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Pharmaceuticals - Community Register
Community register of medicinal products for human use
|Auth. number :||EU/1/10/660|
|ATC:||Anatomical main group: L - Antineoplastic and immunomodulating agents|
Therapeutic subgroup: L01 - Cytostatics
Pharmacological subgroup: L01X - Other cytostatics
Chemical subgroup: L01XX - Other antineoplastic agents
Chemical substance: L01XX17 - Topotecan
(See WHO ATC Index)
|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.
|Marketing Authorisation Holder:||Actavis Group PTC ehf.
Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Iceland
Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".|
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Community Register.
|Close date procedure||Procedure type||EMEA number||Decision||summary publ||decision docs||annex|
|10/01/2011||Centralised - Authorisation||EMEA/H/C/2282||(2011)66 of 06/01/2011|
|01/12/2011||Centralised - Variation||EMEA/H/C/2282/IB/1|
|Updated with Decision(2012)4756 of 04/07/2012|
|06/07/2012||Centralised - Variation||(2012)4756 of 04/07/2012|
|13/08/2014||Centralised - Notification||EMEA/H/C/2282/N/3|
|17/01/2015||Centralised - Variation||EMEA/H/C/2282/IB/04|