760 results
Keyword Icatibant Teva Remove keyword
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Human medicine European public assessment report (EPAR): Icatibant Accord
icatibant acetate, Angioedemas, Hereditary
Date of authorisation: 16/07/2021,
, Authorised, Last updated: 06/09/2021
Icatibant Accord Cardiovascular Diseases Vascular … Icatibant Accord … EMA/308584/2021 EMEA/H/C/0005083 Icatibant Accord icatibant) An overview of Icatibant Accord and why it is authorised … -
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Human medicine European public assessment report (EPAR): Firazyr
icatibant, Angioedemas, Hereditary
Date of authorisation: 11/07/2008, Revision: 23, Authorised, Last updated: 28/04/2023Authorised icatibant Overview This is a summary … medicine. active substance icatibant. Because the number of patients … of Firazyr contains 30 mg icatibant in 3 ml. The medicine is … -
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Opinion/decision on a Paediatric investigation plan (PIP): Firazyr, icatibant
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Other
PIP number: EMEA-000408-PIP02-12, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 23/11/2012, Last updated: 07/01/2013, Compliance check: XFirazyr Active substance icatibant Therapeutic area Other Decision … product specific waiver for icatibant (Firazyr), (EMEA-000408-PIP02-12 … product specific waiver for icatibant (Firazyr), (EMEA-000408-PIP02-12 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Firazyr, icatibant acetate
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Other
PIP number: EMEA-000408-PIP01-08-M05, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 30/10/2015, Last updated: 21/12/2016, Compliance check: V, 19/08/2016Firazyr Active substance icatibant acetate Therapeutic area … paediatric investigation plan for icatibant acetate (Firazyr), (EMEA-000408-PIP01-08-M05 … paediatric investigation plan for icatibant acetate (Firazyr), (EMEA-000408-PIP01-08-M05 … -
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Withdrawn application: Firazyr
icatibant, date of withdrawal: 14/02/2014, Post-authorisation, Last updated: 21/02/2014authorisation for Firazyr (icatibant) On 14 February 2014 … contains the active substance icatibant. It has been authorised since … active substance in Firazyr, icatibant, blocks the receptors that … -
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Orphan designation: icatibant acetate for: Treatment of angioedema
Date of designation: 18/02/2003, Expired, Last updated: 12/08/2020icatibant acetate … icatibant acetate … -
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Withdrawn application: Pioglitazone Teva Generics
pioglitazone, date of withdrawal: 26/01/2012, Initial authorisation, Last updated: 03/07/2012Pioglitazone Teva Generics: Withdrawn applicati … Pioglitazone Teva Generics: Withdrawal of the … authorisation) Pioglitazone Teva Generics pioglitazone On … -
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Withdrawn application: Clopidogrel Teva Pharma
clopidogrel, date of withdrawal: 22/04/2009, Initial authorisation, Last updated: 23/04/2009Clopidogrel Teva Pharma: Withdrawn application … Clopidogrel Teva Pharma: Withdrawal of the … application for Clopidogrel Teva Pharma clopidogrel … -
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Human medicine European public assessment report (EPAR): Tevagrastim (updated)
filgrastim, Neutropenia; Hematopoietic Stem Cell Transplantation; Cancer
Date of authorisation: 15/09/2008,
, Revision: 17, Authorised, Last updated: 24/05/2023
Tevagrastim Agranulocytosis Leukopenia Leukocyte … part of the EPAR). What is Tevagrastim? Tevagrastim is a solution for injection … active substance filgrastim. Tevagrastim is a ‘ A medicine that … -
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Human medicine European public assessment report (EPAR): Nevirapine Teva
nevirapine, HIV Infections
Date of authorisation: 30/11/2009,, Revision: 11, Withdrawn, Last updated: 21/03/2023
Nevirapine Teva Blood-Borne Infections Communicable … Nevirapine Teva … Public statement Nevirapine Teva (nevirapine) Withdrawal … -
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Human medicine European public assessment report (EPAR): Efavirenz Teva
efavirenz, HIV Infections
Date of authorisation: 09/01/2012,, Revision: 12, Authorised, Last updated: 03/03/2023
Efavirenz Teva Blood-Borne Infections Communicable … Efavirenz Teva … for the public Efavirenz Teva efavirenz This is a summary … -
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Human medicine European public assessment report (EPAR): Olanzapine Teva
olanzapine, Schizophrenia; Bipolar Disorder
Date of authorisation: 12/12/2007,, Revision: 29, Authorised, Last updated: 22/11/2022
Olanzapine Teva Schizophrenia Spectrum and … Olanzapine Teva … Olanzapine Teva, INN-olanzapine 7 … -
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Human medicine European public assessment report (EPAR): Lamivudine Teva
lamivudine, Hepatitis B, Chronic
