Pemetrexed Pfizer (previously known as Pemetrexed Hospira UK Limited)

Withdrawn

This medicine's authorisation has been withdrawn

pemetrexed

Overview

The marketing authorisation has been withdrawn at the request of the marketing authorisation holder.

 

Pemetrexed Hospira UK Limited : EPAR - Summary for the public

Reference Number: EMA/147008/2017

Product information

Pemetrexed Pfizer : EPAR - Product Information

21/10/2020

This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.

 

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).

Pemetrexed Pfizer : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Pemetrexed Pfizer (previously known as 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

AdoptedReference Number: EMA/CHMP/270680/2017

CHMP summary of positive opinion for Pemetrexed Hospira UK Limited

AdoptedReference Number: EMA/CHMP/96855/2017