Imatinib Koanaa

Withdrawn

This medicine's authorisation has been withdrawn

imatinib

Overview

The marketing authorisation for Imatinib Koanaa has been withdrawn at the request of the marketing-authorisation holder.

Imatinib Koanaa : EPAR - Medicine overview

Reference Number: EMA/429510/2021

Imatinib Koanaa : EPAR - Risk-management-plan summary

Product information

Imatinib Koanaa : EPAR - Product information

22/09/2021

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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 Koanaa : EPAR - All authorised presentations

Product details

• Name of medicine:
  Imatinib Koanaa
• Active substance:
  imatinib mesilate
• 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
  • Gastrointestinal Stromal Tumors
• Anatomical therapeutic chemical (ATC) code:
  L01EA01

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Imatinib Koanaa is indicated for the treatment of

• adult and 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.
• adult and paediatric patients with Ph+ CML in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis.
• adult and paediatric 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 effect of Imatinib on the outcome of bone marrow transplantation has not been determined.

Imatinib Koanaa is indicated for

• the treatment of adult patients with Kit (CD 117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (GIST).
• the adjuvant treatment of adult patients who are at significant risk of relapse following resection of Kit (CD117)-positive GIST. Patients who have a low or very low risk of recurrence should not receive adjuvant treatment.
• 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.

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 GIST and DFSP and on recurrence-free survival in adjuvant GIST. The experience with Imatinib in patients with MDS/MPD associated with PDGFR gene re-arrangements is very limited (see section 5.1). Except in newly diagnosed chronic phase CML, there are no controlled trials demonstrating a clinical benefit or increased survival for these diseases.

Authorisation details

• EMA product number:
  EMEA/H/C/005595
• 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:
  Koanaa Healthcare GmbH

  Fehrgasse 7; 2401 Fischamend; Austria

• Opinion adopted:
  22/07/2021
• Marketing authorisation issued:
  22/09/2021

Assessment history

Initial marketing authorisation documents

Imatinib Koanaa : EPAR - Public assessment report

AdoptedReference Number: EMA/CHMP/444756/2021

CHMP summary of positive opinion for Imatinib Koanaa

AdoptedReference Number: EMA/338599/2021