Overview

The marketing authorisation for Topotecan Actavis has been withdrawn at the request of the marketing-authorisation holder.

Topotecan Actavis : EPAR - Summary for the public

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Product information

Topotecan Actavis : EPAR - Product Information

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română (RO) (699.4 KB - PDF)
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slovenščina (SL) (991.93 KB - PDF)
Suomi (FI) (1 MB - PDF)
svenska (SV) (606.96 KB - PDF)

Latest procedure affecting product information: IB/0013

15/01/2019

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This medicine’s product information is available in all official EU languages.
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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 Actavis : EPAR - All Authorised presentations

български (BG) (489.63 KB - PDF)
español (ES) (466.96 KB - PDF)
čeština (CS) (480.22 KB - PDF)
dansk (DA) (469.25 KB - PDF)
Deutsch (DE) (469.91 KB - PDF)
eesti keel (ET) (467.21 KB - PDF)
ελληνικά (EL) (499.01 KB - PDF)
français (FR) (467.55 KB - PDF)
hrvatski (HR) (512.75 KB - PDF)
íslenska (IS) (468.92 KB - PDF)
italiano (IT) (466.89 KB - PDF)
latviešu valoda (LV) (481.27 KB - PDF)
lietuvių kalba (LT) (468.73 KB - PDF)
magyar (HU) (477.71 KB - PDF)
Malti (MT) (479.1 KB - PDF)
Nederlands (NL) (467.37 KB - PDF)
norsk (NO) (466.47 KB - PDF)
polski (PL) (481.66 KB - PDF)
português (PT) (477.54 KB - PDF)
română (RO) (468.57 KB - PDF)
slovenčina (SK) (478.48 KB - PDF)
slovenščina (SL) (476.63 KB - PDF)
Suomi (FI) (466.56 KB - PDF)
svenska (SV) (468.56 KB - PDF)

Product details

Name of medicine
Topotecan Actavis
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

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/001031

Generic

This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines.

Marketing authorisation holder
Actavis Group PTC ehf

Dalshraun 1
220 Hafnarfjordur
Iceland

Marketing authorisation issued
24/07/2009
Revision
6

Assessment history

Topotecan Actavis : EPAR - Procedural steps taken and scientific information after authorisation

Topotecan Actavis : EPAR - Public assessment report

Committee for medicinal products for human use, summary of positive opinion for Topotecan Actavis

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