Human medicines European public assessment report (EPAR): Topotecan Hospira, topotecan, Date of authorisation: 09/06/2010, Revision: 22, Status: Authorised

Topotecan Hospira RSS Authorised This medicine is authorised for use in the European Union topotecan Medicine Human Authorised Application under evaluation CHMP opinion European Commission decision Overview 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. Expand section Collapse section 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. Topotecan Hospira : EPAR - Summary for the public English (EN) (49.26 KB - PDF) First published: 22/06/2010 Last updated: 21/04/2015 View Other languages (22) български (BG) (110.17 KB - PDF) First published: 22/06/2010 Last updated: 21/04/2015 View español (ES) (105.67 KB - PDF) First published: 22/06/2010 Last updated: 21/04/2015 View čeština (CS) (107 KB - PDF) First published: 22/06/2010 Last updated: 21/04/2015 View dansk (DA) (103.96 KB - PDF) First published: 22/06/2010 Last updated: 21/04/2015 View Deutsch (DE) (104.72 KB - PDF) First published: 22/06/2010 Last updated: 21/04/2015 View eesti keel (ET) (85.4 KB - PDF) First published: 22/06/2010 Last updated: 21/04/2015 View ελληνικά (EL) (112.63 KB - PDF) First published: 22/06/2010 Last updated: 21/04/2015 View français (FR) (106.15 KB - PDF) First published: 22/06/2010 Last updated: 21/04/2015 View hrvatski (HR) (93.12 KB - PDF) First published: 22/06/2010 Last updated: 21/04/2015 View italiano (IT) (81.5 KB - PDF) First published: 22/06/2010 Last updated: 21/04/2015 View latviešu valoda (LV) (109.3 KB - PDF) First published: 22/06/2010 Last updated: 21/04/2015 View lietuvių kalba (LT) (125.99 KB - PDF) First published: 22/06/2010 Last updated: 21/04/2015 View magyar (HU) (100.65 KB - PDF) First published: 22/06/2010 Last updated: 21/04/2015 View Malti (MT) (118.06 KB - PDF) First published: 22/06/2010 Last updated: 21/04/2015 View Nederlands (NL) (82.11 KB - PDF) First published: 22/06/2010 Last updated: 21/04/2015 View polski (PL) (106.79 KB - PDF) First published: 22/06/2010 Last updated: 21/04/2015 View português (PT) (87.98 KB - PDF) First published: 22/06/2010 Last updated: 21/04/2015 View română (RO) (102.08 KB - PDF) First published: 22/06/2010 Last updated: 21/04/2015 View slovenčina (SK) (104 KB - PDF) First published: 22/06/2010 Last updated: 21/04/2015 View slovenščina (SL) (93.21 KB - PDF) First published: 22/06/2010 Last updated: 21/04/2015 View Suomi (FI) (80.05 KB - PDF) First published: 22/06/2010 Last updated: 21/04/2015 View svenska (SV) (80.53 KB - PDF) First published: 22/06/2010 Last updated: 21/04/2015 View Product information Topotecan Hospira : EPAR - Product Information English (EN) (330.6 KB - PDF) First published: 22/06/2010 Last updated: 31/03/2026 View Other languages (24) български (BG) (358.2 KB - PDF) First published: 22/06/2010 Last updated: 31/03/2026 View español (ES) (293.65 KB - PDF) First published: 22/06/2010 Last updated: 31/03/2026 View čeština (CS) (369.55 KB - PDF) First published: 22/06/2010 Last updated: 31/03/2026 View dansk (DA) (247.99 KB - PDF) First published: 22/06/2010 Last updated: 31/03/2026 View Deutsch (DE) (303.78 KB - PDF) First published: 22/06/2010 Last updated: 31/03/2026 View eesti keel (ET) (306.48 KB - PDF) First published: 22/06/2010 Last updated: 31/03/2026 View ελληνικά (EL) (360.22 KB - PDF) First published: 22/06/2010 Last updated: 31/03/2026 View français (FR) (328.78 KB - PDF) First published: 22/06/2010 Last updated: 31/03/2026 View hrvatski (HR) (343.68 KB - PDF) First published: 22/06/2010 Last updated: 31/03/2026 View íslenska (IS) (270 KB - PDF) First published: 