10702 results
Keyword Atazanavir Accord Remove keyword
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Human medicine European public assessment report (EPAR): Atazanavir Mylan
atazanavir (as sulfate), HIV Infections
Date of authorisation: 22/08/2016,
, Revision: 11, Authorised, Last updated: 03/02/2022
Atazanavir Mylan Immunologic Deficiency … assessment report (EPAR) for Atazanavir Mylan. It explains how the … practical advice on how to use Atazanavir Mylan. For practical information … -
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Human medicine European public assessment report (EPAR): Atazanavir Krka
atazanavir (as sulfate), HIV Infections
Date of authorisation: 25/03/2019,, Revision: 1, Authorised, Last updated: 09/12/2021
Atazanavir Krka Blood-Borne Infections Communicable … Authorised atazanavir Overview Atazanavir Krka is an HIV medicine used … Doctors should prescribe Atazanavir Krka only after they have … -
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Human medicine European public assessment report (EPAR): Evotaz
cobicistat, atazanavir, HIV Infections
Date of authorisation: 13/07/2015, Revision: 12, Authorised, Last updated: 18/02/2022atazanavir / cobicistat … EMEA/H/C/003904 Evotaz (atazanavir / cobicistat) An overview … contains the active substances atazanavir and cobicistat. The medicine … -
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Human medicine European public assessment report (EPAR): Reyataz
atazanavir (as sulfate), HIV Infections
Date of authorisation: 01/03/2004, Revision: 52, Authorised, Last updated: 18/02/2022Authorised atazanavir sulfate Overview This document … medicine. active substance atazanavir. It is available as capsules … active substance in Reyataz, atazanavir, is a protease inhibitor … -
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Opinion/decision on a Paediatric investigation plan (PIP): Evotaz, cobicistat, atazanavir (sulfate)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-001465-PIP01-13-M03, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Age-appropriate oral solid dosage form
Decision date: 22/12/2020, Last updated: 24/09/2021, Compliance check: XActive substance cobicistat atazanavir (sulfate) Therapeutic area … paediatric investigation plan for atazanavir (sulphate) / cobicistat … EMEA-001465-PIP01-13-M03) in accordance with Regulation (EC) No … -
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Opinion/decision on a Paediatric investigation plan (PIP): Reyataz, atazanavir sulfate
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-000804-PIP01-09-M02, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, Hard oral powder
Decision date: 10/04/2014, Last updated: 27/07/2015, Compliance check: V, 13/02/2015Reyataz Active substance atazanavir sulfate Therapeutic area … paediatric investigation plan for atazanavir (sulphate) (Reyataz), (EMEA-000804-PIP01-09-M02 … EMEA-000804-PIP01-09-M02) in accordance with Regulation (EC) No 1901/2006 … -
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Referral: Panexcell
atazanavir, atazanavir sulfate, Amoxicillin trihydrate, iron sucrose, amoxicillin, azithromycin dihydrate, carbocisteine, trimethoprim, Article 31 referrals
Status: European Commission final decision, opinion/position date: 27/02/2020, EC decision date: 24/09/2020, Last updated: 22/10/2020atazanavir atazanavir sulfate Amoxicillin trihydrate iron … -
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Opinion/decision on a Paediatric investigation plan (PIP): ritonavir, atazanavir sulfate
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-002588-PIP01-19, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 04/12/2019, Last updated: 03/04/2020, Compliance check: XKey facts ritonavir atazanavir sulfate Infectious diseasesP/0396/2019EMEA-002588-PIP01-19 … granting of a waiver for atazanavir (sulfate) / ritonavir (EMEA-002588-PIP01-19 … ritonavir atazanavir sulfate … -
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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: Sitagliptin Accord
sitagliptin, opinion date: 24/02/2022, Positive, Last updated: 25/02/2022Sitagliptin Accord: Pending EC decision … authorisation) Sitagliptin Accord sitagliptin On 24 February … medicinal product Sitagliptin Accord, intended for the treatment … -
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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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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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Summary of opinion: Sitagliptin / Metformin hydrochloride Accord
sitagliptin, metformin hydrochloride, opinion date: 19/05/2022, Positive, Last updated: 20/05/2022Metformin hydrochloride Accord: Pending EC decision … Metformin hydrochloride Accord … medicines are manufactured according to the same quality standards … -
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Human medicine European public assessment report (EPAR): Posaconazole Accord
posaconazole, Mycoses
Date of authorisation: 25/07/2019,, Revision: 5, Authorised, Last updated: 09/02/2022
Posaconazole Accord Infections Bacterial Infections … Posaconazole Accord … medicines are manufactured according to the same quality standards … -
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Human medicine European public assessment report (EPAR): Aripiprazole Accord (updated)
aripiprazole, Schizophrenia; Bipolar Disorder
Date of authorisation: 15/11/2015,, Revision: 14, Authorised, Last updated: 13/06/2022
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): Dexmedetomidine Accord
dexmedetomidine, Premedication
Date of authorisation: 13/02/2020,, Revision: 4, Authorised, Last updated: 12/04/2022
Dexmedetomidine Accord Therapeutics Drug Therapy … Dexmedetomidine Accord … medicines are manufactured according to the same quality standards … -
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Human medicine European public assessment report (EPAR): Imatinib Accord (updated)
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: 23, Authorised, Last updated: 23/06/2022
Imatinib Accord Neoplasms Cancer Leukemia … report (EPAR) for Imatinib Accord. It explains how the Agency … advice on how to use Imatinib Accord. For practical information … -
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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): Pregabalin Accord
pregabalin, Anxiety Disorders; Epilepsy
Date of authorisation: 28/08/2015,, Revision: 14, Authorised, Last updated: 21/04/2022
Pregabalin Accord Mental Disorders Nervous … Pregabalin Accord … medicines are manufactured according to the same quality standards … -
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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 … medicines are manufactured according to the same quality standards … -
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Human medicine European public assessment report (EPAR): Fampridine Accord
Fampridine, Multiple Sclerosis
Date of authorisation: 24/09/2020,, Revision: 1, Authorised, Last updated: 10/05/2022
Fampridine Accord Nervous System Diseases Autoimmune … Fampridine Accord … medicines are manufactured according to the same quality standards … -
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Human medicine European public assessment report (EPAR): Eptifibatide Accord
eptifibatide, Myocardial Infarction
Date of authorisation: 11/01/2016,, Revision: 5, Authorised, Last updated: 13/04/2022
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): Cabazitaxel Accord
cabazitaxel, Prostatic Neoplasms, Castration-Resistant
Date of authorisation: 28/08/2020,, Revision: 2, Authorised, Last updated: 08/04/2022
Cabazitaxel Accord Prostatic Neoplasms Genital … Cabazitaxel 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: 3, Authorised, Last updated: 04/04/2022
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): Azacitidine Accord
azacitidine, Myelodysplastic Syndromes; Leukemia, Myelomonocytic, Chronic; Leukemia, Myeloid, Acute
Date of authorisation: 13/02/2020,, Revision: 4, Authorised, Last updated: 04/04/2022
Azacitidine Accord Cancer Neoplasms Bone … Azacitidine Accord … medicines are manufactured according to the same quality standards …