Overview
The marketing authorisation has been withdrawn at the request of the marketing authorisation holder.
Pemetrexed Hospira UK Limited : EPAR - Summary for the public
Product information
Pemetrexed Pfizer : EPAR - Product Information
21/10/2020
This medicine’s product information is available in all official EU languages.
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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).
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).
Assessment history
Pemetrexed Pfizer : EPAR - Procedural steps taken and scientific information after authorisation