429 results
Keyword Amorolfina Sandoz Remove keyword
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Withdrawn application: Duloxetine Sandoz
duloxetine, date of withdrawal: 08/04/2015, Initial authorisation, Last updated: 24/04/2015Duloxetine Sandoz: Withdrawn application … Duloxetine Sandoz: Withdrawal of the marketing … application for Duloxetine Sandoz (duloxetine) On 08 April … -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)
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
temozolomide, Glioma; Glioblastoma
Date of authorisation: 15/03/2010,
, Revision: 17, Withdrawn, Last updated: 06/03/2023
Temozolomide Sandoz Cancer Neuroectodermal … Temozolomide Sandoz … statement Temozolomide Sandoz (temozolomide) Withdrawal … -
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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 … 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 … Aripiprazole Sandoz … Aripiprazole Sandoz EPAR summary 30 … -
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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
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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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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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,
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, 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 … -
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Human medicine European public assessment report (EPAR): Zarzio
filgrastim, Neutropenia; Hematopoietic Stem Cell Transplantation; Cancer
Date of authorisation: 06/02/2009,, Revision: 22, Authorised, Last updated: 10/02/2023
throughout the EU for Zarzio to Sandoz GmbH on 6 February 2009 … -
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Human medicine European public assessment report (EPAR): Hycamtin
topotecan, Ovarian Neoplasms; Uterine Cervical Neoplasms; Small Cell Lung Carcinoma
Date of authorisation: 12/11/1996, Revision: 38, Authorised, Last updated: 16/01/2023Marketing-authorisation holder Sandoz Pharmaceuticals d.d. Revision … -
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Human medicine European public assessment report (EPAR): Atriance
nelarabine, Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
Date of authorisation: 22/08/2007,, 
, Revision: 26, Authorised, Last updated: 16/01/2023
Marketing-authorisation holder Sandoz Pharmaceuticals d.d. Revision … -
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Human medicine European public assessment report (EPAR): Riximyo
rituximab, Lymphoma, Non-Hodgkin; Arthritis, Rheumatoid; Microscopic Polyangiitis; Wegener Granulomatosis
Date of authorisation: 15/06/2017,, Revision: 11, Authorised, Last updated: 31/08/2022
Marketing-authorisation holder Sandoz GmbH Revision 11 Date of … this medicinal product is Sandoz GmbH. Riximyo will be available … -
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Human medicine European public assessment report (EPAR): Rixathon
rituximab, Lymphoma, Non-Hodgkin; Arthritis, Rheumatoid; Leukemia, Lymphocytic, Chronic, B-Cell; Wegener Granulomatosis; Microscopic Polyangiitis; Pemphigus
Date of authorisation: 15/06/2017,, Revision: 9, Authorised, Last updated: 31/08/2022
Marketing-authorisation holder Sandoz GmbH Revision 9 Date of issue … -
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Human medicine European public assessment report (EPAR): Binocrit
epoetin alfa, Anemia; Kidney Failure, Chronic
Date of authorisation: 28/08/2007,, Revision: 20, Authorised, Last updated: 31/10/2019
Marketing-authorisation holder Sandoz GmbH Revision 20 Date of … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 20-23 April 2015
CHMP, Last updated: 24/04/2015Pregabalin Sandoz … -
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Opinion/decision on a Paediatric investigation plan (PIP): amlodipine, hydrochlorothiazide, Ramipril
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-002906-PIP01-20, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 19/03/2021, Last updated: 09/11/2021, Compliance check: Xof hypertension Oral use Sandoz GmbH E-mail: caroline.kleinjan@sandoz.com … application submitted by Sandoz GmbH on 23 October 2020 under … decision is addressed to Sandoz GmbH, Biochemiestrasse 10 …