375 results
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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 … been formally notified by Krka, d.d., Novo mesto of its decision … -
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Referral: Angiotensin-II-receptor antagonists (sartans) containing a tetrazole group (updated)
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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Human medicine European public assessment report (EPAR): Neparvis
sacubitril, valsartan, Heart Failure
Date of authorisation: 26/05/2016,
, Revision: 11, Authorised, Last updated: 24/02/2021
Neparvis was compared to enalapril, another medicine used for … 4,212) patients treated with enalapril. In general, patients were … Neparvis was more effective than enalapril. What are the risks associated … -
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Human medicine European public assessment report (EPAR): Entresto
sacubitril, valsartan, Heart Failure
Date of authorisation: 19/11/2015, Revision: 12, Authorised, Last updated: 07/12/2020Entresto was compared to enalapril, another medicine used for … 4,212) patients treated with enalapril. In general, patients were … Entresto was more effective than enalapril. What are the risks associated … -
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Human medicine European public assessment report (EPAR): Tolura
telmisartan, Hypertension
Date of authorisation: 04/06/2010,
, Revision: 9, Authorised, Last updated: 16/09/2020
throughout the EU for Tolura to Krka, d.d., Novo mesto on 4 June … medicines . Publication details >Krka, d.d., Novo mesto 9 04/06/2010 … Novo mesto 9 04/06/2010 Krka, d.d., Novo mesto Šmarješka … -
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Human medicine European public assessment report (EPAR): Nimvastid
rivastigmine, Dementia, Alzheimer Disease, Parkinson Disease
Date of authorisation: 11/05/2009,, Revision: 8, Authorised, Last updated: 28/02/2018
European Union for Nimvastid to KRKA,d.d., Novo mesto on 11 May 2009 … medicines . Publication details >Krka, d.d., Novo mesto8 11/05/2009 … -
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Human medicine European public assessment report (EPAR): Zyllt
clopidogrel (as hydrogen sulfate), Peripheral Vascular Diseases, Stroke, Acute Coronary Syndrome, Myocardial Infarction
Date of authorisation: 28/09/2009,, Revision: 13, Authorised, Last updated: 10/03/2020
throughout the EU for Zyllt to Krka, d.d., Novo mesto on 28 September … medicines . Publication details >Krka, d.d., Novo mesto13 28/09/2009 … d.d., Novo mesto13 28/09/2009 KRKA d.d., Novo mesto Šmarješka … -
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Human medicine European public assessment report (EPAR): Zalasta
olanzapine, Schizophrenia, Bipolar Disorder
Date of authorisation: 27/09/2007,, Revision: 17, Authorised, Last updated: 25/03/2020
throughout the EU for Zalasta to KRKA, d.d., Novo mesto on 27 September … medicines . Publication details >Krka17 27/09/2007 Smarjeska cesta … -
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Human medicine European public assessment report (EPAR): Irbesartan Zentiva (previously Irbesartan Winthrop) (updated)
irbesartan, Hypertension
Date of authorisation: 19/01/2007, Revision: 24, Authorised, Last updated: 18/03/2021for hypertension (atenolol, enalapril or amlodipine) in 823 patients … hypertension (atenolol, enalapril or amlodipine) in 823 patients … -
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Human medicine European public assessment report (EPAR): Karvea
irbesartan, Hypertension
Date of authorisation: 26/08/1997, Revision: 40, Authorised, Last updated: 01/03/2021for hypertension (atenolol, enalapril or amlodipine) in 823 patients … hypertension (atenolol, enalapril or amlodipine) in 823 patients … -
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Human medicine European public assessment report (EPAR): Aprovel
irbesartan, Hypertension
Date of authorisation: 26/08/1997, Revision: 42, Authorised, Last updated: 01/03/2021for hypertension (atenolol, enalapril or amlodipine) in 823 patients … hypertension (atenolol, enalapril or amlodipine) in 823 patients … -
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Human medicine European public assessment report (EPAR): Kinzalmono (previously Telmisartan Boehringer Ingelheim Pharma KG)
telmisartan, Hypertension
Date of authorisation: 16/12/1998, Revision: 30, Authorised, Last updated: 18/12/2020hypertension (atenolol, lisinopril, enalapril and amlodipine). The main … hypertension (atenolol, lisinopril, enalapril and amlodipine). The main … -
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Human medicine European public assessment report (EPAR): Ifirmacombi
irbesartan, hydrochlorothiazide, Hypertension
Date of authorisation: 04/03/2011,, Revision: 11, Authorised, Last updated: 30/10/2020
