1937 results
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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 Place … -
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Human medicine European public assessment report (EPAR): Imatinib Teva B.V.
imatinib mesilate, Dermatofibrosarcoma; Gastrointestinal Stromal Tumors; Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Date of authorisation: 15/11/2017,, Withdrawn, Last updated: 09/10/2018
Imatinib Teva B.V. Dermatofibrosarcoma Gastrointestinal … Imatinib Teva B.V … Imatinib Teva B.V imatinib imatinib mesilate … -
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Human medicine European public assessment report (EPAR): Imatinib Actavis
imatinib, Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Myelodysplastic-Myeloproliferative Diseases; Hypereosinophilic Syndrome; Dermatofibrosarcoma
Date of authorisation: 17/04/2013,, Revision: 13, Withdrawn, Last updated: 05/07/2022
Imatinib Actavis Cancer Leukemia … Imatinib Actavis … EMEA/H/C/002594 Public statement Imatinib Actavis imatinib) Withdrawal of the marketing … -
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Human medicine European public assessment report (EPAR): Imatinib Accord
imatinib, Precursor Cell Lymphoblastic Leukemia-Lymphoma; Dermatofibrosarcoma; Myelodysplastic-Myeloproliferative Diseases; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Hypereosinophilic Syndrome
Date of authorisation: 30/06/2013,, Revision: 20, Authorised, Last updated: 14/12/2022
Imatinib Accord Neoplasms Cancer Leukemia … Imatinib Accord … summary for the public Imatinib Accord imatinib This is a summary of the … -
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Human medicine European public assessment report (EPAR): Imatinib medac
imatinib, Precursor Cell Lymphoblastic Leukemia-Lymphoma; Dermatofibrosarcoma; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Myelodysplastic-Myeloproliferative Diseases; Hypereosinophilic Syndrome
Date of authorisation: 25/09/2013,, Revision: 5, Withdrawn, Last updated: 16/10/2019
Imatinib medac Precursor Cell Lymphoblastic … Withdrawn imatinib Overview The The approval … marketing authorisation for Imatinib Medac has been withdrawn … -
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Human medicine European public assessment report (EPAR): Imatinib Koanaa
imatinib mesilate, Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Myelodysplastic-Myeloproliferative Diseases; Hypereosinophilic Syndrome; Dermatofibrosarcoma; Gastrointestinal Stromal Tumors
Date of authorisation: 22/09/2021,, Authorised, Last updated: 01/10/2021
Imatinib Koanaa Leukemia, Myelogenous … Imatinib Koanaa … EMA/429510/2021 EMEA/H/C/005595 Imatinib Koanaa imatinib) An overview of Imatinib Koanaa and why it is authorised … -
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Human medicine European public assessment report (EPAR): Glivec
imatinib, Precursor Cell Lymphoblastic Leukemia-Lymphoma; Gastrointestinal Stromal Tumors; Dermatofibrosarcoma; Myelodysplastic-Myeloproliferative Diseases; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Hypereosinophilic Syndrome
Date of authorisation: 07/11/2001,
, Revision: 45, Authorised, Last updated: 29/03/2023
imatinib … for the public Glivec imatinib This is a summary of the … contains the active substance imatinib. It is available as capsules … -
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Opinion/decision on a Paediatric investigation plan (PIP): Glivec, imatinib mesilate
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-000463-PIP01-08-M03, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard, Film-coated tablet
Decision date: 28/01/2012, Last updated: 23/02/2012, Compliance check: V, 09/03/2012name Glivec Active substance imatinib mesilate Therapeutic area … paediatric investigation plan for imatinib mesilate (Glivec) (EMEA-000463-PIP01-08-M03 … paediatric investigation plan for imatinib mesilate (Glivec) (EMEA-000463-PIP01-08-M03 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Glivec, imatinib mesilate
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-000463-PIP02-10, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Capsule, hard, Age-appropriate oral solid dosage form
Decision date: 08/04/2011, Last updated: 12/05/2011, Compliance check: Xname Glivec Active substance imatinib mesilate Therapeutic area … granting of a waiver for imatinib (mesilate) (Glivec) (EMEA-000463-PIP02-10 … granting of a waiver for imatinib (mesilate) (Glivec) (EMEA-000463-PIP02-10 … -
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Withdrawn application: Ruvise
imatinib, date of withdrawal: 21/02/2013, Initial authorisation, Last updated: 10/04/2013application for Ruvise (imatinib) On 17 January 2013 Novartis … contains the active substance imatinib. It was to be available as … mg). Medicines containing imatinib are currently approved in … -
