Basic Information
EMA regulatory identification and product classification information
EMA Identifiers
Overview Summary
Comprehensive product overview and regulatory summary
This is a summary of the European public assessment report (EPAR) for Pemetrexed medac. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Pemetrexed medac.
For practical information about using Pemetrexed medac, patients should read the package leaflet or contact their doctor or pharmacist.
Active Substances (1)
pemetrexed
Documents (10)
Pemetrexed medac : EPAR - Risk-management-plan summary
December 8, 2015
RISK_MANAGEMENT_PLAN_SUMMARY
Pemetrexed medac : EPAR - Procedural steps taken and scientific information after authorisation
May 28, 2025
CHANGES_SINCE_INITIAL_AUTHORISATION
Pemetrexed medac : EPAR - Public assessment report
December 8, 2015
INITIAL_MARKETING_AUTHORISATION_DOCUMENTS
Pemetrexed medac : EPAR - Public assessment report
December 8, 2015
CHANGES_SINCE_INITIAL_AUTHORISATION
CHMP summary of opinion for Pemetrexed medac
September 24, 2015
CHANGES_SINCE_INITIAL_AUTHORISATION
Pemetrexed medac : EPAR - Summary for the public
December 8, 2015
OVERVIEW_DOCUMENT
Pemetrexed medac : EPAR - All Authorised presentations
December 8, 2015
AUTHORISED_PRESENTATIONS
CHMP summary of opinion for Pemetrexed medac
September 24, 2015
INITIAL_MARKETING_AUTHORISATION_DOCUMENTS
Pemetrexed medac : EPAR - Product Information
December 8, 2015
DRUG_PRODUCT_INFORMATION
Pemetrexed medac : EPAR - Procedural steps taken and scientific information after authorisation (archive)
June 1, 2017
CHANGES_SINCE_INITIAL_AUTHORISATION
Overview Q&A (8)
Question
How is Pemetrexed medac used?
Answer
Pemetrexed medac is available as a powder that is made up into a solution for infusion (drip) into a vein. The medicine can only be obtained with a prescription and should only be given under the supervision of a doctor who is qualified in the use of chemotherapy.
The recommended dose is 500 mg per square metre of body surface area (calculated using the patient’s height and weight). It is given once every three weeks as an infusion lasting 10 minutes. To reduce side effects, patients should take a corticosteroid (a type of medicine that reduces inflammation) and folic acid (a type of vitamin), and receive injections of vitamin B12 during treatment with Pemetrexed medac. When Pemetrexed medac is given with cisplatin, an ‘anti-emetic’ medicine (to prevent vomiting) and fluids (to prevent dehydration) should also be given before or after the cisplatin dose.
Treatment should be delayed or stopped, or the dose reduced, in patients whose blood counts are abnormal or who have certain other side effects. For more information, see the summary of product characteristics (also part of the EPAR).
Question
How does Pemetrexed medac work?
Answer
The active substance in Pemetrexed medac, pemetrexed, is a cytotoxic medicine (a medicine that kills cells that are dividing, such as cancer cells), which belongs to the group ‘antimetabolites’. In the body, pemetrexed is converted into an active form that blocks the activity of the enzymes that are involved in producing ‘nucleotides’ (the building blocks of DNA and RNA, the genetic material of cells). As a result, the active form of pemetrexed slows down the formation of DNA and RNA and prevents the cells from dividing and multiplying. The conversion of pemetrexed into its active form occurs more readily in cancer cells than in normal cells, leading to higher levels of the active form of the medicine and a longer duration of action in cancer cells. This results in the division of cancer cells being reduced, while normal cells are only slightly affected.
Question
What measures are being taken to ensure the safe and effective use of Pemetrexed medac?
Answer
A risk management plan has been developed to ensure that Pemetrexed medac is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Pemetrexed medac, including the appropriate precautions to be followed by healthcare professionals and patients.
Further information can be found in the Pemetrexed medac : EPAR - Risk-management-plan summary.
Question
Other information about Pemetrexed medac
Answer
The European Commission granted a marketing authorisation valid throughout the European Union for Pemetrexed medac on 27 November 2015.
For more information about treatment with Pemetrexed medac, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Question
What are the benefits and risks of Pemetrexed medac?
Answer
Because Pemetrexed medac is a generic medicine, its benefits and risks are taken as being the same as the reference medicine’s.
Question
Why is Pemetrexed medac approved?
Answer
The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Pemetrexed medac has been shown to be comparable to Alimta. Therefore, the CHMP’s view was that, as for Alimta, the benefit outweighs the identified risk. The Committee recommended that Pemetrexed medac be approved for use in the EU.
Question
How has Pemetrexed medac been studied?
Answer
The company provided data from the published literature on pemetrexed. No additional studies were needed as Pemetrexed medac is a generic medicine that is given by infusion and contains the same active substance as the reference medicine, Alimta.
Question
What is Pemetrexed medac and what is it used for?
Answer
Pemetrexed medac 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 a platinum-based chemotherapy.
Pemetrexed medac is a ‘generic medicine’. This means that Pemetrexed medac is similar to a ‘reference medicine’ already authorised in the European Union (EU) called Alimta.
Pemetrexed medac contains the active substance pemetrexed.