Imatinib Actavis

Withdrawn

This medicine's authorisation has been withdrawn

imatinib

Overview

The marketing authorisation for Imatinib Actavis has been withdrawn at the request of the marketing-authorisation holder.

Imatinib Actavis : EPAR - Medicine overview

Reference Number: EMA/30081/2019

Product information

Imatinib Actavis : EPAR - Product Information

Latest procedure affecting product information: IA/0020

16/12/2021

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Product information documents contain:

• summary of product characteristics (annex I);
• manufacturing authorisation holder responsible for batch release (annex IIA);
• conditions of the marketing authorisation (annex IIB);
• labelling (annex IIIA);
• package leaflet (annex IIIB).

Imatinib Actavis : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Imatinib Actavis
• Active substance:
  imatinib
• International non-proprietary name (INN) or common name:
  imatinib
• Therapeutic area (MeSH):
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Myelodysplastic-Myeloproliferative Diseases
  • Hypereosinophilic Syndrome
  • Dermatofibrosarcoma
• Anatomical therapeutic chemical (ATC) code:
  L01EA01

Pharmacotherapeutic group

• Protein kinase inhibitors
• Antineoplastic agents

Therapeutic indication

Imatinib Actavis is indicated for the treatment of:

• paediatric patients with newly diagnosed Philadelphia chromosome (bcr-abl) positive (Ph+) chronic myeloid leukaemia (CML) for whom bone marrow transplantation is not considered as the first line of treatment;
• paediatric patients with Ph+ CML in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis;
• adult patients with Ph+ CML in blast crisis;
• adult patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) integrated with chemotherapy;
• adult patients with relapsed or refractory Ph+ ALL as monotherapy;
• adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with platelet-derived growth factor receptor (PDGFR) gene re-arrangements;
• adult patients with advanced hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukaemia (CEL) with FIP1L1-PDGFR rearrangement;
• the treatment of adult patients with unresectable dermatofibrosarcoma protuberans (DFSP) and adult patients with recurrent and/or metastatic DFSP who are not eligible for surgery.

The effect of imatinib on the outcome of bone marrow transplantation has not been determined.

Imatinib Actavis is indicated for:

• In adult and paediatric patients, the effectiveness of imatinib is based on overall haematological and cytogenetic response rates and progression-free survival in CML, on haematological and cytogenetic response rates in Ph+ ALL, MDS/MPD, on haematological response rates in HES/CEL and on objective response rates in adult patients with unresectable and/or metastatic DFSP. The experience with imatinib in patients with MDS/MPD associated with PDGFR gene re-arrangements is very limited. There are no controlled trials demonstrating a clinical benefit or increased survival for these diseases.

Authorisation details

• EMA product number:
  EMEA/H/C/002594
• Generic:

  This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines.

• Marketing authorisation holder:
  Actavis Group PTC ehf

  Reykjavíkurvegur 76-78; Hafnarfjörður; Iceland

• Opinion adopted:
  21/02/2013
• Marketing authorisation issued:
  17/04/2013
• Revision:
  13

Assessment history

Changes since initial authorisation of medicine

Imatinib Actavis : EPAR - Procedural steps taken and scientific information after authorisation

Imatinib Actavis-H-C-2594-X-0003 : EPAR - Assessment Report - Extension

AdoptedReference Number: EMA/284461/2014

Initial marketing authorisation documents

Imatinib Actavis : EPAR - Public assessment report

Adopted

CHMP summary of positive opinion for Imatinib Actavis

AdoptedReference Number: EMA/CHMP/82403/2013