3266 results
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Withdrawn application: Duloxetine Sandoz
duloxetine, date of withdrawal: 08/04/2015, Initial authorisation, Last updated: 24/04/2015Duloxetine Sandoz: Withdrawn application … application for Duloxetine Sandoz (duloxetine) On 08 April … duloxetine) On 08 April 2015, Sandoz GmbH officially notified … -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) : EPAR - Summary for the … Levodopa/Carbidopa/Entacapone Sandoz) levodopa carbidopa entacap … -
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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/Cambodia/e0826360/2020 (H3N2) - like strain (A/Cambodia/e0826360/2020 IVR‐224) B/Washington/02/2019 – like strain (B/Victoria/705/2018 BVR‐11) B/Phuket/3073/2013 – like strain (B/Phuket/3073/2013 BVR‐1B), Influenza, Human
Date of authorisation: 20/05/2020,
, Revision: 2, Authorised, Last updated: 29/07/2021
B/Washington/02/2019 – like strain (B/Victoria/705/2018 BVR‐11) 15 micrograms HA** B/Phuket/3073/2013 … strain (B/Phuket/3073/2013 BVR‐1B) 15 micrograms HA** *propagated … B/Washington/02/2019 – like strain (B/Victoria/705/2018 BVR‐11) B/Phuket/3073/2013 – like … -
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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: 7, Authorised, Last updated: 23/06/2021
Pregabalin Sandoz Anxiety Disorders Neuralgia … 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: 8, Authorised, Last updated: 10/07/2020
Aripiprazole Sandoz Schizophrenia Bipolar Disor … 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: 16, Authorised, Last updated: 14/10/2019
Temozolomide Sandoz Glioma Glioblastoma … 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): 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): 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 … 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 GmbH
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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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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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 … report (EPAR) for Pemetrexed Sandoz. It explains how the Agency … on how to use Pemetrexed Sandoz. 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 … 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): Ribavirin Teva Pharma B.V. (updated)
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 … documents Ribavirin Teva Pharma B.V. : EPAR - Medicine overview … details >Ribavirin Teva Pharma B.V.EMEA/H/C/001064RibavirinribavirinHepatitis … -
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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: 15, Authorised, Last updated: 12/05/2021
Lamivudine Teva Pharma B.V. HIV Infections … is Lamivudine Teva Pharma B.V.? Lamivudine Teva Pharma B.V. is an antiviral medicine … mg). Lamivudine Teva Pharma B.V. is a ‘generic medicine’ … -
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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 … authorisation for Imatinib Teva B.V. has been withdrawn at the … Summary documents Imatinib Teva B.V. : EPAR - Summary for the … -
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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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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) (updated)
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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Human medicine European public assessment report (EPAR): Budesonide/Formoterol Teva Pharma B.V. (updated)
budesonide, formoterol fumarate dihydrate, Asthma, Pulmonary Disease, Chronic Obstructive
Date of authorisation: 03/04/2020, Revision: 1, Authorised, Last updated: 13/07/2021onide/Formoterol Teva Pharma B.V. Asthma Pulmonary Disease … 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): 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: 27/11/2018, Compliance check: XA/(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 … -
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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 …