Zactran RSS Authorised This medicine is authorised for use in the European Union gamithromycinMedicineVeterinaryAuthorised
Page contentsPage contents Overview Product information Product details Authorisation details Assessment history News on Zactran 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)Prima publicare: 01/08/2008 Cea mai recent: 28/06/2024 Vizualizare Alte limbi (25) български (BG) (93.36 KB - PDF) Prima publicare: 01/08/2008 Cea mai recent: 28/06/2024 Vizualizare español (ES) (81.97 KB - PDF) Prima publicare: 01/08/2008 Cea mai recent: 28/06/2024 Vizualizare čeština (CS) (93.99 KB - PDF) Prima publicare: 01/08/2008 Cea mai recent: 28/06/2024 Vizualizare dansk (DA) (83.34 KB - PDF) Prima publicare: 01/08/2008 Cea mai recent: 28/06/2024 Vizualizare Deutsch (DE) (82.76 KB - PDF) Prima publicare: 01/08/2008 Cea mai recent: 28/06/2024 Vizualizare eesti (ET) (82.18 KB - PDF) Prima publicare: 01/08/2008 Cea mai recent: 28/06/2024 Vizualizare ελληνικά (EL) (93.76 KB - PDF) Prima publicare: 01/08/2008 Cea mai recent: 28/06/2024 Vizualizare français (FR) (82.44 KB - PDF) Prima publicare: 01/08/2008 Cea mai recent: 28/06/2024 Vizualizare Gaeilge (GA) (83.57 KB - PDF) Prima publicare: 01/08/2008 Cea mai recent: 28/06/2024 Vizualizare hrvatski (HR) (92.27 KB - PDF) Prima publicare: 01/08/2008 Cea mai recent: 28/06/2024 Vizualizare italiano (IT) (82.29 KB - PDF) Prima publicare: 01/08/2008 Cea mai recent: 28/06/2024 Vizualizare latviešu (LV) (94.29 KB - PDF) Prima publicare: 01/08/2008 Cea mai recent: 28/06/2024 Vizualizare lietuvių (LT) (94.03 KB - PDF) Prima publicare: 01/08/2008 Cea mai recent: 28/06/2024 Vizualizare magyar (HU) (94.15 KB - PDF) Prima publicare: 01/08/2008 Cea mai recent: 28/06/2024 Vizualizare Malti (MT) (95.95 KB - PDF) Prima publicare: 01/08/2008 Cea mai recent: 28/06/2024 Vizualizare Nederlands (NL) (82.05 KB - PDF) Prima publicare: 01/08/2008 Cea mai recent: 28/06/2024 Vizualizare polski (PL) (95.62 KB - PDF) Prima publicare: 01/08/2008 Cea mai recent: 28/06/2024 Vizualizare português (PT) (83.01 KB - PDF) Prima publicare: 01/08/2008 Cea mai recent: 28/06/2024 Vizualizare română (RO) (94.17 KB - PDF) Prima publicare: 01/08/2008 Cea mai recent: 28/06/2024 Vizualizare slovenčina (SK) (94.08 KB - PDF) Prima publicare: 01/08/2008 Cea mai recent: 28/06/2024 Vizualizare slovenščina (SL) (82.27 KB - PDF) Prima publicare: 01/08/2008 Cea mai recent: 28/06/2024 Vizualizare suomi (FI) (81.54 KB - PDF) Prima publicare: 01/08/2008 Cea mai recent: 28/06/2024 Vizualizare svenska (SV) (82.05 KB - PDF) Prima publicare: 01/08/2008 Cea mai recent: 28/06/2024 Vizualizare Íslenska (IS) (83.29 KB - PDF) Prima publicare: 01/08/2008 Cea mai recent: 28/06/2024 Vizualizare norsk (NO) (82 KB - PDF) Prima publicare: 01/08/2008 Cea mai recent: 28/06/2024 Vizualizare Product information Zactran : EPAR - Product information English (EN) (81.49 KB - PDF)Prima publicare: 04/08/2009 Cea mai recent: 28/06/2024 Vizualizare Alte limbi (25) български (BG) (91.78 KB - PDF) Prima publicare: 04/08/2009 Cea mai recent: 28/06/2024 Vizualizare español (ES) (81.51 KB - PDF) Prima publicare: 04/08/2009 Cea mai recent: 28/06/2024 Vizualizare čeština (CS) (92.48 KB - PDF) Prima publicare: 04/08/2009 Cea mai recent: 28/06/2024 