Pharmaceuticals - Community Register


Community list of not active medicinal products for human use


Product information

Invented name: Evotopin
Auth. number : EU/1/96/028
Active substance : Topotecan hydrochloride
ATC: Anatomical main group: L - Antineoplastic and immunomodulating agents
Therapeutic subgroup: L01 - Antineoplastic agents
Pharmacological subgroup: L01X - Other antineoplastic agents
Chemical subgroup: L01XX - Other antineoplastic agents
Chemical substance: L01XX17 - topotecan
(See WHO ATC Index)
Indication: Ovary metastatic carcinoma
Marketing Authorisation Holder: SmithKline Beecham plc
980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom
EPAR and active package presentations

Package presentations

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.

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
10/12/1996 Centralised - Authorisation EMEA/H/C/124 (96)3640 of 09/12/1996
27/01/1998 Centralised - Authorisation EMEA/H/C/124/II/1 (1998)184 of 26/01/1998
08/10/1998 Centralised - Variation (no change in Commission Decision) EMEA/H/C/124/I/3
07/12/1998 Centralised - Variation (no change in Commission Decision) EMEA/H/C/124/I/5
02/02/1999 Centralised - Variation EMEA/H/C/124/I/4 (1999)174 of 26/01/1999
08/04/1999 Centralised - Variation (rejected) EMEA/H/C/124/II/2 (1999)877 of 29/03/1999
23/04/1999 Centralised - Variation EMEA/H/C/124/II/6 (1999)1009 of 19/04/1999
18/05/1999 Centralised - Variation (no change in Commission Decision) EMEA/H/C/124/I/8-9
09/07/1999 Centralised - Notification EMEA/H/C/124/N/7 (1999)1848 of 01/07/1999
28/01/2000 Centralised - Withdrawal (2000)115 of 20/01/2000