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Withdrawn application: Glivec
imatinib, date of withdrawal: 18/10/2006, Post-authorisation, Last updated: 23/10/2006non-proprietary name (INN): imatinib On 18 October 2006, Novartis … contains the active substance imatinib. It is available as capsules … active substance in Glivec, imatinib, is a protein-tyrosine kinase … -
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Orphan designation: imatinib for: Treatment of pulmonary arterial hypertension
Date of designation: 21/06/2021, Positive, Last updated: 11/05/2022imatinib … 11 2.1.6. imatinib - EMA/OD/0000051869 … imatinib … -
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Orphan designation: imatinib for: Treatment of acute respiratory distress syndrome (ARDS)
Date of designation: 19/11/2014, Positive, Last updated: 06/08/2021imatinib … opinion on orphan designation Imatinib for the treatment of acute … opinion on orphan designation Imatinib for the treatment of acute … -
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Opinion/decision on a Paediatric investigation plan (PIP): imatinib
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-002643-PIP01-19-M01, Route(s) of administration: Naso-gastric use, Oral use, Pharmaceutical form(s): Powder for oral solution
Decision date: 29/10/2021, Last updated: 13/02/2023, Compliance check: XKey facts imatinib OncologyP/0424/2021EMEA-002643-PIP01-19-M01 … paediatric investigation plan for imatinib (as imatinib mesylate) (EMEA-002643-PIP01-19-M01 … paediatric investigation plan for imatinib (as imatinib mesylate), (EMEA-002643-PIP01-19-M01 … -
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Orphan designation: imatinib mesilate for: Treatment of dermatofibrosarcoma protuberans
Date of designation: 26/08/2005, Expired, Last updated: 09/02/2015imatinib mesilate … opinion on orphan designation Imatinib mesilate for the treatment … opinion on orphan designation Imatinib mesilate for the treatment … -
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Orphan designation: imatinib mesilate for: Treatment of malignant gastrointestinal stromal tumours
Date of designation: 20/11/2001, Expired, Last updated: 09/02/2015imatinib mesilate … opinion on orphan designation Imatinib mesilate for the treatment … opinion on orphan designation Imatinib mesilate for the treatment … -
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Orphan designation: imatinib mesilate for: Treatment of acute lymphoblastic leukaemia
Date of designation: 26/08/2005, Expired, Last updated: 10/02/2015imatinib mesilate … opinion on orphan designation Imatinib mesilate for the treatment … opinion on orphan designation Imatinib mesilate for the treatment … -
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Orphan designation: imatinib mesilate for: Treatment of chronic myeloid leukaemia
Date of designation: 15/02/2001, Expired, Last updated: 10/02/2015imatinib mesilate … opinion on orphan designation Imatinib mesilate for treatment of … opinion on orphan designation Imatinib mesilate for treatment of … -
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Orphan designation: imatinib mesilate for: Treatment of myelodysplastic / myeloproliferative diseases
Date of designation: 23/12/2005, Expired, Last updated: 09/02/2015imatinib mesilate … opinion on orphan designation Imatinib mesilate for the treatment … Limited, United Kingdom, for imatinib mesilate for the treatment … -
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Orphan designation: imatinib mesilate for: Treatment of chronic eosinophilic leukaemia and the hypereosinophilic syndrome
Date of designation: 28/10/2005, Expired, Last updated: 09/02/2015imatinib mesilate … opinion on orphan designation Imatinib mesilate for the treatment … opinion on orphan designation Imatinib mesilate for the treatment … -
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Orphan designation: imatinib mesilate for: Treatment of mastocytosis
Date of designation: 26/08/2005, Withdrawn, Last updated: 10/02/2015imatinib mesilate … opinion on orphan designation Imatinib mesilate for the treatment … opinion on orphan designation Imatinib mesilate for the treatment … -
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Human medicine European public assessment report (EPAR): Zoledronic acid Teva
zoledronic acid, Fractures, Bone; Cancer
Date of authorisation: 16/08/2012,, Revision: 14, Authorised, Last updated: 11/10/2021
Zoledronic acid Teva Wounds and Injuries Cancer Neoplasms Fractures … EPAR) for Zoledronic acid Teva. It explains how the Committee … of use for Zoledronic acid Teva. Expand section Collapse section … -
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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): 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 … authorisation for Nevirapine Teva has been withdrawn at the … Summary documents Nevirapine Teva : EPAR - Summary for the …