18060 results
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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 System Diseases Central Nervous System … report (EPAR) for Pregabalin Sandoz GmbH. It explains how the Agency … on how to use Pregabalin Sandoz GmbH. For practical information … -
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Withdrawn application: Diractin
date of withdrawal: 23/07/2008, Initial authorisation, Last updated: 24/07/2008Diractin: Withdrawn application … Diractin, INN ketoprofen European Medicines … marketing application for Diractin International non-proprietary … -
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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 … Neoplasms Thoracic Neoplasms Lung Diseases Respiratory Tract Diseases Adenoma Neoplasms, Glandular … duct details Name Pemetrexed Sandoz Agency product number EMEA/H/C/004011 … -
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Human medicine European public assessment report (EPAR): Clopidogrel ratiopharm GmbH
clopidogrel, Peripheral Vascular Diseases; Acute Coronary Syndrome; Myocardial Infarction; Stroke
Date of authorisation: 28/07/2009,, Revision: 12, Withdrawn, Last updated: 25/01/2021
Clopidogrel ratiopharm GmbH Peripheral Vascular Diseases Acute Coronary Syndrome Myocardial … for Clopidogrel Ratiopharm GmbH has been withdrawn at the … documents Clopidogrel ratiopharm GmbH : EPAR - Summary for the … -
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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 Diseases Synucleinopathies Central … adults with Parkinson’s disease (a progressive brain disorder that causes shaking, slow … treatments for Parkinson’s disease) but are having ‘fluctuations’ … -
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Human medicine European public assessment report (EPAR): Clopidogrel Acino Pharma GmbH
clopidogrel, Peripheral Vascular Diseases; Stroke; Myocardial Infarction
Date of authorisation: 21/09/2009,, Revision: 1, Withdrawn, Last updated: 26/07/2012
Clopidogrel Acino Pharma GmbH Peripheral Vascular Diseases Stroke Myocardial Infarctio … Clopidogrel Acino Pharma GmbH has been withdrawn at the … Clopidogrel Acino Pharma GmbH : EPAR - Summary for the … -
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Withdrawn application: Pioglitazone ratiopharm GmbH
pioglitazone, date of withdrawal: 03/02/2012, Initial authorisation, Last updated: 30/04/2012Pioglitazone ratiopharm GmbH: Withdrawn application … February 2012, ratiopharm GmbH officially notified the Committee … for Pioglitazone ratiopharm GmbH, for the treatment of type 2 diabetes. What is Pioglitazone ratiopharm … -
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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 System Diseases Central Nervous System Diseases Brain … information about Pregabalin Sandoz The European Commission granted … European Union for Pregabalin Sandoz on 19 June 2015. For more … -
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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 Nervous System Diseases Brain Diseases Mental … details Name Rivastigmine Sandoz Agency product number EMEA/H/C/001183 … MeSH) Dementia Alzheimer Disease Parkinson Disease Anatomical therapeutic chemical … -
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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 … Spectrum and Other Psychotic Disorders Mental Disorders Bipolar and Related Disorders Schizophrenia Bipolar … manic episodes in bipolar I disorder, the company that markets … -
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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 Infarctio … 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): 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 Diseases Skin Diseases Breast Diseases Pathological Conditions … details Name Ibandronic Acid Sandoz Agency product number EMEA/H/C/002367 … dose(s) to treat the same disease(s). For more information, see … -
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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 the The … authorisation for Duloxetine Sandoz, for the treatment of depression … -
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Referral: Ketoprofen topical
ketoprofen, associated names: Fastum, Ketum, Orudis, Article 107 procedures (prior to July 2012)
Status: European Commission final decision, opinion/position date: 22/07/2010, EC decision date: 29/11/2010, Last updated: 28/10/2011Ketoprofen topical … procedure under Article 107 of Directive 2001/83/EC The European Medicines … safety and effectiveness of ketoprofen-containing medicines used topically … -
