Pemetrexed Lilly
pemetrexed
Table of contents
Overview
The marketing authorisation for Pemetrexed Lilly has been withdrawn at the request of the marketing-authorisation holder.
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List item
Pemetrexed Lilly : EPAR - Summary for the public (PDF/744.06 KB)
First published: 02/10/2015
Last updated: 26/11/2021
EMA/509168/2015 -
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Pemetrexed Lilly : EPAR - Risk-management-plan summary (PDF/660.07 KB)
First published: 02/10/2015
Last updated: 26/11/2021
EMA/512407/2015
Authorisation details
| Product details | |
|---|---|
| Name |
Pemetrexed Lilly
|
| Agency product number |
EMEA/H/C/004114
|
| Active substance |
pemetrexed
|
| 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 |
Eli Lilly Netherlands
|
| Revision |
7
|
| Date of issue of marketing authorisation valid throughout the European Union |
14/09/2015
|
| Contact address |
Grootslag 1-5
PO Box 379 NL-3991 RA Houten The Netherlands |
Product information
18/06/2021 Pemetrexed Lilly - EMEA/H/C/004114 - N/0013
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
Antineoplastic agents
Therapeutic indication
Malignant pleural mesothelioma
Pemetrexed Lilly in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma.
Non-small cell lung cancer
Pemetrexed Lilly 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.
Pemetrexed Lilly 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.
Pemetrexed Lilly 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.