13050 results
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Human medicine European public assessment report (EPAR): Tandemact
pioglitazone, glimepiride, Diabetes Mellitus, Type 2
Date of authorisation: 08/01/2007, Revision: 20, Authorised, Last updated: 28/02/2022substances, pioglitazone and glimepiride. It is available as tablets … pioglitazone and 2 or 4 mg glimepiride, or 45 mg pioglitazone and … mg pioglitazone and 4 mg glimepiride). What is Tandemact used for … -
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Human medicine European public assessment report (EPAR): Avaglim
rosiglitazone, glimepiride, Diabetes Mellitus, Type 2
Date of authorisation: 27/06/2006, Revision: 11, Withdrawn, Last updated: 12/08/2011rosiglitazone / glimepiride … Avaglim rosiglitazone and glimepiride This document is a summary … substances, rosiglitazone and glimepiride. It is available as triangular … -
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Referral: Glimepirida Parke-Davis
glimepiride, associated names: Glimepiride Pfizer, Glimepirid Pfizer, Glimepiride tablets 2 mg, Glimepiride tablets 3 mg, Glimepiride tablets 4 mg, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 19/07/2012, EC decision date: 19/11/2012, Last updated: 06/12/2012Glimepirida Parke-Davis … authorisation of the medicine Glimepirida Parke-Davis glimepiride, tablets 2, 3 and 4 mg … concluded that the benefits of Glimepirida Parke-Davis outweigh its … -
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Referral: Amaryl
glimepiride, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 17/04/1996, EC decision date: 29/08/1996, Last updated: 03/08/1998Non-Proprietary Name (INN): Glimepiride: Background information PDF … About this medicineAmaryl glimepirideAbout this procedureCPMP/1416/98 … Non-Proprietary Name (INN): Glimepiride BACKGROUND INFORMATION On … -
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Opinion/decision on a Paediatric investigation plan (PIP): glimepiride, Atorvastatin calcium
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-001232-PIP01-11, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 30/05/2012, Last updated: 25/06/2012, Compliance check: XActive substance glimepiride Atorvastatin calcium Therapeutic … product specific waiver for glimepiride / atorvastatin (calcium … product specific waiver for glimepiride / atorvastatin (calcium … -
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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): 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): 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 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 (updated)
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): Azacitidine Accord (updated)
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 Overview 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): 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): 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: 16, Authorised, Last updated: 20/03/2023
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): 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): 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): 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): 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 is a cancer medicine used … these patients, Bortezomib Accord is used either on its own … -
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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): Posaconazole Accord
posaconazole, Mycoses
Date of authorisation: 25/07/2019,, Revision: 7, Authorised, Last updated: 19/12/2022
Posaconazole Accord Infections Bacterial Infections … Posaconazole Accord is an antifungal medicine … in spores). Posaconazole Accord is also used to prevent invasive … -
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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 … -
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Human medicine European public assessment report (EPAR): Lenalidomide Accord
lenalidomide, Multiple Myeloma
Date of authorisation: 20/09/2018,, Revision: 9, Authorised, Last updated: 31/03/2022
Lenalidomide Accord Cancer Neoplasms Neoplasms … Lenalidomide Accord is a medicine used for the … multiple myeloma, Lenalidomide Accord is used: in adults who have …