Topotecan Hospira

topotecan

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This is a summary of the European public assessment report (EPAR) for Topotecan Hospira. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Topotecan Hospira.

What is Topotecan Hospira?

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

Topotecan Hospira is a ‘hybrid medicine’. This means that Topotecan Hospira is similar to a ‘reference medicine’ already authorised in the European Union (EU). The reference medicine Hycamtin is available as a powder to be made up into a solution for infusion and not as a concentrate.

What is Topotecan Hospira used for?

Topotecan Hospira is used on its own to treat 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 Hospira used?

Treatment with Topotecan Hospira 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 Hospira to be used depends on the type of cancer that it is being used to treat and the patient’s weight and height. For lung cancer, Topotecan Hospira is given 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 Hospira 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 Hospira work?

The active substance in Topotecan Hospira, 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 Hospira also affects non-cancer cells, which causes side effects.

How has Topotecan Hospira been studied?

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

What are the benefit and risk of Topotecan Hospira?

Because Topotecan Hospira produces the same levels of the active substance in the body as the reference medicine, its benefit and risk are taken as being the same as the reference medicine’s.

Why has Topotecan Hospira been approved?

The CHMP concluded that, in accordance with EU requirements, Topotecan Hospira 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 Hospira be given marketing authorisation.

Other information about Topotecan Hospira

The European Commission granted a marketing authorisation valid throughout the EU for Topotecan Hospira on 10 June 2010.

For more information about treatment with Topotecan Hospira, read the Package Leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Name Language First published Last updated
Topotecan Hospira : EPAR - Summary for the public BG = bălgarski 22/06/2010 21/04/2015
Topotecan Hospira : EPAR - Summary for the public ES = español 22/06/2010 21/04/2015
Topotecan Hospira : EPAR - Summary for the public CS = čeština 22/06/2010 21/04/2015
Topotecan Hospira : EPAR - Summary for the public DA = dansk 22/06/2010 21/04/2015
Topotecan Hospira : EPAR - Summary for the public DE = Deutsch 22/06/2010 21/04/2015
Topotecan Hospira : EPAR - Summary for the public ET = eesti keel 22/06/2010 21/04/2015
Topotecan Hospira : EPAR - Summary for the public EL = elliniká 22/06/2010 21/04/2015
Topotecan Hospira : EPAR - Summary for the public EN = English 22/06/2010 21/04/2015
Topotecan Hospira : EPAR - Summary for the public FR = français 22/06/2010 21/04/2015
Topotecan Hospira : EPAR - Summary for the public IT = italiano 22/06/2010 21/04/2015
Topotecan Hospira : EPAR - Summary for the public LV = latviešu valoda 22/06/2010 21/04/2015
Topotecan Hospira : EPAR - Summary for the public LT = lietuvių kalba 22/06/2010 21/04/2015
Topotecan Hospira : EPAR - Summary for the public HU = magyar 22/06/2010 21/04/2015
Topotecan Hospira : EPAR - Summary for the public MT = Malti 22/06/2010 21/04/2015
Topotecan Hospira : EPAR - Summary for the public NL = Nederlands 22/06/2010 21/04/2015
Topotecan Hospira : EPAR - Summary for the public PL = polski 22/06/2010 21/04/2015
Topotecan Hospira : EPAR - Summary for the public PT = português 22/06/2010 21/04/2015
Topotecan Hospira : EPAR - Summary for the public RO = română 22/06/2010 21/04/2015
Topotecan Hospira : EPAR - Summary for the public SK = slovenčina 22/06/2010 21/04/2015
Topotecan Hospira : EPAR - Summary for the public SL = slovenščina 22/06/2010 21/04/2015
Topotecan Hospira : EPAR - Summary for the public FI = suomi 22/06/2010 21/04/2015
Topotecan Hospira : EPAR - Summary for the public SV = svenska 22/06/2010 21/04/2015
Topotecan Hospira : EPAR - Summary for the public HR = Hrvatski 22/06/2010 21/04/2015

This EPAR was last updated on 28/01/2016 .

Authorisation details

Product details

Product details for Topotecan Hospira
NameTopotecan Hospira
Agency product numberEMEA/H/C/001192
Active substance

topotecan

International non-proprietary name (INN) or common name

topotecan

Therapeutic area Small Cell Lung CarcinomaUterine Cervical Neoplasms
Anatomical therapeutic chemical (ATC) code L01XX17

Publication details

Publication details for Topotecan Hospira
Marketing-authorisation holder

Hospira UK Ltd
 

Revision7
Date of issue of marketing authorisation valid throughout the European Union10/06/2010

Contact address:

Hospira UK Limited
Horizon
Honey Lane
Hurley      
Maidenhead SL6 6RJ
United Kingdom