Date of authorisation: 23/10/2009,, Revision: 13, Authorised, Last updated: 17/11/2022
Lamivudine Teva Infections Communicable … Lamivudine Teva … for the public Lamivudine Teva lamivudine This is a summary … -
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Human medicine European public assessment report (EPAR): Levetiracetam Teva
levetiracetam, Epilepsy
Date of authorisation: 25/08/2011,, Revision: 19, Authorised, Last updated: 06/07/2022
Levetiracetam Teva Nervous System Diseases Central … levetiracetam Overview Levetiracetam Teva is an epilepsy medicine … whole brain. Levetiracetam Teva can also be used as an add-on … -
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Human medicine European public assessment report (EPAR): Sildenafil Teva
sildenafil, Erectile Dysfunction
Date of authorisation: 30/11/2009,, Revision: 17, Authorised, Last updated: 04/07/2022
Sildenafil Teva Male Urogenital Diseases Genital … Sildenafil Teva … Sildenafil Teva, INN-sildenafil 7 … -
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Human medicine European public assessment report (EPAR): Imatinib Teva
imatinib, Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Myelodysplastic-Myeloproliferative Diseases; Hypereosinophilic Syndrome; Dermatofibrosarcoma
Date of authorisation: 07/01/2013,, Revision: 18, Authorised, Last updated: 09/06/2022
Imatinib Teva Leukemia, Myelogenous, Chronic … Imatinib Teva … Imatinib Teva, INN-imatinib 30 Churchill … -
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Human medicine European public assessment report (EPAR): Temozolomide Teva
temozolomide, Glioma; Glioblastoma
Date of authorisation: 28/01/2010,, Revision: 21, Authorised, Last updated: 18/02/2022
Temozolomide Teva Cancer Neuroectodermal … Temozolomide Teva … Temozolomide Teva, INN: temozolomide EMA/523990/2014 … -
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Human medicine European public assessment report (EPAR): Telmisartan Teva
Telmisartan, Hypertension
Date of authorisation: 25/01/2010,, Revision: 11, Withdrawn, Last updated: 17/09/2021
Telmisartan Teva Hypertension … Telmisartan Teva … Public statement Telmisartan Teva Withdrawal of the marketing … -
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Human medicine European public assessment report (EPAR): Irbesartan Teva
irbesartan, Hypertension
Date of authorisation: 30/10/2009,, Revision: 15, Authorised, Last updated: 06/09/2021
Irbesartan Teva Cardiovascular Diseases Vascular … EPAR). What is Irbesartan Teva? Irbesartan Teva is a medicine that contains … 150 and 300 mg). Irbesartan Teva is a ‘ A generic medicine … -
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Human medicine European public assessment report (EPAR): Repaglinide Teva
repaglinide, Diabetes Mellitus, Type 2
Date of authorisation: 28/06/2009,, Revision: 9, Authorised, Last updated: 17/12/2021
Repaglinide Teva Nutritional and Metabolic … Repaglinide Teva … EMEA/H/C/ 1067 Repaglinide Teva repaglinide EPAR summary … -
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Human medicine European public assessment report (EPAR): Ribavirin Teva
Ribavirin, Hepatitis C, Chronic
Date of authorisation: 31/03/2009,, Revision: 15, Withdrawn, Last updated: 09/07/2021
Ribavirin Teva Hepatitis C, Chronic … Ribavirin Teva … seven medicines (Cilazapril Teva, Fenofibrato Pensa, Fenofibrato … -
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Human medicine European public assessment report (EPAR): Desloratadine Teva
desloratadine, Rhinitis, Allergic, Perennial; Rhinitis, Allergic, Seasonal
Date of authorisation: 24/11/2011,, Revision: 18, Authorised, Last updated: 09/06/2022
Desloratadine Teva Respiratory Tract Diseases Nose … EPAR) for Desloratadine Teva. It explains how the The committee … of use for Desloratadine Teva. What is Desloratadine Teva? Desloratadine Teva is a medicine containing … -
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Human medicine European public assessment report (EPAR): Entacapone Teva
entacapone, Parkinson Disease
Date of authorisation: 18/02/2011,, Revision: 10, Authorised, Last updated: 28/09/2021
Entacapone Teva Nervous System Diseases Central … Entacapone Teva … Entacapone Teva-INN-Entacapone HCl 30 Churchill Place … -
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Human medicine European public assessment report (EPAR): Docetaxel Teva
docetaxel, Head and Neck Neoplasms; Carcinoma, Non-Small-Cell Lung; Adenocarcinoma; Prostatic Neoplasms; Stomach Neoplasms; Breast Neoplasms
Date of authorisation: 26/01/2010,, Revision: 18, Withdrawn, Last updated: 14/12/2021
Docetaxel Teva Cancer Neoplasms Breast … Docetaxel Teva … Public statement Docetaxel Teva Withdrawal of the marketing … -
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Human medicine European public assessment report (EPAR): Cabazitaxel Teva
cabazitaxel, Prostatic Neoplasms
Date of refusal: 11/07/2019, Refused, Last updated: 24/07/2019Cabazitaxel Teva Prostatic Neoplasms … Cabazitaxel Teva … Cabazitaxel Teva cabazitaxel cabazitaxel …