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April 2018

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20/04/2018Pending EC decision: Dany's BienenWohl,

oxalic acid dihydrate

Opinion date: 19-Apr-2018
20/04/2018News and press releases: Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 17-19 April 2018
20/04/2018Pending EC decision: Credelio,

lotilaner

Opinion date: 19-Apr-2018
20/04/2018News and press releases: Eye injuries in people and dogs when using Osurnia ear gel for dogs
20/04/2018Ethical use of animals in medicine testing
20/04/2018Criteria for classification of critical medicinal products (updated)
20/04/2018Points to consider for the overall assessment of a supply shortage of a medicinal product due to GMP Non-compliance /quality defects (updated)
20/04/2018Human medicines European public assessment report (EPAR): Vemlidy,

tenofovir alafenamide

Revision: 3, Authorised
20/04/2018Pending EC decision: EnCyzix,

enclomifene

Opinion date: 25-Jan-2018 (updated)
20/04/2018Pending EC decision: Alsitek,

masitinib

Opinion date: 18-Apr-2018
20/04/2018Opinion/decision on a Paediatric investigation plan (PIP): -,

Eculizumab

Therapeutic area: Immunology-Rheumatology-Transplantation (updated)
20/04/2018Opinion/decision on a Paediatric investigation plan (PIP): -,

Solithromycin

Therapeutic area: Infectious diseases (updated)
20/04/2018Opinion/decision on a Paediatric investigation plan (PIP): Flublok,

Trivalent, seasonal, recombinant influenza hemagglutinin vaccine

Therapeutic area: Vaccines/Infectious diseases (updated)
20/04/2018Opinion/decision on a Paediatric investigation plan (PIP): -,

Solithromycin

Therapeutic area: Infectious diseases (updated)
20/04/2018Human medicines European public assessment report (EPAR): Xeloda,

capecitabine

Revision: 23, Authorised
20/04/2018Veterinary medicine European public assessment report (EPAR): Suvaxyn Circo,

porcine circovirus vaccine (inactivated, recombinant)

Revision: 0, Authorised
19/04/2018Agenda: Agenda - Paediatric strategy forum for medicinal product development of checkpoint inhibitors for use in combination therapy in paediatric patients
19/04/2018Multi-stakeholder workshop to further improve the implementation of the Paediatric Regulation, European Medicines Agency, London, UK, From: 20-Mar-2018, To: 20-Mar-2018 (updated)
19/04/2018Paediatric strategy forum for medicinal product development of checkpoint inhibitors for use in combination therapy in paediatric patients, European Medicines Agency, London, UK, From: 05-Sep-2018, To: 06-Sep-2018
19/04/2018Human medicines European public assessment report (EPAR): Odefsey,

emtricitabine / rilpivirine / tenofovir alafenamide

Revision: 11, Authorised
19/04/2018Human medicines European public assessment report (EPAR): Ziagen,

abacavir

Revision: 35, Authorised
19/04/2018Agenda: Programme - EMA/EC multi-stakeholder workshop to further improve the implementation of the paediatric regulation (updated)
19/04/2018Human medicines European public assessment report (EPAR): Celsentri,

maraviroc

Revision: 21, Authorised
19/04/2018Agenda: Agenda - CAT agenda of the 18-20 April 2018 meeting
19/04/2018Human medicines European public assessment report (EPAR): Nimenrix,

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

Revision: 22, Authorised
19/04/2018Suxamethonium: List of nationally authorised medicinal products - PSUSA/00002834/201708
19/04/2018Typhoid polysaccharide vaccine: List of nationally authorised medicinal products - PSUSA/00003065/201708
19/04/2018Aciclovir / hydrocortisone: List of nationally authorised medicinal products - PSUSA/00003065/201708
19/04/2018Buprenorphine: List of nationally authorised medicinal products - PSUSA/00000459/201707
19/04/2018Norethisterone: List of nationally authorised medicinal products - PSUSA/00002188/201708
19/04/2018Human medicines European public assessment report (EPAR): Ameluz,

5-aminolevulinic acid hydrochloride

Revision: 11, Authorised
19/04/2018Overview of comments received on "Qualification opinion on Proactive in chronic obstructive pulmonary disease (COPD)"
19/04/2018Regulatory and procedural guideline: Qualification opinion on Proactive in chronic obstructive pulmonary disease (COPD), adopted
19/04/2018Opinion/decision on a Paediatric investigation plan (PIP): -,

Gadolinium, [α3,α6,α9-tris[3-[(2,3-dihydroxypropyl)amino]-3-oxopropyl]-3,6,9,15-tetraazabicyclo[9.3.1]pentadeca-1(15),11,13-triene-3,6,9-triacetato(3-)-κN3,κN6,κN9,κN15,κO3,κO6,κO9]-(P03277)

Therapeutic area: Diagnostic (updated)
19/04/2018Opinion/decision on a Paediatric investigation plan (PIP): -,

Birch pollen extract (Betula verrucosa)

Therapeutic area: Pneumology-allergology (updated)
19/04/2018Opinion/decision on a Paediatric investigation plan (PIP): -,

Human normal immunoglobulin

Therapeutic area: Immunology-Rheumatology-Transplantation (updated)
19/04/2018Opinion/decision on a Paediatric investigation plan (PIP): Influvac Tetra,

Influenza virus surface antigens (haemagglutinin and neuraminidase) of the following strains: A/(H1N1), A/(H3N2), B/Yamagata lineage, B/Victoria lineage

Therapeutic area: Vaccines (updated)
19/04/2018Opinion/decision on a Paediatric investigation plan (PIP): -,

Burosumab

Therapeutic area: Other (updated)
19/04/2018Opinion/decision on a Paediatric investigation plan (PIP): Keytruda,

