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Keyword Atazanavir Mylan Remove keyword
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Human medicine European public assessment report (EPAR): Atazanavir Mylan (updated)
atazanavir (as sulfate), HIV Infections
Date of authorisation: 22/08/2016,
, Revision: 14, Authorised, Last updated: 17/05/2023
Atazanavir Mylan Immunologic Deficiency Syndromes Immune … Atazanavir Mylan … Atazanavir Mylan, INN atazanavir 30 Churchill Place … -
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Human medicine European public assessment report (EPAR): Atazanavir Krka
atazanavir (as sulfate), HIV Infections
Date of authorisation: 25/03/2019,, Revision: 1, Authorised, Last updated: 09/12/2021
Atazanavir Krka Blood-Borne Infections Communicable … Atazanavir Krka … OF THE MEDICINAL PRODUCT Atazanavir Krka 150 mg hard capsules Atazanavir Krka 200 mg hard capsules Atazanavir Krka 300 mg hard capsules 2 … -
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Human medicine European public assessment report (EPAR): Evotaz
cobicistat, atazanavir, HIV Infections
Date of authorisation: 13/07/2015, Revision: 14, Authorised, Last updated: 25/04/2023atazanavir / cobicistat … EMEA/H/C/003904 Evotaz (atazanavir / cobicistat) An overview … contains the active substances atazanavir and cobicistat. The medicine … -
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Human medicine European public assessment report (EPAR): Reyataz
atazanavir (as sulfate), HIV Infections
Date of authorisation: 01/03/2004, Revision: 53, Authorised, Last updated: 17/10/2022atazanavir sulfate … for the public Reyataz atazanavir This document is a summary … contains the active substance atazanavir. It is available as capsules … -
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Opinion/decision on a Paediatric investigation plan (PIP): Evotaz, cobicistat, atazanavir (sulfate)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-001465-PIP01-13-M04, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Age-appropriate oral solid dosage form
Decision date: 31/01/2022, Last updated: 17/04/2023, Compliance check: XActive substance cobicistat atazanavir (sulfate) Therapeutic area … paediatric investigation plan for atazanavir (sulphate) / cobicistat … paediatric investigation plan for atazanavir (sulphate) / cobicistat … -
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Opinion/decision on a Paediatric investigation plan (PIP): Reyataz, atazanavir sulfate
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-000804-PIP01-09-M02, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, Hard oral powder
Decision date: 10/04/2014, Last updated: 27/07/2015, Compliance check: V, 13/02/2015Reyataz Active substance atazanavir sulfate Therapeutic area … paediatric investigation plan for atazanavir (sulphate) (Reyataz), (EMEA-000804-PIP01-09-M02 … paediatric investigation plan for atazanavir (sulphate) (Reyataz), (EMEA-000804-PIP01-09-M02 … -
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Referral: Panexcell
atazanavir, atazanavir sulfate, Amoxicillin trihydrate, iron sucrose, amoxicillin, azithromycin dihydrate, carbocisteine, trimethoprim, Article 31 referrals
Status: European Commission final decision, opinion/position date: 27/02/2020, EC decision date: 24/09/2020, Last updated: 22/10/2020atazanavir atazanavir sulfate Amoxicillin trihydrate iron … -
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Opinion/decision on a Paediatric investigation plan (PIP): ritonavir, atazanavir sulfate
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Infectious diseases
PIP number: EMEA-002588-PIP01-19, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 04/12/2019, Last updated: 06/12/2022, Compliance check: XKey facts ritonavir atazanavir sulfate Infectious diseasesP/0396/2019EMEA-002588-PIP01-19 … granting of a waiver for atazanavir (sulfate) / ritonavir (EMEA-002588-PIP01-19 … Generic Related documents Atazanavir / Ritonavir - Notification … -
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Human medicine European public assessment report (EPAR): Ritonavir Mylan (updated)
ritonavir, HIV Infections
Date of authorisation: 09/11/2017,, Revision: 14, Authorised, Last updated: 17/05/2023
Ritonavir Mylan Blood-Borne Infections Communicable … report (EPAR) for Ritonavir Mylan. It explains how the Agency … advice on how to use Ritonavir Mylan. For practical information … -
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Human medicine European public assessment report (EPAR): Clopidogrel Taw Pharma (previously Clopidogrel Mylan)
clopidogrel hydrochloride, Peripheral Vascular Diseases; Stroke; Myocardial Infarction; Acute Coronary Syndrome
Date of authorisation: 21/09/2009,, Revision: 20, Authorised, Last updated: 01/07/2022
Pharma (previously Clopidogrel Mylan) Vascular Diseases Cardiovascular … Pharma (previously Clopidogrel Mylan) … Pharma (previously Clopidogrel Mylan) clopidogrel clopidogrel … -
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Withdrawn application: Rotigotine Mylan
rotigotine, date of withdrawal: 22/12/2017, Initial authorisation, Last updated: 11/07/2018Rotigotine Mylan: Withdrawn application … Rotigotine Mylan: Withdrawal of the marketing … application for Rotigotine Mylan (rotigotine) On 22 December … -
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Withdrawn application: Fingolimod Mylan