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National expert: Mirna Galovic, Agency for Medicinal Products and Medical Devices of Croatia (updated)
- Declaration of interests - 80.61 KB | PDF
- Curriculum Vitae - 17.19 KB | PDF
Head of quality department Krka-farma d.o.o. (Croatia) Establishment … director for Quality Management Krka-farma d.o.o. (Croatia) Management … Indication 08/2004-11/2018 KRKA-FARMA d.o.o. Cross product responsibility … -
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Human medicine European public assessment report (EPAR): Tolucombi
telmisartan, hydrochlorothiazide, Hypertension
Date of authorisation: 13/03/2013,, Revision: 9, Authorised, Last updated: 28/09/2020
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Press release: New medicine to treat heart failure recommended for approval
CHMP, Last updated: 25/09/2015of Entresto compared with enalapril (an ACE inhibitor) was assessed … Entresto was more effective than enalapril in reducing deaths from cardiovascular … the patients treated with enalapril. The trial also found that … -
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Human medicine European public assessment report (EPAR): Micardis
telmisartan, Hypertension
Date of authorisation: 16/12/1998, Revision: 24, Authorised, Last updated: 18/12/2020hypertension (atenolol, lisinopril, enalapril and amlodipine). The main … hypertension (atenolol, lisinopril, enalapril and amlodipine). The main … -
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Opinion/decision on a Paediatric investigation plan (PIP): Olmesartan medoxomil, Amlodipine besilate
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-001852-PIP01-15, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 27/11/2015, Last updated: 07/01/2016, Compliance check: Xof hypertension Oral use Krka, d.d., Novo mesto Slovenia … 2742 E-mail: tomaz.kralj@krka.biz W: decision granting … application submitted by Krka, d.d., Novo mesto on 30 July … -
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Human medicine European public assessment report (EPAR): Pritor
telmisartan, Hypertension
Date of authorisation: 11/12/1998, Revision: 29, Authorised, Last updated: 10/12/2020hypertension (atenolol, lisinopril, enalapril and amlodipine). The main … hypertension (atenolol, lisinopril, enalapril and amlodipine). The main … -
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Human medicine European public assessment report (EPAR): Dasselta
desloratadine, Rhinitis, Allergic, Perennial, Rhinitis, Allergic, Seasonal, Urticaria
Date of authorisation: 28/11/2011,, Revision: 11, Authorised, Last updated: 29/05/2020
medicines . Publication details >Krka, d.d., Novo mesto11 28/11/2011 … -
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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: Xhypercholesterolaemia Oral use Krka, d.d., Novo mesto Tel. +38 … 2055 E-mail: tomaz.kralj@krka.biz W: decision granting … application submitted by Krka, d.d., Novo mesto on 12 June … -
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Opinion/decision on a Paediatric investigation plan (PIP): Ramipril, amlodipine
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-001871-PIP01-15, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 04/02/2016, Last updated: 22/04/2016, Compliance check: Xof hypertension Oral use Krka, d.d., Novo mesto Slovenia … application submitted by Krka, d.d., Novo mesto on 23 October … decision is addressed to Krka, d.d., Novo mesto, Šmarješka … -
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Opinion/decision on a Paediatric investigation plan (PIP): telmisartan, Amlodipine besilate
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-001845-PIP01-15, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 30/10/2015, Last updated: 22/12/2015, Compliance check: Xof hypertension Oral use Krka, d.d. Novo mesto Croatia Tel … 2153 E-mail: helen.lukin@krka.biz W: decision granting … application submitted by Krka, d.d., Novo mesto on 27 July … -
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Opinion/decision on a Paediatric investigation plan (PIP): amlodipine, Rosuvastatin, perindopril tert-butylamine
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-001772-PIP01-15, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 04/09/2015, Last updated: 23/10/2015, Compliance check: Xmetabolism disorders Oral use Krka, d.d., Novo mesto Slovenia … application submitted by Krka, d.d., Novo mesto on 8 April … decision is addressed to Krka, d.d., Novo mesto, Šmarješka … -
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National expert: Monika Posega, Agency for medicinal products and medical devices of the Republic of Slovenia (updated)
- Declaration of interests - 79.79 KB | PDF
- Curriculum Vitae - 16.72 KB | PDF
2006-June 2009 Sales agent KRKA, d.d., Novo mesto (Slovenia) Marketing … Promotion of sales of medicines KRKA, d.d., Novo mesto (Slovenia) Pharmacodynamic …