22/06/2010 Last updated: 31/03/2026 View italiano (IT) (316.23 KB - PDF) First published: 22/06/2010 Last updated: 31/03/2026 View latviešu valoda (LV) (343.42 KB - PDF) First published: 22/06/2010 Last updated: 31/03/2026 View lietuvių kalba (LT) (332.07 KB - PDF) First published: 22/06/2010 Last updated: 31/03/2026 View magyar (HU) (322.74 KB - PDF) First published: 22/06/2010 Last updated: 31/03/2026 View Malti (MT) (380.25 KB - PDF) First published: 22/06/2010 Last updated: 31/03/2026 View Nederlands (NL) (288.46 KB - PDF) First published: 22/06/2010 Last updated: 31/03/2026 View norsk (NO) (307.32 KB - PDF) First published: 22/06/2010 Last updated: 31/03/2026 View polski (PL) (328.92 KB - PDF) First published: 22/06/2010 Last updated: 31/03/2026 View português (PT) (261.67 KB - PDF) First published: 22/06/2010 Last updated: 31/03/2026 View română (RO) (341.33 KB - PDF) First published: 22/06/2010 Last updated: 31/03/2026 View slovenčina (SK) (342.89 KB - PDF) First published: 22/06/2010 Last updated: 31/03/2026 View slovenščina (SL) (314.38 KB - PDF) First published: 22/06/2010 Last updated: 31/03/2026 View Suomi (FI) (261.42 KB - PDF) First published: 22/06/2010 Last updated: 31/03/2026 View svenska (SV) (250.84 KB - PDF) First published: 22/06/2010 Last updated: 31/03/2026 View Latest procedure affecting product information: N/0000339309 31/03/2026 This medicine’s product information is available in all official EU languages . Select 'available languages' to access the language you need. Product information documents contain: summary of product characteristics (annex I); manufacturing authorisation holder responsible for batch release (annex IIA); conditions of the marketing authorisation (annex IIB); labelling (annex IIIA); package leaflet (annex IIIB). Topotecan Hospira : EPAR - All Authorised presentations English (EN) (22.86 KB - PDF) First published: 22/06/2010 Last updated: 22/06/2010 View Other languages (21) български (BG) (55.46 KB - PDF) First published: 22/06/2010 Last updated: 22/06/2010 View español (ES) (24.56 KB - PDF) First published: 22/06/2010 Last updated: 22/06/2010 View čeština (CS) (51.65 KB - PDF) First published: 22/06/2010 Last updated: 22/06/2010 View dansk (DA) (24.91 KB - PDF) First published: 22/06/2010 Last updated: 22/06/2010 View Deutsch (DE) (23.39 KB - PDF) First published: 22/06/2010 Last updated: 22/06/2010 View eesti keel (ET) (23.21 KB - PDF) First published: 22/06/2010 Last updated: 22/06/2010 View ελληνικά (EL) (53.97 KB - PDF) First published: 22/06/2010 Last updated: 22/06/2010 View français (FR) (23.73 KB - PDF) First published: 22/06/2010 Last updated: 22/06/2010 View italiano (IT) (22.97 KB - PDF) First published: 22/06/2010 Last updated: 22/06/2010 View latviešu valoda (LV) (51.57 KB - PDF) First published: 22/06/2010 Last updated: 22/06/2010 View lietuvių kalba (LT) (50.89 KB - PDF) First published: 22/06/2010 Last updated: 22/06/2010 View magyar (HU) (37.22 KB - PDF) First published: 22/06/2010 Last updated: 22/06/2010 View Malti (MT) (52.03 KB - PDF) First published: 22/06/2010 Last updated: 22/06/2010 View Nederlands (NL) (23.97 KB - PDF) First published: 22/06/2010 Last updated: 22/06/2010 View polski (PL) (52.85 KB - PDF) First published: 22/06/2010 Last updated: 22/06/2010 View português (PT) (24.25 KB - PDF) First published: 22/06/2010 Last updated: 22/06/2010 View română (RO) (52.25 KB - PDF) First published: 22/06/2010 Last updated: 22/06/2010 View slovenčina (SK) (51.93 KB - PDF) First published: 22/06/2010 Last updated: 22/06/2010 View slovenščina (SL) (23.35 KB - PDF) First published: 22/06/2010 Last updated: 22/06/2010 