Potactasol

topotecan

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

What is Potactasol?

Potactasol is a medicine that contains the active substance topotecan. It is available as a powder to be made up into a solution for infusion (drip) into a vein.

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

What is Potactasol used for?

Potactasol is a cancer 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 cancer medicine) to treat women with cancer of the cervix, when the cancer has come back after radiotherapy, or when the disease is at an advanced stage (the cancer has spread beyond the cervix).

The medicine can only be obtained with a prescription.

How is Potactasol used?

Treatment with Potactasol 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 dose of Potactasol to be used depends on the type of cancer that it is being used to treat and the patient’s weight and height. When Potactasol is used on its own for ovarian cancer, it is given by infusion over 30 minutes. For both ovarian and lung cancer, Potactasol 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, Potactasol is given as an infusion 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.

Doses of Potactasol may need to be adjusted or treatment delayed, depending on side effects. For full details, see the summary of product characteristics, also part of the EPAR.

How does Potactasol work?

The active substance in Potactasol, topotecan, is a cancer 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. Potactasol also affects non‑cancer cells, which causes side effects.

How has Potactasol been studied?

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

What are the benefits and risks of Potactasol?

Because Potactasol is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine’s.

Why has Potactasol been approved?

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

Other information about Potactasol

The European Commission granted a marketing authorisation valid throughout the European Union for Potactasol to on 06 January 2011.

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

Name Language First published Last updated
Potactasol : EPAR - Summary for the public BG = bălgarski 2011-01-17 2015-11-10
Potactasol : EPAR - Summary for the public ES = español 2011-01-17 2015-11-10
Potactasol : EPAR - Summary for the public CS = čeština 2011-01-17 2015-11-10
Potactasol : EPAR - Summary for the public DA = dansk 2011-01-17 2015-11-10
Potactasol : EPAR - Summary for the public DE = Deutsch 2011-01-17 2015-11-10
Potactasol : EPAR - Summary for the public ET = eesti keel 2011-01-17 2015-11-10
Potactasol : EPAR - Summary for the public EL = elliniká 2011-01-17 2015-11-10
Potactasol : EPAR - Summary for the public EN = English 2011-01-17 2015-11-10
Potactasol : EPAR - Summary for the public FR = français 2011-01-17 2015-11-10
Potactasol : EPAR - Summary for the public IT = italiano 2011-01-17 2015-11-10
Potactasol : EPAR - Summary for the public LV = latviešu valoda 2011-01-17 2015-11-10
Potactasol : EPAR - Summary for the public LT = lietuvių kalba 2011-01-17 2015-11-10
Potactasol : EPAR - Summary for the public HU = magyar 2011-01-17 2015-11-10
Potactasol : EPAR - Summary for the public MT = Malti 2011-01-17 2015-11-10
Potactasol : EPAR - Summary for the public NL = Nederlands 2011-01-17 2015-11-10
Potactasol : EPAR - Summary for the public PL = polski 2011-01-17 2015-11-10
Potactasol : EPAR - Summary for the public PT = português 2011-01-17 2015-11-10
Potactasol : EPAR - Summary for the public RO = română 2011-01-17 2015-11-10
Potactasol : EPAR - Summary for the public SK = slovenčina 2011-01-17 2015-11-10
Potactasol : EPAR - Summary for the public SL = slovenščina 2011-01-17 2015-11-10
Potactasol : EPAR - Summary for the public FI = suomi 2011-01-17 2015-11-10
Potactasol : EPAR - Summary for the public SV = svenska 2011-01-17 2015-11-10
Potactasol : EPAR - Summary for the public HR = Hrvatski 2011-01-17 2015-11-10

This EPAR was last updated on 13/04/2018 .

Authorisation details

Product details

Product details for Potactasol
NamePotactasol
Agency product numberEMEA/H/C/002282
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
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 Potactasol
Marketing-authorisation holder

Actavis Group PTC ehf

Revision6
Date of issue of marketing authorisation valid throughout the European Union06/01/2011

Contact address:

