327 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Withdrawn application: Duloxetine Sandoz
duloxetine, date of withdrawal: 08/04/2015, Initial authorisation, Last updated: 24/04/2015Duloxetine Sandoz: Withdrawn application … application for Duloxetine Sandoz (duloxetine) On 08 April … duloxetine) On 08 April 2015, Sandoz GmbH officially notified … -
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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) … Levodopa/Carbidopa/Entacapone Sandoz) levodopa carbidopa entacap … -
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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 … Pregabalin Sandoz … for the public Pregabalin Sandoz pregabalin This is a summary … -
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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 Disor … Aripiprazole Sandoz … Aripiprazole Sandoz EPAR summary 30 … -
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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 … Temozolomide Sandoz … Temozolomide Sandoz, INN-temozolomide EMA/729989/2014 … -
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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 … Rivastigmine Sandoz … Rivastigmine Sandoz, INN-rivastigmine … -
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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 … Clopidogrel Sandoz … Clopidogrel Sandoz (clopidogrel) Withdrawal … -
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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 Epil … 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): 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 … Ibandronic Acid Sandoz … public Ibandronic Acid Sandoz ibandronic acid This document … -
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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 … Pemetrexed Sandoz … for the public Pemetrexed Sandoz pemetrexed This is a summary … -
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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 … Methylphenidate Sandoz … Methylphenidate Sandoz - QA - EN 7 Westferry … -
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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 … Budesonide Sandoz … Budesonide Sandoz referrals European … -
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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 … Calcium Sandoz … Calcium Sandoz and associated names, INN-Calcium … -
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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 … Mometasone Furoate Sandoz … answers on Mometasone Furoate Sandoz (mometasone furoate nasal … -
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Referral: Loratadine Sandoz 10
loratadine 10 mg tablets, 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 … Loratadine Sandoz 10 … referral for Loratadine Sandoz 10 loratadine 10 mg tablets … -
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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: 17, Authorised, Last updated: 08/10/2019
throughout the EU for Zarzio to Sandoz GmbH on 6 February 2009 … -
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Human medicine European public assessment report (EPAR): Ziextenzo
pegfilgrastim, Neutropenia
Date of authorisation: 22/11/2018,
, , Revision: 2, Authorised, Last updated: 13/01/2020
Marketing-authorisation holder Sandoz GmbH Revision 2 Date of issue … this medicinal product is Sandoz GmbH. Ziextenzo will be … -
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Opinion/decision on a Paediatric investigation plan (PIP): clopidogrel hydrogen sulfate, acetylsalicylic acid
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-001257-PIP01-11, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 25/04/2012, Last updated: 24/05/2012, Compliance check: XContact for public enquiries Sandoz BV The Netherlands Phone … application submitted by Sandoz BV on 2 December 2011 under … decision is addressed to Sandoz BV, Veluwezoom 22, 1327 AH … -
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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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Human medicine European public assessment report (EPAR): Zessly
infliximab, Arthritis, Psoriatic, Psoriasis, Crohn Disease, Arthritis, Rheumatoid, Colitis, Ulcerative, Spondylitis, Ankylosing
Date of authorisation: 18/05/2018,, , Revision: 6, Authorised, Last updated: 11/11/2020
Marketing-authorisation holder Sandoz GmbH Revision 6 Date of issue … -
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Human medicine European public assessment report (EPAR): Hyrimoz
adalimumab, Hidradenitis Suppurativa, Crohn Disease, Arthritis, Juvenile Rheumatoid, Uveitis, Arthritis, Rheumatoid, Colitis, Ulcerative, Spondylitis, Ankylosing, Skin Diseases, Papulosquamous, Arthritis, Psoriatic
Date of authorisation: 26/07/2018,, , Revision: 7, Authorised, Last updated: 06/11/2020
Marketing-authorisation holder Sandoz GmbH Revision 7 Date of issue … -
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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: 4, Authorised, Last updated: 13/01/2020
Marketing-authorisation holder Sandoz GmbH Revision 4 Date of issue … 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: 3, Authorised, Last updated: 28/11/2019
Marketing-authorisation holder Sandoz GmbH Revision 3 Date of issue … this medicinal product is Sandoz GmbH. Rixathon will be … -
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Press release: European Medicines Agency recommends precautionary recall of batches of clopidogrel-containing medicines from Acino Pharma GmbH
Last updated: 25/03/2010Ratiopharm GmbH and Clopidogrel Sandoz. The Marketing Authorisation … Ratiopharm GmbH and Clopidogrel Sandoz. The Marketing Authorisation … -
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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 …