Pemetrexed Krka

Withdrawn

This medicine's authorisation has been withdrawn

pemetrexed

Overview

On 28 June 2024, the European Commission withdrew the marketing authorisation for Pemetrexed Krka (Pemetrexed) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, KRKA, d.d., Novo mesto, which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons. 

Pemetrexed Krka was granted marketing authorisation in the EU on 22 May 2018 for treatment of malignant pleural mesothelioma and non-small cell lung cancer treatment of malignant pleural mesothelioma and non-small cell lung cancer. The marketing authorisation was initially valid for a 5- year period. It was then granted unlimited validity in 2023. The product had not been marketed in the EU since 2022. 

Pemetrexed Krka is a generic medicine of Alimta. There are other generic medicinal products of Alimta authorised and marketed in the EU. 

The European Public Assessment Report (EPAR) for Pemetrexed Krka is updated to indicate that the marketing authorisation is no longer valid.

Pemetrexed Krka : EPAR - Medicine overview

Reference Number: EMA/303183/2018

Pemetrexed Krka : EPAR - Risk-management-plan summary

Product information

Pemetrexed Krka : EPAR - Product Information

Pemetrexed Krka : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Pemetrexed Krka
• Active substance:
  pemetrexed disodium
• International non-proprietary name (INN) or common name:
  pemetrexed
• Therapeutic area (MeSH):
  • Carcinoma, Non-Small-Cell Lung
  • Mesothelioma
• Anatomical therapeutic chemical (ATC) code:
  L01BA04

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Malignant pleural mesothelioma

Pemetrexed Krka in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma.

Non-small cell lung cancer

Pemetrexed Krka in combination with cisplatin is indicated for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology.

Pemetrexed Krka is indicated as monotherapy for the maintenance treatment of locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy.

Pemetrexed Krka is indicated as monotherapy for the second-line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology.

Authorisation details

• EMA product number:
  EMEA/H/C/003958
• 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:
  KRKA d.d.

  Šmarješka cesta 6 ; 8501 Novo mesto ; Slovenia

• Opinion adopted:
  22/03/2018
• Marketing authorisation issued:
  22/05/2018
• Revision:
  6

Assessment history

Changes since initial authorisation of medicine

Pemetrexed Krka : EPAR - Procedural steps taken and scientific information after authorisation

Initial marketing authorisation documents

Pemetrexed Krka : EPAR - Public assessment report

Reference Number: EMA/CHMP/225126/2018

CHMP summary of positive opinion for Pemetrexed Krka

Adopted Reference Number: EMA/CHMP/10762/2018