Pemetrexed Accord

pemetrexed

  • Email
  • Help

About

This is a summary of the European public assessment report (EPAR) for Pemetrexed Accord. 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 Accord.

For practical information about using Pemetrexed Accord, patients should read the package leaflet or contact their doctor or pharmacist.

What is Pemetrexed Accord and what is it used for?

Pemetrexed Accord 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 Accord is a ‘generic medicine’. This means that Pemetrexed Accord is similar to a ‘reference medicine’ already authorised in the European Union (EU) called Alimta.

Pemetrexed Accord contains the active substance pemetrexed.

How is Pemetrexed Accord used?

Pemetrexed Accord 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 cancer medicines.

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 Accord. When Pemetrexed Accord 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).

How does Pemetrexed Accord work?

The active substance in Pemetrexed Accord, 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.

How has Pemetrexed Accord been studied?

The company provided data from the published literature on pemetrexed. No additional studies were needed as Pemetrexed Accord is a generic medicine that is given by infusion and contains the same active substance as the reference medicine, Alimta.

What are the benefits and risks of Pemetrexed Accord?

Because Pemetrexed Accord is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.

Why is Pemetrexed Accord approved?

The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Pemetrexed Accord 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 Accord be approved for use in the EU.

What measures are being taken to ensure the safe and effective use of Pemetrexed Accord?

A risk management plan has been developed to ensure that Pemetrexed Accord 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 Accord, including the appropriate precautions to be followed by healthcare professionals and patients.

Further information can be found in the summary of the risk management plan.

Other information about Pemetrexed Accord

The European Commission granted a marketing authorisation valid throughout the European Union for Pemetrexed Accord on 18 January 2016.

For more information about treatment with Pemetrexed Accord, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Name Language First published Last updated
Pemetrexed Accord : EPAR - Summary for the public BG = bălgarski 29/01/2016  
Pemetrexed Accord : EPAR - Summary for the public ES = español 29/01/2016  
Pemetrexed Accord : EPAR - Summary for the public CS = čeština 29/01/2016  
Pemetrexed Accord : EPAR - Summary for the public DA = dansk 29/01/2016  
Pemetrexed Accord : EPAR - Summary for the public DE = Deutsch 29/01/2016  
Pemetrexed Accord : EPAR - Summary for the public ET = eesti keel 29/01/2016  
Pemetrexed Accord : EPAR - Summary for the public EL = elliniká 29/01/2016  
Pemetrexed Accord : EPAR - Summary for the public EN = English 29/01/2016  
Pemetrexed Accord : EPAR - Summary for the public FR = français 29/01/2016  
Pemetrexed Accord : EPAR - Summary for the public IT = italiano 29/01/2016  
Pemetrexed Accord : EPAR - Summary for the public LV = latviešu valoda 29/01/2016  
Pemetrexed Accord : EPAR - Summary for the public LT = lietuvių kalba 29/01/2016  
Pemetrexed Accord : EPAR - Summary for the public HU = magyar 29/01/2016  
Pemetrexed Accord : EPAR - Summary for the public MT = Malti 29/01/2016  
Pemetrexed Accord : EPAR - Summary for the public NL = Nederlands 29/01/2016  
Pemetrexed Accord : EPAR - Summary for the public PL = polski 29/01/2016  
Pemetrexed Accord : EPAR - Summary for the public PT = português 29/01/2016  
Pemetrexed Accord : EPAR - Summary for the public RO = română 29/01/2016  
Pemetrexed Accord : EPAR - Summary for the public SK = slovenčina 29/01/2016  
Pemetrexed Accord : EPAR - Summary for the public SL = slovenščina 29/01/2016  
Pemetrexed Accord : EPAR - Summary for the public FI = suomi 29/01/2016  
Pemetrexed Accord : EPAR - Summary for the public SV = svenska 29/01/2016  
Pemetrexed Accord : EPAR - Summary for the public HR = Hrvatski 29/01/2016  
Name Language First published Last updated
Pemetrexed Accord : EPAR - Risk-management-plan summary (English only) 29/01/2016  

This EPAR was last updated on 29/01/2016 .

Authorisation details

Product details

Product details for Pemetrexed Accord
NamePemetrexed Accord
Agency product numberEMEA/H/C/004072
Active substance

pemetrexed disodium hemipentahydrate

International non-proprietary name (INN) or common name

pemetrexed

Therapeutic area Carcinoma, Non-Small-Cell LungMesothelioma
Anatomical therapeutic chemical (ATC) code L01BA04
Generic

A generic medicine is a medicine which is similar to a medicine that has already been authorised (the 'reference medicine'). A generic medicine contains the same quantity of active substance(s) as the reference medicine. Generic and reference medicines are used at the same dose to treat the same disease, and they are equally safe and effective.

