309 results
Keyword Eplerenone Krka Remove keyword
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Opinion/decision on a Paediatric investigation plan (PIP): eplerenone, Furosemide (new)
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-003065-PIP01-21, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 03/12/2021, Last updated: 13/03/2023, Compliance check: XKey facts eplerenone Furosemide Cardiovascular … product specific waiver for eplerenone / furosemide (EMEA-003065-PIP01-21 … product specific waiver for eplerenone / furosemide (EMEA-003065-PIP01-21 … -
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Human medicine European public assessment report (EPAR): Lenalidomide Krka d.d. Novo mesto (previously Lenalidomide Krka)
lenalidomide hydrochloride monohydrate, Multiple Myeloma; Lymphoma, Follicular
Date of authorisation: 11/02/2021,
, Revision: 3, Authorised, Last updated: 17/12/2021
Lenalidomide Krka d.d. Novo mesto (previously … previously Lenalidomide Krka) Cancer Neoplasms Neoplasms … Lenalidomide Krka d.d. Novo mesto (previously … -
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Human medicine European public assessment report (EPAR): Ecansya (previously Capecitabine Krka) (updated)
capecitabine, Colonic Neoplasms; Breast Neoplasms; Colorectal Neoplasms; Stomach Neoplasms
Date of authorisation: 20/04/2012,, Revision: 14, Authorised, Last updated: 07/03/2023
previously Capecitabine Krka) Cancer Neoplasms Colorectal … previously Capecitabine Krka) … authorisation) Capecitabine Krka Capecitabine On 16 February … -
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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) Cardiovascular Diseases Vascular … throughout the EU for Irbesartan Krka on 1 December 2008. The name … masta (previously Irbesartan Krka) irbesartan irbesartan hydro … -
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Withdrawn application: Desloratadine Krka
desloratadine, date of withdrawal: 14/10/2011, Initial authorisation, Last updated: 17/11/2011Desloratadine Krka: Withdrawn application … authorisation) Desloratadine Krka desloratadine On 22 September … medicinal product Desloratadine Krka 5 mg film-coated tablets … -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): Lenalidomide Krka (previously Lenalidomide Krka d.d. Novo mesto)
lenalidomide hydrochloride monohydrate, Multiple Myeloma; Myelodysplastic Syndromes; Lymphoma, Follicular; Lymphoma, Mantle-Cell
Date of authorisation: 11/02/2021,, Revision: 3, Authorised, Last updated: 22/12/2021
Lenalidomide Krka (previously Lenalidomide Krka d.d. Novo mesto) Cancer Neoplasms Neoplasms … Lenalidomide Krka (previously Lenalidomide Krka d.d. Novo mesto … EMEA/H/C/005348 Lenalidomide Krka (lenalidomide) An overview … -
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Human medicine European public assessment report (EPAR): Darunavir Krka
darunavir, HIV Infections
Date of authorisation: 26/01/2018,, Revision: 9, Authorised, Last updated: 16/02/2023
Darunavir Krka Immunologic Deficiency Syndromes Immune … Darunavir Krka … Darunavir Krka, INN-darunavir 30 … -
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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: 8, Authorised, Last updated: 14/12/2022
Repaglinide Krka Nutritional and Metabolic … Repaglinide Krka … Repaglinide Krka, INN-repaglinide European … -
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Human medicine European public assessment report (EPAR): Febuxostat Krka
febuxostat, Hyperuricemia; Gout
Date of authorisation: 28/03/2019,, Revision: 3, Authorised, Last updated: 07/04/2022
Febuxostat Krka Pathological Conditions … 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): Pemetrexed Krka
pemetrexed disodium, Carcinoma, Non-Small-Cell Lung; Mesothelioma
Date of authorisation: 22/05/2018,, Revision: 6, Authorised, Last updated: 22/02/2023
Pemetrexed Krka Cancer Neoplasms Carcinoma … pemetrexed Overview Pemetrexed Krka is a cancer medicine used … chemotherapy. Pemetrexed Krka contains the The substance … -
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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: 8, Withdrawn, Last updated: 03/02/2023
Darunavir Krka d.d. Immunologic Deficiency … authorisation for Darunavir Krka d.d. has expired following … Summary documents Darunavir Krka d.d. : EPAR - Summary for … -
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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 … Pioglitazone Krka … Pioglitazone Krka, INN-pioglitazone 30 … -
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Human medicine European public assessment report (EPAR): Abiraterone Krka (updated)
abiraterone acetate, Prostatic Neoplasms
Date of authorisation: 24/06/2021,, Revision: 2, Authorised, Last updated: 08/03/2023
Abiraterone Krka Genital Neoplasms, Male Urogenital … Abiraterone Krka … EMEA/H/C/005649 Abiraterone Krka (abiraterone acetate) An … -
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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: 18, Authorised, Last updated: 10/06/2022
Clopidogrel Krka Vascular Diseases Cardiovascular … 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,, Revision: 1, Authorised, Last updated: 09/12/2021
Atazanavir Krka Blood-Borne Infections Communicable … Atazanavir Krka … MEDICINAL PRODUCT Atazanavir Krka 150 mg hard capsules Atazanavir … -
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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,, Revision: 2, Authorised, Last updated: 17/12/2021
Lenalidomide Krka d.d. Cancer Neoplasms Neoplasms … 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) 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): Clopidogrel Krka d.d. (previously Zopya)
clopidogrel (as hydrochloride), Peripheral Vascular Diseases; Stroke; Myocardial Infarction
Date of authorisation: 20/09/2009,, Revision: 14, Authorised, Last updated: 10/06/2022
Clopidogrel Krka d.d. (previously Zopya) Vascular … 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): Efavirenz/Emtricitabine/Tenofovir disoproxil Krka
efavirenz, emtricitabine, tenofovir disoproxil succinate, HIV Infections
Date of authorisation: 08/02/2018,, Revision: 9, Authorised, Last updated: 05/12/2022
itabine/Tenofovir disoproxil Krka Blood-Borne Infections Communicable … 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 d.d.
emtricitabine, tenofovir disoproxil succinate, HIV Infections
Date of authorisation: 28/04/2017,, Revision: 9, Authorised, Last updated: 15/06/2022
itabine/Tenofovir disoproxil Krka d.d. Blood-Borne Infections Communicable … itabine/Tenofovir disoproxil Krka d.d … Emtricitabine/tenofovir disoproxil Krka d.d. Procedural steps taken … -
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Human medicine European public assessment report (EPAR): Emtricitabine/Tenofovir disoproxil Krka
emtricitabine, tenofovir disoproxil succinate, HIV Infections
Date of authorisation: 09/12/2016,, Revision: 11, Authorised, Last updated: 29/10/2021
itabine/Tenofovir disoproxil Krka Blood-Borne Infections Communicable … itabine/Tenofovir disoproxil Krka … Emtricitabine/Teno fovir disoproxil Krka 200 mg / 245 mg Film-coated … -
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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 … application for Desloratadine Krka (desloratadine … Krka, d.d., Novo mesto withdraws … -
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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 …