17810 results
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Human medicine European public assessment report (EPAR): Temozolomide Sandoz
temozolomide, Glioma; Glioblastoma
Date of authorisation: 15/03/2010,
, Revision: 16, Authorised, Last updated: 14/10/2019
Temozolomide Sandoz Cancer Neuroectodermal … Embryonal Neoplasms Neoplasms, Nerve Tissue Astrocytoma Glioma Glioma Glioblastoma … summary of the European public assessment report (EPAR) for Temozolomide … -
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Withdrawn application: Duloxetine Sandoz
duloxetine, date of withdrawal: 08/04/2015, Initial authorisation, Last updated: 24/04/2015Duloxetine Sandoz: Withdrawn application … Overview On 08 April 2015, Sandoz GmbH officially notified … human medicines. Abbreviated as CHMP. More information … -
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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: 9, Authorised, Last updated: 08/02/2022Levodopa/Carbidopa/Entacapone Sandoz) Nervous System Diseases Neurodegenerative … website. European public assessment reports include the product … information. Abbreviated as EPAR. More information … -
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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: 12, Authorised, Last updated: 20/04/2022
Pregabalin Sandoz Mental Disorders Nervous … website. European public assessment reports include the product … information. Abbreviated as EPAR. More information … -
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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: 12, Authorised, Last updated: 05/10/2021Rivastigmine Sandoz Nervous System Diseases Central … summary of the European public assessment report (EPAR). It explains … Products for Human Use (CHMP) assessed the studies performed, to … -
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Human medicine European public assessment report (EPAR): Aripiprazole Sandoz
aripiprazole, Schizophrenia; Bipolar Disorder
Date of authorisation: 20/08/2015,, Revision: 8, Authorised, Last updated: 10/07/2020
Aripiprazole Sandoz Schizophrenia Spectrum and … website. European public assessment reports include the product … information. Abbreviated as EPAR. More information … -
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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 … authorisation for Clopidogrel Sandoz has been withdrawn at the … Summary documents Clopidogrel Sandoz : EPAR - Summary for the … -
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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: 11, Authorised, Last updated: 21/04/2022
Pregabalin Sandoz GmbH Mental Disorders Nervous … website. European public assessment reports include the product … information. Abbreviated as EPAR. More information … -
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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: 6, Authorised, Last updated: 06/09/2021
Pemetrexed Sandoz Carcinoma, Bronchogenic Bronchial … summary of the European public assessment report (EPAR) for Pemetrexed Sandoz. It explains how the Agency assessed the medicine to recommend … developed to be the same as a medicine that has already … -
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Human medicine European public assessment report (EPAR): Ibandronic Acid Sandoz
ibandronic acid, Breast Neoplasms; Neoplasm Metastasis; Fractures, Bone
Date of authorisation: 26/07/2011,, Revision: 8, Authorised, Last updated: 11/11/2020
Ibandronic Acid Sandoz Skin and Connective Tissue … summary of the European public assessment report (EPAR) for Ibandronic … EPAR) for Ibandronic Acid Sandoz. It explains how the Committee … -
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Human medicine European public assessment report (EPAR): Sycrest
asenapine (as maleate) , Bipolar Disorder
Date of authorisation: 01/09/2010, Revision: 20, Authorised, Last updated: 10/11/2021Authorised asenapine Overview This is a summary … website. European public assessment reports include the product … information. Abbreviated as EPAR. More information … -
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Human medicine European public assessment report (EPAR): Insulin aspart Sanofi
insulin aspart, Diabetes Mellitus
Date of authorisation: 25/06/2020,
, Revision: 3, Authorised, Last updated: 27/01/2022
Insulin aspart Sanofi Glucose Metabolism … Authorised insulin aspart Overview Insulin aspart Sanofi is a medicine used … who have diabetes. Insulin aspart Sanofi is a ‘ A medicine … -
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Human medicine European public assessment report (EPAR): Spectrila
asparaginase, Precursor Cell Lymphoblastic Leukemia-Lymphoma
Date of authorisation: 14/01/2016, Revision: 5, Authorised, Last updated: 09/10/2020asparaginase … for the public Spectrila asparaginase This is a summary of the … summary of the European public assessment report (EPAR) for Spectrila … -
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Human medicine European public assessment report (EPAR): Fiasp
insulin aspart, Diabetes Mellitus
