811 results
Keyword Ritonavir Sandoz Remove keyword
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Human medicine European public assessment report (EPAR): Ritonavir Mylan
ritonavir, HIV Infections
Date of authorisation: 09/11/2017,
, Revision: 8, Authorised, Last updated: 08/12/2020
Ritonavir Mylan HIV Infections … Ritonavir Mylan … summary for the public Ritonavir Mylan ritonavir This is a summary of the … -
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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: 10, Authorised, Last updated: 20/11/2020
Lopinavir/Ritonavir Mylan lopinavir / ritonavir This is a summary of the … substances lopinavir and ritonavir. Lopinavir/Ritonavir Mylan … Ritonavir Mylan lopinavir ritonavir lopinavir ritonavir … -
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Withdrawn application: Duloxetine Sandoz
duloxetine, date of withdrawal: 08/04/2015, Initial authorisation, Last updated: 24/04/2015Duloxetine Sandoz: Withdrawn application … application for Duloxetine Sandoz (duloxetine) On 08 April … duloxetine) On 08 April 2015, Sandoz GmbH officially notified … -
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Human medicine European public assessment report (EPAR): Norvir
ritonavir, HIV Infections
Date of authorisation: 25/08/1996, Revision: 65, Authorised, Last updated: 11/09/2020ritonavir … Norvir, INN-ritonavir EMA/159632/2012 EMEA/H/C/000127 … for the public Norvir ritonavir This is a summary of the … -
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Human medicine European public assessment report (EPAR): Kaletra
lopinavir, ritonavir, HIV Infections
Date of authorisation: 19/03/2001, Revision: 55, Authorised, Last updated: 25/11/2020lopinavir / ritonavir … public Kaletra lopinavir / ritonavir This is a summary of the … substances, lopinavir and ritonavir. How is Kaletra used? Kaletra … -
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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 Kaletra lopinavir ritonavir lopinavir ritonavir lopinavir ritonavir … -
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Human medicine European public assessment report (EPAR): Viekirax
Ombitasvir, paritaprevir, ritonavir, Hepatitis C, Chronic
Date of authorisation: 14/01/2015,
, 
, Revision: 21, Authorised, Last updated: 20/10/2020
ombitasvir / paritaprevir / ritonavir … ombitasvir / paritaprevir / ritonavir) An overview of Viekirax … ombitasvir, paritaprevir and ritonavir. How is Viekirax used? Viekirax … -
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Human medicine European public assessment report (EPAR): Corbilta (previously Levodopa/Carbidopa/Entacapone Sandoz)
levodopa, carbidopa, entacapone, Parkinson Disease
Date of authorisation: 11/11/2013, Revision: 8, Authorised, Last updated: 14/12/2020Levodopa/Carbidopa/Entacapone Sandoz) Parkinson Disease … Levodopa/Carbidopa/Entacapone Sandoz) … Levodopa/Carbidopa/Entacapone Sandoz) levodopa carbidopa entacap … -
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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, 17/07/2015Active substance lopinavir ritonavir Therapeutic area Infectious … investigation plan for lopinavir / ritonavir (Kaletra) (EMEA-001005-PIP01-10-M01 … investigation plan for lopinavir / ritonavir (Kaletra) (EMEA-001005-PIP01-10-M01 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Viekirax, Ombitasvir, paritaprevir, ritonavir
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-001440-PIP01-13-M02, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet, Age-appropriate oral solid dosage form
Decision date: 15/06/2018, Last updated: 22/11/2018, Compliance check: Xsubstance Ombitasvir paritaprevir ritonavir Therapeutic area Infectious … x ombitasvir paritaprevir ritonavir Ombitasvir paritaprevir ritonavir Ombitasvir paritaprevir ritonavir … -
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Referral: Direct-acting antivirals indicated for treatment of hepatitis C (interferon-free)
daclatasvir / dasabuvir / sofosbuvir / ledipasvir / simeprevir / ombitasvir/paritaprevir / ritonavir, associated names: Sovaldi, Olysio, Viekirax, Harvoni, Exviera, Daklinza, Article 20 procedures
Status: European Commission final decision, opinion/position date: 15/12/2016, EC decision date: 23/02/2017, Last updated: 09/03/2017ombitasvir / paritaprevir / ritonavir). Since the start of this review … ombitasvir / paritaprevir / ritonavir). Since the start of this review … r ombitasvir paritaprevir ritonavir daclatasvir / dasabuvir … -
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Human medicine European public assessment report (EPAR): Pregabalin Sandoz
pregabalin, Anxiety Disorders, Neuralgia, Epilepsy
Date of authorisation: 19/06/2015,, Revision: 5, Authorised, Last updated: 27/08/2020
Pregabalin Sandoz Anxiety Disorders Neuralgia … Pregabalin Sandoz … for the public Pregabalin Sandoz pregabalin This is a summary … -
