Zactran RSS Authorised This medicine is authorised for use in the European Union gamithromycin Medicine Veterinary Authorised
Page contentsPage contents Overview Product information Product details Authorisation details Assessment history News on Zactran Topics Application under evaluation CVMP opinion European Commission decision OverviewUp-to-date information on this veterinary medicinal product is available on the Veterinary Medicines Information website Zactran : EPAR - Summary for the public English (EN) (81.94 KB - PDF)First published: 01/08/2008 Last updated: 28/06/2024 View Other languages (25) български (BG) (93.36 KB - PDF) First published: 01/08/2008 Last updated: 28/06/2024 View español (ES) (81.97 KB - PDF) First published: 01/08/2008 Last updated: 28/06/2024 View čeština (CS) (93.99 KB - PDF) First published: 01/08/2008 Last updated: 28/06/2024 View dansk (DA) (83.34 KB - PDF) First published: 01/08/2008 Last updated: 28/06/2024 View Deutsch (DE) (82.76 KB - PDF) First published: 01/08/2008 Last updated: 28/06/2024 View eesti keel (ET) (82.18 KB - PDF) First published: 01/08/2008 Last updated: 28/06/2024 View ελληνικά (EL) (93.76 KB - PDF) First published: 01/08/2008 Last updated: 28/06/2024 View français (FR) (82.44 KB - PDF) First published: 01/08/2008 Last updated: 28/06/2024 View hrvatski (HR) (92.27 KB - PDF) First published: 01/08/2008 Last updated: 28/06/2024 View íslenska (IS) (83.29 KB - PDF) First published: 01/08/2008 Last updated: 28/06/2024 View Gaeilge (GA) (83.57 KB - PDF) First published: 01/08/2008 Last updated: 28/06/2024 View italiano (IT) (82.29 KB - PDF) First published: 01/08/2008 Last updated: 28/06/2024 View latviešu valoda (LV) (94.29 KB - PDF) First published: 01/08/2008 Last updated: 28/06/2024 View lietuvių kalba (LT) (94.03 KB - PDF) First published: 01/08/2008 Last updated: 28/06/2024 View magyar (HU) (94.15 KB - PDF) First published: 01/08/2008 Last updated: 28/06/2024 View Malti (MT) (95.95 KB - PDF) First published: 01/08/2008 Last updated: 28/06/2024 View Nederlands (NL) (82.05 KB - PDF) First published: 01/08/2008 Last updated: 28/06/2024 View norsk (NO) (82 KB - PDF) First published: 01/08/2008 Last updated: 28/06/2024 View polski (PL) (95.62 KB - PDF) First published: 01/08/2008 Last updated: 28/06/2024 View português (PT) (83.01 KB - PDF) First published: 01/08/2008 Last updated: 28/06/2024 View română (RO) (94.17 KB - PDF) First published: 01/08/2008 Last updated: 28/06/2024 View slovenčina (SK) (94.08 KB - PDF) First published: 01/08/2008 Last updated: 28/06/2024 View slovenščina (SL) (82.27 KB - PDF) First published: 01/08/2008 Last updated: 28/06/2024 View Suomi (FI) (81.54 KB - PDF) First published: 01/08/2008 Last updated: 28/06/2024 View svenska (SV) (82.05 KB - PDF) First published: 01/08/2008 Last updated: 28/06/2024 View Product information Zactran : EPAR - Product information English (EN) (81.49 KB - PDF)First published: 04/08/2009 Last updated: 28/06/2024 View Other languages (25) български (BG) (91.78 KB - PDF) First published: 04/08/2009 Last updated: 28/06/2024 View español (ES) (81.51 KB - PDF) First published: 04/08/2009 Last updated: 28/06/2024 View čeština (CS) (92.48 KB - PDF) First published: 04/08/2009 Last updated: 28/06/2024 View dansk (DA) (82.05 KB - PDF) First published: 04/08/2009 Last updated: 28/06/2024 View Deutsch (DE) (81.72 KB - PDF) First published: 04/08/2009 Last updated: 28/06/2024 View eesti keel (ET) (81.22 KB - PDF) First published: 04/08/2009 Last updated: 28/06/2024 View ελληνικά (EL) (91.79 KB - PDF) First published: 04/08/2009 Last updated: 28/06/2024 View français (FR) (81.63 KB - PDF) First published: 04/08/2009 Last updated: 28/06/2024 View hrvatski (HR) (91.56 KB - PDF) First published: 04/08/2009 