Pembrolizumab

Therapeutic area: Oncology (updated)
19/04/2018Opinion/decision on a Paediatric investigation plan (PIP): Vemlidy,

Tenofovir alafenamide

Therapeutic area: Infectious diseases (updated)
19/04/2018Opinion/decision on a Paediatric investigation plan (PIP): Keytruda,

Anti-PD1 humanized monoclonal antibody of the IgG4/kappa class (MK-3475) (pembrolizumab)

Therapeutic area: Oncology (updated)
19/04/2018Opinion/decision on a Paediatric investigation plan (PIP): Orkambi,

Lumacaftor / ivacaftor

Therapeutic area: Other (updated)
19/04/2018Ketoprofen (all formulations except topical): List of nationally authorised medicinal products - PSUSA/00001809/201707
19/04/2018Human medicines European public assessment report (EPAR): Memantine ratiopharm,

memantine

Revision: 5, Authorised
19/04/2018Quinagolide: List of nationally authorised medicinal products - PSUSA/00002590/201707
19/04/2018A common data model in Europe? – Why? Which? How?, European Medicines Agency, London, UK, From: 11-Dec-2017, To: 12-Dec-2017 (updated)
18/04/2018Human medicines European public assessment report (EPAR): Fuzeon,

enfuvirtide

Revision: 19, Authorised
18/04/2018Human tetanus immunoglobulin: List of nationally authorised medicinal products - PSUSA/00002909/201708
18/04/2018Fenofibrate: List of nationally authorised medicinal products - PSUSA/00001362/201707
18/04/2018Opinion/decision on a Paediatric investigation plan (PIP): Evotaz,

Atazanavir (sulphate) / cobicistat

Therapeutic area: Infectious diseases (updated)
18/04/2018Human medicines European public assessment report (EPAR): Cubicin,

daptomycin

Revision: 28, Authorised
18/04/2018Human medicines European public assessment report (EPAR): Ritemvia,

rituximab

Revision: 3, Authorised
18/04/2018Opinion/decision on a Paediatric investigation plan (PIP): -,

N-[(1,3-dicyclohexyl-6-hydroxy-2,4-dioxo-1,2,3,4-tetrahydro-5-pyrimidinyl)carbonyl]glycine (GSK1278863)

Therapeutic area: Haematology-Hemostaseology/Uro-nephrology (updated)
18/04/2018Opinion/decision on a Paediatric investigation plan (PIP): Opdivo,

Nivolumab

Therapeutic area: Oncology (updated)
18/04/2018Regulatory and procedural guideline: Q&A - European Medicines Agency guidance for companies requesting classification as minor uses minor species (MUMS) / limited markets, adopted (updated)
18/04/2018Opinion/decision on a Paediatric investigation plan (PIP): Briviact,

Brivaracetam

Therapeutic area: Neurology
18/04/2018Opinion/decision on a Paediatric investigation plan (PIP): -,

Upadacitinib (ABT-494)

Therapeutic area: Immunology-Rheumatology-Transplantation
18/04/2018Agenda: Agenda - European Medicines Agency veterinary medicines innovation day (updated)
18/04/2018Opinion/decision on a Paediatric investigation plan (PIP): -,

Rosuvastatin (calcium)/ acetylsalicylic acid

Therapeutic area: Cardiovascular diseases
18/04/2018European Medicines Agency veterinary medicines innovation day, European Medicines Agency, London, UK, From: 19-Apr-2018, To: 19-Apr-2018 (updated)
18/04/2018Veterinary medicine European public assessment report (EPAR): Eravac,

Rabbit haemorrhagic disease vaccine (inactivated)

Revision: 3, Authorised
18/04/2018Human medicines European public assessment report (EPAR): Daptomycin Hospira,

daptomycin

Revision: 2, Authorised
18/04/2018Opinion/decision on a Paediatric investigation plan (PIP): Opdivo,

Nivolumab

Therapeutic area: Oncology (updated)
18/04/2018Opinion/decision on a Paediatric investigation plan (PIP): Sivextro,

Tedizolid (phosphate)

Therapeutic area: Infectious diseases (updated)
18/04/2018Veterinary medicine European public assessment report (EPAR): Equilis West Nile,

inactivated chimaeric flavivirus strain YF-WN

Revision: 1, Authorised
18/04/2018Opinion/decision on a Paediatric investigation plan (PIP): Olumiant,

baricitinib

Therapeutic area: Immunology-Rheumatology-Transplantation (updated)
18/04/2018Opinion/decision on a Paediatric investigation plan (PIP): Cinqaero,

Reslizumab

Therapeutic area: Pneumology-allergology (updated)
18/04/2018Opinion/decision on a Paediatric investigation plan (PIP): -,

Tucatinib

Therapeutic area: Oncology
18/04/2018Opinion/decision on a Paediatric investigation plan (PIP): -,

Recombinant human epidermal growth factor

Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
18/04/2018Jobs@EMA User guide (updated)
18/04/2018Opinion/decision on a Paediatric investigation plan (PIP): Praluent,

Alirocumab

Therapeutic area: Endocrinology, -gynacology-fertility-metabolism (updated)
18/04/2018Opinion/decision on a Paediatric investigation plan (PIP): -,

Lucerastat

Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
18/04/2018Opinion/decision on a Paediatric investigation plan (PIP): -,

Fluorocholine (18F)

Therapeutic area: Diagnostic
18/04/2018Opinion/decision on a Paediatric investigation plan (PIP): -,

Maralixibat chloride

Therapeutic area: Gastroentology-Hepatology
18/04/2018Opinion/decision on a Paediatric investigation plan (PIP): -,

