Zactran
Authorised
This medicine is authorised for use in the European Union
gamithromycin
MedicineVeterinaryAuthorised
- Application under evaluation
- CVMP opinion
- European Commission decision
Overview
Up-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: Last updated:
български (BG) (93.36 KB - PDF)
First published: 01/08/2008Last updated: 28/06/2024
español (ES) (81.97 KB - PDF)
First published: 01/08/2008Last updated: 28/06/2024
čeština (CS) (93.99 KB - PDF)
First published: 01/08/2008Last updated: 28/06/2024
dansk (DA) (83.34 KB - PDF)
First published: 01/08/2008Last updated: 28/06/2024
Deutsch (DE) (82.76 KB - PDF)
First published: 01/08/2008Last updated: 28/06/2024
eesti keel (ET) (82.18 KB - PDF)
First published: 01/08/2008Last updated: 28/06/2024
ελληνικά (EL) (93.76 KB - PDF)
First published: 01/08/2008Last updated: 28/06/2024
français (FR) (82.44 KB - PDF)
First published: 01/08/2008Last updated: 28/06/2024
hrvatski (HR) (92.27 KB - PDF)
First published: 01/08/2008Last updated: 28/06/2024
íslenska (IS) (83.29 KB - PDF)
First published: 01/08/2008Last updated: 28/06/2024
Gaeilge (GA) (83.57 KB - PDF)
First published: 01/08/2008Last updated: 28/06/2024
italiano (IT) (82.29 KB - PDF)
First published: 01/08/2008Last updated: 28/06/2024
latviešu valoda (LV) (94.29 KB - PDF)
First published: 01/08/2008Last updated: 28/06/2024
lietuvių kalba (LT) (94.03 KB - PDF)
First published: 01/08/2008Last updated: 28/06/2024
magyar (HU) (94.15 KB - PDF)
First published: 01/08/2008Last updated: 28/06/2024
Malti (MT) (95.95 KB - PDF)
First published: 01/08/2008Last updated: 28/06/2024
Nederlands (NL) (82.05 KB - PDF)
First published: 01/08/2008Last updated: 28/06/2024
norsk (NO) (82 KB - PDF)
First published: 01/08/2008Last updated: 28/06/2024
polski (PL) (95.62 KB - PDF)
First published: 01/08/2008Last updated: 28/06/2024
português (PT) (83.01 KB - PDF)
First published: 01/08/2008Last updated: 28/06/2024
română (RO) (94.17 KB - PDF)
First published: 01/08/2008Last updated: 28/06/2024
slovenčina (SK) (94.08 KB - PDF)
First published: 01/08/2008Last updated: 28/06/2024
slovenščina (SL) (82.27 KB - PDF)
First published: 01/08/2008Last updated: 28/06/2024
Suomi (FI) (81.54 KB - PDF)
First published: 01/08/2008Last updated: 28/06/2024
svenska (SV) (82.05 KB - PDF)
First published: 01/08/2008Last updated: 28/06/2024
Product information
Zactran : EPAR - Product information
English (EN) (81.49 KB - PDF)
First published: Last updated:
български (BG) (91.78 KB - PDF)
First published: 04/08/2009Last updated: 28/06/2024
español (ES) (81.51 KB - PDF)
First published: 04/08/2009Last updated: 28/06/2024
čeština (CS) (92.48 KB - PDF)
First published: 04/08/2009Last updated: 28/06/2024
dansk (DA) (82.05 KB - PDF)
First published: 04/08/2009Last updated: 28/06/2024
Deutsch (DE) (81.72 KB - PDF)
First published: 04/08/2009Last updated: 28/06/2024
eesti keel (ET) (81.22 KB - PDF)
First published: 04/08/2009Last updated: 28/06/2024
ελληνικά (EL) (91.79 KB - PDF)
First published: 04/08/2009Last updated: 28/06/2024
français (FR) (81.63 KB - PDF)
First published: 04/08/2009Last updated: 28/06/2024
hrvatski (HR) (91.56 KB - PDF)
First published: 04/08/2009Last updated: 28/06/2024
íslenska (IS) (81.52 KB - PDF)
First published: 04/08/2009Last updated: 28/06/2024
Gaeilge (GA) (81.36 KB - PDF)
First published: 04/08/2009Last updated: 28/06/2024
italiano (IT) (81.76 KB - PDF)
First published: 04/08/2009Last updated: 28/06/2024
latviešu valoda (LV) (92.14 KB - PDF)
First published: 04/08/2009Last updated: 28/06/2024
lietuvių kalba (LT) (92.19 KB - PDF)
First published: 04/08/2009Last updated: 28/06/2024
magyar (HU) (92.76 KB - PDF)
First published: 04/08/2009Last updated: 28/06/2024
Malti (MT) (93.86 KB - PDF)
First published: 04/08/2009Last updated: 28/06/2024
Nederlands (NL) (81.15 KB - PDF)
First published: 04/08/2009Last updated: 28/06/2024
norsk (NO) (81.52 KB - PDF)
First published: 04/08/2009Last updated: 28/06/2024
polski (PL) (93.22 KB - PDF)
First published: 04/08/2009Last updated: 28/06/2024
português (PT) (82.53 KB - PDF)
First published: 04/08/2009Last updated: 28/06/2024
română (RO) (91.73 KB - PDF)
First published: 04/08/2009Last updated: 28/06/2024
slovenčina (SK) (81.75 KB - PDF)
First published: 04/08/2009Last updated: 28/06/2024
