368 results
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Referral: Renitec
Enalapril, Article 30 referrals
Status: European Commission final decision, opinion/position date: 19/09/2002, EC decision date: 21/05/2003, Last updated: 02/12/2003Enalapril is a highly specific, competitive … the benefit/risk ratio of enalapril is considered to be favourable … Renitec, INN-Enalapril The European Agency … -
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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: 11, Authorised, Last updated: 27/11/2019
masta (previously Irbesartan Krka) Hypertension … masta (previously Irbesartan Krka) … 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: 12, Authorised, Last updated: 31/07/2020
previously Capecitabine Krka) Colonic Neoplasms Breast … previously Capecitabine Krka) … authorisation) Capecitabine Krka Capecitabine On 16 February … -
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Opinion/decision on a Paediatric investigation plan (PIP): Enalapril (maleate)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-001706-PIP01-14-M02, Route(s) of administration: Oral use, Pharmaceutical form(s): Age-appropriate oral solid dosage form
Decision date: 07/12/2018, Last updated: 20/02/2019, Compliance check: XActive substance Enalapril (maleate) Therapeutic area … Enalapril (maleate … -
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Opinion/decision on a Paediatric investigation plan (PIP): Enalapril (maleate)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-001241-PIP02-13-M01, Route(s) of administration: Oral use, Pharmaceutical form(s): Oral solution
Decision date: 03/09/2014, Last updated: 29/09/2014, Compliance check: XActive substance Enalapril (maleate) Therapeutic area … paediatric investigation plan for enalapril (maleate) (EMEA-001241-PIP02-13-M01 … paediatric investigation plan for enalapril (maleate) (EMEA-001241-PIP02-13-M01 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Enalapril (maleate)
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-001516-PIP01-13, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet for oral suspension, Orodispersible film
Decision date: 05/05/2014, Last updated: 06/06/2014, Compliance check: XActive substance Enalapril (maleate) Therapeutic area … the refusal of a waiver for enalapril (maleate) (EMEA-001516-PIP01-13 … the refusal of a waiver for enalapril (maleate) (EMEA-001516-PIP01-13 … -
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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): Darunavir Krka
darunavir, HIV Infections
Date of authorisation: 26/01/2018,, Revision: 6, Authorised, Last updated: 27/01/2021
Darunavir Krka HIV Infections … 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: 6, Authorised, Last updated: 12/11/2020
Repaglinide Krka Diabetes Mellitus, Type 2 … 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: 1, Authorised, Last updated: 29/10/2019
Febuxostat Krka Hyperuricemia Gout … Febuxostat Krka … Febuxostat Krka febuxostat febuxostat … -
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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 Krka … Pemetrexed Krka, INN-pemetrexed 30 … -
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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: 5, Authorised, Last updated: 13/10/2020
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): 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): 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 … Clopidogrel Krka … Clopidogrel Krka, INN-clopidogrel 30 … -
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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 … Actavis captopril imidapril zofenopril candesartan delapril telmisartan aliskiren moexipril enalapril valsartan fosinopril irbesartan perindopril quinapril ramipril eprosartan olmesartan trandolapril losartan azilsartan lisinopril spirapril benazepril cilazapril captopril … -
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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 Krka … Atazanavir Krka atazanavir atazanavir (as … -
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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 Overview Lenalidomide Krka is a medicine used for the … 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 Overview Lenalidomide Krka d.d. is a medicine used for … 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) About this procedure Current … previously Capecitabine Krka) Xeloda Teysuno Capecitabine … previously Capecitabine Krka) capecitabine fluorouracil tegafur flucytosine capecitabine … -
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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),
Date of authorisation: 20/09/2009,, Revision: 11, Authorised, Last updated: 11/03/2020
Clopidogrel Krka d.d. (previously Zopya … Clopidogrel Krka d.d. (previously Zopya … Clopidogrel Krka d.d., INN-clopidogrel … -
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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 Overview Lenalidomide Krka d.d. Novo mesto is a medicine … EMEA/H/C/005348 Lenalidomide Krka d.d. Novo mesto (lenalidomide … -
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Human medicine European public assessment report (EPAR): Emtricitabine/Tenofovir disoproxil Krka d.d. (updated)
emtricitabine, tenofovir disoproxil succinate, HIV Infections
Date of authorisation: 28/04/2017,, Revision: 7, Authorised, Last updated: 22/02/2021
itabine/Tenofovir disoproxil Krka d.d. HIV Infections … 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 (updated)
emtricitabine, tenofovir disoproxil succinate, HIV Infections
Date of authorisation: 09/12/2016,, Revision: 8, Authorised, Last updated: 02/02/2021
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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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: 5, Authorised, Last updated: 26/11/2020
itabine/Tenofovir disoproxil Krka HIV Infections … itabine/Tenofovir disoproxil Krka … Efavirenz-emtricitabine-tenofovir Krka, INN-Efavirenz emtricitabine …