228 results
Keyword Pravastatin Remove keyword
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Human medicine European public assessment report (EPAR): Pravafenix
fenofibrate, Pravastatin, Dyslipidemias
Date of authorisation: 14/04/2011, Revision: 6, Authorised, Last updated: 17/03/2021medicine. active substances pravastatin and fenofibrate. It is available … capsules containing 40 mg pravastatin and 160 mg fenofibrate. What … already being controlled with pravastatin alone but who still need … -
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Referral: Pravachol
pravastatin, Article 30 referrals
Status: European Commission final decision, opinion/position date: 21/11/2003, EC decision date: 02/03/2004, Last updated: 13/05/2004Commission final decision Overview Pravastatin is a hydrophilic inhibitor … 3-hydroxy-3-methyl-glutaryl-Coenzyme A into mevalonic acid). Pravastatin is a serum lipid-lowering … the benefit/risk ratio of pravastatin is considered to be favourable … -
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Orphan designation: Pravastatin, zoledronic acid for: Treatment of Hutchinson-Gilford progeria
Date of designation: 09/06/2010, Positive, Last updated: 23/06/2010Pravastatinzoledronic acid Overview On 9 June 2010 … Prenyl BIO SAS, France, for pravastatin / zoledronic acid for the … substances in this medicine, pravastatin and zoledronic acid, are … -
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Opinion/decision on a Paediatric investigation plan (PIP): Pravastatin sodium, fenofibrate
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: Pravastatin sodium / Fenofibrate, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 15/06/2009, Last updated: 11/08/2009, Compliance check: XPravastatin sodium / Fenofibrate Endocrinology … Key facts Pravastatin sodium fenofibrate Endocrinology … Word - Decision and opinion pravastatin sodium, fenofibrate 00050… … -
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Opinion/decision on a Paediatric investigation plan (PIP): acetylsalicylic acid, Pravastatin sodium
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-001118-PIP01-10, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 08/07/2011, Last updated: 09/08/2011, Compliance check: Xfacts acetylsalicylic acid Pravastatin sodium Cardiovascular diseasesP/174/2011EMEA-001118-PIP01-10 … product specific waiver for pravastatin (sodium) / acetylsalicylic … product specific waiver for pravastatin (sodium) / acetylsalicylic … -
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Opinion/decision on a Paediatric investigation plan (PIP): Pravastatin sodium, Ezetimibe
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-002805-PIP01-20, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 12/08/2020, Last updated: 22/06/2021, Compliance check: XKey facts Pravastatin sodium Ezetimibe Cardiovascular … product specific waiver for pravastatin (sodium) / ezetimibe (EMEA-002805-PIP01 … product specific waiver for pravastatin (sodium) / ezetimibe (EMEA-002805-PIP01- 20 … -
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Opinion/decision on a Paediatric investigation plan (PIP): fenofibrate, Pravastatin sodium, Ezetimibe
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-002835-PIP01-20, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 22/10/2020, Last updated: 22/07/2021, Compliance check: XKey facts fenofibrate Pravastatin sodium Ezetimibe Cardiovascular … waiver for fenofibrate / pravastatin (sodium) / ezetimibe (EMEA-002835-PIP01-20 … waiver for fenofibrate / pravastatin (sodium) / ezetimibe (EMEA-002835-PIP01-20 … -
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Human medicine European public assessment report (EPAR): Cholib
fenofibrate, simvastatin, Dyslipidemias
Date of authorisation: 26/08/2013, Revision: 13, Authorised, Last updated: 13/08/2021statins (atorvastatin and pravastatin) and showed Cholib to be more … statins (atorvastatin and pravastatin) and showed Cholib to be … -
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National expert: Jessica Mwinyi, Medical Products Agency (updated)
- Declaration of interests - 80.22 KB | PDF
- Curriculum Vitae - 30.86 KB | PDF
on the pharmacokinetics of pravastatin Therapeutic drug monitoring Teaching January … -