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Referral: Dolovet Rifen
ketoprofen, Article 33
Status: European Commission final decision, opinion/position date: 09/11/2006, EC decision date: 17/04/2007, Last updated: 07/12/201115g, each containing 2.4g ketoprofen and is authorised for the … procedure under Article 33(4) of Directive 2001/82/EC, as amended. The … the number of animals used did not allow equivalence to … -
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Referral: Ketoprofene Ethypharm LP
ketoprofen, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 29/06/2000, EC decision date: 27/12/2000, Last updated: 28/12/2000Ketoprofene Ethypharm LP … to article 10 of Council Directive 75/319/EEC as amended for … 2001 Reproduction and/or distribution of this document is authorised … -
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Human medicine European public assessment report (EPAR): Temozolomide Sandoz
temozolomide, Glioma; Glioblastoma
Date of authorisation: 15/03/2010,, Revision: 17, Authorised, Last updated: 30/05/2022
Temozolomide Sandoz Cancer Neuroectodermal … report (EPAR) for Temozolomide Sandoz. It explains how the Committee … conditions of use for Temozolomide Sandoz. What is Temozolomide Sandoz? Temozolomide Sandoz is a medicine that contains … -
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Opinion/decision on a Paediatric investigation plan (PIP): ketoprofen
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Pain
PIP number: EMEA-001783-PIP02-15, Route(s) of administration: Cutaneous use, Pharmaceutical form(s): Medicated plaster
Decision date: 21/12/2015, Last updated: 02/02/2016, Compliance check: XKey facts ketoprofen PainP/0317/2015EMEA-001783-PIP02-15 … product-specific waiver for ketoprofen (EMEA-001783-PIP02-15) PDF … product specific waiver for ketoprofen (EMEA-001783-PIP02-15 … -
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Human medicine European public assessment report (EPAR): Tenecteplase Boehringer Ingelheim Pharma GmbH Co. KG
tenecteplase, Myocardial Infarction
Date of authorisation: 23/02/2001, Revision: 2, Withdrawn, Last updated: 05/12/2005Boehringer Ingelheim Pharma GmbH Co. KG Myocardial Infarctio … Boehringer Ingelheim Pharma GmbH Co. KG has been withdrawn … Boehringer Ingelheim Pharma GmbH Co. KGEMEA/H/C/000307tenecteplasetenecteplaseMyocardial … -
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Opinion/decision on a Paediatric investigation plan (PIP): ketoprofen, omeprazole
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Pain
PIP number: EMEA-001361-PIP01-12, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard, Modified release capsule
Decision date: 03/07/2013, Last updated: 13/08/2013, Compliance check: XKey facts ketoprofen omeprazole PainP/0148/2013EMEA-001361-PIP01-12 … product-specific waiver for ketoprofen / omeprazole (EMEA-001361-PIP01-12 … product specific waiver for ketoprofen / omeprazole (EMEA-001361-PIP01-12 … -
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Press release: Idea AG withdraws its marketing authorisation application for Diractin (ketoprofen)
Last updated: 24/07/2008authorisation application for Diractin ketoprofen … authorisation for the medicine Diractin ketoprofen) 22.9 mg gel Diractin was expected to be used for … authorisation application for Diractin ketoprofen) The European Medicines … -
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Withdrawn application: Dimherity
dimethyl fumarate, date of withdrawal: 24/03/2022, Initial authorisation, Last updated: 25/03/2022Dimherity: Withdrawn application … dimethyl fumarate Overview Sandoz GmbH withdrew its application … marketing authorisation of Dimherity for the treatment of adults … -
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Questions and Answers on ketoprofen, ketorolac and piroxicam
Last updated: 31/12/2009Questions and Answers on ketoprofen, ketorolac and piroxicam …
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Press release: European Medicines Agency recommends precautionary recall of batches of clopidogrel-containing medicines from Acino Pharma GmbH
Last updated: 25/03/2010medicines from Acino Pharma GmbH … Clopidogrel Acino Pharma GmbH, Clopidogrel Hexal, Clopidogrel … Ratiopharm, Clopidogrel Ratiopharm GmbH and Clopidogrel Sandoz. The Marketing Authorisation … -
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Referral: Budesonide Sandoz
budesonide, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 20/02/2009, EC decision date: 07/05/2009, Last updated: 25/06/2009Budesonide Sandoz … arbitration procedure following a disagreement among Member States of the … of the medicine Budesonide Sandoz. The Agency's Committee for …