450 results
Keyword Anagrelide Sandoz Remove keyword
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Human medicine European public assessment report (EPAR): Anagrelide Mylan
Anagrelide hydrochloride, Thrombocythemia, Essential
Date of authorisation: 15/02/2018,
, Revision: 5, Authorised, Last updated: 13/05/2022
Anagrelide Mylan Cancer Neoplasms Blood … Authorised anagrelide Overview This is a summary … assessment report (EPAR) for Anagrelide Mylan. It explains how the … -
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Direct healthcare professional communication (DHPC): Xagrid (anagrelide hydrochloride): Risk of thrombosis including cerebral infarction upon abrupt treatment discontinuation
Active substance: Anagrelide, DHPC type: Safety signal, Last updated: 22/02/2022Xagrid (anagrelide hydrochloride): Risk of thrombosis … Xagrid (anagrelide hydrochloride): Risk of thrombosis … plan 27/01/2022 Xagrid (anagrelide hydrochloride): Risk of thrombosis … -
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Opinion/decision on a Paediatric investigation plan (PIP): Xagrid, Anagrelide
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-000720-PIP01-09-M02, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 19/12/2013, Last updated: 09/12/2021, Compliance check: V, 14/02/2014name Xagrid Active substance Anagrelide Therapeutic area Haematology-Hemostaseology … paediatric investigation plan for anagrelide (Xagrid) (EMEA-000720-PIP01-09-M02 … paediatric investigation plan for anagrelide (Xagrid) (EMEA-000720-PIP01-09-M02 … -
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Human medicine European public assessment report (EPAR): Xagrid
Anagrelide, Thrombocythemia, Essential
Date of authorisation: 15/11/2004, Revision: 38, Authorised, Last updated: 08/04/2022Authorised anagrelide Overview Xagrid is a medicine … medicine. active substance anagrelide. How is Xagrid used? Xagrid … active substance in Xagrid, anagrelide, blocks the development and … -
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Withdrawn application: Duloxetine Sandoz
duloxetine, date of withdrawal: 08/04/2015, Initial authorisation, Last updated: 24/04/2015Duloxetine Sandoz: Withdrawn application … Duloxetine Sandoz: Withdrawal of the marketing … application for Duloxetine Sandoz (duloxetine) On 08 April … -
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Orphan designation: Anagrelide hydrochloride for: Treatment of essential thrombocythaemia
Date of designation: 30/12/2000, Expired, Last updated: 08/02/2017Anagrelide hydrochloride Overview Please … Ltd, United Kingdom, for anagrelide hydrochloride for the treatment … Kingdom, in December 2001. Anagrelide hydrochloride has been authorised … -
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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: 9, Authorised, Last updated: 08/02/2022Levodopa/Carbidopa/Entacapone Sandoz) Nervous System Diseases Neurodegenerative … Levodopa/Carbidopa/Entacapone Sandoz) levodopa carbidopa entacap … -
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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: 13, Authorised, Last updated: 01/07/2022
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): Temozolomide Sandoz
temozolomide, Glioma; Glioblastoma
Date of authorisation: 15/03/2010,, Revision: 17, Authorised, Last updated: 30/05/2022
Temozolomide Sandoz Cancer Neuroectodermal … report (EPAR) for Temozolomide Sandoz. It explains how the Committee … conditions of use for Temozolomide Sandoz. What is Temozolomide Sandoz? Temozolomide Sandoz is a medicine that contains … -
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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: 12, Authorised, Last updated: 05/10/2021Rivastigmine Sandoz Nervous System Diseases Central … Rivastigmine Sandoz … Rivastigmine Sandoz, INN-rivastigmine … -
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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 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): 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: 12, Authorised, Last updated: 01/07/2022
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: 6, Authorised, Last updated: 06/09/2021
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: 8, Authorised, Last updated: 11/11/2020
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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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 11-14 December 2017
CHMP, Last updated: 15/12/2017Anagrelide Mylan … -
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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: 18, Authorised, Last updated: 24/06/2021
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: 4, Authorised, Last updated: 03/02/2022
Marketing-authorisation holder Sandoz GmbH Revision 4 Date of issue … -
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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: 24/03/2022, Initial authorisation, Last updated: 25/03/2022dimethyl 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 …