Product information

Product information

24/11/2015  Topotecan Hospira -EMEA/H/C/001192 -IAIN/0024/G

Name Language First published Last updated
Topotecan Hospira : EPAR - Product Information HR = Hrvatski 22/06/2010 28/01/2016
Topotecan Hospira : EPAR - Product Information HR = Hrvatski 22/06/2010 28/01/2016
Topotecan Hospira : EPAR - Product Information HR = Hrvatski 22/06/2010 28/01/2016
Topotecan Hospira : EPAR - Product Information HR = Hrvatski 22/06/2010 28/01/2016
Topotecan Hospira : EPAR - Product Information HR = Hrvatski 22/06/2010 28/01/2016
Topotecan Hospira : EPAR - Product Information HR = Hrvatski 22/06/2010 28/01/2016
Topotecan Hospira : EPAR - Product Information HR = Hrvatski 22/06/2010 28/01/2016
Topotecan Hospira : EPAR - Product Information HR = Hrvatski 22/06/2010 28/01/2016
Topotecan Hospira : EPAR - Product Information HR = Hrvatski 22/06/2010 28/01/2016
Topotecan Hospira : EPAR - Product Information HR = Hrvatski 22/06/2010 28/01/2016
Topotecan Hospira : EPAR - Product Information HR = Hrvatski 22/06/2010 28/01/2016
Topotecan Hospira : EPAR - Product Information HR = Hrvatski 22/06/2010 28/01/2016
Topotecan Hospira : EPAR - Product Information HR = Hrvatski 22/06/2010 28/01/2016
Topotecan Hospira : EPAR - Product Information HR = Hrvatski 22/06/2010 28/01/2016
Topotecan Hospira : EPAR - Product Information HR = Hrvatski 22/06/2010 28/01/2016
Topotecan Hospira : EPAR - Product Information HR = Hrvatski 22/06/2010 28/01/2016
Topotecan Hospira : EPAR - Product Information HR = Hrvatski 22/06/2010 28/01/2016
Topotecan Hospira : EPAR - Product Information HR = Hrvatski 22/06/2010 28/01/2016
Topotecan Hospira : EPAR - Product Information HR = Hrvatski 22/06/2010 28/01/2016
Topotecan Hospira : EPAR - Product Information HR = Hrvatski 22/06/2010 28/01/2016
Topotecan Hospira : EPAR - Product Information HR = Hrvatski 22/06/2010 28/01/2016
Topotecan Hospira : EPAR - Product Information HR = Hrvatski 22/06/2010 28/01/2016
Topotecan Hospira : EPAR - Product Information HR = Hrvatski 22/06/2010 28/01/2016
Topotecan Hospira : EPAR - Product Information HR = Hrvatski 22/06/2010 28/01/2016
Topotecan Hospira : EPAR - Product Information HR = Hrvatski 22/06/2010 28/01/2016

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
Topotecan Hospira : EPAR - All Authorised presentations HR = Hrvatski 22/06/2010  
Topotecan Hospira : EPAR - All Authorised presentations HR = Hrvatski 22/06/2010  
Topotecan Hospira : EPAR - All Authorised presentations HR = Hrvatski 22/06/2010  
Topotecan Hospira : EPAR - All Authorised presentations HR = Hrvatski 22/06/2010  
Topotecan Hospira : EPAR - All Authorised presentations HR = Hrvatski 22/06/2010  
Topotecan Hospira : EPAR - All Authorised presentations HR = Hrvatski 22/06/2010  
Topotecan Hospira : EPAR - All Authorised presentations HR = Hrvatski 22/06/2010  
Topotecan Hospira : EPAR - All Authorised presentations HR = Hrvatski 22/06/2010  
Topotecan Hospira : EPAR - All Authorised presentations HR = Hrvatski 22/06/2010  
Topotecan Hospira : EPAR - All Authorised presentations HR = Hrvatski 22/06/2010  
Topotecan Hospira : EPAR - All Authorised presentations HR = Hrvatski 22/06/2010  
Topotecan Hospira : EPAR - All Authorised presentations HR = Hrvatski 22/06/2010  
Topotecan Hospira : EPAR - All Authorised presentations HR = Hrvatski 22/06/2010  
Topotecan Hospira : EPAR - All Authorised presentations HR = Hrvatski 22/06/2010  
Topotecan Hospira : EPAR - All Authorised presentations HR = Hrvatski 22/06/2010  
Topotecan Hospira : EPAR - All Authorised presentations HR = Hrvatski 22/06/2010  
Topotecan Hospira : EPAR - All Authorised presentations HR = Hrvatski 22/06/2010  
Topotecan Hospira : EPAR - All Authorised presentations HR = Hrvatski 22/06/2010  
Topotecan Hospira : EPAR - All Authorised presentations HR = Hrvatski 22/06/2010  
Topotecan Hospira : EPAR - All Authorised presentations HR = Hrvatski 22/06/2010  
Topotecan Hospira : EPAR - All Authorised presentations HR = Hrvatski 22/06/2010  
Topotecan Hospira : EPAR - All Authorised presentations HR = Hrvatski 22/06/2010  

Pharmacotherapeutic group

Other antineoplastic agents

Therapeutic indication

Topotecan monotherapy is indicated for the treatment of patients with relapsed small-cell lung cancer (SCLC) for whom re-treatment with the first-line regimen is not considered appropriate.

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. 

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Topotecan Hospira : EPAR - Procedural steps taken and scientific information after authorisation HR = Hrvatski 05/03/2012 28/01/2016

Initial marketing-authorisation documents

Name Language First published Last updated
Topotecan Hospira : EPAR - Public assessment report HR = Hrvatski 22/06/2010  
CHMP summary of positive opinion for Topotecan Hospira HR = Hrvatski 19/03/2010  

Authorised

This medicine is approved for use in the European Union