Therapeutic area: Cardiovascular diseases
05/03/2018Opinion/decision on a Paediatric investigation plan (PIP): Jakavi,

Ruxolitinib (phosphate)

Therapeutic area: Oncology
05/03/2018Opinion/decision on a Paediatric investigation plan (PIP): -,

Carotuximab

Therapeutic area: Oncology
05/03/2018Opinion/decision on a Paediatric investigation plan (PIP): -,

Recombinant humanised IgG4 monoclonal antibody against MSRV-Envelope protein (GNbAC1)

Therapeutic area: Neurology
05/03/2018Opinion/decision on a Paediatric investigation plan (PIP): Obizur,

Susoctocog alfa

Therapeutic area: Haematology-Hemostaseology
05/03/2018Opinion/decision on a Paediatric investigation plan (PIP): -,

Iron hydroxyethyl amylopectin heptonate

Therapeutic area: Haematology-Hemostaseology
05/03/2018Opinion/decision on a Paediatric investigation plan (PIP): -,

Synthetic double-stranded siRNA oligonucleotide directed against hydroxyacid oxidase 1 mRNA that is covalently linked to a ligand containing three N-acetylgalactosamine residues (ALN-GO1)

Therapeutic area: Gastroentology-Hepatology
05/03/2018Human medicines European public assessment report (EPAR): Plenadren,

hydrocortisone

Revision: 9, Authorised
05/03/2018Opinion/decision on a Paediatric investigation plan (PIP): -,

Allopregnanolone

Therapeutic area: Psychiatry
05/03/2018Agenda: Agenda - PRAC draft agenda of meeting 5-8 March 2018
05/03/2018Pharmacovigilance Risk Assessment Committee (PRAC): 5-8 March 2018, European Medicines Agency, London, UK, From: 05-Mar-2018, To: 08-Mar-2018 (updated)
05/03/2018Human medicines European public assessment report (EPAR): Zavicefta,

ceftazidime / avibactam

Revision: 3, Authorised
05/03/2018News and press releases: Regulatory information – adjusted fees for applications to EMA from 1 April 2018
05/03/2018Human medicines European public assessment report (EPAR): Orkambi,

lumacaftor / ivacaftor

Revision: 10, Authorised
05/03/2018Human medicines European public assessment report (EPAR): Levodopa/Carbidopa/Entacapone Orion,

levodopa / carbidopa / entacapone

Revision: 9, Authorised
05/03/2018News and press releases: New tracking tool for EMA’s relocation to Amsterdam
05/03/2018List of signals discussed at the PRAC since September 2012 (updated)
05/03/2018PRAC recommendations on signals adopted at the 5-8 February 2018 PRAC meeting, adopted
02/03/2018Human medicines European public assessment report (EPAR): Resolor,

prucalopride

Revision: 20, Authorised
02/03/2018Human medicines European public assessment report (EPAR): Fabrazyme,

agalsidase beta

Revision: 25, Authorised
02/03/2018Opinion/decision on a Paediatric investigation plan (PIP): Gilenya,

Fingolimod (hydrochloride)

Therapeutic area: Neurology (updated)
02/03/2018Opinion/decision on a Paediatric investigation plan (PIP): Travatan,

Travoprost

Therapeutic area: Ophthalmology (updated)
02/03/2018Opinion/decision on a Paediatric investigation plan (PIP): -,

Split influenza virus, inactivated containing antigens equivalent to the B-like strain (B/Yamagata lineage) / Split influenza virus, inactivated containing antigens equivalent to the B-like strain (B/Victoria lineage) / Split influenza virus, inactivated (B/Victoria lineage) / Split influenza virus, inactivated containing antigens equivalent to the A/H1N1-like strain / Split influenza virus, inactivated containing antigens equivalent to the A/H3N2-like strain

Therapeutic area: Vaccines (updated)
02/03/2018Opinion/decision on a Paediatric investigation plan (PIP): -,

Vigabatrin

Therapeutic area: Neurology (updated)
02/03/2018Opinion/decision on a Paediatric investigation plan (PIP): Ixiaro,

Japanese encephalitis virus, inactivated (attenuated strain SA14-14-2 grown in vero cells)

Therapeutic area: Vaccines (updated)
02/03/2018Opinion/decision on a Paediatric investigation plan (PIP): Nucala,

Mepolizumab

Therapeutic area: Pneumology-allergology (updated)
02/03/2018Opinion/decision on a Paediatric investigation plan (PIP): Xeomin, Bocouture,