1,4-dihydro-1-[(2R)-2-(2-methoxyphenyl)-2-[(tetrahydro-2H-pyran-4-yl)oxy]ethyl]-α,α,5-trimethyl-6-(2-oxazolyl)-2,4-dioxo-thieno[2,3-d]pyrimidine-3(2H)-acetic acid (GS-0976)

Therapeutic area: Gastroentology-Hepatology
18/04/2018Opinion/decision on a Paediatric investigation plan (PIP): -,

Upadacitinib (ABT-494)

Therapeutic area: Immunology-Rheumatology-Transplantation
18/04/2018Opinion/decision on a Paediatric investigation plan (PIP): Maci,

Matrix applied characterised autologous cultured chondrocytes

Therapeutic area: Other (updated)
18/04/2018Opinion/decision on a Paediatric investigation plan (PIP): Jardiance,

Empagliflozin

Therapeutic area: Endocrinology, -gynacology-fertility-metabolism (updated)
18/04/2018Opinion/decision on a Paediatric investigation plan (PIP): Zinforo,

Ceftaroline fosamil

Therapeutic area: Infectious diseases (updated)
18/04/2018Human medicines European public assessment report (EPAR): Truxima,

rituximab

Revision: 5, Authorised
18/04/2018Report: Patients, consumers, healthcare professionals key figures - 2017 (updated)
18/04/2018Opinion/decision on a Paediatric investigation plan (PIP): Xeljanz,

Tofacitinib

Therapeutic area: Immunology-Rheumatology-Transplantation (updated)
18/04/2018Human medicines European public assessment report (EPAR): Rituzena (previously Tuxella),

rituximab

Revision: 4, Authorised
18/04/2018Human medicines European public assessment report (EPAR): Blitzima,

rituximab

Revision: 3, Authorised
18/04/2018Opinion/decision on a Paediatric investigation plan (PIP): Trajenta,

Linagliptin

Therapeutic area: Endocrinology, -gynacology-fertility-metabolism (updated)
18/04/2018Innovation in medicines (updated)
18/04/2018Opinion/decision on a Paediatric investigation plan (PIP): Talz,

Ixekizumab

Therapeutic area: Immunology-Rheumatology-Transplantation (updated)
18/04/2018The European innovation offices network - innovators meet regulators
18/04/2018Opinion/decision on a Paediatric investigation plan (PIP): Januvia,

Sitagliptin

Therapeutic area: Endocrinology, -gynacology-fertility-metabolism (updated)
18/04/2018Brexit regulatory preparedness for veterinary medicinal products in the centralised procedure , European Medicines Agency, London, UK, From: 20-Apr-2018, To: 20-Apr-2018 (updated)
18/04/2018Agenda: Agenda - Brexit regulatory preparedness for veterinary medicinal products in the centralised procedure (updated)
17/04/2018Opinion/decision on a Paediatric investigation plan (PIP): Noxafil,

Posaconazole

Therapeutic area: Infectious diseases (updated)
17/04/2018Human medicines European public assessment report (EPAR): Bosulif,

bosutinib

Revision: 13, Authorised
17/04/2018Opinion/decision on a Paediatric investigation plan (PIP): Rapiscan,

Regadenoson

Therapeutic area: Cardiovascular diseases (updated)
17/04/2018Opinion/decision on a Paediatric investigation plan (PIP): Vimpat,

Lacosamide

Therapeutic area: Neurology (updated)
17/04/2018United Kingdom’s withdrawal from the European Union ('Brexit') (updated)
17/04/2018Opinion/decision on a Paediatric investigation plan (PIP): Vimpat,

Lacosamide

Therapeutic area: Neurology (updated)
17/04/2018Opinion/decision on a Paediatric investigation plan (PIP): Ruconest,

Conestat alfa

Therapeutic area: Other (updated)
17/04/2018Opinion/decision on a Paediatric investigation plan (PIP): -,

L-asparaginase encapsulated in erythrocytes

Therapeutic area: Oncology (updated)
17/04/2018Opinion/decision on a Paediatric investigation plan (PIP): Kalydeco,

Ivacaftor

Therapeutic area: Other (updated)
17/04/2018Opinion/decision on a Paediatric investigation plan (PIP): Briviact,

Brivaracetam

Therapeutic area: Neurology (updated)
17/04/2018Opinion/decision on a Paediatric investigation plan (PIP): Eurartesim,

Artenimol / piperaquine phosphate anhydride

Therapeutic area: Infectious diseases (updated)
17/04/2018Opinion/decision on a Paediatric investigation plan (PIP): Bexsero,

Recombinant Neisseria meningitidis group B NHBA fusion protein / recombinant Neisseria meningitidis group B NadA protein / recombinant Neisseria meningitidis group B fHbp fusion protein / Outer Membrane Vesicles (OMV) from Neisseria meningitidis group B strain NZ98/254 measured as amount of total protein containing the PorA P1.4

Therapeutic area: Vaccines (updated)
17/04/2018Opinion/decision on a Paediatric investigation plan (PIP): -,

Obiltoxaximab

Therapeutic area: Infectious diseases
17/04/2018Opinion/decision on a Paediatric investigation plan (PIP): -,

Recombinant Clostridium difficile toxoid A / recombinant Clostridium difficile toxoid B

Therapeutic area: Vaccines
17/04/2018Opinion/decision on a Paediatric investigation plan (PIP): -,

Dienogest / ethinyl estradiol

Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
17/04/2018Diphtheria / tetanus / poliomyelitis (inactivated) vaccine (adsorbed, reduced antigens(s) content): List of nationally authorised medicinal products - PSUSA/00001127/201708
17/04/2018Opinion/decision on a Paediatric investigation plan (PIP): -,

Gilteritinib (as fumarate)

Therapeutic area: Haematology-Hemostaseology
17/04/2018Opinion/decision on a Paediatric investigation plan (PIP): -,

