3679 results
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Withdrawn application: Neofordex
dexamethasone, date of withdrawal: 17/07/2014, Initial authorisation, Last updated: 20/11/2014Neofordex: Withdrawn application … authorisation application for Neofordex (dexamethasone) On 17 … marketing authorisation for Neofordex, for the treatment of multiple … -
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Withdrawn application: Neocepri
date of withdrawal: 16/05/2014, Initial authorisation, Last updated: 14/08/2014Neocepri: Withdrawn application … Neocepri - SMOP 20 March 2014 … initial authorisation) Neocepri folic acid On 20 March … -
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Human medicine European public assessment report (EPAR): Olanzapine Cipla (previously Olanzapine Neopharma)
olanzapine, Schizophrenia; Bipolar Disorder
Date of authorisation: 14/11/2007,
, Revision: 12, Withdrawn, Last updated: 24/07/2014
Cipla (previously Olanzapine Neopharma) Schizophrenia Bipolar Disor … Cipla (previously Olanzapine Neopharma)EMEA/H/C/000793olanzapineolanzapineSchizophreniaBipolar DisorderN05AH03 This is a … Cipla (previously Olanzapine Neopharma) - EMEA/H/C/000793 - IB/14 … -
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Summary of opinion: Neoleish
bacterial DNA plasmid containing LACK gene from Leishmania infantum, opinion date: 10/11/2022, Positive, Last updated: 11/11/2022Neoleish: Pending EC decision … Neoleish … initial authorisation) Neoleish Common name: Canine leishmaniasis … -
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Human medicine European public assessment report (EPAR): Neofordex (updated)
dexamethasone, Multiple Myeloma
Date of authorisation: 16/03/2016, Revision: 10, Authorised, Last updated: 23/01/2023Neofordex Neoplasms, Plasma Cell Cardiovascular … assessment report (EPAR) for Neofordex. It explains how the Agency … practical advice on how to use Neofordex. For practical information … -
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Human medicine European public assessment report (EPAR): Neoclarityn
desloratadine, Rhinitis, Allergic, Perennial; Urticaria; Rhinitis, Allergic, Seasonal
Date of authorisation: 15/01/2001, Revision: 45, Authorised, Last updated: 15/12/2022Neoclarityn Rhinitis, Allergic Respiratory … assessment report (EPAR) for Neoclarityn. It explains how the The committee … the conditions of use for Neoclarityn. What is Neoclarityn? Neoclarityn is a medicine containing … -
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Human medicine European public assessment report (EPAR): NeoSpect
depreotide trifluoroacetate, Radionuclide Imaging
Date of authorisation: 29/11/2000, Revision: 10, Withdrawn, Last updated: 18/11/2010NeoSpect Radionuclide Imaging … marketing authorisation for NeoSpect has been withdrawn at the … holder. Summary documents NeoSpect : EPAR - Summary for the … -
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Human medicine European public assessment report (EPAR): NeoRecormon
epoetin beta, Kidney Failure, Chronic; Anemia; Cancer; Blood Transfusion, Autologous
Date of authorisation: 16/07/1997, Revision: 32, Authorised, Last updated: 18/11/2022NeoRecormon Female Urogenital Diseases Female … Therapy Blood Transfusion Cancer Neoplasms Kidney Failure, Chronic Anemia Cancer Blood … assessment report (EPAR) for NeoRecormon. It explains how the Committee … -
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Orphan designation: Anti-neonatal Fc receptor human monoclonal antibody for: Prevention of haemolytic disease of the foetus and newborn
Date of designation: 17/10/2019, Positive, Last updated: 05/05/2021Anti-neonatal Fc receptor human monoclonal … Excellence GmbH, Germany, for anti-neonatal Fc receptor human monoclonal … orphan designation of anti-neonatal Fc receptor human monoclonal … -
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Veterinary medicine European public assessment report (EPAR): Neocolipor
E. coli adhesin F4 (F4ab, F4ac, F4ad), E. coli adhesin F5, E. coli adhesin F6, E. coli adhesin F41, Sows; Sows (nullipar)