Clostridium botulinum neurotoxin type A (150 kD), free of complexing proteins

Therapeutic area: Dermatology/Ophthalmology/Neurology (updated)
02/03/2018Opinion/decision on a Paediatric investigation plan (PIP): Sycrest,

Asenapine (maleate)

Therapeutic area: Psychiatry (updated)
02/03/2018Opinion/decision on a Paediatric investigation plan (PIP): -,

Recombinant human nerve growth factor

Therapeutic area: Ophthalmology (updated)
02/03/2018Opinion/decision on a Paediatric investigation plan (PIP): Soliris,

Eculizumab

Therapeutic area: Immunology-Rheumatology-Transplantation (updated)
02/03/2018Opinion/decision on a Paediatric investigation plan (PIP): Mimpara,

Cinacalcet (hydrochloride)

Therapeutic area: Uro-nephrology (updated)
02/03/2018Opinion/decision on a Paediatric investigation plan (PIP): Isentress,

Raltegravir

Therapeutic area: Infectious diseases (updated)
02/03/2018Human medicines European public assessment report (EPAR): Cubicin,

daptomycin

Revision: 27, Authorised
02/03/2018Minutes of the PRAC meeting 8-11 January 2018
02/03/2018Opinion/decision on a Paediatric investigation plan (PIP): -,

Lanadelumab (DX-2930)

Therapeutic area: Other (updated)
02/03/2018Opinion/decision on a Paediatric investigation plan (PIP): Bavencio,

Avelumab

Therapeutic area: Oncology (updated)
02/03/2018HMPC meeting report on European Union herbal monographs, guidelines and other activities - 29-30 January 2018 (updated)
02/03/2018Opinion/decision on a Paediatric investigation plan (PIP): -,

Lumicitabine

Therapeutic area: Infectious diseases (updated)
02/03/2018Opinion/decision on a Paediatric investigation plan (PIP): -,

Upadacitinib

Therapeutic area: Immunology-Rheumatology-Transplantation (updated)
02/03/2018Opinion/decision on a Paediatric investigation plan (PIP): -,

Palovarotene

Therapeutic area: Other (updated)
02/03/2018Opinion/decision on a Paediatric investigation plan (PIP): -,

Human normal immunoglobulin

Therapeutic area: Immunology-Rheumatology-Transplantation (updated)
02/03/2018Opinion/decision on a Paediatric investigation plan (PIP): Besponsa,

inotuzumab ozogamicin

Therapeutic area: Haematology-Hemostaseology (updated)
02/03/2018Patient registries (updated)
02/03/2018Opinion/decision on a Paediatric investigation plan (PIP): Imbruvica,

Ibrutinib

Therapeutic area: Oncology (updated)
02/03/2018Opinion/decision on a Paediatric investigation plan (PIP): Mysimba,

Naltrexone (hydrochloride) / bupropion (hydrochloride)

Therapeutic area: Other (updated)
02/03/2018Opinion/decision on a Paediatric investigation plan (PIP): -,

Thrombomodulin alfa

Therapeutic area: Infectious diseases (updated)
02/03/2018Opinion/decision on a Paediatric investigation plan (PIP): Samsca and associated names,

Tolvaptan

Therapeutic area: Endocrinology, -gynacology-fertility-metabolism (updated)
02/03/2018Opinion/decision on a Paediatric investigation plan (PIP): Evicel, Evarrest,

Human fibrinogen / human thrombin

Therapeutic area: Other (updated)
02/03/2018Opinion/decision on a Paediatric investigation plan (PIP): Kevzara,

sarilumab

Therapeutic area: Immunology-Rheumatology-Transplantation (updated)
02/03/2018Human medicines European public assessment report (EPAR): Olysio,

simeprevir

Revision: 13, Authorised
02/03/2018Human medicines European public assessment report (EPAR): Odomzo,

sonidegib

Revision: 5, Authorised
02/03/2018News and press releases: EMA urgently reviewing multiple sclerosis medicine Zinbryta following cases of inflammatory brain disorders
02/03/2018Mandate of the European network of paediatric research-European Medicines Agency working groups (updated)
02/03/2018Newsletter: European network of paediatric research at the European Medicines Agency newsletter: 2017
02/03/2018Agenda: Agenda – Industry stakeholder meeting on Brexit and operation of the centralised procedure for human medicinal products
02/03/2018Industry stakeholder meeting on Brexit and operation of the centralised procedure for human medicinal products, European Medicines Agency, London, UK, From: 23-Mar-2018, To: 23-Mar-2018
01/03/2018Human medicines European public assessment report (EPAR): Tenofovir disoproxil Zentiva,