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Human medicine European public assessment report (EPAR): Aripiprazole Sandoz
aripiprazole, Schizophrenia, Bipolar Disorder
Date of authorisation: 20/08/2015,, Revision: 8, Authorised, Last updated: 10/07/2020
Aripiprazole Sandoz Schizophrenia Bipolar Disor … Aripiprazole Sandoz … Aripiprazole Sandoz EPAR summary 30 … -
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Human medicine European public assessment report (EPAR): Temozolomide Sandoz
temozolomide, Glioma, Glioblastoma
Date of authorisation: 15/03/2010,, Revision: 16, Authorised, Last updated: 14/10/2019
Temozolomide Sandoz Glioma Glioblastoma … Temozolomide Sandoz … Temozolomide Sandoz, INN-temozolomide EMA/729989/2014 … -
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Human medicine European public assessment report (EPAR): Rivastigmine Sandoz
rivastigmine, Dementia, Alzheimer Disease, Parkinson Disease
Date of authorisation: 10/12/2009, Revision: 11, Authorised, Last updated: 04/12/2018Rivastigmine Sandoz Dementia Alzheimer Disease Parkinson … Rivastigmine Sandoz … Rivastigmine Sandoz, INN-rivastigmine … -
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Human medicine European public assessment report (EPAR): Clopidogrel Sandoz
clopidogrel, Peripheral Vascular Diseases, Stroke, Myocardial Infarction
Date of authorisation: 21/09/2009,, Revision: 2, Withdrawn, Last updated: 26/10/2011
Clopidogrel Sandoz Peripheral Vascular Diseases Stroke Myocardial … Clopidogrel Sandoz … Clopidogrel Sandoz (clopidogrel) Withdrawal … -
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Human medicine European public assessment report (EPAR): Pregabalin Sandoz GmbH (updated)
pregabalin, Anxiety Disorders, Epilepsy
Date of authorisation: 19/06/2015,, Revision: 7, Authorised, Last updated: 10/02/2021
Pregabalin Sandoz GmbH Anxiety Disorders Epil … report (EPAR) for Pregabalin Sandoz GmbH. It explains how the … on how to use Pregabalin Sandoz GmbH. For practical information … -
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Human medicine European public assessment report (EPAR): Ibandronic Acid Sandoz
ibandronic acid, Breast Neoplasms, Neoplasm Metastasis, Fractures, Bone
Date of authorisation: 26/07/2011,, Revision: 8, Authorised, Last updated: 11/11/2020
Ibandronic Acid Sandoz Breast Neoplasms Neoplasm … Ibandronic Acid Sandoz … public Ibandronic Acid Sandoz ibandronic acid This document … -
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Human medicine European public assessment report (EPAR): Pemetrexed Sandoz
pemetrexed disodium hemipentahydrate, Carcinoma, Non-Small-Cell Lung, Mesothelioma
Date of authorisation: 18/09/2015,, Revision: 5, Authorised, Last updated: 27/08/2020
Pemetrexed Sandoz Carcinoma, Non-Small-Cell … Pemetrexed Sandoz … for the public Pemetrexed Sandoz pemetrexed This is a summary … -
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Opinion/decision on a Paediatric investigation plan (PIP): Dasabuvir, Ombitasvir, paritaprevir, ritonavir
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Infectious diseases
PIP number: EMEA-001805-PIP01-15, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 02/10/2015, Last updated: 17/12/2015, Compliance check: XDasabuvir Ombitasvir paritaprevir ritonavir Therapeutic area Infectious … fourth active substance, ritonavir, does not act directly against … ombitasvir, paritaprevir and ritonavir are Public summary … -
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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: Xsubstance lopinavir lamivudine ritonavir zidovudine Therapeutic area … lopinavir / lamivudine / ritonavir / zidovudine (EMEA- 001368-PIP01-12 … lopinavir / lamivudine / ritonavir / zidovudine (EMEA- 001368-PIP01-12 … -
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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: XActive substance lopinavir ritonavir lamivudine Therapeutic area … specific waiver for lopinavir / ritonavir / lamivudine (EMEA-001307-PIP01-12 … specific waiver for lopinavir / ritonavir / lamivudine (EMEA-001307-PIP01- 12 … -
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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: XActive substance ritonavir atazanavir sulfate Therapeutic … ritonavir atazanavir sulfate … -
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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: 16/02/2012interaction between Victrelis and ritonavir-boosted HIV protease inhibitors … interaction between Victrelis and ritonavir-boosted HIV protease inhibitors … interaction between Victrelis and ritonavir-boosted HIV protease inhibitors … -
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Referral: Methylphenidate Sandoz
methylphenidate hydrochloride, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 25/07/2013, EC decision date: 09/10/2013, Last updated: 05/12/2013Methylphenidate Sandoz … Methylphenidate Sandoz … Methylphenidate Sandoz - QA - EN 7 Westferry …