Date of authorisation: 14/04/1998, Revision: 14, Authorised, Last updated: 17/02/2021Neocolipor … Neocolipor … EMA/200833/2008 EMEA/V/C/000035 Neocolipor neonatal piglet colibacillosis vaccine … -
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Opinion/decision on a Paediatric investigation plan (PIP): Anti-neonatal Fc receptor human monoclonal antibody
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Other
PIP number: EMEA-002559-PIP01-19, Route(s) of administration: Intravenous use, Subcutaneous use, Pharmaceutical form(s): Concentrate for solution for infusion, Solution for injection
Decision date: 16/08/2019, Last updated: 01/07/2021, Compliance check: XKey facts Anti-neonatal Fc receptor human monoclonal … specific waiver for anti-neonatal Fc receptor human monoclonal … Anti-neonatal Fc receptor human monoclonal … -
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Opinion/decision on a Paediatric investigation plan (PIP): Anti-neonatal Fc receptor human monoclonal antibody
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Other
PIP number: EMEA-002559-PIP02-19, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for infusion, Concentrate for solution for infusion
Decision date: 18/03/2020, Last updated: 01/07/2021, Compliance check: XActive substance Anti-neonatal Fc receptor human monoclonal … Anti-neonatal Fc receptor human monoclonal … -
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Opinion/decision on a Paediatric investigation plan (PIP): Anti-neonatal Fe receptor human monoclonal antibody {M281)
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Other
PIP number: EMEA-002559-PIP03-19, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion, Solution for infusion
Decision date: 09/09/2020, Last updated: 06/07/2021, Compliance check: XKey facts Anti-neonatal Fe receptor human monoclonal … granting of a waiver for anti-neonatal Fc receptor human monoclonal … granting of a waiver for anti-neonatal Fc receptor human monoclonal … -
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Veterinary medicine European public assessment report (EPAR): Locatim (previously Serinucoli)
Bovine concentrated lactoserum containing specific immunoglobulins G against E. coli F5 (K99) adhesin, Calves, neonatal less than 12 hrs of age
Date of authorisation: 29/03/1999, Revision: 15, Authorised, Last updated: 20/10/2021Locatim, oral solution for neonatal calves less than 12 hours … microagglutination method) Neonatal calves less than 12 hours … Pharmacopoeia monograph Neonatal Ruminant Colibacillosis Inactivated … -
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Veterinary medicine European public assessment report (EPAR): Enteroporc Coli
Inactivated fimbrial adhesins of Escherichia coli F4ab, Inactivated fimbrial adhesins of Escherichia coli F4ac, Inactivated fimbrial adhesins of Escherichia coli F5, Inactivated fimbrial adhesins of Escherichia coli F6, Pigs
Date of authorisation: 06/01/2021, Revision: 1, Authorised, Last updated: 12/05/2021Neonatal piglet colibacillosis vaccine … EMEA/V/C/005148 Enteroporc Coli (neonatal piglet colibacillosis vaccine … life. Enteroporc Coli (neonatal piglet colibacillosis vaccine … -
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Referral: Colistin combinations
Colistin sulfate, oxytetracycline hydrochloride, trimethoprim, enrofloxacin, Amoxicillin trihydrate, spiramycin adipate, ampicillin trihydrate, erythromycin estolate, scopolamine, sulfaguanidine, neomycin sulfate, sulfadimethoxine, sulfamethoxypyridazine, doxycycline hyclate, sulfadimidine sodium, chlortetracycline hydrochloride, associated names: Please see Annex I, Article 35
Status: European Commission final decision, opinion/position date: 21/04/2016, EC decision date: 14/07/2016, Last updated: 05/08/2016estolate scopolamine sulfaguanidine neomycin sulfate sulfadimethoxine sulfamethoxypyridazine doxycycline … -
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Veterinary medicine European public assessment report (EPAR): Enteroporc Coli AC