Glutamine (Levoglutamide)

Therapeutic area: Haematology-Hemostaseology
17/04/2018Opinion/decision on a Paediatric investigation plan (PIP): Ampres,

Chloroprocaine (hydrochloride)

Therapeutic area: Anaesthesiology
17/04/2018Veterinary medicine European public assessment report (EPAR): Improvac,

gonadotropin-releasing-factor-analogue-protein conjugate

Revision: 18, Authorised
16/04/2018Committee for Orphan Medicinal Products (COMP): 17-19 April 2018, European Medicines Agency, London, UK, From: 17-Apr-2018, To: 19-Apr-2018 (updated)
16/04/2018Agenda: Agenda - COMP agenda of the 17-19 April 2018 meeting
16/04/2018Triazolam: List of nationally authorised medicinal products - PSUSA/00003023/201707
16/04/2018Committee for Medicinal Products for Veterinary Use (CVMP): 17-19 April 2018, European Medicines Agency, London, UK, From: 17-Apr-2018, To: 19-Apr-2018 (updated)
16/04/2018Agenda: Agenda - CVMP agenda of the 17-19 April 2018 meeting
16/04/2018Orphan designation:

Ornithine phenylacetate

for the: Treatment of acute liver failure (updated)
16/04/2018Report: Medicinal products for human use: monthly figures - March 2018
16/04/2018Human medicines European public assessment report (EPAR): Simponi,

golimumab

Revision: 29, Authorised
16/04/2018Ethinylestradiol / gestodene (transdermal application): List of nationally authorised medicinal products - PSUSA/00010145/201708
16/04/2018Recruitment at the European Medicines Agency (updated)
16/04/201814th Joint European Medicines Agency/European network for Health Technology Assessment dialogue meeting , European Medicines Agency, London, UK, From: 15-Dec-2017, To: 15-Dec-2017 (updated)
16/04/2018Minutes of the 14th Joint European Medicines Agency/European network for Health Technology Assessment dialogue meeting
16/04/2018Human medicines European public assessment report (EPAR): Taltz,

ixekizumab

Revision: 4, Authorised
16/04/2018Human medicines European public assessment report (EPAR): Respreeza,

human alpha1-proteinase inhibitor

Revision: 3, Authorised
16/04/2018Pilocarpine (non ophthalmic formulations): List of nationally authorised medicinal products - PSUSA/00002409/201707
16/04/2018Ethinylestradiol / norethisterone: List of nationally authorised medicinal products - PSUSA/00001312/201708
16/04/2018Fluocinolone acetonide (intravitreal implant in applicator): List of nationally authorised medicinal products - PSUSA/00010224/201708
16/04/2018Clindamycin phosphate / tretinoin: List of nationally authorised medicinal products - PSUSA/00010080/201707
16/04/2018Human medicines European public assessment report (EPAR): Tasigna,

nilotinib

Revision: 32, Authorised
13/04/2018Etoposide: List of nationally authorised medicinal products - PSUSA/00001333/201708
13/04/2018Human medicines European public assessment report (EPAR): Aldara,

imiquimod

Revision: 23, Authorised
13/04/2018Human medicines European public assessment report (EPAR): Tecentriq,

atezolizumab

Revision: 2, Authorised
13/04/2018Report: Small and medium-sized enterprise (SME) Office annual report 2017
13/04/2018Human medicines European public assessment report (EPAR): Menveo,

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

Revision: 22, Authorised
13/04/2018Human medicines European public assessment report (EPAR): Marixino (previously Maruxa),

memantine

Revision: 6, Authorised
13/04/2018Regulatory and procedural guideline: EudraVigilance release notes v.1.12 (updated)
13/04/2018Decision of the Executive Director on a 1-year initiative for fee reductions for notifications of parallel distribution (updated)
13/04/2018Report: 2016 and 2017 annual report on independence
13/04/2018Human medicines European public assessment report (EPAR): Potactasol,

topotecan

Revision: 6, Authorised
13/04/2018Human medicines European public assessment report (EPAR): Saxenda,

liraglutide

Revision: 4, Authorised
13/04/2018Anastrozole: List of nationally authorised medicinal products - PSUSA/00000210/201708
13/04/2018News and press releases: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 9-12 April 2018
13/04/2018Referral: Article 31 referrals, Methotrexate containing medicinal products,

methotrexate

13/04/2018News and press releases: EMA reviewing risk of dosing errors with methotrexate
13/04/2018Human medicines European public assessment report (EPAR): Ravicti,

 glycerol phenylbutyrate

Revision: 6, Authorised
13/04/2018Herbal medicinal products: Piper, Piperis methystici rhizoma, Piper methysticum G. Forst., rhizoma (updated)
13/04/2018Fludarabine: List of nationally authorised medicinal products - PSUSA/00001406/201708
13/04/2018Human medicines European public assessment report (EPAR): Latuda,

lurasidone

Revision: 13, Authorised
13/04/2018Adenosine: List of nationally authorised medicinal products - PSUSA/00000062/201708
13/04/2018Fluvoxamine: List of nationally authorised medicinal products - PSUSA/00001458/201707
12/04/20182018-2019 Work plan for the Patients’ and Consumers’ Working Party (PCWP) and the Healthcare Professionals’ Working Party (HCPWP)
12/04/2018Human medicines European public assessment report (EPAR): Esbriet,

pirfenidone

Revision: 20, Authorised
12/04/2018Human medicines European public assessment report (EPAR): Torisel,

temsirolimus

Revision: 27, Authorised
12/04/2018International collaboration on GMP inspections (updated)
12/04/2018Report: Report on the international Active Pharmaceutical Ingredient (API) inspection programme 2011-2016
12/04/2018News and press releases: Increasing oversight of API manufacturing through international collaboration
12/04/2018Human medicines European public assessment report (EPAR): Zelboraf,

vemurafenib

Revision: 17, Authorised
12/04/2018Human medicines European public assessment report (EPAR): Cinryze,

