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Human medicine European public assessment report (EPAR): Ifirmasta (previously Irbesartan Krka) (updated)
irbesartan hydrochloride, Hypertension
Date of authorisation: 01/12/2008,
, Revision: 12, Authorised, Last updated: 16/03/2021
masta (previously Irbesartan Krka) Hypertension … throughout the EU for Irbesartan Krka on 1 December 2008. The name … gt;Ifirmasta (previously Irbesartan Krka)EMEA/H/C/000962irbesartan hydrochlorideirbesartanHypertensionC09CA04 … -
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Human medicine European public assessment report (EPAR): Ecansya (previously Capecitabine Krka)
capecitabine, Colonic Neoplasms, Breast Neoplasms, Colorectal Neoplasms, Stomach Neoplasms
Date of authorisation: 20/04/2012,
, , Revision: 12, Authorised, Last updated: 31/07/2020
previously Capecitabine Krka) Colonic Neoplasms Breast … authorisation) Capecitabine Krka Capecitabine On 16 February … medicinal product Capecitabine Krka 150 mg, 300 mg, 500 mg film … -
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Withdrawn application: Desloratadine Krka
desloratadine, date of withdrawal: 14/10/2011, Initial authorisation, Last updated: 17/11/2011Desloratadine Krka: Withdrawn application … authorisation) Desloratadine Krka desloratadine On 22 September … medicinal product Desloratadine Krka 5 mg film-coated tablets … -
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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: 3, Authorised, Last updated: 17/03/2021
substances bempedoic acid and ezetimibe. Nustendi is used in combination … statin taken together with ezetimibe. Nustendi can also be used … are not lowered enough by ezetimibe. The medicine can be used … -
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Human medicine European public assessment report (EPAR): Darunavir Krka
darunavir, HIV Infections
Date of authorisation: 26/01/2018,, Revision: 6, Authorised, Last updated: 27/01/2021
Darunavir Krka HIV Infections … report (EPAR) for Darunavir Krka. It explains how the Agency … advice on how to use Darunavir Krka. For practical information … -
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Human medicine European public assessment report (EPAR): Repaglinide Krka
repaglinide, Diabetes Mellitus, Type 2
Date of authorisation: 03/11/2009,, Revision: 6, Authorised, Last updated: 12/11/2020
Repaglinide Krka Diabetes Mellitus, Type 2 … EPAR). What is Repaglinide Krka? Repaglinide Krka is a medicine that contains … pink: 2 mg). Repaglinide Krka is a ‘generic medicine’ … -
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Opinion/decision on a Paediatric investigation plan (PIP): Rosuvastatin, Ezetimibe
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-002202-PIP01-17, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 31/10/2017, Last updated: 12/02/2018, Compliance check: XKey facts Rosuvastatin Ezetimibe Endocrinology, -gynacology-fertility-metabolismP/0335/2017EMEA-002202-PIP01-17 … hypercholesterolaemia Oral use Krka, d.d., Novo mesto Tel. +38 … 2055 E-mail: tomaz.kralj@krka.biz W: decision granting … -
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Human medicine European public assessment report (EPAR): Febuxostat Krka
febuxostat, Hyperuricemia, Gout
Date of authorisation: 28/03/2019,, Revision: 1, Authorised, Last updated: 29/10/2019
Febuxostat Krka Hyperuricemia Gout … febuxostat Overview Febuxostat Krka is a medicine used to treat … as ‘gout’. Febuxostat Krka is used in patients who have … -
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Human medicine European public assessment report (EPAR): Darunavir Krka d.d. (updated)
darunavir, HIV Infections
Date of authorisation: 18/01/2018,, Revision: 6, Authorised, Last updated: 19/03/2021
Darunavir Krka d.d. HIV Infections … Darunavir Krka d.d … Darunavir Krka d.d., INN-darunavir … -
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Human medicine European public assessment report (EPAR): Pemetrexed Krka