CLOSTRIDIUM PERFRINGENS TYPE C, BETA1 TOXOID / Clostridium perfringens, type A, alpha toxoid / Clostridium perfringens, type A, beta2 toxoid / Escherichia coli, fimbrial adhesin F4ab / Escherichia coli, fimbrial adhesin F4ac / Escherichia coli, fimbrial adhesin F5 / Escherichia coli, fimbrial adhesin F6, Pigs
Date of authorisation: 09/12/2020, Revision: 1, Authorised, Last updated: 24/09/2021Neonatal piglet colibacillosis (recombinant … EMEA/V/C/005149 Enteroporc Coli AC ((neonatal piglet colibacillosis (recombinant … Enteroporc Coli AC ((neonatal piglet colibacillosis (recombinant … -
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Human medicine European public assessment report (EPAR): Rybrevant (updated)
amivantamab, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 09/12/2021,
, 
, Revision: 2, Authorised, Last updated: 30/11/2023
Rybrevant Thoracic Neoplasms Respiratory Tract Neoplasms Lung Neoplasms Bronchial Neoplasms Carcinoma, Bronchogenic Respiratory … -
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Human medicine European public assessment report (EPAR): Gliolan
5-aminolevulinic acid hydrochloride, Glioma
Date of authorisation: 07/09/2007, Revision: 7, Authorised, Last updated: 10/08/2022Gliolan Cancer Neoplasms Neoplasms, Neuroepithelial Neuroectodermal … Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial … -
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Human medicine European public assessment report (EPAR): Halaven
Eribulin, Breast Neoplasms; Liposarcoma
Date of authorisation: 17/03/2011, Revision: 29, Authorised, Last updated: 14/11/2022Halaven Neoplasms Cancer Neoplasms, Connective and Soft Tissue S … and Soft Tissue Sarcoma Neoplasms, Adipose Tissue Neoplasms Breast … Therapeutic area (MeSH) Breast Neoplasms Liposarcoma Anatomical therapeutic … -
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Human medicine European public assessment report (EPAR): Yervoy
Ipilimumab, Melanoma; Carcinoma, Renal Cell; Carcinoma, Non-Small-Cell Lung; Mesothelioma, Malignant; Colorectal Neoplasms
Date of authorisation: 13/07/2011, Revision: 50, Authorised, Last updated: 07/12/2022Yervoy Cancer Neoplasms Neoplasms, Germ Cell and Embryonal Neuroectodermal … Tumors Neuroendocrine Tumors Neoplasms, Nerve Tissue Neuroendocrine … Urogenital Diseases Urogenital Neoplasms Urologic … -
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Human medicine European public assessment report (EPAR): Temodal
temozolomide, Glioma; Glioblastoma
Date of authorisation: 26/01/1999, Revision: 35, Authorised, Last updated: 28/11/2022Temodal Neoplasms, Neuroepithelial Neuroectodermal … Neuroepithelial Neuroectodermal Tumors Neoplasms, Nerve Tissue Neoplasms, Glandular and Epithelial Neoplasms, Germ Cell and Embryonal … -
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Human medicine European public assessment report (EPAR): Sunitinib Accord
sunitinib, Gastrointestinal Stromal Tumors; Carcinoma, Renal Cell; Neuroendocrine Tumors
Date of authorisation: 11/02/2021,, , Revision: 1, Authorised, Last updated: 14/12/2021
Sunitinib Accord Cancer Neoplasms Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Gastrointestinal … -
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Human medicine European public assessment report (EPAR): Pemetrexed Baxter (updated)
pemetrexed disodium heptahydrate, Carcinoma, Non-Small-Cell Lung; Mesothelioma
Date of authorisation: 09/12/2022,, Authorised, Last updated: 19/01/2023
Baxter Carcinoma, Bronchogenic Bronchial Neoplasms Lung Neoplasms Respiratory Tract Neoplasms Thoracic … -
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Human medicine European public assessment report (EPAR): Alymsys
bevacizumab, Colorectal Neoplasms; Breast Neoplasms; Ovarian Neoplasms; Peritoneal Neoplasms; Carcinoma, Non-Small-Cell Lung; Carcinoma, Renal Cell; Uterine Cervical Neoplasms
Date of authorisation: 26/03/2021,, 
, Revision: 4, Authorised, Last updated: 15/12/2022
Alymsys Cancer Neoplasms Rectal Diseases Digestive … Diseases Colonic Diseases Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Digestive System Diseases Skin … Therapeutic area (MeSH) Colorectal Neoplasms Breast Neoplasms Ovarian Neoplasms Peritoneal …