C1 inhibitor (human)

Revision: 16, Authorised
12/04/2018Human medicines European public assessment report (EPAR): Zydelig,

idelalisib

Revision: 12, Authorised
12/04/2018Human medicines European public assessment report (EPAR): Leflunomide ratiopharm,

leflunomide

Revision: 12, Authorised
12/04/2018Cover note on eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) substance controlled vocabulary following the quality control exercise (updated)
11/04/2018Human medicines European public assessment report (EPAR): Ocrevus,

ocrelizumab

Revision: 1, Authorised
11/04/2018Human medicines European public assessment report (EPAR): Teysuno,

tegafur / gimeracil / oteracil

Revision: 15, Authorised
11/04/2018Human medicines European public assessment report (EPAR): Xtandi,

enzalutamide

Revision: 13, Authorised
11/04/2018Human medicines European public assessment report (EPAR): Lutathera,

lutetium (177Lu) oxodotreotide

Revision: 1, Authorised
11/04/2018Herbal medicinal products: Gentiana , Gentianae radix, Gentiana lutea L. (updated)
11/04/2018Human medicines European public assessment report (EPAR): Constella,

linaclotide

Revision: 15, Authorised
11/04/2018Human medicines European public assessment report (EPAR): Bexsero,

meningococcal group-B vaccine (rDNA, component, adsorbed)

Revision: 17, Authorised
11/04/2018Human medicines European public assessment report (EPAR): Evotaz,

atazanavir / cobicistat

Revision: 6, Authorised
11/04/2018Human medicines European public assessment report (EPAR): Herceptin,

trastuzumab

Revision: 33, Authorised
11/04/2018Human 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: 37, Authorised
11/04/2018Orphan designation:

N-(tert-butylcarbamoyl)-5-cyano-2-((4'-(difluoromethoxy)-[1,1'-biphenyl]-3-yl)oxy)benzenesulfonamide

for the: Treatment of pulmonary arterial hypertension
11/04/2018Orphan designation:

Recombinant human monoclonal antibody against mannan-binding lectin-associated serine protease-2

for the: Treatment of primary IgA nephropathy
11/04/2018Orphan designation:

Pyridoxal 5'-phosphate

for the: Treatment of pyridoxamine 5'-phosphate oxidase deficiency
11/04/2018Orphan designation:

1-[[[4-(4-Fluoro-2-methyl-1H-indol-5-yloxy)-6-methoxyquinolin-7-yl]oxy]methyl]cyclopropanamine-dihydrochloride

for the: Treatment of soft tissue sarcoma
11/04/2018Orphan designation:

(R)-2-(5-cyano-2-(6-(methoxycarbonyl)-7-methyl-3-oxo-8-(3-(trifluoromethyl)phenyl)-2,3,5,8-tetrahydro-[1,2,4]triazolo[4,3-a]pyrimidine-5-yl)phenyl)-N,N,N-trimethylethanaminium methanesulfonate dehydrate

for the: Treatment of cystic fibrosis
11/04/2018Orphan designation:

Seletalisib

for the: Treatment of activated phosphoinositide 3-kinase delta syndrome
11/04/2018Orphan designation:

Cannabidivarin

for the: Treatment of fragile X syndrome
11/04/2018Orphan designation:

Adenovirus-associated viral vector serotype 8 containing the human RPGR gene

for the: Treatment of retinitis pigmentosa
11/04/2018Orphan designation:

Rusalatide acetate

for the: Treatment of acute radiation syndrome
11/04/2018Orphan designation:

Mertansine functionalised gold nanoconjugate

for the: Treatment of hepatocellular carcinoma
11/04/2018Orphan designation:

Melatonin

for the: Treatment of partial deep dermal and full thickness burns
11/04/2018Redistribution of the UK centrally authorised product portfolio - European Medicines Agency working groups on committees’ operational preparedness
11/04/2018Orphan designation:

Human monoclonal IgG2 antibody against tissue factor pathway inhibitor

for the: Treatment of haemophilia A
11/04/2018News and press releases: Redistribution of UK’s portfolio of centrally authorised products
11/04/2018Orphan designation:

Allogeneic CD4+ and CD25+ T lymphocytes ex vivo incubated with GP120

for the: Treatment in haematopoietic stem cell transplantation
11/04/2018Orphan designation:

Vocimagene amiretrorepvec

for the: Treatment of glioma
11/04/2018Orphan designation:

Levosimendan

for the: Treatment of amyotrophic lateral sclerosis
11/04/2018Human medicines European public assessment report (EPAR): Bondronat,

ibandronic acid

Revision: 25, Authorised
11/04/2018Herbal medicinal products: Fragaria, Fragariae folium, Fragaria vesca L. (updated)
11/04/2018Herbal medicinal products: Arctostaphylos, Uvae ursi folium, Arctostaphylos uva-ursi (L.) Spreng. (updated)
11/04/2018Mometasone: List of nationally authorised medicinal products - PSUSA/00002085/201705 (updated)
11/04/2018Human medicines European public assessment report (EPAR): Bonviva,

ibandronic acid

Revision: 23, Authorised
10/04/2018Orphan designation:

Flucytosine

for the: Treatment of glioma
10/04/2018Orphan designation:

2'-O-(2-Methoxyethyl)-modified antisense oligonucleotide targeting exon 13 in the USH2A gene

for the: Treatment of retinitis pigmentosa
10/04/2018Orphan designation:

6-{[(1R,2S)-2-aminocyclohexyl]amino}-7-fluoro-4-(1-methyl-1H-pyrazol-4-yl)-1,2-dihydro-3H-pyrrolo[3,4-c]pyridin-3-one monocitrate

for the: Treatment of acute myeloid leukaemia
10/04/2018Information Technology Directors Group - List of nominated members (alphabetically by country) (updated)
10/04/2018Paediatric Committee (PDCO): 23-26 January 2018, European Medicines Agency, London, UK, From: 23-Jan-2018, To: 26-Jan-2018 (updated)
10/04/2018Minutes - PDCO minutes of the 23 – 26 January 2018 meeting
10/04/2018Report: Applications for new human medicines under evaluation by the Committee for Medicinal Products for Human Use: April 2018
10/04/2018HMPC meeting report on European Union herbal monographs, guidelines and other activities - 26-27 March 2018
10/04/2018HMPC work plan 2018 (updated)
10/04/2018Committee for Herbal Medicinal Products (HMPC): 26-27 March 2018, European Medicines Agency, London, UK, From: 26-Mar-2018, To: 27-Mar-2018 (updated)
10/04/2018Orphan designation:

Recombinant human alpha-Mannosidase (velmanase alfa)

for the: Treatment of alpha-mannosidosis (updated)
10/04/2018Human medicines European public assessment report (EPAR): Lamzede,

velmanase alfa

Revision: 0, Authorised
10/04/2018Data quality control methodology for data submitted under Article 57(2) of Regulation (EC) No.726/2004 (updated)
10/04/2018Cover note on eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) substance controlled vocabulary following the quality control exercise (updated)
10/04/2018European Medicines Agency substance names best practice: Procedure and principles to handle substance name in the substance management system (updated)
10/04/2018Changes to some business rules of the eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD): Submission of substance information (updated)
10/04/2018Thiocolchicoside: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - EMEA-H-N-PSR-J-0008
10/04/2018Thiocolchicoside: List of nationally authorised medicinal products - EMEA-H-N-PSR-J-0008
10/04/2018Veterinary medicine European public assessment report (EPAR): Vectormune ND,

Newcastle disease and Marek’s disease vaccine (live recombinant)

Revision: 2, Authorised
10/04/2018EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) substances (updated)
10/04/2018EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) pharmaceutical dose forms (updated)
10/04/2018EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) routes of administration (updated)
10/04/2018EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD) organisations (updated)
10/04/2018Human medicines European public assessment report (EPAR): Zerbaxa,

ceftolozane / tazobactam

Revision: 6, Authorised
09/04/2018Misoprostol (gastrointestinal indication): List of nationally authorised medicinal products - PSUSA/00010291/201706
09/04/2018Misoprostol (gastrointestinal indication): CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00010291/201706
09/04/2018Human medicines European public assessment report (EPAR): Faslodex,

fulvestrant

Revision: 19, Authorised
09/04/2018Veterinary medicine European public assessment report (EPAR): Veraflox,

pradofloxacin

Revision: 7, Authorised
09/04/2018Human medicines European public assessment report (EPAR): Remsima,

infliximab

Revision: 11, Authorised
09/04/2018Agenda: Agenda - PRAC draft agenda of meeting 9-12 April 2018
09/04/2018Human medicines European public assessment report (EPAR): Levetiracetam Actavis Group,

levetiracetam

Revision: 10, Authorised
09/04/2018Human medicines European public assessment report (EPAR): Pregabalin Zentiva k.s.,

pregabalin

Revision: 2, Authorised
09/04/2018Human medicines European public assessment report (EPAR): Pregabalin Zentiva,

pregabalin

Revision: 3, Authorised
09/04/2018Human medicines European public assessment report (EPAR): Remicade,

infliximab

Revision: 49, Authorised
09/04/2018Frequently asked questions - Travel reimbursement rules for candidates (updated)
09/04/2018Nitrous oxide, nitrous oxide / oxygen: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010572/201706
09/04/2018Nitrous oxide, nitrous oxide / oxygen: List of nationally authorised medicinal products - PSUSA/00010572/201706
09/04/2018Human medicines European public assessment report (EPAR): Abilify,

aripiprazole

Revision: 41, Authorised
09/04/2018PDCO monthly report of opinions on paediatric investigation plans and other activities 20-23 March 2018
09/04/2018Human medicines European public assessment report (EPAR): Lumark,

lutetium, isotope of mass 177

Revision: 4, Authorised
09/04/2018Public hearing on quinolones and fluoroquinolones - Summary of safety concerns and list of questions
09/04/2018News and press releases: Public hearing on 13 June 2018
09/04/2018Regulatory and procedural guideline: Public Hearing - Guidance for participants (updated)
09/04/2018Human medicines European public assessment report (EPAR): Amlodipine / Valsartan Mylan ,

amlodipine / valsartan

Revision: 2, Authorised
09/04/2018Human medicines European public assessment report (EPAR): Sildenafil ratiopharm,

sildenafil

Revision: 15, Authorised
09/04/2018Procurement (updated)
09/04/2018Human medicines European public assessment report (EPAR): Adynovi,

rurioctocog alfa pegol

Revision: 1, Authorised
09/04/2018Newsletter: Human medicines highlights - April 2018
09/04/2018Human medicines European public assessment report (EPAR): Mycophenolate mofetil Teva,

mycophenolate mofetil

Revision: 19, Authorised
09/04/2018Veterinary medicine European public assessment report (EPAR): Vaxxitek HVT+IBD,

live vaccine against infectious bursal disease and Marek's disease

Revision: 10, Authorised
06/04/2018Minutes of the PRAC meeting 5-8 February 2018
06/04/2018Human medicines European public assessment report (EPAR): Zoledronic acid Teva,

