9423 results
Keyword Ritonavir Accord 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 … assessment report (EPAR) for Ritonavir Mylan. It explains how the … practical advice on how to use Ritonavir Mylan. For practical information … -
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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
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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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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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 … EMEA-001005-PIP01-10-M01) in accordance with Regulation (EC) No 1901/2006 … -
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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: 09/03/2017be monitored and managed according to current clinical A document … be monitored and managed according to current clinical A document … ombitasvir / paritaprevir / ritonavir). Since the start of this review … -
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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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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 … EMEA- 001368-PIP01-12) in accordance with Regulation (EC) No 1901/2006 … -
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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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Withdrawn application: Erlotinib Accord
erlotinib, date of withdrawal: 28/05/2020, Initial authorisation, Last updated: 29/05/2020Erlotinib Accord: Withdrawn application … medicines are manufactured according to the same quality standards … Erlotinib Accord Erlotinib Accord erlotinib … -
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Summary of opinion: Sunitinib Accord
sunitinib, opinion date: 10/12/2020, Positive, Last updated: 11/12/2020Sunitinib Accord: Pending EC decision … medicines are manufactured according to the same quality standards … authorisation) Sunitinib Accord sunitinib On 10 December … -
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Summary of opinion: Abiraterone Accord
abiraterone, opinion date: 25/02/2021, Positive, Last updated: 26/02/2021Abiraterone Accord: Pending EC decision … authorisation) Abiraterone Accord abiraterone On 25 February … medicinal product Abiraterone Accord, intended for the treatment … -
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Withdrawn application: Tigecycline Accord
tigecycline, date of withdrawal: 12/09/2017, Initial authorisation, Last updated: 10/10/2017Tigecycline Accord: Withdrawn application … application for Tigecycline Accord (tigecycline) On 12 September … On 12 September 2017, Accord Healthcare Limited officially … -
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Direct healthcare professional communication (DHPC): Cabazitaxel Accord 20 mg/mL concentrate for solution for infusion: Risk of medication errors and mix-up with Jevtana (60 mg/1.5 mL) concentrate and solvent for solution for infusion
Active substance: cabazitaxel, DHPC type: Medication error, Last updated: 28/10/2020Cabazitaxel Accord 20 mg/mL concentrate for … Cabazitaxel Accord 20 mg/mL concentrate for … Cabazitaxel Accord Cabazitaxel Accord cabazitaxel cabazitaxel ca … -
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Human medicine European public assessment report (EPAR): Palonosetron Accord (updated)
Palonosetron, Vomiting, Nausea, Cancer
Date of authorisation: 26/05/2016,, Revision: 4, Authorised, Last updated: 18/02/2021
Palonosetron Accord Vomiting Nausea Cancer … Palonosetron Accord … medicines are manufactured according to the same quality standards … -
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Human medicine European public assessment report (EPAR): Bortezomib Accord
bortezomib, Multiple Myeloma
Date of authorisation: 20/07/2015,, Revision: 8, Authorised, Last updated: 02/02/2021
Bortezomib Accord Multiple Myeloma … Bortezomib Accord … medicines are manufactured according to the same quality standards … -
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Human medicine European public assessment report (EPAR): Pregabalin Accord (updated)
pregabalin, Anxiety Disorders, Epilepsy
Date of authorisation: 28/08/2015,, Revision: 9, Authorised, Last updated: 24/02/2021
Pregabalin Accord Anxiety Disorders Epilepsy … report (EPAR) for Pregabalin Accord. It explains how the Agency … on how to use Pregabalin Accord. For practical information … -
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Human medicine European public assessment report (EPAR): Lenalidomide Accord (updated)
lenalidomide, Multiple Myeloma
Date of authorisation: 20/09/2018,, Revision: 5, Authorised, Last updated: 17/02/2021
Lenalidomide Accord Multiple Myeloma … Lenalidomide Accord … medicines are manufactured according to the same quality standards … -
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Human medicine European public assessment report (EPAR): Levetiracetam Accord (updated)
levetiracetam, Epilepsy
Date of authorisation: 03/10/2011,, Revision: 12, Authorised, Last updated: 10/02/2021
Levetiracetam Accord Epilepsy … Levetiracetam Accord … medicines are manufactured according to the same quality standards … -
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Human medicine European public assessment report (EPAR): Entecavir Accord
Entecavir, Hepatitis B, Chronic
Date of authorisation: 25/09/2017,, Revision: 3, Authorised, Last updated: 29/01/2021
Entecavir Accord Hepatitis B, Chronic … Entecavir Accord … medicines are manufactured according to the same quality standards … -
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Human medicine European public assessment report (EPAR): Posaconazole Accord
posaconazole, Mycoses
Date of authorisation: 25/07/2019,, Revision: 1, Authorised, Last updated: 24/11/2020
Posaconazole Accord Mycoses … Posaconazole Accord … medicines are manufactured according to the same quality standards …