4259 results
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Human medicine European public assessment report (EPAR): Pemetrexed Sandoz
pemetrexed disodium hemipentahydrate, Carcinoma, Non-Small-Cell Lung; Mesothelioma
Date of authorisation: 18/09/2015,
, Revision: 7, Authorised, Last updated: 27/07/2022
Pemetrexed Sandoz Carcinoma, Bronchogenic Bronchial … Pemetrexed Sandoz … summary for the public Pemetrexed Sandoz pemetrexed This is a summary of the … -
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Human medicine European public assessment report (EPAR): Pemetrexed Baxter
pemetrexed disodium heptahydrate, Carcinoma, Non-Small-Cell Lung; Mesothelioma
Date of authorisation: 09/12/2022,, Authorised, Last updated: 19/01/2023
Pemetrexed Baxter Carcinoma, Bronchogenic Bronchial … Product details Name Pemetrexed Baxter Agency product number … EMEA/H/C/005848 Active substance pemetrexed disodium heptahydrate International … -
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Human medicine European public assessment report (EPAR): Pemetrexed Pfizer (previously Pemetrexed Hospira)
pemetrexed disodium, pemetrexed disodium hemipentahydrate, Carcinoma, Non-Small-Cell Lung; Mesothelioma
Date of authorisation: 19/11/2015,, Revision: 14, Authorised, Last updated: 21/09/2022
Pemetrexed Pfizer (previously Pemetrexed Hospira) Cancer Neoplasms Carcinoma … Pemetrexed Pfizer (previously Pemetrexed Hospira … summary for the public Pemetrexed Hospira pemetrexed This is a summary of the … -
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Withdrawn application: Duloxetine Sandoz
duloxetine, date of withdrawal: 08/04/2015, Initial authorisation, Last updated: 24/04/2015Duloxetine Sandoz: Withdrawn application … Duloxetine Sandoz: Withdrawal of the marketing … application for Duloxetine Sandoz (duloxetine) On 08 April … -
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Human medicine European public assessment report (EPAR): Pemetrexed medac
pemetrexed, Carcinoma, Non-Small-Cell Lung; Mesothelioma
Date of authorisation: 26/11/2015,, Revision: 8, Authorised, Last updated: 09/08/2022
Pemetrexed medac Cancer Neoplasms Carcinoma … Pemetrexed medac … Pemetrexed medac, INN pemetrexed 30 Churchill Place … -
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Human medicine European public assessment report (EPAR): Pemetrexed Lilly
pemetrexed, Carcinoma, Non-Small-Cell Lung; Mesothelioma
Date of authorisation: 14/09/2015,, Revision: 7, Withdrawn, Last updated: 26/11/2021
Pemetrexed Lilly Cancer Neoplasms Carcinoma … Pemetrexed Lilly … EMEA/H/C/004114 Public statement Pemetrexed Lilly Cessation of validity … -
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Human medicine European public assessment report (EPAR): Pemetrexed Krka
pemetrexed disodium, Carcinoma, Non-Small-Cell Lung; Mesothelioma
Date of authorisation: 22/05/2018,, Revision: 6, Authorised, Last updated: 22/02/2023
Pemetrexed Krka Cancer Neoplasms Carcinoma … Pemetrexed Krka … Pemetrexed Krka, INN pemetrexed 30 Churchill Place … -
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Human medicine European public assessment report (EPAR): Pemetrexed Fresenius Kabi
pemetrexed, Carcinoma, Non-Small-Cell Lung; Mesothelioma