zoledronic acid

Revision: 10, Authorised
06/04/2018Human medicines European public assessment report (EPAR): Mysimba,

naltrexone / bupropion

Revision: 9, Authorised
06/04/2018Human medicines European public assessment report (EPAR): Afstyla,

lonoctocog alfa

Revision: 2, Authorised
06/04/2018Human medicines European public assessment report (EPAR): Pixuvri,

pixantrone dimaleate

Revision: 17, Authorised
06/04/2018Human medicines European public assessment report (EPAR): Nuwiq,

simoctocog alfa

Revision: 5, Authorised
06/04/2018Human medicines European public assessment report (EPAR): Lusduna,

insulin glargine

Revision: 1, Authorised
06/04/2018EudraVigilance Expert Working Group (EV-EWG) work programme 2018 (updated)
06/04/2018Addendum to the guideline on the evaluation of medicinal products indicated for treatment of bacterial infections to address paediatric-specific clinical data requirements (updated)
06/04/2018Scientific guideline: Draft addendum to the guideline on the evaluation of medicinal products indicated for treatment of bacterial infections to address paediatric-specific clinical data requirements - First version, draft: consultation open
06/04/2018Human medicines European public assessment report (EPAR): Hemangiol,

propranolol

Revision: 3, Authorised
06/04/2018Human medicines European public assessment report (EPAR): Zinforo,

ceftaroline fosamil

Revision: 16, Authorised
06/04/2018Human medicines European public assessment report (EPAR): Desloratadine Actavis,

desloratadine

Revision: 10, Authorised
06/04/2018Human medicines European public assessment report (EPAR): Keppra,

levetiracetam

Revision: 42, Authorised
06/04/2018Human medicines European public assessment report (EPAR): Dasselta,

desloratadine

Revision: 10, Authorised
06/04/2018Human medicines European public assessment report (EPAR): Xyrem,

sodium oxybate

Revision: 27, Authorised
06/04/2018CHMP ORGAM minutes for the meeting on 12 February 2018
06/04/2018Heads of Medicines Agencies (HMA) / European Medicines Agency (EMA) Joint Big Data Task Force meeting: Identifying solutions for big data challenges, European Medicines Agency, London, UK, From: 04-May-2018, To: 04-May-2018
06/04/2018Committee 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)
06/04/2018List of active substances involved in the pilot on signal detection in EudraVigilance by marketing authorisation holders (updated)
05/04/2018Human medicines European public assessment report (EPAR): Telmisartan Actavis,

telmisartan

Revision: 8, Authorised
05/04/2018Minutes of the Extraordinary Management Board meeting for the building approval process of EMA premises in Amsterdam: 28 February 2018
05/04/2018Extraordinary Management Board meeting: 6 February 2018, European Medicines Agency, London, UK, From: 06-Feb-2018, To: 06-Feb-2018 (updated)
05/04/2018Extraordinary Management Board meeting: 28 February 2018, Lisbon, Portugal, From: 28-Feb-2018, To: 28-Feb-2018 (updated)
05/04/2018Minutes of the Extraordinary Management Board meeting for the building approval process of EMA premises in Amsterdam: 6 February 2018
05/04/2018Human medicines European public assessment report (EPAR): Hirobriz Breezhaler,

indacaterol

Revision: 13, Authorised
05/04/2018Human medicines European public assessment report (EPAR): Perjeta,

pertuzumab

Revision: 14, Authorised
05/04/2018Human medicines European public assessment report (EPAR): Aldurazyme,

laronidase

Revision: 16, Authorised
05/04/2018Human medicines European public assessment report (EPAR): Steglujan,

ertugliflozin / sitagliptin

Revision: 0, Authorised
05/04/2018Human medicines European public assessment report (EPAR): Steglatro,

ertugliflozin

Revision: 0, Authorised
05/04/2018Human medicines European public assessment report (EPAR): Viekirax,

ombitasvir / paritaprevir / ritonavir

Revision: 12, Authorised
05/04/2018Human medicines European public assessment report (EPAR): Lokelma,

sodium zirconium cyclosilicate

Revision: 0, Authorised
05/04/2018Human medicines European public assessment report (EPAR): Segluromet,

ertugliflozin / metformin hydrochloride

Revision: 0, Authorised
05/04/2018Human medicines European public assessment report (EPAR): Zoledronic Acid Hospira,

zoledronic acid

Revision: 12, Authorised
05/04/2018Human medicines European public assessment report (EPAR): Kaletra,

lopinavir / ritonavir

Revision: 47, Authorised
05/04/2018Human medicines European public assessment report (EPAR): Pioglitazone Actavis,

pioglitazone

Revision: 6, Authorised
05/04/2018Human medicines European public assessment report (EPAR): Terrosa,

teriparatide

Revision: 2, Authorised
05/04/2018Human medicines European public assessment report (EPAR): Myfenax,

mycophenolate mofetil

Revision: 18, Authorised
05/04/2018Human medicines European public assessment report (EPAR): EndolucinBeta,

lutetium (177 Lu) chloride

Revision: 2, Authorised
04/04/2018Human medicines European public assessment report (EPAR): Sialanar,

glycopyrronium

Revision: 2, Authorised
04/04/2018Agenda: Agenda - European Medicines Agency (EMA) Human Scientific Committees' Working Parties with Patients’ and Consumers’ Organisations (PCWP) and Healthcare Professionals’ Organisations (HCPWP) joint meeting
04/04/2018European Medicines Agency (EMA) Human Scientific Committees' Working Parties with Patients’ and Consumers’ Organisations (PCWP) and Healthcare Professionals’ Organisations (HCPWP) joint meeting, European Medicines Agency, London, UK, From: 17-Apr-2018, To: 18-Apr-2018
04/04/2018Human medicines European public assessment report (EPAR): Trumenba,

meningococcal group b vaccine (recombinant, adsorbed)