pemetrexed disodium, Carcinoma, Non-Small-Cell Lung, Mesothelioma
Date of authorisation: 22/05/2018,, Revision: 3, Authorised, Last updated: 27/11/2020
Pemetrexed Krka Carcinoma, Non-Small-Cell … pemetrexed Overview Pemetrexed Krka is a cancer medicine used … chemotherapy. Pemetrexed Krka contains the active substance … -
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Human medicine European public assessment report (EPAR): Pioglitazone Krka
pioglitazone hydrochloride, Diabetes Mellitus, Type 2
Date of authorisation: 21/03/2012,, Revision: 2, Withdrawn, Last updated: 26/09/2014
Pioglitazone Krka Diabetes Mellitus, Type 2 … authorisation for Pioglitazone Krka has been withdrawn at the … Summary documents Pioglitazone Krka : EPAR - Summary for the … -
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Human medicine European public assessment report (EPAR): Clopidogrel Krka
clopidogrel (as hydrochloride), Peripheral Vascular Diseases, Stroke, Myocardial Infarction
Date of authorisation: 23/09/2009,, Revision: 15, Authorised, Last updated: 13/01/2021
Clopidogrel Krka Peripheral Vascular Diseases Stroke Myocardial … report (EPAR) for Clopidogrel Krka. It explains how the Agency … on how to use Clopidogrel Krka. For practical information … -
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Human medicine European public assessment report (EPAR): Atazanavir Krka
atazanavir (as sulfate), HIV Infections
Date of authorisation: 25/03/2019,, Authorised, Last updated: 15/05/2019
Atazanavir Krka HIV Infections … atazanavir Overview Atazanavir Krka is an HIV medicine used to … should prescribe Atazanavir Krka only after they have looked … -
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Human medicine European public assessment report (EPAR): Lenalidomide Krka
lenalidomide hydrochloride monohydrate, Multiple Myeloma, Lymphoma, Follicular
Date of authorisation: 11/02/2021,, Authorised, Last updated: 18/02/2021
Lenalidomide Krka Multiple Myeloma Lymphoma … Lenalidomide Krka … EMEA/H/C/005734 Lenalidomide Krka (lenalidomide) An overview … -
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Human medicine European public assessment report (EPAR): Lenalidomide Krka d.d.
lenalidomide hydrochloride hydrate, Multiple Myeloma, Lymphoma, Follicular, Myelodysplastic Syndromes
Date of authorisation: 11/02/2021,, Authorised, Last updated: 18/02/2021
Lenalidomide Krka d.d. Multiple Myeloma Lymphoma … Lenalidomide Krka d.d … EMEA/H/C/005729 Lenalidomide Krka d.d. (lenalidomide) An overview … -
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Referral: Fluorouracil and fluorouracil related substances (capecitabine, tegafur and flucytosine) containing medicinal products
capecitabine, fluorouracil, tegafur, flucytosine, associated names: Xeloda, Teysuno, Capecitabine Accord, Capecitabine Medac, Capecitabine Teva, Ecansya (previously Capecitabine Krka), Article 31 referrals
Status: European Commission final decision, opinion/position date: 30/04/2020, EC decision date: 07/07/2020, Last updated: 23/07/2020previously Capecitabine Krka) Xeloda Teysuno Capecitabine … previously Capecitabine Krka) capecitabine fluorouracil … -
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Direct healthcare professional communication (DHPC): 5-Fluorouracil (i.v.), capecitabine and tegafur containing products: Pre-treatment testing to identify DPD-deficient patients at increased risk of severe toxicity
Active substance: Fluorouracil, capecitabine, tegafur, DHPC type: Referral - Article 31, Last updated: 04/06/2020previously Capecitabine Krka)TeysunoFluorouracilcapecitabinetegafurEMEA/H/A-31/1488VariationReferral - Article 31Fluorouracil … previously Capecitabine Krka) Teysuno Xeloda Capecitabine … previously Capecitabine Krka) Teysuno Xeloda Capecitabine … -
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Human medicine European public assessment report (EPAR): Clopidogrel Krka d.d. (previously Zopya)
clopidogrel (as hydrochloride),
Date of authorisation: 20/09/2009,, Revision: 11, Authorised, Last updated: 11/03/2020
