264 results
Keyword Lopinavir Remove keyword
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Human medicine European public assessment report (EPAR): Lopinavir/Ritonavir Mylan
lopinavir, ritonavir, HIV Infections
Date of authorisation: 14/01/2016,
, Revision: 14, Authorised, Last updated: 09/06/2022
Lopinavir/Ritonavir Mylan Blood-Borne Infections Communicable … Authorised lopinavirritonavir Overview This is a summary … assessment report (EPAR) for Lopinavir/Ritonavir Mylan. It explains how the … -
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Direct healthcare professional communication (DHPC): Kaletra (lopinavir/ritonavir) oral solution, 2 bottle pack containing 2-ml oral dosing syringes: Presence of amide particles in 2-ml oral dosing syringes
Active substance: lopinavir, ritonavir, DHPC type: Quality defect, Last updated: 04/01/2021Kaletra (lopinavir/ritonavir) oral solution, 2 bottle … Kaletra (lopinavir/ritonavir) oral solution, 2 bottle … Kaletra (lopinavir/ritonavir) oral solution, 2 bottle … -
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Human medicine European public assessment report (EPAR): Kaletra
lopinavir, ritonavir, HIV Infections
Date of authorisation: 19/03/2001, Revision: 57, Authorised, Last updated: 18/05/2021lopinavir / ritonavir … for the public Kaletra lopinavir / ritonavir This is a summary … contains two active substances, lopinavir and ritonavir. How is Kaletra … -
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Opinion/decision on a Paediatric investigation plan (PIP): Kaletra, lopinavir, ritonavir
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-001005-PIP01-10-M01, Route(s) of administration: Oral use, Pharmaceutical form(s): Oral solution, Capsule, soft, Film-coated tablet
Decision date: 23/07/2012, Last updated: 27/07/2015, Compliance check: V, 17/07/2015Kaletra Active substance lopinavir ritonavir Therapeutic area … paediatric investigation plan for lopinavir / ritonavir (Kaletra) (EMEA-001005-PIP01-10-M01 … paediatric investigation plan for lopinavir / ritonavir (Kaletra) (EMEA-001005-PIP01-10-M01 … -
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Opinion on medicine for use outside EU: Aluvia
lopinavir, ritonavir, HIV Infections, ATC code: J05AR10 Opinion number: H-W-764, Positive opinion Opinion date: 21/09/2006, Last updated: 20/08/2020lopinavirritonavirPositive opinion Overview Aluvia is … for the public Aluvia lopinavir and ritonavir This document … contains two active substances, lopinavir and ritonavir. It is available … -
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Opinion/decision on a Paediatric investigation plan (PIP): lopinavir, lamivudine, ritonavir, zidovudine
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Infectious diseases
PIP number: EMEA-001368-PIP01-12, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 30/07/2013, Last updated: 03/09/2013, Compliance check: XKey facts lopinavir lamivudine ritonavir zidovudine … product-specific waiver for lopinavir / lamivudine / ritonavir … product specific waiver for lopinavir / lamivudine / ritonavir … -
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Opinion/decision on a Paediatric investigation plan (PIP): lopinavir, ritonavir, lamivudine
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Infectious diseases
PIP number: EMEA-001307-PIP01-12, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 20/11/2012, Last updated: 11/01/2013, Compliance check: XKey facts lopinavir ritonavir lamivudine Infectious … product-specific waiver for lopinavir / ritonavir / lamivudine … product specific waiver for lopinavir / ritonavir / lamivudine … -
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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: 18/02/2022Reyataz with ritonavir-boosted lopinavir (another antiviral medicine … saquinavir or ritonavir-boosted lopinavir. The final study compared … saquinavir with ritonavir-boosted lopinavir in 358 patients. The main … -
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Human medicine European public assessment report (EPAR): Telzir
fosamprenavir calcium, HIV Infections
Date of authorisation: 12/07/2004, Revision: 47, Authorised, Last updated: 11/04/2022Telzir with ritonavir-boosted lopinavir, with around three-quarters … than the comparator medicine lopinavir, with patients taking lopinavir having larger reductions … -
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Human medicine European public assessment report (EPAR): Invirase
saquinavir, HIV Infections
