Topotecan Teva

topotecan

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This is a summary of the European Public Assessment Report (EPAR). It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach their recommendations on how to use the medicine.

If you need more information about your medical condition or your treatment, read the Package Leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more information on the basis for the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).

What is Topotecan Teva?

Topotecan Teva is a concentrate that is made up into a solution for infusion (drip into a vein). It contains the active substance topotecan.

Topotecan Teva is a ‘generic medicine’. This means that Topotecan Teva is similar to a ‘reference medicine’ already authorised in the European Union (EU) called Hycamtin.

What is Topotecan Teva used for?

Topotecan Teva is an anticancer medicine. It is used on its own to treat patients with:

  • metastatic cancer of the ovary (when the cancer has spread to other parts of the body). It is used after at least one other treatment has failed;
  • small cell lung cancer, when the cancer has relapsed (come back). It is used when giving the original treatment again is not recommended.

It is also used together with cisplatin (another anticancer medicine) to treat women with cervical cancer (cancer of the cervix), when the cancer has come back after radiotherapy, or when the disease is at an advanced stage (stage IVB: the cancer has spread beyond the cervix).

The medicine can only be obtained with a prescription.

How is Topotecan Teva used?

Treatment with Topotecan Teva should only be given under the supervision of a doctor experienced in the use of chemotherapy. Infusions should be carried out in a specialised cancer ward. The patient’s blood levels of white blood cells, platelets and haemoglobin should be checked before treatment, to ensure that they are above set minimum levels. The doses may need to be adjusted or other medicines given to the patients, when the level of white blood cells remains particularly low.

The dose of Topotecan Teva to be used depends on the type of cancer that it is being used to treat and the patient’s weight and height. Topotecan Teva is given as an infusion lasting 30 minutes every day for five days with a three-week interval between the start of each course. Treatment may continue until the disease gets worse.

When used with cisplatin in cervical cancer, Topotecan Teva is given on days 1, 2 and 3 (with cisplatin given on day 1). This is repeated every 21 days for six courses or until the disease gets worse.

For full details, see the Summary of Product Characteristics (also part of the EPAR).

How does Topotecan Teva work?

The active substance in Topotecan Teva, topotecan, is an anticancer medicine that belongs to the group ‘topoisomerase inhibitors’. It blocks an enzyme called topoisomerase I, which is involved in the division of DNA. When the enzyme is blocked, the DNA strands break. This prevents the cancer cells from dividing and they eventually die. Topotecan Teva also affects non-cancer cells, which causes side effects.

How has Topotecan Teva been studied?

Because Topotecan Teva is a generic medicine, the company has provided data from the published literature on topotecan. No additional studies were needed as Topotecan Teva is a generic medicine that is given by infusion and contains the same active substance as the reference medicine, Hycamtin.

What are the benefit and risk of Topotecan Teva?

Because Topotecan Teva is a generic medicine, its benefit and risk are taken as being the same as those of the reference medicine.

Why has Topotecan Teva been approved?

The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Topotecan Teva has been shown to be comparable to Hycamtin. Therefore, the CHMP’s view was that, as for Hycamtin, the benefit outweighs the identified risk. The Committee recommended that Topotecan Teva be given marketing authorisation.

Other information about Topotecan Teva

The European Commission granted a marketing authorisation valid throughout the EU for Topotecan Teva to Teva Pharma B.V. on 21 September 2009.