slovenščina (SL) (81.76 KB - PDF)
First published: 04/08/2009Last updated: 28/06/2024
Suomi (FI) (81.11 KB - PDF)
First published: 04/08/2009Last updated: 28/06/2024
svenska (SV) (81.47 KB - PDF)
First published: 04/08/2009Last updated: 28/06/2024
Zactran : EPAR - All Authorised presentations
English (EN) (81.94 KB - PDF)
First published: Last updated:
български (BG) (93.36 KB - PDF)
First published: 03/08/2009Last updated: 28/06/2024
español (ES) (81.97 KB - PDF)
First published: 03/08/2009Last updated: 28/06/2024
čeština (CS) (93.99 KB - PDF)
First published: 03/08/2009Last updated: 28/06/2024
dansk (DA) (83.34 KB - PDF)
First published: 03/08/2009Last updated: 28/06/2024
Deutsch (DE) (82.76 KB - PDF)
First published: 03/08/2009Last updated: 28/06/2024
eesti keel (ET) (82.18 KB - PDF)
First published: 03/08/2009Last updated: 28/06/2024
ελληνικά (EL) (93.76 KB - PDF)
First published: 03/08/2009Last updated: 28/06/2024
français (FR) (82.44 KB - PDF)
First published: 03/08/2009Last updated: 28/06/2024
hrvatski (HR) (92.27 KB - PDF)
First published: 03/08/2009Last updated: 28/06/2024
íslenska (IS) (83.29 KB - PDF)
First published: 03/08/2009Last updated: 28/06/2024
Gaeilge (GA) (83.57 KB - PDF)
First published: 03/08/2009Last updated: 28/06/2024
italiano (IT) (82.29 KB - PDF)
First published: 03/08/2009Last updated: 28/06/2024
latviešu valoda (LV) (94.29 KB - PDF)
First published: 03/08/2009Last updated: 28/06/2024
lietuvių kalba (LT) (94.03 KB - PDF)
First published: 03/08/2009Last updated: 28/06/2024
magyar (HU) (94.15 KB - PDF)
First published: 03/08/2009Last updated: 28/06/2024
Malti (MT) (95.95 KB - PDF)
First published: 03/08/2009Last updated: 28/06/2024
Nederlands (NL) (82.05 KB - PDF)
First published: 03/08/2009Last updated: 28/06/2024
norsk (NO) (82 KB - PDF)
First published: 03/08/2009Last updated: 28/06/2024
polski (PL) (95.62 KB - PDF)
First published: 03/08/2009Last updated: 28/06/2024
português (PT) (83.01 KB - PDF)
First published: 03/08/2009Last updated: 28/06/2024
română (RO) (94.17 KB - PDF)
First published: 03/08/2009Last updated: 28/06/2024
slovenčina (SK) (94.08 KB - PDF)
First published: 03/08/2009Last updated: 28/06/2024
slovenščina (SL) (82.27 KB - PDF)
First published: 03/08/2009Last updated: 28/06/2024
Suomi (FI) (81.54 KB - PDF)
First published: 03/08/2009Last updated: 28/06/2024
svenska (SV) (82.05 KB - PDF)
First published: 03/08/2009Last updated: 28/06/2024
Product details
- Name of medicine
- Zactran
- Active substance
- gamithromycin
- International non-proprietary name (INN) or common name
- gamithromycin
Pharmacotherapeutic group
Antibacterials for systemic useAuthorisation details
- EMA product number
- EMEA/V/C/000129
Assessment history
Zactran : EPAR - Procedural steps taken and scientific information after authorisation
English (EN) (81.94 KB - PDF)
First published: Last updated:
Zactran-V-C-129-II-0036 : EPAR - Assessment Report - Variation
Adopted
English (EN) (81.49 KB - PDF)
First published: Last updated:
CVMP post-authorisation summary of positive opinion for ZactranIII
AdoptedReference Number: EMA/CVMP/763148/2017
English (EN) (68.17 KB - PDF)
First published: Last updated:
Zactran-V-C-129-X-0034 : EPAR - Assessment Report - Variation
Adopted
English (EN) (81.49 KB - PDF)
First published: Last updated:
CVMP post-authorisation summary of positive opinion for Zactran (X/0034)
AdoptedReference Number: EMA/CVMP/129619/2017
English (EN) (65.32 KB - PDF)
First published: Last updated:
Zactran-V-C-129-X-0027 : EPAR - Assessment Report - Variation
Adopted
English (EN) (81.49 KB - PDF)
First published: Last updated:
CVMP post-authorisation summary of positive opinion for Zactran
AdoptedReference Number: EMA/CVMP/749682/2015
English (EN) (74.54 KB - PDF)
First published: Last updated:
Zactran : EPAR - Scientific Discussion
English (EN) (81.49 KB - PDF)
First published: Last updated:
Zactran : EPAR - Procedural steps taken before authorisation
English (EN) (38.51 KB - PDF)
First published: Last updated:
Committee for medicinal products for veterinary use summary of opinion: Zactran: International Non-proprietary Names (INN): Gamithromycin
AdoptedReference Number: EMEA/CVMP/220772/2008
English (EN) (33.29 KB - PDF)
First published: Last updated:
News on Zactran
Topics
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