Date of authorisation: 03/10/1996, Revision: 48, Authorised, Last updated: 25/11/2021Invirase with indinavir and with lopinavir (other antiviral medicines … Invirase with indinavir or lopinavir (other HIV medicines). The … indinavir but more effective than lopinavir in reducing the viral load … -
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Human medicine European public assessment report (EPAR): Prezista (updated)
darunavir, HIV Infections
Date of authorisation: 11/02/2007, Revision: 53, Authorised, Last updated: 17/08/2022Prezista with ritonavir-boosted lopinavir (another protease inhibitor … taking ritonavir-boosted lopinavir (271 out of 346). Three studies … Prezista with ritonavir-boosted lopinavir in 604 patients who had taken … -
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Human medicine European public assessment report (EPAR): Norvir
ritonavir, HIV Infections
Date of authorisation: 25/08/1996, Revision: 66, Authorised, Last updated: 29/03/2021atazanavir, fosamprenavir, lopinavir, saquinavir, tipranavir and … atazanavir, fosamprenavir, lopinavir, saquinavir, tipranavir and … -
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Human medicine European public assessment report (EPAR): Ritonavir Mylan
ritonavir, HIV Infections
Date of authorisation: 09/11/2017,, Revision: 12, Authorised, Last updated: 06/05/2022
darunavir, fosamprenavir, lopinavir, saquinavir, and tipranavir … darunavir, fosamprenavir, lopinavir, saquinavir, and tipranavir … -
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Press release: European Medicines Agency informs doctors and patients about drug interaction between Victrelis and ritonavir-boosted HIV protease inhibitors
CHMP, Last updated: 16/02/2012atazanavir, darunavir and lopinavir. A drug interaction study … ritonavir-boosted darunavir or lopinavir, although this effect was … ritonavir-boosted darunavir or lopinavir in HIV and hepatitis C co-infected … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 16-19 November 2015
Last updated: 20/11/2015Lopinavir … -
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Human medicine European public assessment report (EPAR): Truvada
emtricitabine, tenofovir disoproxil fumarate, HIV Infections
Date of authorisation: 20/02/2005, Revision: 45, Authorised, Last updated: 31/05/2021tenofovir disoproxil, taken with lopinavir and ritonavir (other antiviral … tenofovir disoproxil, taken with lopinavir and ritonavir (other antiviral … -
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Press release: Update on treatments and vaccines against COVID-19 under development
Last updated: 31/03/2020remdesivir (investigational) lopinavir/ritonavir (currently authorised as … -
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National expert: Pere Domingo, Spanish Agency of Medicines and Medical Devices (updated)
- Declaration of interests - 82.83 KB | PDF
- Curriculum Vitae - 126.21 KB | PDF
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National expert: Vidar Ormaasen, Norwegian Medicines Agency (updated)
- Declaration of interests - 79.79 KB | PDF
- Curriculum Vitae - 30.12 KB | PDF
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Press release: Meeting highlights from the Committee for Medicinal Products for Human Use, 18-21 September 2006
CHMP, Last updated: 21/09/2006positive opinion for Aluvia (lopinavir/ritonavir), from Abbott Laboratories … positive opinion for Aluvia (lopinavir/ritonavir), from Abbott Laboratories … -
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National expert: Filip Josephson, Medical Products Agency (updated)
- Declaration of interests - 79.84 KB | PDF
- Curriculum Vitae - 19.33 KB | PDF
Differential effects of efavirenz, lopinavir/r, and atazanavir/r on the initial … efavirenz, atazanavir or lopinavir exposure in the NORTHIV trial … -
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National expert: Audrey Sultana, Medicines Authority (updated)
- Declaration of interests - 79.78 KB | PDF
- Curriculum Vitae - 18.44 KB | PDF
Authorisation Application Lopinavir/Ritonavir Mylan -Marketing Authorisation … -
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National expert: Emile F. Schippers, European Medicines Agency (updated)
- Declaration of interests - 79.84 KB | PDF
- Curriculum Vitae - 33.36 KB | PDF
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National expert: Thomas Sudhop, Federal Institute for Drugs and Medical Devices (updated)
- Declaration of interests - 80.08 KB | PDF
- Curriculum Vitae - 35.36 KB | PDF
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Human medicine European public assessment report (EPAR): Exviera (updated)
dasabuvir sodium, Hepatitis C, Chronic
Date of authorisation: 14/01/2015,
, Revision: 25, Authorised, Last updated: 12/08/2022