701 results
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Orphan designation: Lactobacillus acidophilus and Bifidobacterium bifidum for: Prevention of necrotising enterocolitis
Date of first decision: 16/01/2014, Positive, Last updated: 23/01/2014Italy, for Lactobacillus acidophilus and Bifidobacterium bifidum … expected to work? Lactobacillus acidophilus and Bifidobacterium bifidum … designation Lactobacillus acidophilus and Bifidobacterium bifidum … -
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Withdrawn application: Ambrisentan Zentiva
ambrisentan, date of withdrawal: 29/04/2019, Initial authorisation, Last updated: 29/05/2019Ambrisentan Zentiva: Withdrawn application … Ambrisentan Zentiva Ambrisentan Zentiva ambrisentan ambrisentan … -
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Human medicine European public assessment report (EPAR): Sevelamer carbonate Winthrop (previously Sevelamer carbonate Zentiva)
sevelamer carbonate, Hyperphosphatemia, Renal Dialysis
Date of authorisation: 15/01/2015, Revision: 17, Authorised, Last updated: 27/11/2020previously Sevelamer carbonate Zentiva) Hyperphosphatemia Renal … previously Sevelamer carbonate Zentiva) … authorisation) Sevelamer carbonate Zentiva sevelamer carbonate On … -
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Opinion/decision on a Paediatric investigation plan (PIP): 2,6-Bis-{(1-napthalenyl-3,6-disulfonic acid)-oxyacetamido}-2,6-bis-2,6-bis-2,6-bis-(2,6-diamino-hexanoylamino)-2,6-diamino-hexanoic acid (diphenylmethyl)-amide, polysodium salt
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Other
PIP number: EMEA-001354-PIP01-12, Route(s) of administration: Vaginal use, Pharmaceutical form(s): Vaginal gel
Decision date: 26/02/2013, Last updated: 23/04/2013, Compliance check: X2,6-Bis-{(1-napthalenyl-3,6-disulfonic acid)-oxyacetamido}-2,6-bis-2,6-bis-2,6-bis-(2,6-diamino-hexanoylamino)-2,6-diamino-hexanoic … 2,6-Bis-{(1-napthalenyl-3,6-disulfonic acid)-oxyacetamido}-2,6-bis-2,6-bis-2,6-bis-(2,6-diamino-hexanoylamino)-2,6-diamino-hexanoic … 2,6-Bis-{(1- napthalenyl-3,6-disulfonic acid)-oxyacetamido}-2,6-bis-2,6-bis-2,6-bis-(2,6-diamino-hexanoylamino)- 2,6-diamino-hexanoic … -
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Withdrawn application: Docetaxel Zentiva (previously Docetaxel Winthrop)
docetaxel, date of withdrawal: 14/11/2008, Post-authorisation, Last updated: 17/11/2008Docetaxel Zentiva (previously Docetaxel Winthrop) Docetaxel … Docetaxel Winthrop) Docetaxel Zentiva (previously Docetaxel Winthro … -
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Human medicine European public assessment report (EPAR): Duloxetine Zentiva (updated)
duloxetine, Anxiety Disorders, Depressive Disorder, Major, Neuralgia, Diabetes Mellitus
Date of authorisation: 20/08/2015,
, Revision: 8, Authorised, Last updated: 10/02/2021
Duloxetine Zentiva Anxiety Disorders Depressive … report (EPAR) for Duloxetine Zentiva. It explains how the Agency … on how to use Duloxetine Zentiva. For practical information … -
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Human medicine European public assessment report (EPAR): Riluzole Zentiva
Riluzole, Amyotrophic Lateral Sclerosis
Date of authorisation: 07/05/2012, Revision: 11, Authorised, Last updated: 01/10/2020Riluzole Zentiva Amyotrophic Lateral Sclerosi … Riluzole Zentiva … Riluzole Zentiva, INN-riluzole 7 Westferry … -
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Human medicine European public assessment report (EPAR): Aripiprazole Zentiva
aripiprazole, Schizophrenia, Bipolar Disorder
Date of authorisation: 25/06/2015,, Revision: 7, Authorised, Last updated: 17/06/2020
Aripiprazole Zentiva Schizophrenia Bipolar Disor … Aripiprazole Zentiva … Aripiprazole Zentiva, INN-aripiprazole … -
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Human medicine European public assessment report (EPAR): Pregabalin Zentiva
pregabalin, Anxiety Disorders, Epilepsy
Date of authorisation: 17/07/2015,, Revision: 7, Authorised, Last updated: 10/06/2020
Pregabalin Zentiva Anxiety Disorders Epilepsy … Pregabalin Zentiva … Pregabalin Zentiva, INN-pregabalin EMA/351750/2015 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Clopidogrel Zentiva (previously Clopidogrel Winthrop), clopidogrel
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: Clopidogrel, Route(s) of administration: Oral use, Pharmaceutical form(s): Age-appropriate oral formulation, Film-coated tablet
Decision date: 22/09/2009, Last updated: 07/12/2009, Compliance check: XInvented name Clopidogrel Zentiva (previously Clopidogrel Winthrop … Clopidogrel Zentiva (previously Clopidogrel Winthrop) Clopidogrel … Clopidogrel Winthrop) Clopidogrel Zentiva (previously Clopidogrel Winth … -
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Human medicine European public assessment report (EPAR): Pregabalin Zentiva k.s.
