Pemetrexed Krka
pemetrexed
Table of contents
Overview
Pemetrexed Krka is a cancer medicine used to treat two types of lung cancer:
- malignant pleural mesothelioma (a cancer of the lining of the lungs that is usually caused by exposure to asbestos), where it is used together with cisplatin in patients who have not received chemotherapy before and whose cancer cannot be removed by surgery;
- advanced non-small-cell lung cancer of the kind known as ‘non-squamous’, where it is used either in combination with cisplatin in previously untreated patients or on its own in patients who have previously received cancer treatment. It can also be used as a maintenance treatment in patients who have received platinum-based chemotherapy.
Pemetrexed Krka contains the active substance pemetrexed. It is a ‘generic medicine’. This means that Pemetrexed Krka contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the EU called Alimta.
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List item
Pemetrexed Krka : EPAR - Medicine overview (PDF/98.49 KB)
First published: 08/06/2018
Last updated: 08/06/2018
EMA/303183/2018 -
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Pemetrexed Krka : EPAR - Risk-management-plan summary (PDF/111.33 KB)
First published: 08/06/2018
Last updated: 08/06/2018
Authorisation details
Product details | |
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Name |
Pemetrexed Krka
|
Agency product number |
EMEA/H/C/003958
|
Active substance |
pemetrexed disodium
|
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 | |
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Marketing-authorisation holder |
KRKA d.d.
|
Revision |
6
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Date of issue of marketing authorisation valid throughout the European Union |
22/05/2018
|
Contact address |
Šmarješka cesta 6 8501 Novo mesto Slovenia |
Product information
15/02/2023 Pemetrexed Krka - EMEA/H/C/003958 - R/0009
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 Krka in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma.
Non-small cell lung cancer
Pemetrexed Krka 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 Krka 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 Krka 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.