13233 results
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Human medicine European public assessment report (EPAR): Mysimba
bupropion hydrochloride, naltrexone hydrochloride, Obesity; Overweight
Date of authorisation: 26/03/2015,
, Revision: 24, Authorised, Last updated: 03/03/2023
Authorised naltrexonebupropion Overview This is a summary … medicine. active substances naltrexone and bupropion, which are … tablets containing 7.2 mg naltrexone and 78 mg bupropion and can … -
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Opinion/decision on a Paediatric investigation plan (PIP): Mysimba, bupropion hydrochloride, naltrexone hydrochloride
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Other
PIP number: EMEA-001373-PIP01-12-M04, Route(s) of administration: Oral use, Pharmaceutical form(s): Prolonged-release tablet
Decision date: 08/09/2021, Last updated: 12/01/2023, Compliance check: Xsubstance bupropion hydrochloride naltrexone hydrochloride Therapeutic … paediatric investigation plan for naltrexone (hydrochloride) / bupropion … EMEA-001373-PIP01-12-M04) in accordance with Regulation (EC) No … -
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Orphan designation: Refusal of orphan designation for the treatment of fibromyalgia
Date of refusal of designation: 06/10/2016, Negative, Last updated: 13/12/2016Naltrexone … opinion on orphan designation Naltrexone for the treatment of fibromyalgia … opinion on orphan designation Naltrexone for the treatment of fibromyalgia … -
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Orphan designation: Refusal of orphan designation for the treatment of fibromyalgia
Date of refusal of designation: 07/11/2020, Negative, Last updated: 24/02/2020Naltrexone … Naltrexone … -
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Orphan designation: (R-S) baclofen, naltrexone hydrochloride, D-sorbitol for: Treatment of Charcot-Marie-Tooth disease type 1A
Date of designation: 26/03/2014, Positive, Last updated: 16/07/2021combination of (R-S) baclofen, naltrexone hydrochloride and D-sorbitol … substances: (R-S) baclofen, naltrexone hydrochloride and D-sorbitol … for other indications. In accordance with Regulation (EC) No 141/2000 … -
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Opinion/decision on a Paediatric investigation plan (PIP): (RS)-Bacoflen, D-Sorbitol (PXT3003), naltrexone hydrochloride
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-002164-PIP01-17-M02, Route(s) of administration: Oral use, Pharmaceutical form(s): Oral solution
Decision date: 29/01/2020, Last updated: 12/06/2020, Compliance check: XRS)-Bacoflen D-Sorbitol (PXT3003) naltrexone hydrochloride NeurologyP/0030/2020EMEA-002164-PIP01-17-M02 … plan for (RS)-baclofen / Naltrexone HCl / D-Sorbitol (PXT3003 … oflen D-Sorbitol (PXT3003) naltrexone hydrochloride … -
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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 … Overview On 12 September 2017, Accord Healthcare Limited officially notified … authorisation for Tigecycline Accord, for the treatment of certain … -
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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 … Direct healthcare professional communication … communication (DHPC): Cabazitaxel Accord 20 mg/mL concentrate for … -
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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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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: 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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Human medicine European public assessment report (EPAR): Deferasirox Accord
deferasirox, Iron Overload; beta-Thalassemia
Date of authorisation: 09/01/2020,
, Revision: 4, Authorised, Last updated: 08/05/2023
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): Cabazitaxel Accord
cabazitaxel, Prostatic Neoplasms, Castration-Resistant
Date of authorisation: 28/08/2020,, Revision: 3, Authorised, Last updated: 16/01/2023
Cabazitaxel Accord Prostatic Neoplasms Genital … 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): 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 is a medicine used to treat … themselves. Teriflunomide Accord is used in the type of MS … -
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Human medicine European public assessment report (EPAR): Levetiracetam Accord
levetiracetam, Epilepsy
Date of authorisation: 03/10/2011,, Revision: 15, Authorised, Last updated: 24/03/2023
Levetiracetam Accord Nervous System Diseases Central … EPAR) for Levetiracetam Accord. It explains how the The committee … of use for Levetiracetam Accord. What is Levetiracetam Accord and what is it used for … -
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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 … Dexmedetomidine Accord is a medicine used to sedate … sedation). Dexmedetomidine Accord contains the active substance … -
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Human medicine European public assessment report (EPAR): Pregabalin Accord
pregabalin, Anxiety Disorders; Epilepsy
Date of authorisation: 28/08/2015,, Revision: 15, Authorised, Last updated: 09/01/2023
Pregabalin Accord Mental Disorders Nervous … report (EPAR) for Pregabalin Accord. It explains how the Agency … on how to use Pregabalin Accord. For practical information … -
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Human medicine European public assessment report (EPAR): Palonosetron Accord
Palonosetron, Vomiting; Nausea; Cancer
Date of authorisation: 26/05/2016,, Revision: 5, Authorised, Last updated: 13/01/2022
Palonosetron Accord Pathological Conditions … report (EPAR) for Palonosetron Accord. It explains how the Agency … on how to use Palonosetron Accord. For practical information … -
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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 … 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): Eptifibatide Accord
eptifibatide, Myocardial Infarction
Date of authorisation: 11/01/2016,, Revision: 6, Authorised, Last updated: 21/04/2023
Eptifibatide Accord Cardiovascular Diseases Heart … report (EPAR) for Eptifibatide Accord. It explains how the Agency … on how to use Eptifibatide Accord. For practical information … -
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Human medicine European public assessment report (EPAR): Azacitidine Accord
azacitidine, Myelodysplastic Syndromes; Leukemia, Myelomonocytic, Chronic; Leukemia, Myeloid, Acute
Date of authorisation: 13/02/2020,, Revision: 6, Authorised, Last updated: 29/03/2023
Azacitidine Accord Cancer Neoplasms Bone … Azacitidine Accord is used for the treatment … myeloid cells). Azacitidine Accord is used in patients with … -
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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: 4, Authorised, Last updated: 29/07/2022
Tigecycline Accord Infections Bacterial Infections … Tigecycline Accord is a medicine used to treat … treatment difficult. Tigecycline Accord should be used only when … -
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Human medicine European public assessment report (EPAR): Apixaban Accord
Apixaban, Venous Thromboembolism; Stroke; Arthroplasty
Date of authorisation: 23/07/2020,, Revision: 2, Authorised, Last updated: 19/05/2022
Apixaban Accord Thromboembolism Embolism … Apixaban Accord is a medicine used to prevent … reoccurrence. Additionally, Apixaban Accord is used to prevent stroke … -
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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 … report (EPAR) for Voriconazole Accord. It explains how the Agency … on how to use Voriconazole Accord. For practical information …