pregabalin, Anxiety Disorders, Neuralgia, Epilepsy
Date of authorisation: 27/02/2017,, Revision: 6, Authorised, Last updated: 08/04/2020
Pregabalin Zentiva k.s. Anxiety Disorders Neur … Pregabalin Zentiva k.s … for the public Pregabalin Zentiva k.s. pregabalin This is … -
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Human medicine European public assessment report (EPAR): Ivabradine Zentiva
ivabradine hydrochloride, Angina Pectoris, Heart Failure
Date of authorisation: 11/11/2016,, Revision: 2, Authorised, Last updated: 06/03/2020
Ivabradine Zentiva Angina Pectoris Heart Failu … Ivabradine Zentiva … INN-ivabradine Ivabradine Zentiva 30 Churchill Place … -
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Human medicine European public assessment report (EPAR): Clopidogrel Zentiva (previously Clopidogrel Winthrop) (updated)
clopidogrel, Stroke, Peripheral Vascular Diseases, Myocardial Infarction, Acute Coronary Syndrome
Date of authorisation: 15/07/2008, Revision: 27, Authorised, Last updated: 02/02/2021Clopidogrel Zentiva (previously Clopidogrel Winthrop) Stroke Peripheral … Clopidogrel Zentiva (previously Clopidogrel Winth … the public Clopidogrel Zentiva1 clopidogrel This is a … -
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Human medicine European public assessment report (EPAR): Irbesartan Zentiva (previously Irbesartan Winthrop)
irbesartan, Hypertension
Date of authorisation: 19/01/2007, Revision: 23, Authorised, Last updated: 18/11/2020Irbesartan Zentiva (previously Irbesartan Winthr … Irbesartan Zentiva (previously Irbesartan Winthr … Irbesartan Zentiva, INN-irbesartan 7 … -
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Human medicine European public assessment report (EPAR): Docetaxel Zentiva (previously Docetaxel Winthrop)
docetaxel, Head and Neck Neoplasms, Carcinoma, Non-Small-Cell Lung, Adenocarcinoma, Prostatic Neoplasms, Stomach Neoplasms, Breast Neoplasms
Date of authorisation: 20/04/2007, Revision: 30, Authorised, Last updated: 20/12/2019Docetaxel Zentiva (previously Docetaxel Winthrop) Head … Docetaxel Zentiva (previously Docetaxel Winthro … Docetaxel Zentiva (previously Docetaxel Winthro … -
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Human medicine European public assessment report (EPAR): Leflunomide Zentiva (previously Leflunomide Winthrop)
leflunomide, Arthritis, Rheumatoid, Arthritis, Psoriatic
Date of authorisation: 08/01/2010, Revision: 15, Authorised, Last updated: 13/06/2019Leflunomide Zentiva (previously Leflunomide Winthrop) Arthritis … Leflunomide Zentiva (previously Leflunomide Winth … Leflunomide Zentiva (previously Leflunomide Winth … -
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Human medicine European public assessment report (EPAR): Tenofovir disoproxil Zentiva
tenofovir disoproxil phosphate, HIV Infections
Date of authorisation: 15/09/2016,, Revision: 8, Authorised, Last updated: 28/01/2021
Tenofovir disoproxil Zentiva HIV Infections … Tenofovir disoproxil Zentiva … public Tenofovir disoproxil Zentiva tenofovir disoproxil This … -
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Human medicine European public assessment report (EPAR): Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva (updated)
efavirenz, emtricitabine, tenofovir disoproxil phosphate, HIV Infections
Date of authorisation: 17/07/2017,, Revision: 6, Authorised, Last updated: 22/02/2021
itabine/Tenofovir disoproxil Zentiva HIV Infections … itabine/Tenofovir disoproxil Zentiva … Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva, INN-Efavirenz/Emtricitabine/Tenofovir … -