View Suomi (FI) (23.55 KB - PDF) First published: 22/06/2010 Last updated: 22/06/2010 View svenska (SV) (24.09 KB - PDF) First published: 22/06/2010 Last updated: 22/06/2010 View Product details Name of medicine Topotecan Hospira Active substance topotecan International non-proprietary name (INN) or common name topotecan Therapeutic area (MeSH) Uterine Cervical Neoplasms Small Cell Lung Carcinoma Anatomical therapeutic chemical (ATC) code L01CE01 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. Authorisation details EMA product number EMEA/H/C/001192 Marketing authorisation holder Pfizer Europe MA EEIG Boulevard de la Plaine 17 1050 Bruxelles Belgium Opinion adopted 18/03/2010 Marketing authorisation issued 09/06/2010 Revision 22 Assessment history Expand section Collapse section Changes since initial authorisation of medicine Topotecan Hospira : EPAR - Procedural steps taken and scientific information after authorisation English (EN) (145.42 KB - PDF) First published: 04/09/2025 Last updated: 31/03/2026 View Topotecan Hospira : EPAR - Procedural steps taken and scientific information after authorisation (archive) English (EN) (151.39 KB - PDF) First published: 05/03/2012 Last updated: 04/09/2025 View Initial marketing authorisation documents Topotecan Hospira : EPAR - Public assessment report English (EN) (165.9 KB - PDF) First published: 22/06/2010 Last updated: 22/06/2010 View CHMP summary of positive opinion for Topotecan Hospira Adopted Reference Number: EMA/CHMP/43325/2010 English (EN) (51.7 KB - PDF) First published: 19/03/2010 Last updated: 19/03/2010 View Product information – with tracked changes The approved product information for this medicine is available below showing the changes since the previous procedure affecting the product information. The same document without tracked changes is above under 'Product information'. Topotecan Hospira : EPAR – Product information - tracked changes English (EN) (96.49 KB - DOCX) First published: 31/03/2026 View Other languages (24) български (BG) (123.55 KB - DOCX) First published: 31/03/2026 View español (ES) (103.14 KB - DOCX) First published: 31/03/2026 View čeština (CS) (110.16 KB - DOCX) First published: 31/03/2026 View dansk (DA) (90.78 KB - DOCX) First published: 31/03/2026 View Deutsch (DE) (116.98 KB - DOCX) First published: 31/03/2026 View eesti keel (ET) (104.05 KB - DOCX) First published: 31/03/2026 View ελληνικά (EL) (118.81 KB - DOCX) First published: 31/03/2026 View français (FR) (116.28 KB - DOCX) First published: 31/03/2026 View hrvatski (HR) (110.56 KB - DOCX) First published: 31/03/2026 View íslenska (IS) (110.32 KB - DOCX) First published: 31/03/2026 View italiano (IT) (99.91 KB - DOCX) First published: 31/03/2026 View latviešu valoda (LV) (114.1 KB - DOCX) First published: 31/03/2026 View lietuvių kalba (LT) (98.65 KB - DOCX) First published: 31/03/2026 View magyar (HU) (96.93 KB - DOCX) First published: 31/03/2026 View Malti (MT) (120.62 KB - DOCX) First published: 31/03/2026 View Nederlands (NL) (106.1 KB - DOCX) First published: 31/03/2026 View norsk (NO) (103.42 KB - DOCX) First published: 31/03/2026 View polski (PL) (101 KB - DOCX) First published: 31/03/2026 View português (PT) (97.39 KB - DOCX) First published: 31/03/2026 View română (RO) (112.71 KB - DOCX) First published: 31/03/2026 View slovenčina (SK) (115.25 KB - DOCX) First published: 31/03/2026 View slovenščina (SL) (104.21 KB - DOCX) First published: 31/03/2026 View Suomi (FI) (104.84 KB - DOCX) First published: 31/03/2026 View svenska (SV) (105.58 KB - DOCX) First published: 31/03/2026 View This page was last updated on 31/03/2026 Share this page