tenofovir disoproxil

Revision: 3, Authorised
01/03/2018Report: Outcome of the European Medicines Agency (EMA) survey on centralised initial marketing authorisation procedure 2016/2017
01/03/2018Human medicines European public assessment report (EPAR): Olumiant,

baricitinib

Revision: 3, Authorised
01/03/2018Call for scientific data for use in HMPC assessment work on Hamamelis virginiana L., folium et cortex aut ramunculus destillatum – First version, draft: consultation open
01/03/2018Call for scientific data for use in HMPC assessment work on Hamamelis virginiana L., cortex – First version, draft: consultation open
01/03/2018Herbal medicinal products: Echinacea, Echinaceae angustifoliae radix, Echinacea angustifolia DC. (updated)
01/03/2018Herbal medicinal products: Hamamelis, Hamamelidis folium, Hamamelis virginiana L. (updated)
01/03/2018Herbal medicinal products: Ilex, Mate folium, Ilex paraguariensis St. Hilaire (updated)
01/03/2018Herbal medicinal products: Hamamelis, Hamamelidis cortex, Hamamelis virginiana L. (updated)
01/03/2018Mandate, objectives and rules of procedure for the joint CVMP/CHMP working group on the application of the 3Rs (replacement, reduction and refinement) in regulatory testing of medicinal products (J3RsWG) (updated)
01/03/2018Human medicines European public assessment report (EPAR): Cervarix,

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

Revision: 30, Authorised
01/03/2018Herbal medicinal products: Phaseolus, Phaseoli fructus (sine semine), Phaseolus vulgaris L. (updated)
01/03/2018Herbal medicinal products: Leonurus, Leonuri cardiacae herba, Leonurus cardiaca L. (updated)
01/03/2018Call for scientific data for use in HMPC assessment work on Ilex paraguariensis St. Hilaire, folium – Revision 1, draft: consultation open
01/03/2018Herbal medicinal products: Hamamelis, Hamamelidis folium et cortex aut ramunculus destillatum, Hamamelis virginiana L. (updated)
01/03/2018Call for scientific data for use in HMPC assessment work on Leonurus cardiaca L., herba – Revision 1, draft: consultation open
01/03/2018Call for scientific data for use in HMPC assessment work on Phaseolus vulgaris L., fructus – Revision 1, draft: consultation open
01/03/2018Call for scientific data for use in HMPC assessment work on Echinaceae angustifolia DC., radix – First version, draft: consultation open
01/03/2018Call for scientific data for use in HMPC assessment work on Hamamelis virginiana L., folium – First version, draft: consultation open
01/03/2018Human medicines European public assessment report (EPAR): Entyvio,

vedolizumab

Revision: 9, Authorised
01/03/2018Human medicines European public assessment report (EPAR): Plavix,

clopidogrel

Revision: 36, Authorised
01/03/2018Human medicines European public assessment report (EPAR): Alkindi,

hydrocortisone

Revision: 0, Authorised
01/03/2018Human medicines European public assessment report (EPAR): Trulicity,

dulaglutide

Revision: 7, Authorised
01/03/2018Human medicines European public assessment report (EPAR): Mycamine,

micafungin

Revision: 12, Authorised
01/03/2018Human medicines European public assessment report (EPAR): Hemlibra,

emicizumab

Revision: 0, Authorised
01/03/2018Questions and answers on the impact of Mutual Recognition Agreement between the European Union and the United States as of 1 March 2018 (updated)
01/03/2018News and press releases: Four more EU Member States benefit from EU-US mutual recognition agreement for inspections
01/03/2018Mutual recognition agreements (updated)
01/03/2018Excipients labelling (updated)
01/03/2018Annex to the European Commission guideline on ‘Excipients in the labelling and package leaflet of medicinal products for human use’ (updated)
01/03/2018Clinical investigation of new medicinal products for the treatment of acute coronary syndrome (updated)
01/03/2018Clinical investigation of medicinal products in the treatment of chronic heart failure (updated)
01/03/2018Referral: Article 31 referrals, Paracetamol modified-release,

paracetamol

(updated)
01/03/2018Human medicines European public assessment report (EPAR): Quinsair,

levofloxacin

Revision: 6, Authorised
01/03/2018News and press releases: European Medicines Agency welcomes new Head of Veterinary Medicines