4464 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, Revision: 16, Withdrawn, Last updated: 12/10/2023
Pregabalin Sandoz GmbH Mental Disorders Nervous … authorisation for Pregabalin Sandoz GmbH has been withdrawn at the … Summary documents Pregabalin Sandoz GmbH : EPAR - Summary for the … -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Withdrawn application: Pioglitazone ratiopharm GmbH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date of withdrawal: 03/02/2012, Initial authorisation, Last updated: 30/04/2012Pioglitazone ratiopharm GmbH: Withdrawn application … Pioglitazone ratiopharm GmbH: Withdrawal of the marketing … Pioglitazone ratiopharm GmbH pioglitazone On 21 July … -
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Referral: Neurontin
gabapentin, Article 30 referrals
Status: European Commission final decision, opinion/position date: 01/06/2006, EC decision date: 04/08/2006, Last updated: 06/09/2006Commission final decision Overview Gabapentin (Neurontin and associated … precise mechanism of action of gabapentin is not known Gabapentin is structurally related to … Non-Proprietary Name (INN): Gabapentin: Background information PDF … -
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Opinion/decision on a Paediatric investigation plan (PIP): gabapentin
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Pain
PIP number: EMEA-001310-PIP01-12-M03, Route(s) of administration: Oral use, Pharmaceutical form(s): Oral solution
Decision date: 19/07/2018, Last updated: 21/06/2023, Compliance check: XKey facts gabapentin PainP/0198/2018EMEA-001310-PIP01-12-M03 … paediatric investigation plan for gabapentin (EMEA-001310-PIP01-12-M03 … gabapentin … -
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Opinion/decision on a Paediatric investigation plan (PIP): gabapentin
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Neurology; Pain
PIP number: EMEA-002994-PIP01-21, Route(s) of administration: Oral use, Pharmaceutical form(s): Prolonged-release tablet
Decision date: 12/08/2021, Last updated: 12/09/2022, Compliance check: XKey facts gabapentin NeurologyPainP/0335/2021EMEA-002994-PIP01-21 … product specific waiver for gabapentin (EMEA-002994-PIP01-21) PDF … product specific waiver for gabapentin (EMEA-002994-PIP01-21) in … -
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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 … Clopidogrel ratiopharm GmbH … Clopidogrel ratiopharm GmbH Withdrawal of the marketing … -
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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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Opinion/decision on a Paediatric investigation plan (PIP): Trazodone (hydrochloride), gabapentin
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Pain
PIP number: EMEA-002263-PIP01-17, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 16/03/2018, Last updated: 19/06/2018, Compliance check: XTrazodone (hydrochloride) gabapentin PainP/0089/2018EMEA-002263-PIP01-17 … trazodone (hydrochloride) / gabapentin (EMEA-002263- PIP01-17) PDF … trazodone (hydrochloride) / gabapentin (EMEA-002263-PIP01-17) 30 … -
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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 … Clopidogrel Acino Pharma GmbH Public Statement 7 … -
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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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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): Pregabalin Sandoz (updated)
pregabalin, Anxiety Disorders; Neuralgia; Epilepsy
Date of authorisation: 19/06/2015,, Revision: 17, Authorised, Last updated: 22/11/2023
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): 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 … details Name Clopidogrel Sandoz Agency product number EMEA/H/C/001174 … Marketing-authorisation holder Acino Pharma GmbH Revision 2 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 … details Name Temozolomide Sandoz Agency product number EMEA/H/C/001128 … Marketing-authorisation holder Sandoz GmbH Revision 17 Date of issue … -
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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: 14, Authorised, Last updated: 25/09/2023Rivastigmine Sandoz Nervous System Diseases Central … details Name Rivastigmine Sandoz Agency product number EMEA/H/C/001183 … Marketing-authorisation holder Sandoz GmbH Revision 14 Date of issue … -
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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 … details Name Aripiprazole Sandoz Agency product number EMEA/H/C/004008 … Marketing-authorisation holder Sandoz GmbH Revision 9 Date of issue … -
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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 … details Name Ibandronic Acid Sandoz Agency product number EMEA/H/C/002367 … Marketing-authorisation holder Sandoz GmbH Revision 9 Date of issue … -
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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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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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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: 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 … -
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Referral: Mometasone Furoate Sandoz
mometasone furoate, associated names: Mometasone Sandoz, Mometasone Sandoz 50, Mometasone Furoato Sandoz 50, Mommox, Nasometi, Fumomo 50, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 19/07/2012, EC decision date: 08/10/2012, Last updated: 24/01/2013Mometasone Furoate Sandoz … medicine Mometasone Furoate Sandoz. The Agency's Committee for … benefits of Mometasone Furoate Sandoz outweigh its risks, and that …