Pemetrexed Pfizer (previously known as Pemetrexed Hospira UK Limited)

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pemetrexed

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation has been withdrawn at the request of the marketing authorisation holder.

 

This EPAR was last updated on 29/07/2021

Authorisation details

Product details
Name
Pemetrexed Pfizer (previously known as Pemetrexed Hospira UK Limited)
Agency product number
EMEA/H/C/004488
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
GenericGeneric

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.

Publication details
Marketing-authorisation holder
Pfizer Europe MA EEIG
Revision
7
Date of issue of marketing authorisation valid throughout the European Union
24/04/2017
Contact address

Boulevard de la Plaine 17
1050 Bruxelles
Belgium

Product information

21/10/2020 Pemetrexed Pfizer (previously known as Pemetrexed Hospira UK Limited) - EMEA/H/C/004488 -

Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

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).

Assessment history

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