Date of authorisation: 22/07/2016,, Revision: 13, Authorised, Last updated: 27/07/2022
Pemetrexed Fresenius Kabi Cancer Neoplasms Carcinoma … Pemetrexed Fresenius Kabi … summary for the public Pemetrexed Fresenius Kabi pemetrexed This is a summary of the … -
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Human medicine European public assessment report (EPAR): Pemetrexed Accord
pemetrexed disodium hemipentahydrate, Carcinoma, Non-Small-Cell Lung; Mesothelioma
Date of authorisation: 18/01/2016,, Revision: 9, Authorised, Last updated: 03/11/2022
Pemetrexed Accord Carcinoma, Bronchogenic Bronchial … Pemetrexed Accord … Pemetrexed Accord, INN pemetrexed EMA/783154/2015 EMEA/H/C/004072 … -
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Human medicine European public assessment report (EPAR): Pemetrexed Pfizer (previously known as Pemetrexed Hospira UK Limited)
pemetrexed ditromethamine, Carcinoma, Non-Small-Cell Lung; Mesothelioma
Date of authorisation: 24/04/2017,, Revision: 7, Withdrawn, Last updated: 29/07/2021
Pemetrexed Pfizer (previously known as Pemetrexed Hospira UK Limited) Carcinoma … Pemetrexed Pfizer (previously known as Pemetrexed Hospira UK Limited … EMEA/H/C/004488 Public statement Pemetrexed Pfizer Cessation of validity … -
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Withdrawn application: Pemetrexed ditromethamine Hospira
pemetrexed, date of withdrawal: 22/09/2016, Initial authorisation, Last updated: 21/12/2016Pemetrexed ditromethamine Hospira: Withdrawn … Pemetrexed ditromethamine Hospira; INN pemetrexed (as ditromethamine … authorisation application for Pemetrexed (as ditromethamine) Hospira … -
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Human medicine European public assessment report (EPAR): Armisarte (previously Pemetrexed Actavis) (updated)
pemetrexed diacid monohydrate, Carcinoma, Non-Small-Cell Lung; Mesothelioma
Date of authorisation: 18/01/2016, Revision: 13, Authorised, Last updated: 01/06/2023Armisarte (previously Pemetrexed Actavis) Cancer Neoplasms Carcinoma … Authorised pemetrexed Overview This is a summary … medicine. active substance pemetrexed. How is Armisarte used? Armisarte … -
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Human medicine European public assessment report (EPAR): Alimta
pemetrexed, Mesothelioma; Carcinoma, Non-Small-Cell Lung
Date of authorisation: 20/09/2004, Revision: 27, Authorised, Last updated: 03/05/2022EMEA/H/C/000564 Active substance pemetrexed International non-proprietary … name (INN) or common name pemetrexed Therapeutic area (MeSH) Mesothelioma … holder Eli Lilly Nederland B.V. Revision 27 Date of issue … -
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Human medicine European public assessment report (EPAR): Corbilta (previously Levodopa/Carbidopa/Entacapone Sandoz)
levodopa, carbidopa, entacapone, Parkinson Disease
Date of authorisation: 11/11/2013, Revision: 10, Authorised, Last updated: 16/01/2023Levodopa/Carbidopa/Entacapone Sandoz) Nervous System Diseases Neurodegenerative … Levodopa/Carbidopa/Entacapone Sandoz) : EPAR - All Authorised presentations … Levodopa/Carbidopa/Entacapone Sandoz) : EPAR - Procedural steps … -
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Withdrawn application: Parsaclisib Incyte Biosciences Distribution B.V.