Name Language First published Last updated
Topotecan Teva : EPAR - Summary for the public BG = bălgarski 2009-10-06  
Topotecan Teva : EPAR - Summary for the public ES = español 2009-10-06  
Topotecan Teva : EPAR - Summary for the public CS = čeština 2009-10-06  
Topotecan Teva : EPAR - Summary for the public DA = dansk 2009-10-06  
Topotecan Teva : EPAR - Summary for the public DE = Deutsch 2009-10-06  
Topotecan Teva : EPAR - Summary for the public ET = eesti keel 2009-10-06  
Topotecan Teva : EPAR - Summary for the public EL = elliniká 2009-10-06  
Topotecan Teva : EPAR - Summary for the public EN = English 2009-10-06  
Topotecan Teva : EPAR - Summary for the public FR = français 2009-10-06  
Topotecan Teva : EPAR - Summary for the public IT = italiano 2009-10-06  
Topotecan Teva : EPAR - Summary for the public LV = latviešu valoda 2009-10-06  
Topotecan Teva : EPAR - Summary for the public LT = lietuvių kalba 2009-10-06  
Topotecan Teva : EPAR - Summary for the public HU = magyar 2009-10-06  
Topotecan Teva : EPAR - Summary for the public MT = Malti 2009-10-06  
Topotecan Teva : EPAR - Summary for the public NL = Nederlands 2009-10-06  
Topotecan Teva : EPAR - Summary for the public PL = polski 2009-10-06  
Topotecan Teva : EPAR - Summary for the public PT = português 2009-10-06  
Topotecan Teva : EPAR - Summary for the public RO = română 2009-10-06  
Topotecan Teva : EPAR - Summary for the public SK = slovenčina 2009-10-06  
Topotecan Teva : EPAR - Summary for the public SL = slovenščina 2009-10-06  
Topotecan Teva : EPAR - Summary for the public FI = suomi 2009-10-06  
Topotecan Teva : EPAR - Summary for the public SV = svenska 2009-10-06  

This EPAR was last updated on 08/03/2018 .

Authorisation details

Product details

Product details for Topotecan Teva
NameTopotecan Teva
Agency product numberEMEA/H/C/001071
Active substance

topotecan

International non-proprietary name (INN) or common name

topotecan

Therapeutic area Small Cell Lung CarcinomaUterine Cervical NeoplasmsOvarian Neoplasms
Anatomical therapeutic chemical (ATC) code L01XX17
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 Topotecan Teva
Marketing-authorisation holder

Teva B.V.

Revision7
Date of issue of marketing authorisation valid throughout the European Union21/09/2009

Contact address:

Teva B.V.
Swensweg 5
2031GA Haarlem
The Netherlands

Product information

Product information

14/12/2017  Topotecan Teva -EMEA/H/C/001071 -IA/0013

Name Language First published Last updated
Topotecan Teva : EPAR - Product Information SV = svenska 2009-10-06 2018-03-08
Topotecan Teva : EPAR - Product Information SV = svenska 2009-10-06 2018-03-08
Topotecan Teva : EPAR - Product Information SV = svenska 2009-10-06 2018-03-08
Topotecan Teva : EPAR - Product Information SV = svenska 2009-10-06 2018-03-08
Topotecan Teva : EPAR - Product Information SV = svenska 2009-10-06 2018-03-08
Topotecan Teva : EPAR - Product Information SV = svenska 2009-10-06 2018-03-08
Topotecan Teva : EPAR - Product Information SV = svenska 2009-10-06 2018-03-08
Topotecan Teva : EPAR - Product Information SV = svenska 2009-10-06 2018-03-08
Topotecan Teva : EPAR - Product Information SV = svenska 2009-10-06 2018-03-08
Topotecan Teva : EPAR - Product Information SV = svenska 2009-10-06 2018-03-08
Topotecan Teva : EPAR - Product Information SV = svenska 2009-10-06 2018-03-08
Topotecan Teva : EPAR - Product Information SV = svenska 2009-10-06 2018-03-08
Topotecan Teva : EPAR - Product Information SV = svenska 2009-10-06 2018-03-08
Topotecan Teva : EPAR - Product Information SV = svenska 2009-10-06 2018-03-08
Topotecan Teva : EPAR - Product Information SV = svenska 2009-10-06 2018-03-08
Topotecan Teva : EPAR - Product Information SV = svenska 2009-10-06 2018-03-08
Topotecan Teva : EPAR - Product Information SV = svenska 2009-10-06 2018-03-08
Topotecan Teva : EPAR - Product Information SV = svenska 2009-10-06 2018-03-08
Topotecan Teva : EPAR - Product Information SV = svenska 2009-10-06 2018-03-08
Topotecan Teva : EPAR - Product Information SV = svenska 2009-10-06 2018-03-08
Topotecan Teva : EPAR - Product Information SV = svenska 2009-10-06 2018-03-08
Topotecan Teva : EPAR - Product Information SV = svenska 2009-10-06 2018-03-08
Topotecan Teva : EPAR - Product Information SV = svenska 2009-10-06 2018-03-08
Topotecan Teva : EPAR - Product Information SV = svenska 2009-10-06 2018-03-08
Topotecan Teva : EPAR - Product Information SV = svenska 2009-10-06 2018-03-08

