Pharmaceuticals - Community Register

  

Community list of not active medicinal products for human use


WITHDRAWN  

Product information

Invented name: Opulis
Auth. number : EU/1/00/158
INN : desloratadine
ATC: Anatomical main group: R - Respiratory system
Therapeutic subgroup: R06 - Antihistamines for systemic use
Pharmacological subgroup: R06A - Antihistamines for systemic use
Chemical subgroup: R06AX - Other antihistamines for systemic use
Chemical substance: R06AX27 - Desloratadine
(See WHO ATC Index)
Indication: Symptoms associated with seasonal allergic rhinitis
Marketing Authorisation Holder: Schering-Plough Europe
Rue de Stalle, 73, 1180 Bruxelles, Belgique / Stallestraat, 73, 1180 Brussel/Bruxelles, Belgique/België

  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
18/01/2001 Centralised - Authorisation EMEA/H/C/311 (2001)10 of 15/01/2001
08/08/2001 Centralised - Variation EMEA/H/C/311/II/1 (2001)2086 of 06/08/2001
24/09/2001 Centralised - Variation EMEA/H/C/311/II/2 (2001)2740 of 20/09/2001
13/03/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/311/I/8
16/04/2002 Centralised - Variation EMEA/H/C/311/II/7 (2002)1498 of 12/04/2002
18/04/2002 Centralised - Variation EMEA/H/C/311/X/4 (2002)1512 of 16/04/2002
18/04/2002 Centralised - Variation EMEA/H/C/311/X/5 (2002)1518 of 16/04/2002
22/05/2002 Centralised - Variation EMEA/H/C/311/II/6 (2002)1963 of 17/05/2002
22/07/2002 Centralised - Variation EMEA/H/C/311/II/9 (2002)2848 of 18/07/2002
30/08/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/311/I/12, 14
02/10/2002 Centralised - Variation EMEA/H/C/311/I/13 (2002)3643 of 30/09/2002
02/10/2002 Centralised - Variation EMEA/H/C/311/II/10, 11 (2002)3650 of 30/09/2002
19/03/2003 Centralised - Variation EMEA/H/C/311/II/16 (2003)867 of 17/03/2003
26/03/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/311/I/17
01/08/2003 Centralised - Variation EMEA/H/C/311/II/19, 20 (2003)2839 of 30/07/2003
16/02/2004 Centralised - Variation EMEA/H/C/311/II/21 (2004)514 of 12/02/2004
12/03/2004 Centralised - Withdrawal (2004)853 of 10/03/2004