9985 results
Keyword Atazanavir Accord Remove keyword
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Human medicine European public assessment report (EPAR): Atazanavir Krka
atazanavir (as sulfate), HIV Infections
Date of authorisation: 25/03/2019,
, Authorised, Last updated: 15/05/2019
Atazanavir Krka HIV Infections … 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): Atazanavir Mylan (updated)
atazanavir (as sulfate), HIV Infections
Date of authorisation: 22/08/2016,, Revision: 10, Authorised, Last updated: 27/08/2021
Atazanavir Mylan HIV Infections … Authorised atazanavir Overview This is a summary … assessment report (EPAR) for Atazanavir Mylan. It explains how the … -
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Human medicine European public assessment report (EPAR): Reyataz
atazanavir (as sulfate), HIV Infections
Date of authorisation: 01/03/2004, Revision: 50, Authorised, Last updated: 15/09/2020Authorised atazanavir sulfate Overview This document … contains the active substance atazanavir. It is available as capsules … active substance in Reyataz, atazanavir, is a protease inhibitor … -
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Human medicine European public assessment report (EPAR): Evotaz
cobicistat, atazanavir sulfate, HIV Infections
Date of authorisation: 13/07/2015, Revision: 10, Authorised, Last updated: 29/04/2020Authorised atazanavircobicistat Overview This is a summary … contains the active substances atazanavir and cobicistat. The medicine … expected to be resistant to atazanavir. How is Evotaz used? Evotaz … -
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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-M02, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Age-appropriate oral solid dosage form
Decision date: 30/01/2018, Last updated: 18/04/2018, Compliance check: XKey facts Evotaz cobicistat atazanavir sulfate Infectious diseasesP/0009/2018EMEA-001465-PIP01-13-M02 … paediatric investigation plan for atazanavir (sulphate) / cobicistat (Evotaz … paediatric investigation plan for atazanavir (sulphate) / cobicistat (Evotaz … -
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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, 13/02/2015Key facts Reyataz atazanavir sulfate Infectious diseasesP/0098/2014EMEA-000804-PIP01-09-M02 … paediatric investigation plan for atazanavir (sulphate) (Reyataz), (EMEA-000804-PIP01-09-M02 … paediatric investigation plan for atazanavir (sulphate) (Reyataz), (EMEA-000804-PIP01-09-M02 … -
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Summary of opinion: Evotaz
atazanavir, cobicistat, opinion date: 21/05/2021, Positive, Last updated: 21/05/2021authorisation) Evotaz atazanavir / cobicistat On 20 May … associated with resistance to atazanavir (see sections 4.4 and 5.1 … Evotaz Evotaz atazanavir cobicistat cobicistat atazanavir sulfate … -
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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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Withdrawn application: Tigecycline Accord
tigecycline, date of withdrawal: 12/09/2017, Initial authorisation, Last updated: 10/10/2017Tigecycline Accord: Withdrawn application … application for Tigecycline Accord (tigecycline) On 12 September … On 12 September 2017, Accord Healthcare Limited officially … -
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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): Posaconazole Accord (updated)
posaconazole, Mycoses
Date of authorisation: 25/07/2019,, Revision: 3, Authorised, Last updated: 13/09/2021
Posaconazole Accord Mycoses … posaconazole Overview 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): Levetiracetam Accord (updated)
levetiracetam, Epilepsy
Date of authorisation: 03/10/2011,, Revision: 13, Authorised, Last updated: 10/09/2021
Levetiracetam Accord Epilepsy … 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): Lacosamide Accord (updated)
lacosamide, Epilepsy
Date of authorisation: 18/09/2017,, Revision: 6, Authorised, Last updated: 26/08/2021
Lacosamide Accord Epilepsy … Lacosamide Accord … for the public Lacosamide Accord lacosamide This is a summary … -
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Human medicine European public assessment report (EPAR): Bortezomib Accord
bortezomib, Multiple Myeloma
Date of authorisation: 20/07/2015,, Revision: 10, Authorised, Last updated: 05/08/2021
Bortezomib Accord Multiple Myeloma … Bortezomib 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: 2, Authorised, Last updated: 29/07/2021
Azacitidine Accord Myelodysplastic Syndromes Leukemia … 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): Apixaban Accord
Apixaban, Venous Thromboembolism; Stroke; Arthroplasty
Date of authorisation: 23/07/2020,, Revision: 1, Authorised, Last updated: 21/07/2021
Apixaban Accord Venous Thromboembolism Stro … Apixaban Accord … medicines are manufactured according to the same quality standards … -
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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: 1, Authorised, Last updated: 08/07/2021
Deferasirox Accord Iron Overload beta-Thalasse … Deferasirox Accord … medicines are manufactured according to the same quality standards … -
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Human medicine European public assessment report (EPAR): Lenalidomide Accord
lenalidomide, Multiple Myeloma
Date of authorisation: 20/09/2018,, Revision: 7, Authorised, Last updated: 02/06/2021
Lenalidomide Accord Multiple Myeloma … Lenalidomide 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: 14, Authorised, Last updated: 04/06/2021
Capecitabine Accord Colonic Neoplasms Breast … capecitabine Overview Capecitabine Accord is a cancer medicine that … bowel) cancer. Capecitabine Accord is used on its own or with … -
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Human medicine European public assessment report (EPAR): Temozolomide Accord
temozolomide, Glioma; Glioblastoma
Date of authorisation: 15/03/2010,, Revision: 20, Authorised, Last updated: 09/03/2021
Temozolomide Accord Glioma Glioblastoma … Temozolomide 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: 9, Authorised, Last updated: 24/02/2021
Pregabalin Accord Anxiety Disorders Epilepsy … Pregabalin Accord … medicines are manufactured according to the same quality standards … -
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Human medicine European public assessment report (EPAR): Palonosetron Accord
Palonosetron, Vomiting; Nausea; Cancer
Date of authorisation: 26/05/2016,, Revision: 4, Authorised, Last updated: 18/02/2021
Palonosetron Accord Vomiting Nausea Cancer … Palonosetron 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: 3, Authorised, Last updated: 29/01/2021
Entecavir Accord Hepatitis B, Chronic … Entecavir Accord … medicines are manufactured according to the same quality standards …