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
Topotecan Teva : EPAR - All Authorised presentations SV = svenska 2009-10-06  
Topotecan Teva : EPAR - All Authorised presentations SV = svenska 2009-10-06  
Topotecan Teva : EPAR - All Authorised presentations SV = svenska 2009-10-06  
Topotecan Teva : EPAR - All Authorised presentations SV = svenska 2009-10-06  
Topotecan Teva : EPAR - All Authorised presentations SV = svenska 2009-10-06  
Topotecan Teva : EPAR - All Authorised presentations SV = svenska 2009-10-06  
Topotecan Teva : EPAR - All Authorised presentations SV = svenska 2009-10-06  
Topotecan Teva : EPAR - All Authorised presentations SV = svenska 2009-10-06  
Topotecan Teva : EPAR - All Authorised presentations SV = svenska 2009-10-06  
Topotecan Teva : EPAR - All Authorised presentations SV = svenska 2009-10-06  
Topotecan Teva : EPAR - All Authorised presentations SV = svenska 2009-10-06  
Topotecan Teva : EPAR - All Authorised presentations SV = svenska 2009-10-06  
Topotecan Teva : EPAR - All Authorised presentations SV = svenska 2009-10-06  
Topotecan Teva : EPAR - All Authorised presentations SV = svenska 2009-10-06  
Topotecan Teva : EPAR - All Authorised presentations SV = svenska 2009-10-06  
Topotecan Teva : EPAR - All Authorised presentations SV = svenska 2009-10-06  
Topotecan Teva : EPAR - All Authorised presentations SV = svenska 2009-10-06  
Topotecan Teva : EPAR - All Authorised presentations SV = svenska 2009-10-06  
Topotecan Teva : EPAR - All Authorised presentations SV = svenska 2009-10-06  
Topotecan Teva : EPAR - All Authorised presentations SV = svenska 2009-10-06  
Topotecan Teva : EPAR - All Authorised presentations SV = svenska 2009-10-06  
Topotecan Teva : EPAR - All Authorised presentations SV = svenska 2009-10-06  

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Topotecan monotherapy is indicated for the treatment of:

  • patients with metastatic carcinoma of the ovary after failure of first line or subsequent therapy;
  • patients with relapsed small cell lung cancer [SCLC] for whom re-treatment with the first-line regimen is not considered appropriate (see section 5.1).

Topotecan in combination with cisplatin is indicated for patients with carcinoma of the cervix recurrent after radiotherapy and for patients with Stage IVB disease. Patients with prior exposure to cisplatin require a sustained treatment free interval to justify treatment with the combination (see section 5.1).

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Topotecan Teva : EPAR - Procedural steps taken and scientific information after authorisation SV = svenska 2010-02-12 2018-03-08

Initial marketing-authorisation documents

Name Language First published Last updated
Topotecan Teva : EPAR - Public assessment report SV = svenska 2009-10-06  
Committee for medicinal products for human use, summary of positive opinion for Topotecan Teva SV = svenska 2009-06-25  

Authorised

This medicine is approved for use in the European Union

More information on Topotecan Teva