Pemetrexed Pfizer (previously Pemetrexed Hospira UK Limited)

Withdrawn

This medicine's authorisation has been withdrawn

pemetrexed

Overview

On 26 April 2020, the marketing authorisation of Pemetrexed Pfizer (pemetrexed) ceased to be valid in the European Union (EU). The cessation of validity is due to the fact that the marketing authorisation holder, Pfizer Europe MA EEIG, had not marketed Pemetrexed Pfizer in the EU since its initial marketing authorisation. 

In accordance with provisions of the sunset clause1, the marketing authorisation of the medicinal product lapsed as the product had not been marketed in any of the EU Member States within three years of its initial authorisation. Pfizer Europe MA EEIG confirmed that the product had not been marketed for commercial reasons. 

Pemetrexed Pfizer was granted marketing authorisation in the EU on 26 April 2017 and was indicated

• in combination with cisplatin for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma and for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology;
• 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 and for the secondline treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology. 

The marketing authorisation was initially valid for a 5-year period. Pemetrexed Pfizer 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Public Assessment Report (EPAR) for Pemetrexed Pfizer is updated to indicate that the marketing authorisation is no longer valid.

Pemetrexed Hospira UK Limited : EPAR - Summary for the public

Reference Number: EMA/147008/2017

Product information

Pemetrexed Pfizer : EPAR - Product Information

Pemetrexed Pfizer : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Pemetrexed Pfizer (previously Pemetrexed Hospira UK Limited)
• Active substance:
  pemetrexed ditromethamine
• 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

• ANTIMETABOLITES
• Folic acid analogues

Therapeutic indication

Malignant pleural mesothelioma

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

Non-small cell lung cancer

Pemetrexed Hospira UK Limited 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 (see SmPC section 5.1).

Pemetrexed Hospira UK Limited 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 (see SmPC section 5.1).

Pemetrexed Hospira UK Limited 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 (see SmPC section 5.1).

Authorisation details

• EMA product number:
  EMEA/H/C/004488
• 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:
  Pfizer Europe MA EEIG

  Boulevard de la Plaine 17; 1050 Bruxelles; Belgium

• Opinion adopted:
  23/02/2017
• Marketing authorisation issued:
  24/04/2017
• Revision:
  7

Assessment history

Changes since initial authorisation of medicine

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

Initial marketing authorisation documents

Pemetrexed Hospira UK Limited : EPAR - Public assessment report

Adopted Reference Number: EMA/CHMP/270680/2017

CHMP summary of positive opinion for Pemetrexed Hospira UK Limited

Adopted Reference Number: EMA/CHMP/96855/2017