Actavis Group PTC ehf
Reykjavíkurvegur 76 - 78
IS-220 Hafnarfjörður
Iceland

Product information

Product information

20/03/2018  Potactasol -EMEA/H/C/002282 -N/0014

Name Language First published Last updated
Potactasol : EPAR - Product Information HR = Hrvatski 2011-01-17 2018-04-13
Potactasol : EPAR - Product Information HR = Hrvatski 2011-01-17 2018-04-13
Potactasol : EPAR - Product Information HR = Hrvatski 2011-01-17 2018-04-13
Potactasol : EPAR - Product Information HR = Hrvatski 2011-01-17 2018-04-13
Potactasol : EPAR - Product Information HR = Hrvatski 2011-01-17 2018-04-13
Potactasol : EPAR - Product Information HR = Hrvatski 2011-01-17 2018-04-13
Potactasol : EPAR - Product Information HR = Hrvatski 2011-01-17 2018-04-13
Potactasol : EPAR - Product Information HR = Hrvatski 2011-01-17 2018-04-13
Potactasol : EPAR - Product Information HR = Hrvatski 2011-01-17 2018-04-13
Potactasol : EPAR - Product Information HR = Hrvatski 2011-01-17 2018-04-13
Potactasol : EPAR - Product Information HR = Hrvatski 2011-01-17 2018-04-13
Potactasol : EPAR - Product Information HR = Hrvatski 2011-01-17 2018-04-13
Potactasol : EPAR - Product Information HR = Hrvatski 2011-01-17 2018-04-13
Potactasol : EPAR - Product Information HR = Hrvatski 2011-01-17 2018-04-13
Potactasol : EPAR - Product Information HR = Hrvatski 2011-01-17 2018-04-13
Potactasol : EPAR - Product Information HR = Hrvatski 2011-01-17 2018-04-13
Potactasol : EPAR - Product Information HR = Hrvatski 2011-01-17 2018-04-13
Potactasol : EPAR - Product Information HR = Hrvatski 2011-01-17 2018-04-13
Potactasol : EPAR - Product Information HR = Hrvatski 2011-01-17 2018-04-13
Potactasol : EPAR - Product Information HR = Hrvatski 2011-01-17 2018-04-13
Potactasol : EPAR - Product Information HR = Hrvatski 2011-01-17 2018-04-13
Potactasol : EPAR - Product Information HR = Hrvatski 2011-01-17 2018-04-13
Potactasol : EPAR - Product Information HR = Hrvatski 2011-01-17 2018-04-13
Potactasol : EPAR - Product Information HR = Hrvatski 2011-01-17 2018-04-13
Potactasol : EPAR - Product Information HR = Hrvatski 2011-01-17 2018-04-13

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
Potactasol : EPAR - All Authorised presentations HR = Hrvatski 2011-01-17  
Potactasol : EPAR - All Authorised presentations HR = Hrvatski 2011-01-17  
Potactasol : EPAR - All Authorised presentations HR = Hrvatski 2011-01-17  
Potactasol : EPAR - All Authorised presentations HR = Hrvatski 2011-01-17  
Potactasol : EPAR - All Authorised presentations HR = Hrvatski 2011-01-17  
Potactasol : EPAR - All Authorised presentations HR = Hrvatski 2011-01-17  
Potactasol : EPAR - All Authorised presentations HR = Hrvatski 2011-01-17  
Potactasol : EPAR - All Authorised presentations HR = Hrvatski 2011-01-17  
Potactasol : EPAR - All Authorised presentations HR = Hrvatski 2011-01-17  
Potactasol : EPAR - All Authorised presentations HR = Hrvatski 2011-01-17  
Potactasol : EPAR - All Authorised presentations HR = Hrvatski 2011-01-17  
Potactasol : EPAR - All Authorised presentations HR = Hrvatski 2011-01-17  
Potactasol : EPAR - All Authorised presentations HR = Hrvatski 2011-01-17  
Potactasol : EPAR - All Authorised presentations HR = Hrvatski 2011-01-17  
Potactasol : EPAR - All Authorised presentations HR = Hrvatski 2011-01-17  
Potactasol : EPAR - All Authorised presentations HR = Hrvatski 2011-01-17  
Potactasol : EPAR - All Authorised presentations HR = Hrvatski 2011-01-17  
Potactasol : EPAR - All Authorised presentations HR = Hrvatski 2011-01-17  
Potactasol : EPAR - All Authorised presentations HR = Hrvatski 2011-01-17  
Potactasol : EPAR - All Authorised presentations HR = Hrvatski 2011-01-17  
Potactasol : EPAR - All Authorised presentations HR = Hrvatski 2011-01-17  
Potactasol : EPAR - All Authorised presentations HR = Hrvatski 2011-01-17  

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 thefirst-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
Potactasol : EPAR - Procedural steps taken and scientific information after authorisation HR = Hrvatski 2015-02-06 2018-04-13

Initial marketing-authorisation documents

Name Language First published Last updated
Potactasol : EPAR - Public assessment report HR = Hrvatski 2011-01-17  
CHMP summary of positive opinion for Potactasol HR = Hrvatski 2010-10-22  

Authorised

This medicine is approved for use in the European Union

More information on Potactasol