4139 results
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Referral: Serotonin-specific reuptake inhibitors and serotonin-noradrenaline reuptake inhibitors
atomoxetine, citalopram, escitalopram, fluoxetine, fluvoxamine, mianserine, milnacipran, mirtazapine, paroxetine, reboxetine, sertraline, venlafaxine, Article 31 referrals
Status: European Commission final decision, opinion/position date: 21/04/2005, EC decision date: 19/08/2005, Last updated: 03/11/2005substances: atomoxetine, citalopram, duloxetine, escitalopram … SSRIs / SNRIs: atomoxetine, citalopram, duloxetine, escitalopram … the product information of citalopram, duloxetine 1 , escitalopram … -
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Withdrawn application: Duloxetine Sandoz
duloxetine, date of withdrawal: 08/04/2015, Initial authorisation, Last updated: 24/04/2015Duloxetine Sandoz: Withdrawn application … Duloxetine Sandoz: Withdrawal of the marketing … application for Duloxetine Sandoz (duloxetine) On 08 April … -
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Withdrawn application: Parsaclisib Incyte Biosciences Distribution B.V.
parsaclisib, date of withdrawal: 27/06/2022, Initial authorisation, Last updated: 08/11/2022Biosciences Distribution B.V.: Withdrawn application … Biosciences Distribution B.V.: Withdrawal of the marketing … Biosciences Distribution B.V. (parsaclisib) Incyte … -
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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): Fluad Tetra (updated)
A/Victoria/2570/2019 (H1N1)pdm09 like strain (A/Victoria/2570/2019 IVR‐215) A/Darwin/9/2021 (H3N2) like strain (A/Darwin/6/2021 IVR-227) B/Austria/1359417/2021 like strain (B/Austria/1359417/2021 BVR-26) B/Phuket/3073/2013 like strain (B/Phuket/3073/2013 BVR‐1B), Influenza, Human
Date of authorisation: 20/05/2020,
, Revision: 5, Authorised, Last updated: 16/01/2023
B/Austria/1359417/2021 BVR-26) 15 micrograms HA** B/Phuket/3073/2013 … strain (B/Phuket/3073/2013 BVR‐1B) 15 micrograms HA** *propagated … strain (B/Austria/1359417/2021 BVR-26) B/Phuket/3073/2013 like strain … -
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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): 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): 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): Ribavirin Teva Pharma B.V.
Ribavirin, Hepatitis C, Chronic
Date of authorisation: 01/07/2009,, Revision: 14, Withdrawn, Last updated: 09/07/2021
Ribavirin Teva Pharma B.V. Hepatitis C, Chronic … Ribavirin Teva Pharma B.V … and Ribavirin Teva Pharma B.V.) some of the studies that … -
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Human medicine European public assessment report (EPAR): Lamivudine Teva Pharma B.V.
lamivudine, HIV Infections
Date of authorisation: 10/12/2009,, Revision: 18, Authorised, Last updated: 18/01/2022
Lamivudine Teva Pharma B.V. Blood-Borne Infections Communicable … Lamivudine Teva Pharma B.V … Lamivudine Teva Pharma B.V. lamivudine This is a … -
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Human medicine European public assessment report (EPAR): Imatinib Teva B.V.
imatinib mesilate, Dermatofibrosarcoma; Gastrointestinal Stromal Tumors; Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Date of authorisation: 15/11/2017,, Withdrawn, Last updated: 09/10/2018
Imatinib Teva B.V. Dermatofibrosarcoma Gastrointestinal … Imatinib Teva B.V … Imatinib Teva B.V. imatinib imatinib mesilate … -
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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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Human medicine European public assessment report (EPAR): Clopidogrel Teva Pharma B.V.
clopidogrel (as hydrobromide), Peripheral Vascular Diseases; Acute Coronary Syndrome; Myocardial Infarction; Stroke
Date of authorisation: 16/06/2011,, Revision: 4, Withdrawn, Last updated: 03/02/2015
Clopidogrel Teva Pharma B.V. Peripheral Vascular Diseases Acute … for Clopidogrel Teva Pharma B.V. has been withdrawn at the … documents Clopidogrel Teva Pharma B.V. : EPAR - Summary for the … -
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Human medicine European public assessment report (EPAR): Clopidogrel Teva Generics B.V.