Clopidogrel Krka d.d. (previously Zopya … report (EPAR) for Clopidogrel Krka d.d. It explains how the … conditions of use for Clopidogrel Krka d.d. What is Clopidogrel Krka d.d.? Clopidogrel Krka d.d. is a medicine that contains … -
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Human medicine European public assessment report (EPAR): Lenalidomide Krka d.d. Novo mesto
lenalidomide hydrochloride monohydrate, Multiple Myeloma, Myelodysplastic Syndromes, Lymphoma, Follicular, Lymphoma, Mantle-Cell
Date of authorisation: 11/02/2021,, Authorised, Last updated: 18/02/2021
Lenalidomide Krka d.d. Novo mesto Multiple … Lenalidomide Krka d.d. Novo mesto … EMEA/H/C/005348 Lenalidomide Krka d.d. Novo mesto (lenalidomide … -
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Opinion/decision on a Paediatric investigation plan (PIP): Ezetimibe
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-000007-PIP04-12, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 20/07/2012, Last updated: 22/08/2012, Compliance check: XEzetrol and associated names Ezetimibe Cardiovascular diseasesP/0135/2012EMEA-000007-PIP04-12 … product specific waiver for ezetimibe (Ezetrol and associated names … product specific waiver for ezetimibe (Ezetrol and associated names … -
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Opinion/decision on a Paediatric investigation plan (PIP): Ezetimibe
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Cardiovascular diseases
PIP number: P/15/2011, Route(s) of administration: Oral, Pharmaceutical form(s): Tablet
Decision date: 28/03/2012, Last updated: 20/04/2012, Compliance check: V, 17/01/2013Ezetrol and associated names Ezetimibe Cardiovascular diseasesP/0061/2012P/15/2011 … paediatric investigation plan for ezetimibe (Ezetrol and associated names … paediatric investigation plan for Ezetimibe (Ezetrol and associated names … -
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Opinion/decision on a Paediatric investigation plan (PIP): Ezetimibe, simvastatin
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: Ezetimibe and simvastatin (fixed combination), Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 14/09/2008, Last updated: 10/10/2008, Compliance check: XEzetimibe and simvastatin (fixed combination) Endocrinology … and associated trade names Ezetimibe simvastatin Endocrinology … Investigation Plan for[d2] ezetimibe and simvastatin (fixed combination … -
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Opinion/decision on a Paediatric investigation plan (PIP): Rosuvastatin, Ezetimibe
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-002257-PIP01-17, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 16/03/2018, Last updated: 19/06/2018, Compliance check: XKey facts Rosuvastatin Ezetimibe Cardiovascular diseasesP/0090/2018EMEA-002257-PIP01-17 … waiver for rosuvastatin / ezetimibe (EMEA-002257-PIP01-17) PDF … waiver for rosuvastatin / ezetimibe (EMEA-002257-PIP01-17) in … -
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Opinion/decision on a Paediatric investigation plan (PIP): Ezetimibe, Rosuvastatin
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-001344-PIP02-17, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 11/04/2018, Last updated: 26/07/2018, Compliance check: XKey facts Zenon Suvezen Ezetimibe Rosuvastatin Cardiovascular … product specific waiver for ezetimibe / rosuvastatin (Zenon, Suvezen … Ezetimibe Rosuvastatin … -
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Opinion/decision on a Paediatric investigation plan (PIP): Atorvastatin, Ezetimibe
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-002207-PIP01-17, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 01/12/2017, Last updated: 07/03/2018, Compliance check: XKey facts Atorvastatin Ezetimibe Cardiovascular diseasesEMEA-002207-PIP01-17EMEA-002207-PIP01-17 … waiver for atorvastatin / ezetimibe (EMEA-002207-PIP01-17) PDF … waiver for atorvastatin / ezetimibe (EMEA-002207-PIP01-17 …