195 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: 17/03/2021contains the 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 (new)
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: 12, Authorised, Last updated: 12/11/2020statins (atorvastatin and pravastatin) and showed Cholib to be more … statins (atorvastatin and pravastatin) and showed Cholib to be … -
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National expert: Aleksandar Knezevic, Agency for Medicinal Products and Medical Devices of Croatia (updated)
- Declaration of interests - 84.23 KB | PDF
- Curriculum Vitae - 100.44 KB | PDF
Laboratoires SMB PRAVAFENIX (pravastatin/fenofibrate) treatment of dislipidaemia … -
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National expert: Jessica Mwinyi, Medical Products Agency (updated)
- Declaration of interests - 79.76 KB | PDF
- Curriculum Vitae - 28.85 KB | PDF
on the pharmacokinetics of pravastatin Therapeutic drug monitoring Teaching January … -
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Human medicine European public assessment report (EPAR): Nustendi (updated)
Bempedoic acid, Ezetimibe, Hypercholesterolemia, Dyslipidemias
Date of authorisation: 27/03/2020,
, Revision: 4, Authorised, Last updated: 06/07/2021
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Human medicine European public assessment report (EPAR): Nilemdo
Bempedoic acid, Hypercholesterolemia, Dyslipidemias
Date of authorisation: 01/04/2020,, Revision: 4, Authorised, Last updated: 21/06/2021
mg, atorvastatin 80 mg, pravastatin 80 mg, and rosuvastatin 40 … in AUC of atorvastatin, pravastatin, and rosuvastatin (administered … -
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Human medicine European public assessment report (EPAR): Epclusa (updated)
Sofosbuvir, velpatasvir, Hepatitis C, Chronic
Date of authorisation: 06/07/2016,, 
, Revision: 15, Authorised, Last updated: 22/07/2021
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Human medicine European public assessment report (EPAR): Hepcludex (updated)
Bulevirtide acetate, Hepatitis D, Chronic
Date of authorisation: 31/07/2020,, 
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, Revision: 2, Authorised, Last updated: 01/07/2021
atorvastatin, pitavastatin, pravastatin, rosuvastatin, and thyroid … -
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Human medicine European public assessment report (EPAR): Atripla
efavirenz, emtricitabine, tenofovir disoproxil fumarate, HIV Infections
Date of authorisation: 13/12/2007, Revision: 35, Authorised, Last updated: 22/06/2021 -
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Human medicine European public assessment report (EPAR): Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva
efavirenz, emtricitabine, tenofovir disoproxil phosphate, HIV Infections
Date of authorisation: 17/07/2017,
, Revision: 7, Authorised, Last updated: 18/05/2021
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Human medicine European public assessment report (EPAR): Translarna (updated)
Ataluren, Muscular Dystrophy, Duchenne
Date of authorisation: 31/07/2014,, , , Revision: 20, Authorised, Last updated: 28/06/2021
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Human medicine European public assessment report (EPAR): Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan
efavirenz, emtricitabine, tenofovir disoproxil maleate, HIV Infections
Date of authorisation: 05/09/2017,, Revision: 10, Authorised, Last updated: 07/05/2021
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Human medicine European public assessment report (EPAR): Prevymis (updated)
Letermovir, Cytomegalovirus Infections
Date of authorisation: 08/01/2018,, , Revision: 9, Authorised, Last updated: 08/07/2021
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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: 6, Authorised, Last updated: 08/04/2021
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Human medicine European public assessment report (EPAR): Ulipristal Acetate Gedeon Richter (updated)
ulipristal acetate, Leiomyoma
Date of authorisation: 27/08/2018,
, Revision: 1, Withdrawn, Last updated: 09/07/2021
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Human medicine European public assessment report (EPAR): Maviret
glecaprevir, pibrentasvir, Hepatitis C, Chronic
Date of authorisation: 26/07/2017,, , Revision: 12, Authorised, Last updated: 26/04/2021
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Human medicine European public assessment report (EPAR): Ibrance (updated)
palbociclib, Breast Neoplasms
Date of authorisation: 09/11/2016,, Revision: 13, Authorised, Last updated: 21/07/2021
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Human medicine European public assessment report (EPAR): Mektovi (updated)
binimetinib, Melanoma
Date of authorisation: 20/09/2018,, Revision: 4, Authorised, Last updated: 09/07/2021
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Human medicine European public assessment report (EPAR): Harvoni (updated)
ledipasvir, Sofosbuvir, Hepatitis C, Chronic
Date of authorisation: 17/11/2014,, , Revision: 22, Authorised, Last updated: 13/07/2021