Revision: 2, Authorised
04/04/2018Human medicines European public assessment report (EPAR): Strensiq,

asfotase alfa

Revision: 6, Authorised
04/04/2018Human medicines European public assessment report (EPAR): Myclausen,

mycophenolate mofetil

Revision: 13, Authorised
04/04/2018Human medicines European public assessment report (EPAR): Litak,

cladribine

Revision: 7, Authorised
04/04/2018Human medicines European public assessment report (EPAR): Pregabalin Sandoz,

pregabalin

Revision: 3, Authorised
04/04/2018Human medicines European public assessment report (EPAR): Tyverb,

lapatinib

Revision: 26, Authorised
04/04/2018Human medicines European public assessment report (EPAR): Omidria,

phenylephrine / ketorolac

Revision: 2, Authorised
04/04/2018Human medicines European public assessment report (EPAR): Alecensa,

alectinib

Revision: 5, Authorised
04/04/2018Joint Biologics Working Party / Quality Working Party workshop with stakeholders in relation to prior knowledge and its use in regulatory applications, European Medicines Agency, London, UK, From: 23-Nov-2017, To: 23-Nov-2017 (updated)
04/04/2018Human medicines European public assessment report (EPAR): Masipro,

masitinib

Revision: 0, Refused
04/04/2018Human medicines European public assessment report (EPAR): M-M-RVaxPro,

measles, mumps and rubella vaccine (live)

Revision: 20, Authorised
04/04/2018Human medicines European public assessment report (EPAR): Lonquex,

lipegfilgrastim

Revision: 12, Authorised
04/04/2018Human medicines European public assessment report (EPAR): Edurant,

rilpivirine

Revision: 12, Authorised
04/04/2018Human medicines European public assessment report (EPAR): Alofisel,

darvadstrocel

Revision: 0, Authorised
03/04/2018Human medicines European public assessment report (EPAR): Evarrest,

human fibrinogen / human thrombin

Revision: 4, Withdrawn
03/04/2018Human medicines European public assessment report (EPAR): Cyramza,

ramucirumab

Revision: 7, Authorised
03/04/2018Orphan designation:

4-(4-{[2-(4-Chlorophenyl)-4,4-dimethylcyclohex-1-en-1-yl]methyl}piperazin-1-yl)-N-({3-nitro-4-[(tetrahydro-2H-pyran-4-ylmethyl)amino]phenyl}sulfonyl)-2-(1H-pyrrolo[2,3-b]pyridin-5-yloxy)benzamide (venetoclax)

for the: Treatment of chronic lymphocytic leukaemia (updated)
03/04/2018Funding (updated)
03/04/2018Human medicines European public assessment report (EPAR): Tamiflu,

oseltamivir

Revision: 30, Authorised
03/04/2018Bilastine: CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00003163/201703 (updated)
03/04/2018Statement of expenses for candidates (updated)
03/04/2018Decision of the Executive Director on the contribution to travel and subsistence expenses for candidates invited to attend a selection procedure (test, interview) or medical examination (updated)
03/04/2018Human medicines European public assessment report (EPAR): Privigen,

human normal immunoglobulin (IVIg)

Revision: 21, Authorised
03/04/2018Human medicines European public assessment report (EPAR): Caprelsa,

vandetanib

Revision: 11, Authorised
03/04/2018Human medicines European public assessment report (EPAR): Maviret,

glecaprevir / pibrentasvir

Revision: 2, Authorised
03/04/2018Orphan designation: , for the: Diagnosis of gastro-entero-pancreatic neuroendocrine tumours (updated)
03/04/2018Interferon alpha-2a: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00009197/201706
03/04/2018Interferon alpha-2a: List of nationally authorised medicinal products - PSUSA/00009197/201706
03/04/2018List of signals discussed at the PRAC since September 2012 (updated)
03/04/2018New product information wording: extracts from PRAC recommendations on signals adopted at the 5-8 March 2018 PRAC
03/04/2018PRAC recommendations on signals adopted at the 5-8 March 2018 PRAC meeting, adopted
03/04/2018Public consultation concerning the European Union template for good manufacturing practice (GMP) non-compliance statement
03/04/2018Scientific guideline: Public consultation concerning the European Union template for good manufacturing practice (GMP) non-compliance statement, draft: consultation open
03/04/2018Good manufacturing practice (updated)
03/04/2018PRAC recommendations on safety signals (updated)
03/04/2018CAT monthly report of application procedures, guidelines and related documents on advanced therapies: March 2018
03/04/2018Orphan designation:

Chimeric monoclonal antibody against claudin 6

for the: Treatment of ovarian cancer (updated)
03/04/2018Orphan designation:

Chimeric monoclonal antibody against claudin-18 splice variant 2

for the: treatment of gastric cancer (updated)
03/04/2018Orphan designation:

Encapsulated human retinal pigment epithelial cell line transfected with plasmid vector expressing human ciliary neurotropic factor

for the: Treatment of macular telangiectasia type 2 (updated)
03/04/2018Orphan designation:

Sodium (1R,3R,4R,5S)-3-({2-N-acetylamino-2-deoxy-3-O-[(1S)-1-carboxylato-2-cyclohexylethyl]-beta-D-galactopyranosyl}oxy)-4-({6-deoxy-alpha-L-galactopyranosyl}oxy)-5-ethyl-cyclohexan-1-yl-(38-oxo-2,5,8,11,14,17,20,23,26,29,32,35-dodecaoxa-39-azahentetracontan-41-yl)carboxamide

for the: Treatment of acute myeloid leukaemia (updated)