Pharmaceuticals - Community Register


Community list of not active medicinal products for human use


Product information

Invented name: Turvel IV
Auth. number : EU/1/98/062
Active substance : alatrofloxacin
ATC: Anatomical main group: J - General antiinfectives for systemic use
Therapeutic subgroup: J01 - Antibacterials for systemic use
Pharmacological subgroup: J01M - Quinolone antibacterials
Chemical subgroup: J01MA - Fluoroquinolones
Chemical substance: J01MA - Fluoroquinolones
(See WHO ATC Index)
Indication: Broad spectrum quinolone antibacterial agent indicated for the treatment of the following infections in adults : pneumonia, intra-abdominal infections, acute pelvic infections, skin and soft tissue infections
Marketing Authorisation Holder: Roerig Farmaceutici Italiana S.p.A.
156-Km 50, 04010 Borgo San Michele (Latina), Italia
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
20/07/1998 Centralised - Authorisation EMEA/H/C/159 (1998)1831 of 03/07/1998
29/01/1999 Centralised - Variation EMEA/H/C/159/II/1 (1999)157 of 26/01/1999
13/08/1999 Centralised - Suspension of martketing authorisation EMEA/H/C/159/Z/3 (1999)2677 of 10/08/1999
18/09/2000 Centralised - Prolongation of suspension EMEA/H/C/159/Z/4 (2000)2465 of 12/09/2000
23/03/2001 Centralised - Withdrawal (2001)573 of 20/03/2001