12109 results
Keyword Bosentan Accord Remove keyword
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Human medicine European public assessment report (EPAR): Tracleer
bosentan (as monohydrate), Scleroderma, Systemic; Hypertension, Pulmonary
Date of authorisation: 14/05/2002, Revision: 42, Authorised, Last updated: 13/02/2023bosentan … Tracleer, INN-bosentan 30 Churchill Place … authorisation(s) Active substance(s): bosentan Procedure No. EMEA/H/C/PSUSA/00000425/201511 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Tracleer, Bosentan
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Pneumology-allergology
PIP number: EMEA-000425-PIP02-10-M04, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Dispersible tablet
Decision date: 29/04/2013, Last updated: 31/05/2013, Compliance check: V, 21/03/2014Tracleer Active substance Bosentan Therapeutic area Pneumology-allergology … paediatric investigation plan for bosentan (Tracleer) (EMEA-000425-PIP02-10-M04 … paediatric investigation plan for bosentan (Tracleer) (EMEA-000425-PIP02-10-M04 … -
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Human medicine European public assessment report (EPAR): Stayveer
bosentan (as monohydrate), Hypertension, Pulmonary; Scleroderma, Systemic
Date of authorisation: 24/06/2013, Revision: 15, Authorised, Last updated: 13/02/2023Authorised bosentan monohydrate Overview Stayveer … medicine. active substance bosentan. This medicine is the same … active substance in Stayveer, bosentan, blocks a naturally occurring … -
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Orphan designation: Bosentan for: Treatment of pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension
Date of designation: 15/02/2001, Expired, Last updated: 27/02/2013Pharmaceuticals, France, for bosentan for the treatment of pulmonary … United Kingdom in July 2001. Bosentan for treatment of pulmonary … orphan-drug designation. Bosentan might be of potential significant … -
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Orphan designation: Bosentan for: Treatment of systemic sclerosis (scleroderma)
Date of designation: 18/03/2003, Withdrawn, Last updated: 08/05/2014Limited, United Kingdom, for bosentan for the treatment of systemic … treatment of systemic sclerosis. Bosentan for treatment of systemic … orphan drug designation. Bosentan might be of potential significant … -
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Orphan designation: Bosentan for: Treatment of idiopathic pulmonary fibrosis
Date of designation: 05/09/2008, Withdrawn, Last updated: 08/05/2014Limited, United Kingdom, for bosentan for the treatment of idiopathic … orphan drug designation. Bosentan might be of potential significant … medicine expected to work? Bosentan opposes the effect of a substance … -
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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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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: Degarelix Accord
degarelix acetate, opinion date: 20/07/2023, Positive, Last updated: 21/07/2023Degarelix Accord: Pending EC decision … Degarelix Accord … authorisation) Degarelix Accord degarelix acetate On 20 … -
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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): Lenalidomide Accord (updated)
lenalidomide, Multiple Myeloma
Date of authorisation: 20/09/2018,
, Revision: 11, Authorised, Last updated: 22/09/2023
Lenalidomide Accord Cancer Neoplasms Neoplasms … Lenalidomide 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: 12, Authorised, Last updated: 16/08/2023
Lacosamide Accord Nervous System Diseases Central … report (EPAR) for Lacosamide Accord. It explains how the Agency … on how to use Lacosamide Accord. For practical information … -
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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: 5, Authorised, Last updated: 28/09/2023
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): Docetaxel Accord (updated)
docetaxel, Head and Neck Neoplasms; Carcinoma, Non-Small-Cell Lung; Adenocarcinoma; Prostatic Neoplasms; Breast Neoplasms
Date of authorisation: 22/05/2012,, Revision: 17, Authorised, Last updated: 14/09/2023
