8692 results
-
List item
Orphan designation: Lactobacillus acidophilus and Bifidobacterium bifidum for: Prevention of necrotising enterocolitis
Date of designation: 16/01/2014, Positive, Last updated: 23/01/2014Lactobacillus acidophilus and Bifidobacterium bifidum … the European Commission to Laboratorio Farmaceutico S.I.T. s.r.l … Italy, for Lactobacillus acidophilus and Bifidobacterium bifidum … -
List item
Human medicine European public assessment report (EPAR): Xaluprine (previously Mercaptopurine Nova Laboratories)
6-mercaptopurine monohydrate, Leukemia, Lymphoid
Date of authorisation: 09/03/2012, Revision: 14, Authorised, Last updated: 15/12/2022previously Mercaptopurine Nova Laboratories) Cancer Leukemia Neoplasms Lymphoproliferative … previously Mercaptopurine Nova Laboratories) … authorisation) Mercaptopurine Nova Laboratories mercaptopurine On 21 July … -
List item
Herbal medicinal product: Eucalypti folium
Eucalyptus globulus Labill., Eucalyptus leaf, F: Assessment finalised, Last updated: 16/03/2022tree Eucalyptus globulus Labill. Preparations from dried eucalyptus … considered the results of laboratory tests as well as studies … leaf Eucalyptus globulus Labill., folium This is a summary … -
List item
Herbal medicinal product: Eucalypti aetheroleum
Eucalyptus globulus Labill.; Eucalyptus polybractea R.T. Baker; Eucalyptus smithii R.T. Baker., Eucalyptus Oil, F: Assessment finalised, Last updated: 02/03/2021mainly Eucalyptus gobulus Labill., Eucalyptus polybractea R.T … Eucalyptus oil Eucalyptus gobulus Labill., Eucalyptus polybractea R.T … mainly Eucalyptus gobulus Labill., Eucalyptus polybractea R.T … -
List item
Human medicine European public assessment report (EPAR): Labazenit
budesonide, salmeterol, Asthma
Date of refusal: 06/09/2013, Refused, Last updated: 22/03/2013Labazenit Asthma … for the medicinal product Labazenit, intended for the treatment … applied for authorisation is Laboratoires SMB s.a. The applicant requested … -
List item
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 … 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 … -
List item
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: 19, Authorised, Last updated: 11/01/2023previously Sevelamer carbonate Zentiva) Nutritional and Metabolic … previously Sevelamer carbonate Zentiva) … authorisation) Sevelamer carbonate Zentiva sevelamer carbonate On … -
List item
Withdrawn application: Ambrisentan Zentiva
ambrisentan, date of withdrawal: 29/04/2019, Initial authorisation, Last updated: 29/05/2019Ambrisentan Zentiva: Withdrawn application … product characteristics, the labelling and the package leaflet … be described both on the label and in the package leaflet … -
List item
Human medicine European public assessment report (EPAR): Riluzole Zentiva
Riluzole, Amyotrophic Lateral Sclerosis
Date of authorisation: 07/05/2012, Revision: 13, Authorised, Last updated: 22/11/2022Riluzole Zentiva Nervous System Diseases Central … report (EPAR) for Riluzole Zentiva. It explains how the The committee … conditions of use for Riluzole Zentiva. What is Riluzole Zentiva? Riluzole Zentiva is a medicine containing … -
List item
Human medicine European public assessment report (EPAR): Pregabalin Zentiva
pregabalin, Anxiety Disorders; Epilepsy
Date of authorisation: 17/07/2015,
, Revision: 15, Authorised, Last updated: 09/02/2023
Pregabalin Zentiva Mental Disorders Nervous … Pregabalin Zentiva … product characteristics, the labelling and the package leaflet … -
List item
Human medicine European public assessment report (EPAR): Aripiprazole Zentiva
aripiprazole, Schizophrenia; Bipolar Disorder
Date of authorisation: 25/06/2015,, Revision: 9, Authorised, Last updated: 26/08/2022
Aripiprazole Zentiva Schizophrenia Spectrum and … report (EPAR) for Aripiprazole Zentiva. It explains how the Agency … on how to use Aripiprazole Zentiva. For practical information … -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Fluoride 18-labelled Prostate-Specific Membrane Antigen-1007 ([18F]PSMA-1007)
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Diagnostic; Oncology
PIP number: EMEA-002918-PIP01-20, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for injection
Decision date: 26/03/2021, Last updated: 09/11/2021, Compliance check: XKey facts Fluoride 18-labelled Prostate-Specific Membrane … specific waiver for fluoride 18-labelled prostate-specific membrane … specific waiver for fluoride 18-labelled prostate-specific membrane … -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Gallium 68-labelled Prostate-Specific Membrane Antigen-11 (68Ga-PSMA-11)
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Diagnostic; Oncology
PIP number: EMEA-002577-PIP01-19, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for injection/infusion
