16163 results
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Human medicine European public assessment report (EPAR): Pregabalin Sandoz GmbH (updated)
pregabalin, Anxiety Disorders, Epilepsy
Date of authorisation: 19/06/2015,
, Revision: 7, Authorised, Last updated: 10/02/2021
Pregabalin Sandoz GmbH Anxiety Disorders Epilepsy … 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Withdrawn application: Diractin
date of withdrawal: 23/07/2008, Initial authorisation, Last updated: 24/07/2008Diractin: Withdrawn application … Diractin, INN ketoprofen European Medicines … marketing application for Diractin International non-proprietary … -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: 5, Authorised, Last updated: 27/08/2020
Pemetrexed Sandoz Carcinoma, Non-Small-Cell … duct details Name Pemetrexed Sandoz Agency product number EMEA/H/C/004011 … Active substance pemetrexed disodium hemipentahydrate International … -
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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: 11, Authorised, Last updated: 04/12/2018Rivastigmine Sandoz Dementia Alzheimer Disease Parkinson Disease … 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): Corbilta (previously Levodopa/Carbidopa/Entacapone Sandoz)
levodopa, carbidopa, entacapone, Parkinson Disease
Date of authorisation: 11/11/2013, Revision: 8, Authorised, Last updated: 14/12/2020Levodopa/Carbidopa/Entacapone Sandoz) Parkinson Disease … Levodopa/Carbidopa/Entacapone Sandoz) Agency product number EMEA/H/C/002785 … Therapeutic area (MeSH) 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 Bipolar Disorder … details Name Aripiprazole Sandoz Agency product number EMEA/H/C/004008 … MeSH) Schizophrenia Bipolar Disorder Anatomical therapeutic chemical … -
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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: 5, Authorised, Last updated: 27/08/2020
Pregabalin Sandoz Anxiety Disorders Neuralgia Epilepsy … duct details Name Pregabalin Sandoz Agency product number EMEA/H/C/004010 … Therapeutic area (MeSH) Anxiety Disorders Neuralgia Epilepsy Anatomical … -
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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 … details Name Clopidogrel Sandoz Agency product number EMEA/H/C/001174 … MeSH) Peripheral Vascular Diseases Stroke Myocardial Infarction … -
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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 … Name Clopidogrel ratiopharm GmbH Agency product number EMEA/H/C/001165 … MeSH) Peripheral Vascular Diseases Acute Coronary Syndrome Myocardial … -
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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 Agency product number EMEA/H/C/001175 … MeSH) Peripheral Vascular Diseases Stroke Myocardial Infarction … -
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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 … dose(s) to treat the same disease(s) as the reference medicine … and its packaging can be different from those of the reference … -
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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 … dose(s) to treat the same disease(s) as the reference medicine … and its packaging can be different from those of the reference … -
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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 … mg of the active substance ketoprofen, which is a non-steroidal … for about 25 years under different tradenames. Kétoprofène … -
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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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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 Glioma Glioblastoma … details Name Temozolomide Sandoz Agency product number EMEA/H/C/001128 … dose(s) to treat the same disease(s). For more information, see … -
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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 Breast Neoplasms Neoplasm … 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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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 … BOEHRINGER INGELHEIM PHARMA GmbH & Co. KG (tenecteplase … -
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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: XActive substance ketoprofen Therapeutic area Pain Decision … product specific waiver for ketoprofen (EMEA-001783-PIP02-15 … product specific waiver for ketoprofen (EMEA-001783-PIP02-15) in … -
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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: XActive substance ketoprofen omeprazole Therapeutic area … 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 application for Diractin ketoprofen … authorisation application for Diractin ketoprofen) The European Medicines … -
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Questions and Answers on ketoprofen, ketorolac and piroxicam
Last updated: 31/12/2009Questions and Answers on ketoprofen, ketorolac and piroxicam … Questions 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 … -
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Veterinary medicine European public assessment report (EPAR): Dicural
difloxacin, Turkeys, Dogs, Cattle, Chicken
Date of authorisation: 16/01/1998, Revision: 7, Withdrawn, Last updated: 29/10/2015Dicural … Dicural … Dicural, INN Difloxacin Me di cin al p ro du ct n o …