Docetaxel Accord Cancer Neoplasms Breast … docetaxel Overview Docetaxel Accord is a cancer medicine used … breast cancer. Docetaxel Accord can be used on its own after … -
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Human medicine European public assessment report (EPAR): Deferasirox Accord (updated)
deferasirox, Iron Overload; beta-Thalassemia
Date of authorisation: 09/01/2020,, Revision: 5, Authorised, Last updated: 14/09/2023
Deferasirox Accord Nutritional and Metabolic … deferasirox Overview Deferasirox Accord is a medicine used to treat … from the gut. Deferasirox Accord contains the The substance … -
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Human medicine European public assessment report (EPAR): Tolvaptan Accord
Tolvaptan, Inappropriate ADH Syndrome, Authorised, Last updated: 14/08/2023
Tolvaptan Accord Pituitary Diseases Hypothalamic … tolvaptan Overview Tolvaptan Accord is a medicine for treating … in the blood. Tolvaptan Accord is a ‘ A generic medicine … -
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Human medicine European public assessment report (EPAR): Cabazitaxel Accord
cabazitaxel, Prostatic Neoplasms, Castration-Resistant
Date of authorisation: 28/08/2020,, Revision: 5, Authorised, Last updated: 27/07/2023
Cabazitaxel Accord Prostatic Neoplasms Genital … cabazitaxel Overview Cabazitaxel Accord is a cancer medicine used to … prostate fluid). Cabazitaxel Accord is used when the cancer has … -
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Human medicine European public assessment report (EPAR): Levetiracetam Accord
levetiracetam, Epilepsy
Date of authorisation: 03/10/2011,, Revision: 16, Authorised, Last updated: 21/06/2023
Levetiracetam Accord Nervous System Diseases Central … Levetiracetam Accord … medicines are manufactured according to the same quality standards … -
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Human medicine European public assessment report (EPAR): Temozolomide Accord
temozolomide, Glioma; Glioblastoma
Date of authorisation: 15/03/2010,, Revision: 23, Authorised, Last updated: 27/06/2023
Temozolomide Accord Cancer Neuroectodermal … Temozolomide Accord … medicines are manufactured according to the same quality standards … -
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Human medicine European public assessment report (EPAR): Tigecycline Accord
Tigecycline, Soft Tissue Infections; Intraabdominal Infections; Bacterial Infections; Skin Diseases, Infectious
Date of authorisation: 17/04/2020,, Revision: 5, Authorised, Last updated: 07/07/2023
Tigecycline Accord Infections Bacterial Infections … Tigecycline 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: 17, Authorised, Last updated: 14/06/2023
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): Capecitabine Accord
capecitabine, Colonic Neoplasms; Breast Neoplasms; Colorectal Neoplasms; Stomach Neoplasms
Date of authorisation: 20/04/2012,, Revision: 16, Authorised, Last updated: 03/08/2023
Capecitabine Accord Cancer Neoplasms Colorectal … Capecitabine Accord … medicines are manufactured according to the same quality standards … -
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Human medicine European public assessment report (EPAR): Plerixafor Accord
Plerixafor, Multiple Myeloma; Hematopoietic Stem Cell Transplantation
Date of authorisation: 16/12/2022,
, , Revision: 1, Authorised, Last updated: 07/08/2023
Plerixafor Accord Lymphoproliferative Disorders Lymphatic … plerixafor Overview Plerixafor Accord is a medicine used to mobilise … same patient. Plerixafor Accord is used together with the … -
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Human medicine European public assessment report (EPAR): Eptifibatide Accord
eptifibatide, Myocardial Infarction
Date of authorisation: 11/01/2016,, Revision: 6, Authorised, Last updated: 21/04/2023
Eptifibatide Accord Cardiovascular Diseases Heart … Eptifibatide Accord … medicines are manufactured according to the same quality standards … -
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Human medicine European public assessment report (EPAR): Dexmedetomidine Accord
dexmedetomidine, Premedication
Date of authorisation: 13/02/2020,, Revision: 6, Authorised, Last updated: 25/01/2023
Dexmedetomidine Accord Therapeutics Drug Therapy … Overview Dexmedetomidine Accord is a medicine used to sedate … sedation). Dexmedetomidine Accord contains the The substance …