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Human medicine European public assessment report (EPAR): Irbesartan Hydrochlorothiazide Zentiva (previously Irbesartan Hydrochlorothiazide Winthrop)
irbesartan, hydrochlorothiazide, Hypertension
Date of authorisation: 18/01/2007, Revision: 26, Authorised, Last updated: 10/11/2020besartan Hydrochlorothiazide Zentiva (previously Irbesartan Hydrochlorothiazide … besartan Hydrochlorothiazide Zentiva (previously Irbesartan Hydrochlorothiazide … Irbesartan Hydrochlorothiazide Zentiva1 irbesartan / hydrochlorothiazide … -
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Human medicine European public assessment report (EPAR): Emtricitabine/Tenofovir disoproxil Zentiva
emtricitabine, tenofovir disoproxil phosphate, HIV Infections
Date of authorisation: 09/11/2016,, Revision: 4, Authorised, Last updated: 07/04/2020
itabine/Tenofovir disoproxil Zentiva HIV Infections … itabine/Tenofovir disoproxil Zentiva … Emtricitabine/Tenofovir disoproxil Zentiva , INN-emtricitabine/tenofovir … -
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Human medicine European public assessment report (EPAR): Clopidogrel/Acetylsalicylic acid Zentiva (previously DuoCover)
clopidogrel, acetylsalicylic acid, Acute Coronary Syndrome, Myocardial Infarction
Date of authorisation: 14/03/2010, Revision: 22, Authorised, Last updated: 13/11/2019idogrel/Acetylsalicylic acid Zentiva (previously DuoCover) Acute … idogrel/Acetylsalicylic acid Zentiva (previously DuoCover … Clopidogrel/Acetylsalicylic acid Zentiva1 clopidogrel / acetylsalicylic … -
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Press release: Updated advice on body fat changes and lactic acidosis with HIV medicines
CHMP, Last updated: 23/10/2015body fat changes and lactic acidosis with HIV medicines … body fat changes and lactic acidosis with HIV medicines … body fat changes and lactic acidosis with HIV medicines 23 … -
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Referral: Angiotensin-II-receptor antagonists (sartans) containing a tetrazole group (updated)
valsartan, candesartan, irbesartan, losartan and 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: 02/03/2021Irbesartan/Hydrochlorothiazide Teva Irbesartan Zentiva (previously Irbesartan Winthrop … Irbesartan Hydrochlorothiazide Zentiva (previously Irbesartan Hydrochlorothiazide … Irbesartan Hydrochlorothiazide Zentiva EMEA/H/A-31/1471/C/783/0101 … -
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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: 08/10/2014Krka) Irbesartan Teva Irbesartan Zentiva (previously Irbesartan Winthrop) Karvea Sabervel CoAprovel Ifirmacombi Irbesartan/Hydrochlorothiazide … Teva Irbesartan Hydrochlorothiazide Zentiva (previously Irbesartan Hydrochlorothiazide … Krka) Irbesartan Teva Irbesartan Zentiva (previously Irbesartan Winthrop) Karvea Sabervel CoAprovel Ifirmacombi Irbesartan/Hydrochlorothiazide … -
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Orphan designation: tripotassium citrate monohydrate, Potassium hydrogen carbonate for: Treatment of distal renal tubular acidosis
Date of first decision: 20/06/2017, Positive, Last updated: 17/07/2017treatment of distal renal tubular acidosis. Expand section Collapse section … What is distal renal tubular acidosis? Distal renal tubular acidosis is a kidney disease in which … type of distal renal tubular acidosis, usually first detected in …