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Human medicine European public assessment report (EPAR): Hepcludex
Bulevirtide acetate, Hepatitis D, Chronic
Date of authorisation: 31/07/2020,
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, Revision: 8, Authorised, Last updated: 22/12/2022
atorvastatin, pitavastatin, pravastatin, rosuvastatin, and thyroid … paritaprevir, pitavastatin, pravastatin, repaglinide, rosuvastatin … -
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Human medicine European public assessment report (EPAR): Efavirenz/Emtricitabine/Tenofovir disoproxil Krka
efavirenz, emtricitabine, tenofovir disoproxil succinate, HIV Infections
Date of authorisation: 08/02/2018,
, Revision: 9, Authorised, Last updated: 05/12/2022
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Human medicine European public assessment report (EPAR): Darunavir Krka
darunavir, HIV Infections
Date of authorisation: 26/01/2018,, Revision: 8, Authorised, Last updated: 23/11/2022
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Human medicine European public assessment report (EPAR): Tabrecta (updated)
capmatinib dihydrochloride monohydrate, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 20/06/2022,, Revision: 1, Authorised, Last updated: 25/01/2023
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Human medicine European public assessment report (EPAR): Kisqali (updated)
ribociclib succinate, Breast Neoplasms
Date of authorisation: 22/08/2017, Revision: 12, Authorised, Last updated: 11/01/2023 -
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Human medicine European public assessment report (EPAR): Cabazitaxel Accord (updated)
cabazitaxel, Prostatic Neoplasms, Castration-Resistant
Date of authorisation: 28/08/2020,, Revision: 3, Authorised, Last updated: 16/01/2023
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Human medicine European public assessment report (EPAR): Prezista
darunavir, HIV Infections
Date of authorisation: 11/02/2007, Revision: 54, Authorised, Last updated: 13/12/2022 -
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Human medicine European public assessment report (EPAR): Darunavir Mylan
darunavir, HIV Infections
Date of authorisation: 03/01/2017,, Revision: 12, Authorised, Last updated: 04/11/2022
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Human medicine European public assessment report (EPAR): Teriflunomide Mylan (updated)
Teriflunomide, Multiple Sclerosis, Relapsing-Remitting
Date of authorisation: 09/11/2022,, Revision: 1, Authorised, Last updated: 16/01/2023
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Human medicine European public assessment report (EPAR): Kaletra
lopinavir, ritonavir, HIV Infections
Date of authorisation: 19/03/2001, Revision: 60, Authorised, Last updated: 29/11/2022 -
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Human medicine European public assessment report (EPAR): Rozlytrek
Entrectinib, Cancer; Carcinoma, Non-Small-Cell Lung
Date of authorisation: 31/07/2020,, , Revision: 5, Authorised, Last updated: 29/11/2022
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Human medicine European public assessment report (EPAR): Paxlovid (updated)
nirmatrelvir, ritonavir, COVID-19 virus infection
Date of authorisation: 28/01/2022,, Revision: 8, Authorised, Last updated: 25/01/2023
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Human medicine European public assessment report (EPAR): Prevymis
Letermovir, Cytomegalovirus Infections
Date of authorisation: 08/01/2018,, Revision: 13, Authorised, Last updated: 24/11/2022
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Human medicine European public assessment report (EPAR): Sustiva
efavirenz, HIV Infections
Date of authorisation: 28/05/1999, Revision: 46, Authorised, Last updated: 17/10/2022 -
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Human medicine European public assessment report (EPAR): Stocrin
efavirenz, HIV Infections
Date of authorisation: 28/05/1999, Revision: 47, Authorised, Last updated: 05/10/2022 -
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Human medicine European public assessment report (EPAR): Rezolsta
darunavir, cobicistat, HIV Infections
Date of authorisation: 19/11/2014, Revision: 15, Authorised, Last updated: 13/12/2022