4304 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: 14, Authorised, Last updated: 05/01/2023
Pregabalin Sandoz GmbH Mental Disorders Nervous … 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Withdrawn application: Pioglitazone ratiopharm GmbH
pioglitazone, date of withdrawal: 03/02/2012, Initial authorisation, Last updated: 30/04/2012Pioglitazone ratiopharm GmbH: Withdrawn application … Pioglitazone ratiopharm GmbH: Withdrawal of the marketing … Pioglitazone ratiopharm GmbH pioglitazone On 21 July … -
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Human medicine European public assessment report (EPAR): Tandemact
pioglitazone, glimepiride, Diabetes Mellitus, Type 2
Date of authorisation: 08/01/2007, Revision: 20, Authorised, Last updated: 28/02/2022Active substance pioglitazone glimepiride International non-proprietary … common name pioglitazone glimepiride Therapeutic area (MeSH) Diabetes … CHEPLAPHARM Arzneimittel GmbH Revision 20 Date of issue … -
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Human medicine European public assessment report (EPAR): Avaglim
rosiglitazone, glimepiride, Diabetes Mellitus, Type 2
Date of authorisation: 27/06/2006, Revision: 11, Withdrawn, Last updated: 12/08/2011rosiglitazone / glimepiride … Avaglim rosiglitazone and glimepiride This document is a summary … substances, rosiglitazone and glimepiride. It is available as triangular … -
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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Date of authorisation: 28/07/2009,, Revision: 12, Withdrawn, Last updated: 25/01/2021
Clopidogrel ratiopharm GmbH Peripheral Vascular Diseases Acute … for Clopidogrel Ratiopharm GmbH has been withdrawn at the … documents Clopidogrel ratiopharm GmbH : EPAR - Summary for the … -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): 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 … Clopidogrel Acino Pharma GmbH has been withdrawn at the … Clopidogrel Acino Pharma GmbH : EPAR - Summary for 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 … 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: Glimepirida Parke-Davis
glimepiride, associated names: Glimepiride Pfizer, Glimepirid Pfizer, Glimepiride tablets 2 mg, Glimepiride tablets 3 mg, Glimepiride tablets 4 mg, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 19/07/2012, EC decision date: 19/11/2012, Last updated: 06/12/2012Glimepirida Parke-Davis … authorisation of the medicine Glimepirida Parke-Davis glimepiride, tablets 2, 3 and 4 mg … concluded that the benefits of Glimepirida Parke-Davis outweigh its … -
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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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Referral: Amaryl
glimepiride, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 17/04/1996, EC decision date: 29/08/1996, Last updated: 03/08/1998Non-Proprietary Name (INN): Glimepiride: Background information PDF … About this medicineAmaryl glimepirideAbout this procedureCPMP/1416/98 … Non-Proprietary Name (INN): Glimepiride BACKGROUND INFORMATION On … -
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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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Human medicine European public assessment report (EPAR): Temozolomide Sandoz (updated)
temozolomide, Glioma; Glioblastoma
Date of authorisation: 15/03/2010,, Revision: 17, Withdrawn, Last updated: 06/03/2023
Temozolomide Sandoz Cancer Neuroectodermal … authorisation for Temozolomide Sandoz has been withdrawn at the … Summary documents Temozolomide Sandoz : EPAR - Summary for the … -
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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): 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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Opinion/decision on a Paediatric investigation plan (PIP): glimepiride, Atorvastatin calcium
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-001232-PIP01-11, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 30/05/2012, Last updated: 25/06/2012, Compliance check: XActive substance glimepiride Atorvastatin calcium Therapeutic … product specific waiver for glimepiride / atorvastatin (calcium … product specific waiver for glimepiride / atorvastatin (calcium … -
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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 … 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): 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 … that markets Aripiprazole Sandoz will provide educational … information about Aripiprazole Sandoz The European Commission granted … -
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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: 9, Authorised, Last updated: 06/07/2022
Ibandronic Acid Sandoz Skin and Connective Tissue … EPAR) for Ibandronic Acid Sandoz. It explains how the Committee … of use for Ibandronic Acid Sandoz. What is Ibandronic Acid Sandoz? Ibandronic Acid Sandoz is a medicine that contains … -
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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 … duct details Name Pemetrexed Sandoz Agency product number EMEA/H/C/004011 … Marketing-authorisation holder Sandoz GmbH Revision 7 Date of issue … -
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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 … of the medicine Budesonide Sandoz. The Agency's Committee for … the benefits of Budesonide Sandoz outweigh its risks, and the … -
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Press release: BioPartners GmbH withdraws its application for Biferonex (interferon beta-1a)
Last updated: 29/05/2009BioPartners GmbH withdraws its application … BioPartners GmbH withdraws its application … PRESS RELEASE BioPartners GmbH withdraws its application … -
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Referral: Methylphenidate Sandoz
methylphenidate hydrochloride, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 25/07/2013, EC decision date: 09/10/2013, Last updated: 05/12/2013Methylphenidate Sandoz … medicine Methylphenidate Sandoz. The Agency's Committee for … benefits of Methylphenidate Sandoz outweigh its risks, and the … -
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Referral: Calcium Sandoz
Calcium lactate gluconate, Calcium carbonate, Article 30 referrals
Status: European Commission final decision, opinion/position date: 21/04/2005, EC decision date: 09/08/2005, Last updated: 09/08/2005Calcium Sandoz … medicinal product Calcium Sandoz Effervescent tablets, 500/1000 … benefit/risk ratio of Calcium Sandoz Effervescent tablets, 500/1000 … -
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Referral: Loratadine Sandoz 10
loratadine, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 29/05/2009, EC decision date: 06/08/2009, Last updated: 12/12/2009Loratadine Sandoz 10 … of the medicine Loratadine Sandoz 10. The Agency's Committee … the benefits of Loratadine Sandoz 10 do not outweigh its risks …