Last updated: 28/06/2024 View íslenska (IS) (81.52 KB - PDF) First published: 04/08/2009 Last updated: 28/06/2024 View Gaeilge (GA) (81.36 KB - PDF) First published: 04/08/2009 Last updated: 28/06/2024 View italiano (IT) (81.76 KB - PDF) First published: 04/08/2009 Last updated: 28/06/2024 View latviešu valoda (LV) (92.14 KB - PDF) First published: 04/08/2009 Last updated: 28/06/2024 View lietuvių kalba (LT) (92.19 KB - PDF) First published: 04/08/2009 Last updated: 28/06/2024 View magyar (HU) (92.76 KB - PDF) First published: 04/08/2009 Last updated: 28/06/2024 View Malti (MT) (93.86 KB - PDF) First published: 04/08/2009 Last updated: 28/06/2024 View Nederlands (NL) (81.15 KB - PDF) First published: 04/08/2009 Last updated: 28/06/2024 View norsk (NO) (81.52 KB - PDF) First published: 04/08/2009 Last updated: 28/06/2024 View polski (PL) (93.22 KB - PDF) First published: 04/08/2009 Last updated: 28/06/2024 View português (PT) (82.53 KB - PDF) First published: 04/08/2009 Last updated: 28/06/2024 View română (RO) (91.73 KB - PDF) First published: 04/08/2009 Last updated: 28/06/2024 View slovenčina (SK) (81.75 KB - PDF) First published: 04/08/2009 Last updated: 28/06/2024 View slovenščina (SL) (81.76 KB - PDF) First published: 04/08/2009 Last updated: 28/06/2024 View Suomi (FI) (81.11 KB - PDF) First published: 04/08/2009 Last updated: 28/06/2024 View svenska (SV) (81.47 KB - PDF) First published: 04/08/2009 Last updated: 28/06/2024 View Zactran : EPAR - All Authorised presentations English (EN) (81.94 KB - PDF)First published: 03/08/2009 Last updated: 28/06/2024 View Other languages (25) български (BG) (93.36 KB - PDF) First published: 03/08/2009 Last updated: 28/06/2024 View español (ES) (81.97 KB - PDF) First published: 03/08/2009 Last updated: 28/06/2024 View čeština (CS) (93.99 KB - PDF) First published: 03/08/2009 Last updated: 28/06/2024 View dansk (DA) (83.34 KB - PDF) First published: 03/08/2009 Last updated: 28/06/2024 View Deutsch (DE) (82.76 KB - PDF) First published: 03/08/2009 Last updated: 28/06/2024 View eesti keel (ET) (82.18 KB - PDF) First published: 03/08/2009 Last updated: 28/06/2024 View ελληνικά (EL) (93.76 KB - PDF) First published: 03/08/2009 Last updated: 28/06/2024 View français (FR) (82.44 KB - PDF) First published: 03/08/2009 Last updated: 28/06/2024 View hrvatski (HR) (92.27 KB - PDF) First published: 03/08/2009 Last updated: 28/06/2024 View íslenska (IS) (83.29 KB - PDF) First published: 03/08/2009 Last updated: 28/06/2024 View Gaeilge (GA) (83.57 KB - PDF) First published: 03/08/2009 Last updated: 28/06/2024 View italiano (IT) (82.29 KB - PDF) First published: 03/08/2009 Last updated: 28/06/2024 View latviešu valoda (LV) (94.29 KB - PDF) First published: 03/08/2009 Last updated: 28/06/2024 View lietuvių kalba (LT) (94.03 KB - PDF) First published: 03/08/2009 Last updated: 28/06/2024 View magyar (HU) (94.15 KB - PDF) First published: 03/08/2009 Last updated: 28/06/2024 View Malti (MT) (95.95 KB - PDF) First published: 03/08/2009 Last updated: 28/06/2024 View Nederlands (NL) (82.05 KB - PDF) First published: 03/08/2009 Last updated: 28/06/2024 View norsk (NO) (82 KB - PDF) First published: 03/08/2009 Last updated: 28/06/2024 View polski (PL) (95.62 KB - PDF) First published: 03/08/2009 Last updated: 28/06/2024 View português (PT) (83.01 KB - PDF) First published: 03/08/2009 Last updated: 28/06/2024 View română (RO) (94.17 KB - PDF) First published: 03/08/2009 Last updated: 28/06/2024 View slovenčina (SK) (94.08 KB - PDF) First published: 03/08/2009 Last updated: 28/06/2024 View slovenščina (SL) (82.27 KB - PDF) First published: 03/08/2009 Last updated: 28/06/2024 View Suomi (FI) (81.54 KB - PDF) First published: 03/08/2009 Last updated: 28/06/2024 View svenska (SV) (82.05 KB - PDF) First published: 03/08/2009 Last updated: 28/06/2024 View Product details Name of medicine Zactran Active substance gamithromycin International non-proprietary name (INN) or common name gamithromycin Pharmacotherapeutic groupAntibacterials for systemic use Authorisation details EMA product number EMEA/V/C/000129 Assessment history Expand section Collapse section Changes since initial authorisation of medicine Zactran : EPAR - Procedural steps taken and scientific information after authorisation English (EN) (81.94 KB - PDF)First published: 05/10/2009 Last updated: 28/06/2024 View Zactran-V-C-129-II-0036 : EPAR - Assessment Report - VariationAdopted English (EN) (81.49 KB - PDF)First published: 07/03/2018 Last updated: 28/06/2024 View CVMP post-authorisation summary of positive opinion for ZactranIIIAdopted Reference Number: EMA/CVMP/763148/2017 English (EN) (68.17 KB - PDF)First published: 08/12/2017 Last updated: 08/12/2017 View Zactran-V-C-129-X-0034 : EPAR - Assessment Report - VariationAdopted English (EN) (81.49 KB - PDF)First published: 22/05/2017 Last updated: 28/06/2024 View CVMP post-authorisation summary of positive opinion for Zactran (X/0034)Adopted Reference Number: EMA/CVMP/129619/2017 English (EN) (65.32 KB - PDF)First published: 17/03/2017 Last updated: 17/03/2017 View Zactran-V-C-129-X-0027 : EPAR - Assessment Report - VariationAdopted English (EN) (81.49 KB - PDF)First published: 23/03/2016 Last updated: 28/06/2024 View CVMP post-authorisation summary of positive opinion for ZactranAdopted Reference Number: EMA/CVMP/749682/2015 English (EN) (74.54 KB - PDF)First published: 11/12/2015 Last updated: 11/12/2015 View Initial marketing authorisation documents Zactran : EPAR - Scientific Discussion English (EN) (81.49 KB - PDF)First published: 30/07/2008 Last updated: 28/06/2024 View Zactran : EPAR - Procedural steps taken before authorisation English (EN) (38.51 KB - PDF)First published: 24/07/2008 Last updated: 24/07/2008 View Committee for medicinal products for veterinary use summary of opinion: Zactran: International Non-proprietary Names (INN): GamithromycinAdopted Reference Number: EMEA/CVMP/220772/2008 English (EN) (33.29 KB - PDF)First published: 16/05/2008 Last updated: 16/05/2008 View News on Zactran Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 5-7 December 202308/12/2023 Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 11-13 July 202314/07/2023 Meeting highlights from the Committee for Medicinal Products for Veterinary Use (CVMP) 16-17 February 202119/02/2021 Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 3-5 December 201906/12/2019 Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 11-13 September 201814/09/2018 Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 5–7 December 201708/12/2017 Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 13-15 June 201716/06/2017 Committee for Medicinal Products for Veterinary Use (CVMP) Meeting of 14-16 March 201717/03/2017 Committee for Medicinal Products for Veterinary Use (CVMP) meeting 6-8 December 201609/12/2016 Committee for Medicinal Products for Veterinary Use (CVMP) Meeting of 14-16 June 201617/06/2016 Committee for Medicinal Products for Veterinary Use (CVMP) Meeting of 8-10 December 201511/12/2015 Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 7-9 October 201410/10/2014 Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 11-13 June 201314/06/2013 Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 14-16 May 201317/05/2013 Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 12-14 June 201215/06/2012 Committee for Medicinal Products for Veterinary Use: Meeting of 8-10 December 200911/12/2009 Topics Medicines This page was last updated on 28/06/2024 Share this page