606 results
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Human medicine European public assessment report (EPAR): Ziagen
abacavir, HIV Infections
Date of authorisation: 08/07/1999, Revision: 46, Authorised, Last updated: 29/08/2022abacavir … Human Use (CHMP) Ziagen (abacavir sulfate) Procedure No … Protocol 1052 for Ziagen (Abacavir pharmacokinetics during chronic … -
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Human medicine European public assessment report (EPAR): Kivexa
abacavir, lamivudine, HIV Infections
Date of authorisation: 16/12/2004, Revision: 36, Authorised, Last updated: 23/08/2022abacavir / lamivudine … combination containing 600 mg abacavir and 300 mg lamivudine through … Kivexa, which contains 600 mg abacavir and 300 mg lamivudine in … -
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Opinion/decision on a Paediatric investigation plan (PIP): Triumeq, dolutegravir, abacavir, lamivudine
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-001219-PIP01-11-M05, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Dispersible tablet
Decision date: 17/03/2021, Last updated: 23/11/2021, Compliance check: XActive substance dolutegravir abacavir lamivudine Therapeutic area … plan for dolutegravir / abacavir / lamivudine (Triumeq), (EMEA-001219-PIP01-11-M05 … plan for dolutegravir / abacavir / lamivudine (Triumeq), (EMEA-001219-PIP01-11-M05 … -
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Human medicine European public assessment report (EPAR): Triumeq
dolutegravir sodium, lamivudine, abacavir (as sulfate), HIV Infections
Date of authorisation: 31/08/2014, Revision: 31, Authorised, Last updated: 20/04/2023Authorised abacavir sulfate / dolutegravir sodium … substances : dolutegravir, abacavir and lamivudine. How is Triumeq … of an allergic reaction to abacavir, so they should not take Triumeq. … -
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Human medicine European public assessment report (EPAR): Trizivir
abacavir (as sulfate), lamivudine, zidovudine, HIV Infections
Date of authorisation: 27/12/2000, Revision: 42, Authorised, Last updated: 27/09/2022abacavir (as sulfate) / lamivudine … tablet contains 300 mg of abacavir (as sulfate), 150 mg lamivudine … replaces the three components (abacavir, lamivudine and zidovudine … -
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Opinion/decision on a Paediatric investigation plan (PIP): abacavir, lamivudine, efavirenz
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Infectious diseases
PIP number: EMEA-002114-PIP01-16, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 30/06/2017, Last updated: 25/07/2017, Compliance check: XKey facts abacavir lamivudine efavirenz Infectious … product-specific waiver for abacavir / lamivudine / efavirenz … product specific waiver for abacavir / lamivudine / efavirenz … -
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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 … Clopidogrel Taw Pharma Clopidogrel Mylan received a The approval to … Pharma (previously Clopidogrel Mylan) : EPAR - Summary for the … -
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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 … report (EPAR) for Darunavir Mylan. It explains how the Agency … advice on how to use Darunavir Mylan. For practical information … -
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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): 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): 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): Rivaroxaban Mylan
rivaroxaban, Venous Thromboembolism; Pulmonary Embolism; Acute Coronary Syndrome; Stroke; Coronary Artery Disease; Peripheral Arterial Disease; Atrial Fibrillation
Date of authorisation: 12/11/2021,, Revision: 2, Authorised, Last updated: 21/04/2023
Rivaroxaban Mylan Cardiovascular Diseases Vascular … rivaroxaban Overview Rivaroxaban Mylan is an anticoagulant medicine … with aspirin. Rivaroxaban Mylan contains the The substance … -
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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 … -
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Human medicine European public assessment report (EPAR): Olanzapine Mylan
olanzapine, Schizophrenia; Bipolar Disorder
Date of authorisation: 06/10/2008,, Revision: 18, Authorised, Last updated: 17/01/2023
Olanzapine Mylan Schizophrenia Spectrum and … Olanzapine Mylan … REPORT (EPAR) OLANZAPINE MYLAN EPAR summary for the public … -
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Human medicine European public assessment report (EPAR): Teriflunomide Mylan
Teriflunomide, Multiple Sclerosis, Relapsing-Remitting
Date of authorisation: 09/11/2022,, Revision: 1, Authorised, Last updated: 16/01/2023
Teriflunomide Mylan Multiple Sclerosis Demyelinating … Teriflunomide Mylan … EMEA/H/C/005962 Teriflunomide Mylan (teriflunomide) An overview … -
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Human medicine European public assessment report (EPAR): Lenalidomide Mylan
lenalidomide, Multiple Myeloma
Date of authorisation: 18/12/2020,, Revision: 7, Authorised, Last updated: 05/10/2022
Lenalidomide Mylan Cancer Neoplasms Neoplasms … Lenalidomide Mylan … EMEA/H/C/005306 Lenalidomide Mylan (lenalidomide) An overview …