11962 results
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Human medicine European public assessment report (EPAR): Darunavir Krka (updated)
darunavir, HIV Infections
Date of authorisation: 26/01/2018,
, Revision: 10, Authorised, Last updated: 15/05/2023
Darunavir Krka Immunologic Deficiency … assessment report (EPAR) for Darunavir Krka. It explains how the … practical advice on how to use Darunavir Krka. For practical information … -
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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 … assessment report (EPAR) for Darunavir Mylan. It explains how the … practical advice on how to use Darunavir Mylan. For practical information … -
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Human medicine European public assessment report (EPAR): Darunavir Krka d.d.
darunavir, HIV Infections
Date of authorisation: 18/01/2018,, Revision: 8, Withdrawn, Last updated: 03/02/2023
Darunavir Krka d.d. Immunologic Deficiency … Darunavir Krka d.d … medicines are manufactured according to the same quality standards … -
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Opinion/decision on a Paediatric investigation plan (PIP): Prezista, darunavir
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: Darunavir, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Oral suspension
Decision date: 31/07/2010, Last updated: 27/08/2010, Compliance check: V, 13/12/2011Darunavir Infectious diseases … paediatric investigation plan for darunavir (Prezista), (EMEA-000038-PIP01-07-M03 … EMEA-000038-PIP01-07-M03) in accordance with Regula... (PDF/118.28 … -
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Human medicine European public assessment report (EPAR): Prezista
darunavir, HIV Infections
Date of authorisation: 11/02/2007, Revision: 54, Authorised, Last updated: 03/03/2023darunavir … CHMP) Prezista Darunavir Procedure No. EMEA/H/C/000707/PSUV/059 … Safety Update Report for darunavir summarises the safety data … -
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Human medicine European public assessment report (EPAR): Rezolsta
darunavir, cobicistat, HIV Infections
Date of authorisation: 19/11/2014, Revision: 15, Authorised, Last updated: 13/12/2022darunavir / cobicistat … following a worksharing procedure according to Article 20 of Commission … Package Leaflets are updated accordingly. In addition, sections 4.4 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Rezolsta, darunavir, cobicistat
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-001280-PIP01-12-M04, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Dispersible tablet
Decision date: 19/07/2021, Last updated: 25/07/2022, Compliance check: XRezolsta Active substance darunavir cobicistat Therapeutic area … paediatric investigation plan for darunavir / cobicistat (Rezolsta … EMEA-001280-PIP01-12-M04) in accordance with Regulation (EC) No 1901/2006 … -
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Human medicine European public assessment report (EPAR): Symtuza
darunavir, cobicistat, emtricitabine, tenofovir alafenamide, HIV Infections
Date of authorisation: 21/09/2017, Revision: 17, Authorised, Last updated: 21/03/2023darunavir / cobicistat / emtricitabine … authorisation) Symtuza darunavir / cobicistat / emtricitabine … of four active substances (darunavir, cobicistat, emtricitabine … -
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Opinion/decision on a Paediatric investigation plan (PIP): Symtuza, darunavir, cobicistat, emtricitabine, tenofovir alafenamide
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-001825-PIP01-15-M03, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 10/05/2021, Last updated: 17/02/2022, Compliance check: XSymtuza Active substance darunavir cobicistat emtricitabine … paediatric investigation plan for darunavir / cobicistat / emtricitabine … EMEA-001825-PIP01-15-M03) in accordance with Regulation (EC) No … -
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Opinion/decision on a Paediatric investigation plan (PIP): darunavir, ritonavir
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-002537-PIP02-19, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 12/08/2020, Last updated: 18/06/2021, Compliance check: XKey facts darunavir ritonavir Infectious diseasesP/0308/2020EMEA-002537-PIP02-19 … granting of a waiver for darunavir / ritonavir (EMEA-002537-PIP02-19 … granting of a waiver for darunavir / ritonavir (EMEA-002537-PIP02-19 … -
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Opinion/decision on a Paediatric investigation plan (PIP): darunavir, cobicistat, emtricitabine, tenofovir alafenamide
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-001825-PIP01-15, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Age-appropriate oral solid dosage form
Decision date: 12/05/2016, Last updated: 02/06/2016, Compliance check: XKey facts darunavir cobicistat emtricitabine … granting of a waiver for darunavir / cobicistat / emtricitabine … granting of a waiver for darunavir / cobicistat / emtricitabine … -
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Withdrawn application: Erlotinib Accord
erlotinib, date of withdrawal: 28/05/2020, Initial authorisation, Last updated: 29/05/2020Erlotinib Accord: Withdrawn application … medicines are manufactured according to the same quality standards … Erlotinib Accord Erlotinib Accord erlotinib … -
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Summary of opinion: Tolvaptan Accord
