462 results
Keyword Nimesulide Sandoz Remove keyword
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Referral: Nimesulide
nimesulide, Article 31 referrals
Status: European Commission final decision, opinion/position date: 23/06/2011, EC decision date: 20/01/2012, Last updated: 19/04/2012Nimesulide … systemic medicines containing nimesulide (capsules, tablets, suppositories … concluded that the benefits of nimesulide used systemically continue … -
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Referral: Nimesulide
nimesulide, associated names: Aulin, Nimed, Article 107 procedures (prior to July 2012)
Status: European Commission final decision, opinion/position date: 20/09/2007, EC decision date: 16/10/2009, Last updated: 21/09/2007Nimesulide … formulations' of medicines containing nimesulide has been completed. The European … 16 October 2009. What is nimesulide? Nimesulide is a non-selective non-steroidal … -
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Referral: Nimesulide
nimesulide, Article 31 referrals
Status: European Commission final decision, opinion/position date: 18/12/2003, EC decision date: 26/04/2004, Last updated: 13/05/2004Nimesulide … Commission final decision Overview Nimesulide is a non-steroidal anti-inflammatory … anti-inflammatory drug (NSAID). Nimesulide containing medicinal products … -
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Withdrawn application: Duloxetine Sandoz
duloxetine, date of withdrawal: 08/04/2015, Initial authorisation, Last updated: 24/04/2015Duloxetine Sandoz: Withdrawn application … Duloxetine Sandoz: Withdrawal of the marketing … application for Duloxetine Sandoz (duloxetine) On 08 April … -
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Human medicine European public assessment report (EPAR): Corbilta (previously Levodopa/Carbidopa/Entacapone Sandoz) (updated)
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: 15, Authorised, Last updated: 05/01/2023
Pregabalin Sandoz Mental Disorders Nervous … report (EPAR) for Pregabalin Sandoz. It explains how the Agency … on how to use Pregabalin Sandoz. For practical 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: 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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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 … report (EPAR) for Aripiprazole Sandoz. It explains how the Agency … on how to use Aripiprazole Sandoz. For practical information … -
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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 … Temozolomide Sandoz … Temozolomide Sandoz, INN-temozolomide EMA/729989/2014 … -
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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 (updated)
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 … on how to use Pregabalin Sandoz GmbH. For practical 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: 7, Authorised, Last updated: 27/07/2022
Pemetrexed Sandoz Carcinoma, Bronchogenic Bronchial … Pemetrexed Sandoz … for the public Pemetrexed Sandoz pemetrexed This is a summary … -
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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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Press release: European Medicines Agency concludes review of systemic nimesulide-containing medicines
CHMP, Last updated: 23/06/2011concludes review of systemic nimesulide-containing medicines … concludes review of systemic nimesulide-containing medicines … concludes review of systemic nimesulide-containing medicines 7 Westferry … -
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Press release: European Medicines Agency recommends restricted use of nimesulide-containing medicinal products
Last updated: 21/09/2007recommends restricted use of nimesulide-containing medicinal products … recommends restricted use of nimesulide-containing medicinal products … Microsoft Word - Nimesulide Press release_restriction … -
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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: 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: 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: 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 … -
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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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Press release: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP), 15-18 February 2010
CHMP, Last updated: 19/02/2010Review of nimesulide started … EMA/CHMP/95106/2010 Page 4/4 Review of nimesulide started The Committee started … the benefits and risks of nimesulide-containing medicinal products for systemic … -
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Press release: Meeting highlights from the Committee for Medicinal Products for Human Use,17-20 September 2007
CHMP, Last updated: 21/09/2007Human Use recommendation on nimesulide-containing medicines PDF icon application/pdf … -
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Press release: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP)20-23 June 2011
CHMP, Last updated: 24/06/2011Review of systemic nimesulide-containing medicines concluded … website. Review of systemic nimesulide-containing medicines concluded The … -
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Human medicine European public assessment report (EPAR): Halimatoz
adalimumab, Hidradenitis Suppurativa; Psoriasis; Arthritis, Juvenile Rheumatoid; Uveitis; Arthritis, Rheumatoid; Spondylitis, Ankylosing; Arthritis, Psoriatic
Date of authorisation: 26/07/2018,,
, Revision: 8, Withdrawn, Last updated: 29/01/2021
Marketing-authorisation holder Sandoz GmbH Revision 8 Date of issue … marketing authorisation holder, Sandoz GmbH, which notified the … -
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Withdrawn application: Dimherity
dimethyl fumarate, date of withdrawal: 22/02/2022, Initial authorisation, Last updated: 03/11/2022dimethyl fumarate Overview Sandoz GmbH withdrew its application … Dimherity (dimethyl fumarate) Sandoz GmbH withdrew its application … that, at this point of time, Sandoz GmbH has taken the decision …