Publication details

Publication details for Pemetrexed Accord
Marketing-authorisation holder

Accord Healthcare Ltd

Revision0
Date of issue of marketing authorisation valid throughout the European Union18/01/2016

Contact address:

Accord Healthcare Ltd
Sage House 
319 Pinner Road 
North Harrow HA1 4HF 
United Kingdom

Product information

Product information

18/01/2016  Pemetrexed Accord -EMEA/H/C/004072

Name Language First published Last updated
Pemetrexed Accord : EPAR - Product Information EN = English 29/01/2016  
Pemetrexed Accord : EPAR - Product Information EN = English 29/01/2016  
Pemetrexed Accord : EPAR - Product Information EN = English 29/01/2016  
Pemetrexed Accord : EPAR - Product Information EN = English 29/01/2016  
Pemetrexed Accord : EPAR - Product Information EN = English 29/01/2016  
Pemetrexed Accord : EPAR - Product Information EN = English 29/01/2016  
Pemetrexed Accord : EPAR - Product Information EN = English 29/01/2016  
Pemetrexed Accord : EPAR - Product Information EN = English 29/01/2016  
Pemetrexed Accord : EPAR - Product Information EN = English 29/01/2016  
Pemetrexed Accord : EPAR - Product Information EN = English 29/01/2016  
Pemetrexed Accord : EPAR - Product Information EN = English 29/01/2016  
Pemetrexed Accord : EPAR - Product Information EN = English 29/01/2016  
Pemetrexed Accord : EPAR - Product Information EN = English 29/01/2016  
Pemetrexed Accord : EPAR - Product Information EN = English 29/01/2016  
Pemetrexed Accord : EPAR - Product Information EN = English 29/01/2016  
Pemetrexed Accord : EPAR - Product Information EN = English 29/01/2016  
Pemetrexed Accord : EPAR - Product Information EN = English 29/01/2016  
Pemetrexed Accord : EPAR - Product Information EN = English 29/01/2016  
Pemetrexed Accord : EPAR - Product Information EN = English 29/01/2016  
Pemetrexed Accord : EPAR - Product Information EN = English 29/01/2016  
Pemetrexed Accord : EPAR - Product Information EN = English 29/01/2016  
Pemetrexed Accord : EPAR - Product Information EN = English 29/01/2016  
Pemetrexed Accord : EPAR - Product Information EN = English 29/01/2016  
Pemetrexed Accord : EPAR - Product Information EN = English 29/01/2016  
Pemetrexed Accord : EPAR - Product Information EN = English 29/01/2016  

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.


Name Language First published Last updated
Pemetrexed Accord : EPAR - All Authorised presentations EN = English 29/01/2016  
Pemetrexed Accord : EPAR - All Authorised presentations EN = English 29/01/2016  
Pemetrexed Accord : EPAR - All Authorised presentations EN = English 29/01/2016  
Pemetrexed Accord : EPAR - All Authorised presentations EN = English 29/01/2016  
Pemetrexed Accord : EPAR - All Authorised presentations EN = English 29/01/2016  
Pemetrexed Accord : EPAR - All Authorised presentations EN = English 29/01/2016  
Pemetrexed Accord : EPAR - All Authorised presentations EN = English 29/01/2016  
Pemetrexed Accord : EPAR - All Authorised presentations EN = English 29/01/2016  
Pemetrexed Accord : EPAR - All Authorised presentations EN = English 29/01/2016  
Pemetrexed Accord : EPAR - All Authorised presentations EN = English 29/01/2016  
Pemetrexed Accord : EPAR - All Authorised presentations EN = English 29/01/2016  
Pemetrexed Accord : EPAR - All Authorised presentations EN = English 29/01/2016  
Pemetrexed Accord : EPAR - All Authorised presentations EN = English 29/01/2016  
Pemetrexed Accord : EPAR - All Authorised presentations EN = English 29/01/2016  
Pemetrexed Accord : EPAR - All Authorised presentations EN = English 29/01/2016  
Pemetrexed Accord : EPAR - All Authorised presentations EN = English 29/01/2016  
Pemetrexed Accord : EPAR - All Authorised presentations EN = English 29/01/2016  
Pemetrexed Accord : EPAR - All Authorised presentations EN = English 29/01/2016  
Pemetrexed Accord : EPAR - All Authorised presentations EN = English 29/01/2016  
Pemetrexed Accord : EPAR - All Authorised presentations EN = English 29/01/2016  
Pemetrexed Accord : EPAR - All Authorised presentations EN = English 29/01/2016  
Pemetrexed Accord : EPAR - All Authorised presentations EN = English 29/01/2016  
Pemetrexed Accord : EPAR - All Authorised presentations EN = English 29/01/2016  
Pemetrexed Accord : EPAR - All Authorised presentations EN = English 29/01/2016  
Pemetrexed Accord : EPAR - All Authorised presentations EN = English 29/01/2016  

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Malignant pleural mesothelioma

Pemetrexed Accord in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma.

Non-small cell lung cancer

Pemetrexed Accord 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 Accord 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 Accord 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.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated

Initial marketing-authorisation documents

Name Language First published Last updated
Pemetrexed Accord : EPAR - Public assessment report EN = English 29/01/2016  
CHMP summary of opinion for Pemetrexed Accord EN = English 20/11/2015  

Authorised

This medicine is approved for use in the European Union

More information on Pemetrexed Accord