2198 results
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Human medicine European public assessment report (EPAR): Lenalidomide Krka d.d. Novo mesto (previously Lenalidomide Krka) (updated)
lenalidomide hydrochloride monohydrate, Multiple Myeloma; Lymphoma, Follicular
Date of authorisation: 11/02/2021,
, Revision: 1, Authorised, Last updated: 31/08/2021
Lenalidomide Krka d.d. Novo mesto (previously Lenalidomide … previously Lenalidomide Krka) Multiple Myeloma Lymphoma … lenalidomide Overview Lenalidomide Krka d.d. Novo mesto is a medicine … -
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Human medicine European public assessment report (EPAR): Darunavir Krka d.d.
darunavir, HIV Infections
Date of authorisation: 18/01/2018,, Revision: 6, Authorised, Last updated: 19/03/2021
Darunavir Krka d.d. HIV Infections … report (EPAR) for Darunavir Krka d.d. It explains how the Agency … advice on how to use Darunavir Krka d.d. For practical information … -
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Human medicine European public assessment report (EPAR): Lenalidomide Krka (previously Lenalidomide Krka d.d. Novo mesto) (updated)
lenalidomide hydrochloride monohydrate, Multiple Myeloma; Myelodysplastic Syndromes; Lymphoma, Follicular; Lymphoma, Mantle-Cell
Date of authorisation: 11/02/2021,, Revision: 1, Authorised, Last updated: 01/09/2021
Lenalidomide Krka (previously Lenalidomide Krka d.d. Novo mesto) Multiple Myeloma Myelodysplastic … lymphocytes, Lenalidomide Krka is used in adults whose disease … with rituximab. Lenalidomide Krka contains the The substance … -
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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 Overview Lenalidomide Krka d.d. is a medicine used for the … EMEA/H/C/005729 Lenalidomide Krka d.d. (lenalidomide) An overview … -
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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: 12, Authorised, Last updated: 30/07/2021
Clopidogrel Krka d.d. (previously Zopya … report (EPAR) for Clopidogrel Krka d.d. It explains how the The committee … conditions of use for Clopidogrel Krka d.d. What is Clopidogrel … -
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Human medicine European public assessment report (EPAR): Emtricitabine/Tenofovir disoproxil Krka d.d.
emtricitabine, tenofovir disoproxil succinate, HIV Infections
Date of authorisation: 28/04/2017,, Revision: 8, Authorised, Last updated: 22/04/2021
itabine/Tenofovir disoproxil Krka d.d. HIV Infections … Emtricitabine/Tenofovir disoproxil Krka d.d. is an HIV medicine that is … Emtricitabine/Tenofovir disoproxil Krka d.d contains two active substances … -
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Press release: Krka, d.d., Novo mesto withdraws its marketing authorisation application for Desloratadine Krka (desloratadine)
Last updated: 19/10/2011Krka, d.d., Novo mesto withdraws its … application for Desloratadine Krka (desloratadine … been formally notified by Krka, d.d., Novo mesto of its decision … -
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Human medicine European public assessment report (EPAR): Ifirmasta (previously Irbesartan Krka)
irbesartan hydrochloride, Hypertension
Date of authorisation: 01/12/2008,, Revision: 14, Authorised, Last updated: 03/08/2021
masta (previously Irbesartan Krka) Hypertension … throughout the EU for Irbesartan Krka on 1 December 2008. The name … masta (previously Irbesartan Krka) irbesartan irbesartan hydro … -
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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: 13, Authorised, Last updated: 23/04/2021
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): 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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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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Summary of opinion: Abiraterone Krka
abiraterone acetate, opinion date: 22/04/2021, Positive, Last updated: 23/04/2021Abiraterone Krka : Pending EC decision … authorisation) Abiraterone KRKA abiraterone acetate On … medicinal product Abiraterone KRKA, intended for the treatment … -
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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): 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): 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): Clopidogrel Krka
