Suvaxyn PCV
Withdrawn
This medicine's authorisation has been withdrawn
adjuvanted inactivated vaccine against porcine circovirus type 2 in piglets
MedicineVeterinaryWithdrawn
- Application under evaluation
- CVMP opinion
- European Commission decision
Overview
The marketing authorisation for Suvaxyn PCV has been withdrawn at the request of the marketing authorisation holder.
Suvaxyn PCV : EPAR - Summary for the public
Reference Number: EMA/388793/2009
English (EN) (381.87 KB - PDF)
First published: Last updated:
български (BG) (489.32 KB - PDF)
First published: 11/08/2009Last updated: 15/04/2020
español (ES) (386.75 KB - PDF)
First published: 11/08/2009Last updated: 15/04/2020
čeština (CS) (439.9 KB - PDF)
First published: 11/08/2009Last updated: 15/04/2020
dansk (DA) (382.9 KB - PDF)
First published: 11/08/2009Last updated: 15/04/2020
Deutsch (DE) (387.93 KB - PDF)
First published: 11/08/2009Last updated: 15/04/2020
eesti keel (ET) (381.59 KB - PDF)
First published: 11/08/2009Last updated: 15/04/2020
ελληνικά (EL) (479.18 KB - PDF)
First published: 11/08/2009Last updated: 15/04/2020
français (FR) (410.53 KB - PDF)
First published: 11/08/2009Last updated: 15/04/2020
hrvatski (HR) (409.78 KB - PDF)
First published: 11/08/2009Last updated: 15/04/2020
italiano (IT) (401.12 KB - PDF)
First published: 11/08/2009Last updated: 15/04/2020
latviešu valoda (LV) (435.17 KB - PDF)
First published: 11/08/2009Last updated: 15/04/2020
lietuvių kalba (LT) (437.33 KB - PDF)
First published: 11/08/2009Last updated: 15/04/2020
magyar (HU) (434.38 KB - PDF)
First published: 11/08/2009Last updated: 15/04/2020
Malti (MT) (440.52 KB - PDF)
First published: 11/08/2009Last updated: 15/04/2020
Nederlands (NL) (386.75 KB - PDF)
First published: 11/08/2009Last updated: 15/04/2020
polski (PL) (441.96 KB - PDF)
First published: 11/08/2009Last updated: 15/04/2020
português (PT) (387.12 KB - PDF)
First published: 11/08/2009Last updated: 15/04/2020
română (RO) (441.28 KB - PDF)
First published: 11/08/2009Last updated: 15/04/2020
slovenčina (SK) (438.7 KB - PDF)
First published: 11/08/2009Last updated: 15/04/2020
slovenščina (SL) (603.23 KB - PDF)
First published: 11/08/2009Last updated: 15/04/2020
Suomi (FI) (381.32 KB - PDF)
First published: 11/08/2009Last updated: 15/04/2020
svenska (SV) (381.87 KB - PDF)
First published: 11/08/2009Last updated: 15/04/2020
Product information
Suvaxyn PCV : EPAR - Product Information
English (EN) (419.6 KB - PDF)
First published: Last updated:
български (BG) (1014.19 KB - PDF)
First published: 12/08/2009Last updated: 15/04/2020
español (ES) (604.97 KB - PDF)
First published: 12/08/2009Last updated: 15/04/2020
čeština (CS) (834.34 KB - PDF)
First published: 12/08/2009Last updated: 15/04/2020
dansk (DA) (670.17 KB - PDF)
First published: 12/08/2009Last updated: 15/04/2020
Deutsch (DE) (634.8 KB - PDF)
First published: 12/08/2009Last updated: 15/04/2020
eesti keel (ET) (616.75 KB - PDF)
First published: 12/08/2009Last updated: 15/04/2020
ελληνικά (EL) (1.01 MB - PDF)
First published: 12/08/2009Last updated: 15/04/2020
français (FR) (658.63 KB - PDF)
First published: 12/08/2009Last updated: 15/04/2020
hrvatski (HR) (707.91 KB - PDF)
First published: 12/08/2009Last updated: 15/04/2020
íslenska (IS) (667.28 KB - PDF)
First published: 12/08/2009Last updated: 15/04/2020
italiano (IT) (729.41 KB - PDF)
First published: 12/08/2009Last updated: 15/04/2020
latviešu valoda (LV) (862.59 KB - PDF)
First published: 12/08/2009Last updated: 15/04/2020
lietuvių kalba (LT) (733.89 KB - PDF)
First published: 12/08/2009Last updated: 15/04/2020
magyar (HU) (856.88 KB - PDF)
First published: 12/08/2009Last updated: 15/04/2020
