Pemetrexed Pfizer (previously known as Pemetrexed Hospira UK Limited)
pemetrexed
Table of contents
Overview
The marketing authorisation has been withdrawn at the request of the marketing authorisation holder.
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) |
|
| Anatomical therapeutic chemical (ATC) code |
L01BA04
|
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. |
| 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 |
Product information
21/10/2020 Pemetrexed Pfizer (previously known as Pemetrexed Hospira UK Limited) - EMEA/H/C/004488 -
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).
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
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ANTIMETABOLITES
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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).