parsaclisib, date of withdrawal: 27/06/2022, Initial authorisation, Last updated: 08/11/2022Biosciences Distribution B.V.: Withdrawn application … Biosciences Distribution B.V.: Withdrawal of the marketing … Biosciences Distribution B.V. (parsaclisib) Incyte … -
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Human medicine European public assessment report (EPAR): Ciambra
pemetrexed disodium hemipentahydrate, Carcinoma, Non-Small-Cell Lung; Mesothelioma
Date of authorisation: 02/12/2015,, Revision: 6, Authorised, Last updated: 17/08/2022
pemetrexed … for the public Ciambra pemetrexed This is a summary of the … contains the active substance pemetrexed. http://www.ema.europa.eu/do … -
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Opinion/decision on a Paediatric investigation plan (PIP): Alimta, pemetrexed disodium
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-000126-PIP01-07, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for concentrate for solution for infusion
Decision date: 24/02/2009, Last updated: 23/04/2009, Compliance check: Xname Alimta Active substance pemetrexed disodium Therapeutic area … product-specific waiver for pemetrexed disodium (Alimta) (EMEA-000126-PIP01-07 … product specific waiver for pemetrexed disodium (Alimta) (EMEA-000126-PIP01-07 … -
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Human medicine European public assessment report (EPAR): Fluad Tetra (updated)
A/Victoria/2570/2019 (H1N1)pdm09 like strain (A/Victoria/2570/2019 IVR‐215) A/Darwin/9/2021 (H3N2) like strain (A/Darwin/6/2021 IVR-227) B/Austria/1359417/2021 like strain (B/Austria/1359417/2021 BVR-26) B/Phuket/3073/2013 like strain (B/Phuket/3073/2013 BVR‐1B), Influenza, Human
Date of authorisation: 20/05/2020,
, Revision: 6, Authorised, Last updated: 22/05/2023
strain (B/Austria/1359417/2021 BVR-26) B/Phuket/3073/2013 like strain … strain (B/Phuket/3073/2013 BVR‐1B) International non-proprietary … holder Seqirus Netherlands B.V. Revision 6 Date of issue … -
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Human medicine European public assessment report (EPAR): Temozolomide Sandoz
temozolomide, Glioma; Glioblastoma
Date of authorisation: 15/03/2010,, Revision: 17, Withdrawn, Last updated: 06/03/2023
Temozolomide Sandoz Cancer Neuroectodermal … Temozolomide Sandoz … statement Temozolomide Sandoz (temozolomide) Withdrawal … -
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Human medicine European public assessment report (EPAR): Rivastigmine Sandoz
rivastigmine, Dementia; Alzheimer Disease; Parkinson Disease
Date of authorisation: 10/12/2009, Revision: 13, Authorised, Last updated: 13/10/2022Rivastigmine Sandoz Nervous System Diseases Central … EPAR). What is Rivastigmine Sandoz? Rivastigmine Sandoz is a medicine containing … be used for Rivastigmine Sandoz (‘informed consent’ … -
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Human medicine European public assessment report (EPAR): Pregabalin Sandoz
pregabalin, Anxiety Disorders; Neuralgia; Epilepsy
Date of authorisation: 19/06/2015,, Revision: 15, Authorised, Last updated: 05/01/2023
Pregabalin Sandoz Mental Disorders Nervous … report (EPAR) for Pregabalin Sandoz. It explains how the Agency … on how to use Pregabalin Sandoz. For practical information … -
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Human medicine European public assessment report (EPAR): Aripiprazole Sandoz
aripiprazole, Schizophrenia; Bipolar Disorder
Date of authorisation: 20/08/2015,, Revision: 9, Authorised, Last updated: 01/09/2022
Aripiprazole Sandoz Schizophrenia Spectrum and … Aripiprazole Sandoz … Aripiprazole Sandoz EPAR summary 30 … -
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Human medicine European public assessment report (EPAR): Clopidogrel Sandoz
clopidogrel, Peripheral Vascular Diseases; Stroke; Myocardial Infarction
Date of authorisation: 21/09/2009,, Revision: 2, Withdrawn, Last updated: 26/10/2011
Clopidogrel Sandoz Peripheral Vascular Diseases Stroke Myocardial … Clopidogrel Sandoz … Clopidogrel Sandoz (clopidogrel) Withdrawal … -
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Human medicine European public assessment report (EPAR): Pregabalin Sandoz GmbH
pregabalin, Anxiety Disorders; Epilepsy
Date of authorisation: 19/06/2015,, Revision: 14, Authorised, Last updated: 05/01/2023
Pregabalin Sandoz GmbH Mental Disorders Nervous … report (EPAR) for Pregabalin Sandoz GmbH. It explains how the … on how to use Pregabalin Sandoz GmbH. For practical information … -
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Human medicine European public assessment report (EPAR): Lamivudine Teva Pharma B.V.
lamivudine, HIV Infections
Date of authorisation: 10/12/2009,, Revision: 19, Authorised, Last updated: 21/04/2023
Lamivudine Teva Pharma B.V. Blood-Borne Infections Communicable … Lamivudine Teva Pharma B.V … Lamivudine Teva Pharma B.V. lamivudine This is a …