tolvaptan, opinion date: 26/01/2023, Positive, Last updated: 27/01/2023Tolvaptan Accord: Pending EC decision … authorisation) Tolvaptan Accord tolvaptan On 26 January … medicinal product Tolvaptan Accord, intended for the treatment … -
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Human medicine European public assessment report (EPAR): Zoledronic Acid Accord
zoledronic acid monohydrate, Hypercalcemia; Fractures, Bone; Cancer
Date of authorisation: 16/01/2014,, Revision: 9, Authorised, Last updated: 24/01/2022
Zoledronic Acid Accord Calcium Metabolism Disorders Metabolic … Zoledronic Acid Accord is a medicine used to prevent … breaks in the bone), spinal compression (when the spinal cord is compressed by the bone), bone disorders … -
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Withdrawn application: Tigecycline Accord
tigecycline, date of withdrawal: 12/09/2017, Initial authorisation, Last updated: 10/10/2017Tigecycline Accord: Withdrawn application … Tigecycline Accord: Withdrawal of the marketing … medicines are manufactured according to the same quality standards … -
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Summary of opinion: Dimethyl fumarate Accord
dimethyl fumarate, opinion date: 15/12/2022, Positive, Last updated: 16/12/2022Dimethyl fumarate Accord: Pending EC decision … authorisation) Dimethyl fumarate Accord dimethyl fumarate On 15 … product Dimethyl fumarate Accord, intended for the treatment … -
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Direct healthcare professional communication (DHPC): Cabazitaxel Accord 20 mg/mL concentrate for solution for infusion: Risk of medication errors and mix-up with Jevtana (60 mg/1.5 mL) concentrate and solvent for solution for infusion
Active substance: cabazitaxel, DHPC type: Medication error, Last updated: 28/10/2020Cabazitaxel Accord 20 mg/mL concentrate for … Cabazitaxel Accord 20 mg/mL concentrate for … Cabazitaxel Accord Cabazitaxel Accord cabazitaxel cabazitaxel ca … -
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Human medicine European public assessment report (EPAR): Rivaroxaban Accord (updated)
rivaroxaban, Acute Coronary Syndrome; Coronary Artery Disease; Peripheral Arterial Disease; Venous Thromboembolism; Stroke; Atrial Fibrillation; Pulmonary Embolism
Date of authorisation: 16/11/2020,, Revision: 3, Authorised, Last updated: 30/05/2023
Rivaroxaban Accord Cardiovascular Diseases Vascular … rivaroxaban Overview Rivaroxaban Accord is an anticoagulant medicine … with aspirin. Rivaroxaban Accord contains the The substance … -
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Human medicine European public assessment report (EPAR): Teriflunomide Accord
Teriflunomide, Multiple Sclerosis, Relapsing-Remitting
Date of authorisation: 09/11/2022,, Authorised, Last updated: 14/11/2022
Teriflunomide Accord Multiple Sclerosis Demyelinating … Teriflunomide Accord … medicines are manufactured according to the same quality standards … -
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Human medicine European public assessment report (EPAR): Lacosamide Accord
lacosamide, Epilepsy
Date of authorisation: 18/09/2017,, Revision: 11, Authorised, Last updated: 30/11/2022
Lacosamide Accord Nervous System Diseases Central … Lacosamide Accord … medicines are manufactured according to the same quality standards … -
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Human medicine European public assessment report (EPAR): Aripiprazole Accord
aripiprazole, Schizophrenia; Bipolar Disorder
Date of authorisation: 15/11/2015,, Revision: 15, Authorised, Last updated: 13/07/2022
Aripiprazole Accord Schizophrenia Spectrum and … Aripiprazole Accord … medicines are manufactured according to the same quality standards … -
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Human medicine European public assessment report (EPAR): Entecavir Accord
Entecavir, Hepatitis B, Chronic
Date of authorisation: 25/09/2017,, Revision: 5, Authorised, Last updated: 29/07/2022
Entecavir Accord Infections Communicable … Entecavir Accord … medicines are manufactured according to the same quality standards … -
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Human medicine European public assessment report (EPAR): Imatinib Accord
imatinib, Precursor Cell Lymphoblastic Leukemia-Lymphoma; Dermatofibrosarcoma; Myelodysplastic-Myeloproliferative Diseases; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Hypereosinophilic Syndrome
Date of authorisation: 30/06/2013,, Revision: 20, Authorised, Last updated: 14/12/2022
Imatinib Accord Neoplasms Cancer Leukemia … Imatinib Accord … medicines are manufactured according to the same quality standards … -
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Human medicine European public assessment report (EPAR): Voriconazole Accord
voriconazole, Aspergillosis; Candidiasis; Mycoses
Date of authorisation: 16/05/2013,, Revision: 16, Authorised, Last updated: 25/04/2022
Voriconazole Accord Infections Bacterial Infections … Voriconazole Accord … medicines are manufactured according to the same quality standards … -
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Human medicine European public assessment report (EPAR): Bortezomib Accord
bortezomib, Multiple Myeloma
Date of authorisation: 20/07/2015,, Revision: 13, Authorised, Last updated: 25/03/2022
Bortezomib Accord Hemostatic Disorders Vascular … Bortezomib Accord … medicines are manufactured according to the same quality standards …