Withdrawn
This medicine is now withdrawn from use in the European Union.
Overview
The marketing authorisation for Evotopin has been withdrawn at the request of the marketing authorisation holder.
This EPAR was last updated on 31/12/2009
Authorisation details
| Product details | |
|---|---|
| Name |
Evotopin
|
| Agency product number |
EMEA/H/C/000124
|
| Active substance |
topotecan
|
| International non-proprietary name (INN) or common name |
topotecan
|
| Therapeutic area (MeSH) |
Ovarian Neoplasms
|
| Anatomical therapeutic chemical (ATC) code |
L01XX17
|
| Publication details | |
|---|---|
| Marketing-authorisation holder |
Beecham Group plc
|
| Revision |
0
|
| Date of issue of marketing authorisation valid throughout the European Union |
15/04/1997
|
| Contact address |
,
Great West Road Brentford, Middlesex, TW8 9BD United Kingdom |
Product information
31/12/2009 Evotopin - EMEA/H/C/000124 -
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).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Pharmacotherapeutic group
Pharmacotherapeutic group
Antineoplastic agents
Therapeutic indication
Therapeutic indication
Topotecan is indicated for the treatment of patients with metastatic carcinoma of the ovary after failure of first-line or subsequent therapy.