Vizualizare dansk (DA) (82.05 KB - PDF) Prima publicare: 04/08/2009 Cea mai recent: 28/06/2024 Vizualizare Deutsch (DE) (81.72 KB - PDF) Prima publicare: 04/08/2009 Cea mai recent: 28/06/2024 Vizualizare eesti (ET) (81.22 KB - PDF) Prima publicare: 04/08/2009 Cea mai recent: 28/06/2024 Vizualizare ελληνικά (EL) (91.79 KB - PDF) Prima publicare: 04/08/2009 Cea mai recent: 28/06/2024 Vizualizare français (FR) (81.63 KB - PDF) Prima publicare: 04/08/2009 Cea mai recent: 28/06/2024 Vizualizare Gaeilge (GA) (81.36 KB - PDF) Prima publicare: 04/08/2009 Cea mai recent: 28/06/2024 Vizualizare hrvatski (HR) (91.56 KB - PDF) Prima publicare: 04/08/2009 Cea mai recent: 28/06/2024 Vizualizare italiano (IT) (81.76 KB - PDF) Prima publicare: 04/08/2009 Cea mai recent: 28/06/2024 Vizualizare latviešu (LV) (92.14 KB - PDF) Prima publicare: 04/08/2009 Cea mai recent: 28/06/2024 Vizualizare lietuvių (LT) (92.19 KB - PDF) Prima publicare: 04/08/2009 Cea mai recent: 28/06/2024 Vizualizare magyar (HU) (92.76 KB - PDF) Prima publicare: 04/08/2009 Cea mai recent: 28/06/2024 Vizualizare Malti (MT) (93.86 KB - PDF) Prima publicare: 04/08/2009 Cea mai recent: 28/06/2024 Vizualizare Nederlands (NL) (81.15 KB - PDF) Prima publicare: 04/08/2009 Cea mai recent: 28/06/2024 Vizualizare polski (PL) (93.22 KB - PDF) Prima publicare: 04/08/2009 Cea mai recent: 28/06/2024 Vizualizare português (PT) (82.53 KB - PDF) Prima publicare: 04/08/2009 Cea mai recent: 28/06/2024 Vizualizare română (RO) (91.73 KB - PDF) Prima publicare: 04/08/2009 Cea mai recent: 28/06/2024 Vizualizare slovenčina (SK) (81.75 KB - PDF) Prima publicare: 04/08/2009 Cea mai recent: 28/06/2024 Vizualizare slovenščina (SL) (81.76 KB - PDF) Prima publicare: 04/08/2009 Cea mai recent: 28/06/2024 Vizualizare suomi (FI) (81.11 KB - PDF) Prima publicare: 04/08/2009 Cea mai recent: 28/06/2024 Vizualizare svenska (SV) (81.47 KB - PDF) Prima publicare: 04/08/2009 Cea mai recent: 28/06/2024 Vizualizare Íslenska (IS) (81.52 KB - PDF) Prima publicare: 04/08/2009 Cea mai recent: 28/06/2024 Vizualizare norsk (NO) (81.52 KB - PDF) Prima publicare: 04/08/2009 Cea mai recent: 28/06/2024 Vizualizare Zactran : EPAR - All Authorised presentations English (EN) (81.94 KB - PDF)Prima publicare: 03/08/2009 Cea mai recent: 28/06/2024 Vizualizare Alte limbi (25) български (BG) (93.36 KB - PDF) Prima publicare: 03/08/2009 Cea mai recent: 28/06/2024 Vizualizare español (ES) (81.97 KB - PDF) Prima publicare: 03/08/2009 Cea mai recent: 28/06/2024 Vizualizare čeština (CS) (93.99 KB - PDF) Prima publicare: 03/08/2009 Cea mai recent: 28/06/2024 Vizualizare dansk (DA) (83.34 KB - PDF) Prima publicare: 03/08/2009 Cea mai recent: 28/06/2024 Vizualizare Deutsch (DE) (82.76 KB - PDF) Prima publicare: 03/08/2009 Cea mai recent: 28/06/2024 Vizualizare eesti (ET) (82.18 KB - PDF) Prima publicare: 03/08/2009 Cea mai recent: 28/06/2024 Vizualizare ελληνικά (EL) (93.76 KB - PDF) Prima publicare: 03/08/2009 Cea mai recent: 28/06/2024 Vizualizare français (FR) (82.44 KB - PDF) Prima publicare: 03/08/2009 Cea mai recent: 28/06/2024 Vizualizare Gaeilge (GA) (83.57 KB - PDF) Prima publicare: 03/08/2009 Cea mai recent: 28/06/2024 Vizualizare hrvatski (HR) (92.27 KB - PDF) Prima publicare: 03/08/2009 Cea mai recent: 28/06/2024 Vizualizare