Decision date: 16/08/2019, Last updated: 20/11/2019, Compliance check: XKey facts Gallium 68-labelled Prostate-Specific Membrane … specific waiver for gallium 68-labelled Prostate-Specific Membrane … Gallium 68-labelled Prostate-Specific Membrane … -
List item
Human medicine European public assessment report (EPAR): Duloxetine Zentiva
duloxetine, Neuralgia; Depressive Disorder, Major; Anxiety Disorders; Diabetes Mellitus
Date of authorisation: 20/08/2015,, Revision: 11, Authorised, Last updated: 16/08/2022
Duloxetine Zentiva Nervous System Diseases Neuromuscular … report (EPAR) for Duloxetine Zentiva. It explains how the Agency … on how to use Duloxetine Zentiva. For practical information … -
List item
Human medicine European public assessment report (EPAR): Pregabalin Zentiva k.s. (updated)
pregabalin, Anxiety Disorders; Neuralgia; Epilepsy
Date of authorisation: 27/02/2017,, Revision: 13, Withdrawn, Last updated: 20/03/2023
Pregabalin Zentiva k.s. Mental Disorders Nervous … authorisation for Pregabalin Zentiva k.s. has been withdrawn at … Summary documents Pregabalin Zentiva k.s. : EPAR - Summary for … -
List item
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 … -
List item
Human medicine European public assessment report (EPAR): Ivabradine Zentiva
ivabradine hydrochloride, Angina Pectoris; Heart Failure
Date of authorisation: 11/11/2016,, Revision: 5, Authorised, Last updated: 22/08/2022
Ivabradine Zentiva Pathological Conditions … report (EPAR) for Ivabradine Zentiva. It explains how the Agency … on how to use Ivabradine Zentiva. For practical information … -
List item
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, Withdrawn, Last updated: 20/05/2022Docetaxel Zentiva (previously Docetaxel Winthrop) Neoplasms Cancer Breast … Docetaxel Zentiva (previously Docetaxel Winthro … Public statement Docetaxel Zentiva Withdrawal of the marketing … -
List item
Human medicine European public assessment report (EPAR): Irbesartan Zentiva (previously Irbesartan Winthrop)
irbesartan, Hypertension
Date of authorisation: 19/01/2007, Revision: 28, Authorised, Last updated: 28/09/2022Irbesartan Zentiva (previously Irbesartan Winthrop) Cardiovascular … report (EPAR) for Irbesartan Zentiva. It explains how the The committee … conditions of use for Irbesartan Zentiva. What is Irbesartan Zentiva? Irbesartan Zentiva is a medicine that contains … -
List item
Human medicine European public assessment report (EPAR): Clopidogrel Zentiva (previously Clopidogrel Winthrop)
clopidogrel, Stroke; Peripheral Vascular Diseases; Myocardial Infarction; Acute Coronary Syndrome
Date of authorisation: 15/07/2008, Revision: 31, Authorised, Last updated: 23/06/2022Clopidogrel Zentiva (previously Clopidogrel Winthrop) Cardiovascular … report (EPAR) for Clopidogrel Zentiva. It explains how the The committee … conditions of use for Clopidogrel Zentiva. What is Clopidogrel Zentiva? Clopidogrel Zentiva is a medicine that contains … -
List item
Human medicine European public assessment report (EPAR): Leflunomide Zentiva (previously Leflunomide Winthrop)
leflunomide, Arthritis, Rheumatoid; Arthritis, Psoriatic
Date of authorisation: 08/01/2010, Revision: 18, Authorised, Last updated: 17/05/2022Leflunomide Zentiva (previously Leflunomide Winthrop) Musculoskeletal … 13/05/2022 Leflunomide Zentiva (previously Leflunomide Winthrop … authorisation (annex IIB); labelling (annex IIIA); package leaflet … -
List item
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 … -
List item
Human medicine European public assessment report (EPAR): Tenofovir disoproxil Zentiva
tenofovir disoproxil phosphate, HIV Infections
Date of authorisation: 15/09/2016,, Revision: 12, Authorised, Last updated: 15/09/2022
Tenofovir disoproxil Zentiva Blood-Borne Infections Communicable … Tenofovir disoproxil Zentiva … product characteristics, the labelling and the package leaflet … -
List item
Human medicine European public assessment report (EPAR): Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva
efavirenz, emtricitabine, tenofovir disoproxil phosphate, HIV Infections
Date of authorisation: 17/07/2017,, Revision: 8, Authorised, Last updated: 18/05/2022
itabine/Tenofovir disoproxil Zentiva Blood-Borne Infections Communicable … itabine/Tenofovir disoproxil Zentiva … product characteristics, the labelling and the package leaflet … -
List item
Human medicine European public assessment report (EPAR): Emtricitabine/Tenofovir disoproxil Zentiva
emtricitabine, tenofovir disoproxil phosphate, HIV Infections
Date of authorisation: 09/11/2016,, Revision: 6, Authorised, Last updated: 21/07/2021
itabine/Tenofovir disoproxil Zentiva Blood-Borne Infections Communicable … itabine/Tenofovir disoproxil Zentiva … product characteristics, the labelling and the package leaflet …