fingolimod, date of withdrawal: 08/05/2020, Initial authorisation, Last updated: 17/06/2020Fingolimod Mylan: Withdrawn application … Fingolimod Mylan Fingolimod Mylan fingolimod fingolimod hydro … -
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Withdrawn application: Aripiprazole Mylan
aripiprazole, date of withdrawal: 07/05/2015, Initial authorisation, Last updated: 20/07/2015Aripiprazole Mylan: Withdrawn application … Aripiprazole Mylan: Withdrawal of the marketing … application for Aripiprazole Mylan (aripiprazole) On 7 May … -
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Withdrawn application: Docetaxel Mylan
docetaxel, date of withdrawal: 08/03/2010, Initial authorisation, Last updated: 26/03/2010Docetaxel Mylan: Withdrawn application … Docetaxel Mylan: Withdrawal of the marketing … application for Docetaxel Mylan (docetaxel) On 8 March … -
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Withdrawn application: Aripiprazole Mylan
aripiprazole, date of withdrawal: 08/01/2016, Initial authorisation, Last updated: 29/03/2016Aripiprazole Mylan: Withdrawn application … application for Aripiprazole Mylan (aripiprazole) On 8 January … aripiprazole) On 8 January 2016, Mylan S.A.S. officially notified … -
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Withdrawn application: Alendronic Acid / Colecalciferol Mylan
date of withdrawal: 27/05/2016, Initial authorisation, Last updated: 02/02/2017dronic Acid / Colecalciferol Mylan: Withdrawn application … dronic Acid / Colecalciferol Mylan: Withdrawal of the marketing … Alendronic Acid/Colecalciferol Mylan (alendronic acid and colecalciferol … -
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Human medicine European public assessment report (EPAR): Darunavir Mylan (updated)
darunavir, HIV Infections
Date of authorisation: 03/01/2017,, Revision: 13, Authorised, Last updated: 23/05/2023
Darunavir Mylan Blood-Borne Infections Communicable … Darunavir Mylan … Darunavir Mylan, INN-darunavir 30 … -
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Human medicine European public assessment report (EPAR): Tadalafil Mylan (updated)
tadalafil, Erectile Dysfunction
Date of authorisation: 21/11/2014,, Revision: 15, Authorised, Last updated: 01/06/2023
Tadalafil Mylan Mental Disorders Sexual … report (EPAR) for Tadalafil Mylan. It explains how the Agency … advice on how to use Tadalafil Mylan. For practical information … -
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Human medicine European public assessment report (EPAR): Ambrisentan Mylan
ambrisentan, Hypertension, Pulmonary
Date of authorisation: 20/06/2019,, Revision: 4, Authorised, Last updated: 26/04/2023
Ambrisentan Mylan Lung Diseases Respiratory … ambrisentan Overview Ambrisentan Mylan is a medicine that is used … of the lungs. Ambrisentan Mylan is used in patients with … -
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Human medicine European public assessment report (EPAR): Rivaroxaban Mylan (updated)
rivaroxaban, Venous Thromboembolism; Pulmonary Embolism; Acute Coronary Syndrome; Stroke; Coronary Artery Disease; Peripheral Arterial Disease; Atrial Fibrillation
Date of authorisation: 12/11/2021,, Revision: 3, Authorised, Last updated: 30/05/2023
Rivaroxaban Mylan Cardiovascular Diseases Vascular … Rivaroxaban Mylan … EMEA/H/C/005600 Rivaroxaban Mylan (rivaroxaban) An overview … -
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Human medicine European public assessment report (EPAR): Febuxostat Mylan (updated)
febuxostat, Hyperuricemia; Arthritis, Gouty; Gout
Date of authorisation: 15/06/2017,, Revision: 11, Authorised, Last updated: 16/05/2023
Febuxostat Mylan Pathological Conditions … report (EPAR) for Febuxostat Mylan. It explains how the Agency … on how to use Febuxostat Mylan. For practical information … -
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Human medicine European public assessment report (EPAR): Fulvestrant Mylan
fulvestrant, Breast Neoplasms
Date of authorisation: 08/01/2018,, Revision: 5, Authorised, Last updated: 24/02/2023
Fulvestrant Mylan Neoplasms Cancer Breast … report (EPAR) for Fulvestrant Mylan. It explains how the Agency … on how to use Fulvestrant Mylan. For practical information … -
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Human medicine European public assessment report (EPAR): Azacitidine Mylan
azacitidine, Myelodysplastic Syndromes; Leukemia, Myelomonocytic, Chronic; Leukemia, Myeloid, Acute
Date of authorisation: 27/03/2020,, Revision: 5, Authorised, Last updated: 22/02/2023
Azacitidine Mylan Bone Marrow Diseases Hematologic … Azacitidine Mylan … MEDICINAL PRODUCT Azacitidine Mylan 25 mg/mL powder for suspension … -
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Human medicine European public assessment report (EPAR): Deferasirox Mylan
deferasirox, Iron Overload; beta-Thalassemia
Date of authorisation: 26/09/2019,, Revision: 9, Authorised, Last updated: 28/03/2023
Deferasirox Mylan Nutritional and Metabolic … deferasirox Overview Deferasirox Mylan is a medicine used to treat … from the gut. Deferasirox Mylan contains the The substance … -
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Human medicine European public assessment report (EPAR): Pregabalin Mylan
pregabalin, Anxiety Disorders; Epilepsy
Date of authorisation: 24/06/2015,, Revision: 16, Authorised, Last updated: 13/01/2023
Pregabalin Mylan Mental Disorders Nervous … report (EPAR) for Pregabalin Mylan. It explains how the Agency … on how to use Pregabalin Mylan. For practical information …