italiano (IT) (82.29 KB - PDF) Prima publicare: 03/08/2009 Cea mai recent: 28/06/2024 Vizualizare latviešu (LV) (94.29 KB - PDF) Prima publicare: 03/08/2009 Cea mai recent: 28/06/2024 Vizualizare lietuvių (LT) (94.03 KB - PDF) Prima publicare: 03/08/2009 Cea mai recent: 28/06/2024 Vizualizare magyar (HU) (94.15 KB - PDF) Prima publicare: 03/08/2009 Cea mai recent: 28/06/2024 Vizualizare Malti (MT) (95.95 KB - PDF) Prima publicare: 03/08/2009 Cea mai recent: 28/06/2024 Vizualizare Nederlands (NL) (82.05 KB - PDF) Prima publicare: 03/08/2009 Cea mai recent: 28/06/2024 Vizualizare polski (PL) (95.62 KB - PDF) Prima publicare: 03/08/2009 Cea mai recent: 28/06/2024 Vizualizare português (PT) (83.01 KB - PDF) Prima publicare: 03/08/2009 Cea mai recent: 28/06/2024 Vizualizare română (RO) (94.17 KB - PDF) Prima publicare: 03/08/2009 Cea mai recent: 28/06/2024 Vizualizare slovenčina (SK) (94.08 KB - PDF) Prima publicare: 03/08/2009 Cea mai recent: 28/06/2024 Vizualizare slovenščina (SL) (82.27 KB - PDF) Prima publicare: 03/08/2009 Cea mai recent: 28/06/2024 Vizualizare suomi (FI) (81.54 KB - PDF) Prima publicare: 03/08/2009 Cea mai recent: 28/06/2024 Vizualizare svenska (SV) (82.05 KB - PDF) Prima publicare: 03/08/2009 Cea mai recent: 28/06/2024 Vizualizare Íslenska (IS) (83.29 KB - PDF) Prima publicare: 03/08/2009 Cea mai recent: 28/06/2024 Vizualizare norsk (NO) (82 KB - PDF) Prima publicare: 03/08/2009 Cea mai recent: 28/06/2024 Vizualizare 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)Prima publicare: 05/10/2009 Cea mai recent: 28/06/2024 Vizualizare Zactran-V-C-129-II-0036 : EPAR - Assessment Report - VariationAdopted English (EN) (81.49 KB - PDF)Prima publicare: 07/03/2018 Cea mai recent: 28/06/2024 Vizualizare CVMP post-authorisation summary of positive opinion for ZactranIIIAdopted Reference Number: EMA/CVMP/763148/2017 English (EN) (68.17 KB - PDF)Prima publicare: 08/12/2017 Cea mai recent: 08/12/2017 Vizualizare Zactran-V-C-129-X-0034 : EPAR - Assessment Report - VariationAdopted English (EN) (81.49 KB - PDF)Prima publicare: 22/05/2017 Cea mai recent: 28/06/2024 Vizualizare CVMP post-authorisation summary of positive opinion for Zactran (X/0034)Adopted Reference Number: EMA/CVMP/129619/2017 English (EN) (65.32 KB - PDF)Prima publicare: 17/03/2017 Cea mai recent: 17/03/2017 Vizualizare Zactran-V-C-129-X-0027 : EPAR - Assessment Report - VariationAdopted English (EN) (81.49 KB - PDF)Prima publicare: 23/03/2016 Cea mai recent: 28/06/2024 Vizualizare CVMP post-authorisation summary of positive opinion for ZactranAdopted Reference Number: EMA/CVMP/749682/2015 English (EN) (74.54 KB - PDF)Prima publicare: 11/12/2015 Cea mai recent: 11/12/2015 Vizualizare Initial marketing authorisation documents Zactran : EPAR - Scientific Discussion English (EN) (81.49 KB - PDF)Prima publicare: 30/07/2008 Cea mai recent: 28/06/2024 Vizualizare Zactran : EPAR - Procedural steps taken before authorisation English (EN) (38.51 KB - PDF)Prima publicare: 24/07/2008 Cea mai recent: 24/07/2008 Vizualizare 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)Prima publicare: 16/05/2008 Cea mai recent: 16/05/2008 Vizualizare 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 This page was last updated on 28/06/2024 Share this page