clopidogrel (as hydrochloride), Peripheral Vascular Diseases; Stroke; Myocardial Infarction
Date of authorisation: 23/09/2009,, Revision: 16, Authorised, Last updated: 27/05/2021
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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Herbal medicinal product: Curcumae xanthorrhizae rhizoma
Curcuma xanthorrhiza Roxb. (C. xanthorrhiza D. Dietrich)., Javanese turmeric, F: Assessment finalised, Last updated: 02/02/2021xanthorrhiza Roxb. (C. xanthorrhiza D. Dietrich). Therapeutic area Gastrointestinal … xanthorrhiza Roxb. (C. xanthorrhiza D. Dietrich). Javanese turmeric … -
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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 The substance … -
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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) Teysuno Active substance … previously Capecitabine Krka) Teysuno Xeloda Capecitabine … previously Capecitabine Krka) Teysuno capecitabine capec … -
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Human medicine European public assessment report (EPAR): Efavirenz/Emtricitabine/Tenofovir disoproxil Krka
efavirenz, emtricitabine, tenofovir disoproxil succinate, HIV Infections
Date of authorisation: 08/02/2018,, Revision: 6, Authorised, Last updated: 08/04/2021
itabine/Tenofovir disoproxil Krka HIV Infections … Efavirenz/Emtricitabine/Tenofovir disoproxil Krka. It explains how the Agency … Efavirenz/Emtricitabine/Tenofovir disoproxil Krka, patients should read the … -
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Human medicine European public assessment report (EPAR): Emtricitabine/Tenofovir disoproxil Krka (updated)
emtricitabine, tenofovir disoproxil succinate, HIV Infections
Date of authorisation: 09/12/2016,, Revision: 10, Authorised, Last updated: 21/09/2021
itabine/Tenofovir disoproxil Krka HIV Infections … Emtricitabine/Tenofovir disoproxil Krka is an HIV medicine that is … Emtricitabine/Tenofovir disoproxil Krka is also used to help prevent … -
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Referral: Angiotensin-II-receptor antagonists (sartans) containing a tetrazole group
valsartan, candesartan, irbesartan, losartan, olmesartan, associated names: Karvezide, Karvea, Irbesartan/Hydrochlorothiazide Teva, Irbesartan Zentiva (previously Irbesartan Winthrop), Irbesartan Teva, Irbesartan Hydrochlorothiazide Zentiva (previously Irbesartan Hydrochlorothiazide Winthrop), Ifirmasta (previously Irbesartan Krka), Ifirmacombi, Aprovel, Neparvis, Exforge, Exforge HCT, Entresto, Dafiro HCT, Dafiro, Copalia HCT, Copalia, Amlodipine / Valsartan Mylan , CoAprovel, Article 31 referrals
Status: European Commission final decision, opinion/position date: 12/11/2020, EC decision date: 19/02/2021, Last updated: 19/03/2021Winthrop) Ifirmasta (previously Irbesartan Krka) Ifirmacombi Aprovel Neparvis Exforge Exforge … Winthrop) Ifirmasta (previously Irbesartan Krka) Ifirmacombi Aprovel Neparvis Exforge Exforge … -
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Referral: Renin-angiotensin-system (RAS)-acting agents
captopril, imidapril, zofenopril, candesartan, delapril, telmisartan, aliskiren, moexipril, enalapril, valsartan, fosinopril, irbesartan, perindopril, quinapril, ramipril, eprosartan, olmesartan, trandolapril, losartan, azilsartan, lisinopril, spirapril, benazepril, cilazapril, associated names: Tolucombi, Telmisartan Teva, Telmisartan Teva Pharma, Tolura, Onduarp, Twynsta, Actelsar HCT, Kinzalkomb, MicardisPlus, PritorPlus, Copalia HCT, Dafiro HCT, Exforge HCT, Rasilamlo, Rasilez, Rasilez HCT, Rasitrio, Edarbi, Ipreziv, Aprovel, Ifirmasta (previously Irbesartan Krka), Irbesartan Teva, Irbesartan Zentiva (previously Irbesartan Winthrop), Karvea, Sabervel, CoAprovel, Ifirmacombi, Irbesartan/Hydrochlorothiazide Teva, Irbesartan Hydrochlorothiazide Zentiva (previously Irbesartan Hydrochlorothiazide Winthrop), Karvezide, Kinzalmono (previously Telmisartan Boehringer Ingelheim Pharma KG), Micardis, Pritor, Telmisartan Actavis, Article 31 referrals
Status: European Commission final decision, opinion/position date: 22/05/2014, EC decision date: 04/09/2014, Last updated: 08/10/2014HCT Rasitrio Edarbi Ipreziv Aprovel Ifirmasta (previously Irbesartan Krka) Irbesartan Teva Irbesartan … HCT Rasitrio Edarbi Ipreziv Aprovel Ifirmasta (previously Irbesartan Krka) Irbesartan Teva Irbesartan …