clopidogrel (as hydrochloride), Peripheral Vascular Diseases; Acute Coronary Syndrome; Myocardial Infarction; Stroke
Date of authorisation: 28/10/2010,, Revision: 3, Withdrawn, Last updated: 12/05/2014
Clopidogrel Teva Generics B.V. Peripheral Vascular Diseases Acute … Clopidogrel Teva Generics B.V. has lapsed because it has … Clopidogrel Teva Generics B.V. : EPAR - Summary for the … -
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Referral: Pregsure BVD
inactivated Bovine Viral Diarrhoea (BVD) type 1 virus, cytopathogenic strain 5960, Article 78
Status: European Commission final decision, opinion/position date: 15/07/2010, EC decision date: 07/10/2010, Last updated: 22/10/2010Pregsure BVD … decision Overview Pregsure BVD is an inactivated vaccine … following use of Pregsure BVD in dams, Germany triggered … -
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Human medicine European public assessment report (EPAR): Budesonide/Formoterol Teva Pharma B.V.
budesonide, formoterol fumarate dihydrate, Asthma; Pulmonary Disease, Chronic Obstructive
Date of authorisation: 03/04/2020, Revision: 2, Authorised, Last updated: 08/12/2021onide/Formoterol Teva Pharma B.V. Lung Diseases, Obstructive Lung … Budesonide/Formoterol Teva Pharma B.V. is a medicine used for the … Budesonide/Formoterol Teva Pharma B.V. is also used to relieve … -
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Human medicine European public assessment report (EPAR): Budesonide/Formoterol Teva Pharma B.V.
budesonide, formoterol, Asthma
Date of authorisation: 19/11/2014, Revision: 1, Withdrawn, Last updated: 30/01/2017onide/Formoterol Teva Pharma B.V. Asthma … Budesonide/Formoterol Teva Pharma B.V. has been withdrawn at the … Budesonide/Formoterol Teva Pharma B.V.: EPAR - Summary for the … -
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Opinion/decision on a Paediatric investigation plan (PIP): Fluad Tetra, Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain A (H3N2), Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain B (Yamagata lineage), Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain B (Victoria lineage), Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain A (H1N1)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Vaccines
PIP number: EMEA-001715-PIP01-14-M04, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Suspension for injection
Decision date: 29/01/2020, Last updated: 01/07/2021, Compliance check: Xenquiries Seqirus Netherlands B.V. Tel. +31 646951054 E-mail: … submitted by Seqirus Netherlands B.V. on 17 April 2020 under Article … addressed to Seqirus Netherlands B.V., Paasheuvelweg 28, 1105 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Influenza virus surface antigens (haemagglutinin and neuraminidase) of the following strains: A/(H1N1), A/(H3N2), B/Yamagata lineage, B/Victoria lineage
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Vaccines
PIP number: EMEA-001782-PIP01-15-M03, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Suspension for injection
Decision date: 17/07/2018, Last updated: 16/09/2021, Compliance check: V, 04/09/2020A/(H3N2), B/Yamagata lineage, B/Victoria lineage VaccinesP/0211/2018EMEA-001782-PIP01-15-M03 … Intramuscular use Abbott Biologicals B.V. Tel. +41 6148 70374 Email … A/(H3N2), B/Yamagata lineage, B/Victoria lineage … -
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Opinion/decision on a Paediatric investigation plan (PIP): Split influenza virus, inactivated containing antigens equivalent to the B-like strain (B/Yamagata lineage), Split influenza virus, inactivated containing antigens equivalent to the B-like strain (B/Victoria lineage), Split influenza virus, inactivated (B/Victoria lineage), Split influenza virus, inactivated containing antigens equivalent to the A/H1N1-like strain, Split influenza virus, inactivated containing antigens equivalent to the A/H3N2-like strain
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Vaccines
PIP number: EMEA-001254-PIP01-11-M02, Route(s) of administration: Subcutaneous use, Intramuscular use, Pharmaceutical form(s): Suspension for injection
Decision date: 08/05/2017, Last updated: 02/03/2018, Compliance check: V, 23/06/2017equivalent to the B-like strain (B/Victoria lineage) Split influenza … influenza virus, inactivated (B/Victoria lineage) Split influenza … equivalent to the B-like strain (B/Victoria lineage) / Split influenza … -
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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 …