890 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: 9, Authorised, Last updated: 08/12/2020
Ritonavir Mylan HIV Infections … Authorised ritonavir Overview This is a summary … assessment report (EPAR) for Ritonavir Mylan. It explains how the … -
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Human medicine European public assessment report (EPAR): Lopinavir/Ritonavir Mylan (updated)
lopinavir, ritonavir, HIV Infections
Date of authorisation: 14/01/2016,, Revision: 11, Authorised, Last updated: 04/06/2021
substances lopinavir and ritonavir. Lopinavir/Ritonavir Mylan … 100 mg lopinavir and 25 mg ritonavir; 200 mg lopinavir and 50 mg ritonavir). In adults and adolescents … this medicine, lopinavir and ritonavir, are protease inhibitors … -
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Withdrawn application: Duloxetine Sandoz
duloxetine, date of withdrawal: 08/04/2015, Initial authorisation, Last updated: 24/04/2015Duloxetine Sandoz: Withdrawn application … application for Duloxetine Sandoz (duloxetine) On 08 April … duloxetine) On 08 April 2015, Sandoz GmbH officially notified … -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: 66, Authorised, Last updated: 29/03/2021Authorised ritonavir Overview This is a summary … contains the active substance ritonavir. It is available as an oral … When the active substance, ritonavir, acts as a ‘booster’ it … -
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Human medicine European public assessment report (EPAR): Kaletra (updated)
lopinavir, ritonavir, HIV Infections
Date of authorisation: 19/03/2001, Revision: 57, Authorised, Last updated: 18/05/2021substances , lopinavir and ritonavir. How is Kaletra used? Kaletra … activity against the virus while ritonavir mainly works as a ‘booster’ … public Kaletra lopinavir / ritonavir This is a summary of 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 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: 22, Authorised, Last updated: 12/03/2021
ombitasvir, paritaprevir and ritonavir. How is Viekirax used? Viekirax … mg paritaprevir and 50 mg ritonavir. The recommended dose is two … The third active substance, ritonavir, does not act directly against … -
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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) : EPAR - Summary for the … 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: XViekirax Ombitasvir paritaprevir ritonavir Infectious diseasesP/0179/2018EMEA-001440-PIP01-13-M02 … ombitasvir / paritaprevir / ritonavir (Viekirax), (EMEA-001440-PIP01-13-M02 … x ombitasvir paritaprevir ritonavir Ombitasvir paritaprevir ritonavir Ombitasvir paritaprevir ritonavir … -
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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: 6, Authorised, Last updated: 10/05/2021
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 … report (EPAR) for Aripiprazole Sandoz. It explains how the Agency … on how to use Aripiprazole Sandoz. For practical information … -
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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 … EPAR). What is Rivastigmine Sandoz? Rivastigmine Sandoz is a medicine containing … be used for Rivastigmine Sandoz (‘informed consent’ … -
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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 … authorisation for Clopidogrel Sandoz has been withdrawn at the … Summary documents Clopidogrel Sandoz : EPAR - Summary for the … -
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Human medicine European public assessment report (EPAR): Pregabalin Sandoz GmbH
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 … EPAR) for Ibandronic Acid Sandoz. It explains how the Committee … of use for Ibandronic Acid Sandoz. What is Ibandronic Acid Sandoz? Ibandronic Acid Sandoz is a medicine that contains … -
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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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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 sofosbuvir simeprevir ombi … -
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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 Infectious diseasesP/0228/2015EMEA-001805-PIP01-15 … ombitasvir / paritaprevir / ritonavir (EMEA-0... PDF icon application/pdf … fourth active substance, ritonavir, does not act directly against … -
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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: Xfacts lopinavir lamivudine ritonavir zidovudine Infectious diseasesP/0175/2013EMEA-001368-PIP01-12 … 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: XKey facts lopinavir ritonavir lamivudine Infectious diseasesP/0268/2012EMEA-001307-PIP01-12 … product-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: XKey facts ritonavir atazanavir sulfate Infectious … for atazanavir (sulfate) / ritonavir (EMEA-002588-PIP01-19) PDF … 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 … hepatitis C medicine and the ritonavir-boosted HIV protease inhibitors atazanavir … expected when given with ritonavir-boosted darunavir or lopinavir, although … -
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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 … medicine Methylphenidate Sandoz. The Agency's Committee for … benefits of Methylphenidate Sandoz outweigh its risks, and the …