Date of authorisation: 09/01/2017, Revision: 8, Authorised, Last updated: 23/09/2021Authorised insulin aspart Overview Fiasp is a medicine … active substance insulin aspart, a rapid-acting insulin. How … medicine for end-users, such as patients and animal owners … -
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Human medicine European public assessment report (EPAR): Strensiq
asfotase alfa, Hypophosphatasia
Date of authorisation: 28/08/2015,
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, Revision: 15, Authorised, Last updated: 07/07/2021
Authorised asfotase alfa Overview Strensiq is … medicine. active substance asfotase alfa. Hypophosphatasia is … The medicine is available as a solution for injection … -
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Human medicine European public assessment report (EPAR): NovoRapid
insulin aspart, Diabetes Mellitus
Date of authorisation: 07/09/1999, Revision: 31, Authorised, Last updated: 23/11/2020Authorised insulin aspart Overview This is a summary … website. European public assessment reports include the product … information. Abbreviated as EPAR. More information … -
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Human medicine European public assessment report (EPAR): NovoMix
insulin aspart, Diabetes Mellitus
Date of authorisation: 01/08/2000, Revision: 28, Authorised, Last updated: 12/11/2020Authorised insulin aspart Overview NovoMix is a range … active substance insulin aspart (100 units/ml) combined with … longer acting. It is available as: NovoMix 30 (30% insulin … -
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Human medicine European public assessment report (EPAR): Kirsty (previously Kixelle)
insulin aspart, Diabetes Mellitus
Date of authorisation: 05/02/2021,, , Revision: 1, Authorised, Last updated: 14/09/2021
Authorised insulin aspart Overview Kirsty is a medicine … active substance insulin aspart. How is Kirsty used? Kirsty … prescription. It is given as an injection under the skin … -
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Withdrawn application: Graspa
asparaginase, date of withdrawal: 22/06/2018, Initial authorisation, Last updated: 23/01/2019application for Graspa (L-asparaginase) On 22 June 2018, Erytech … contains the active substance L-asparaginase that has been enclosed in … enclosed in red blood cells. Asparaginase has been used to treat cancer … -
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Human medicine European public assessment report (EPAR): Ryzodeg
insulin aspart, insulin degludec, Diabetes Mellitus
Date of authorisation: 21/01/2013, Revision: 13, Authorised, Last updated: 23/09/2021ised insulin degludecinsulin aspart Overview This is a summary … website. European public assessment reports include the product … information. Abbreviated as EPAR. More information … -
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Opinion/decision on a Paediatric investigation plan (PIP): Sycrest, Asenapine maleate
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Psychiatry
PIP number: EMEA-000228-PIP01-08-M04, Route(s) of administration: Oral use, Pharmaceutical form(s): Sublingual tablet
Decision date: 24/11/2014, Last updated: 02/03/2018, Compliance check: V, 18/08/2017Key facts Sycrest Asenapine maleate PsychiatryP/0299/2014EMEA-000228-PIP01-08-M04 … paediatric investigation plan for asenapine (maleate) (Sycrest) (EMEA-000228-PIP01-08-M04 … paediatric investigation plan for asenapine (maleate) (Sycrest) (EMEA-000228-PIP01-08-M04 … -
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Orphan designation: Recombinant human mesencephalic astrocyte-derived neurotrophic factor for: Treatment of retinitis pigmentosa
Date of designation: 24/04/2015, Positive, Last updated: 23/11/2016ombinant human mesencephalic astrocyte-derived neurotrophic factor Overview … recombinant human mesencephalic astrocyte-derived neurotrophic factor for the … condition is estimated and assessed on the basis of data from … -
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Orphan designation: Asp-Arg-Val-Tyr-Ile-His-Pro for: Treatment of acute lung Injury
Date of designation: 10/10/2012, Withdrawn, Last updated: 19/01/2016Asp-Arg-Val-Tyr-Ile-His-Pro Overview Please note that … Pharmaceuticals Limited, Cyprus, for Asp-Arg-Val-Tyr-Ile-His-Pro for the treatment of acute … transferred to Gregory Fryer Associates Ltd, United Kingdom, in June … -
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Summary of opinion: Truvelog Mix 30
insulin aspart, opinion date: 24/02/2022, Positive, Last updated: 25/02/2022insulin aspart Opinion On 24 February 2022 … human medicines. Abbreviated as CHMP. More information … Mix 30 will be available as a 100 U/ml suspension for … -
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Human medicine European public assessment report (EPAR): Vaxzevria (previously COVID-19 Vaccine AstraZeneca) (updated)
ChAdOx1-SARS-COV-2, COVID-19 virus infection
Date of authorisation: 29/01/2021,
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, Revision: 20, Authorised, Last updated: 12/05/2022
previously COVID-19 Vaccine AstraZeneca) Myelitis Respiratory Tract … previously COVID-19 Vaccine AstraZeneca) … EMA/205598/2021 Pharmacovigilance Risk Assessment Committee (PRAC) Signal assessment report on embolic and thrombotic …