Malti (MT) (896.54 KB - PDF)
First published: 12/08/2009Last updated: 15/04/2020
Nederlands (NL) (646.88 KB - PDF)
First published: 12/08/2009Last updated: 15/04/2020
norsk (NO) (692.85 KB - PDF)
First published: 12/08/2009Last updated: 15/04/2020
polski (PL) (868.69 KB - PDF)
First published: 12/08/2009Last updated: 15/04/2020
português (PT) (655.54 KB - PDF)
First published: 12/08/2009Last updated: 15/04/2020
română (RO) (739.36 KB - PDF)
First published: 12/08/2009Last updated: 15/04/2020
slovenčina (SK) (882.3 KB - PDF)
First published: 12/08/2009Last updated: 15/04/2020
slovenščina (SL) (841.81 KB - PDF)
First published: 12/08/2009Last updated: 15/04/2020
Suomi (FI) (602.66 KB - PDF)
First published: 12/08/2009Last updated: 15/04/2020
svenska (SV) (599.58 KB - PDF)
First published: 12/08/2009Last updated: 15/04/2020
Latest procedure affecting product information:
R/0028
08/04/2020
Suvaxyn PCV : EPAR - All Authorised presentations
English (EN) (228.41 KB - PDF)
First published: Last updated:
български (BG) (242.75 KB - PDF)
First published: 24/07/2009Last updated: 15/04/2020
español (ES) (379.79 KB - PDF)
First published: 24/07/2009Last updated: 15/04/2020
čeština (CS) (390.07 KB - PDF)
First published: 24/07/2009Last updated: 15/04/2020
dansk (DA) (396.86 KB - PDF)
First published: 24/07/2009Last updated: 15/04/2020
Deutsch (DE) (384.45 KB - PDF)
First published: 24/07/2009Last updated: 15/04/2020
eesti keel (ET) (392.78 KB - PDF)
First published: 24/07/2009Last updated: 15/04/2020
ελληνικά (EL) (394.81 KB - PDF)
First published: 24/07/2009Last updated: 15/04/2020
français (FR) (379.22 KB - PDF)
First published: 24/07/2009Last updated: 15/04/2020
hrvatski (HR) (380.85 KB - PDF)
First published: 24/07/2009Last updated: 15/04/2020
italiano (IT) (380.63 KB - PDF)
First published: 24/07/2009Last updated: 15/04/2020
latviešu valoda (LV) (393.73 KB - PDF)
First published: 24/07/2009Last updated: 15/04/2020
lietuvių kalba (LT) (385.98 KB - PDF)
First published: 24/07/2009Last updated: 15/04/2020
magyar (HU) (390.68 KB - PDF)
First published: 24/07/2009Last updated: 15/04/2020
Malti (MT) (399.75 KB - PDF)
First published: 24/07/2009Last updated: 15/04/2020
Nederlands (NL) (381.03 KB - PDF)
First published: 24/07/2009Last updated: 15/04/2020
polski (PL) (405.08 KB - PDF)
First published: 24/07/2009Last updated: 15/04/2020
português (PT) (394.55 KB - PDF)
First published: 24/07/2009Last updated: 15/04/2020
română (RO) (385.59 KB - PDF)
First published: 24/07/2009Last updated: 15/04/2020
slovenčina (SK) (388.43 KB - PDF)
First published: 24/07/2009Last updated: 15/04/2020
slovenščina (SL) (388.21 KB - PDF)
First published: 24/07/2009Last updated: 15/04/2020
Suomi (FI) (392.2 KB - PDF)
First published: 24/07/2009Last updated: 15/04/2020
svenska (SV) (395.22 KB - PDF)
First published: 24/07/2009Last updated: 15/04/2020
Product details
- Name of medicine
- Suvaxyn PCV
- Active substance
- porcine circovirus recombinant virus (CPCV) 1-2, inactivated
- International non-proprietary name (INN) or common name
- adjuvanted inactivated vaccine against porcine circovirus type 2 in piglets
- Species
- Pigs (piglets)
- Anatomical therapeutic chemical veterinary (ATCvet) code
- QI09AA07
Pharmacotherapeutic group
ImmunologicalsTherapeutic indication
Active immunisation of pigs over the age of three weeks against porcine circovirus type 2 (PCV2) to reduce viral load in blood and lymphoid tissues, and the lesions in lymphoid tissues associated with PCV2 infection, as well as to reduce clinical signs - including loss of daily weight gain, and mortality associated with post-weaning multisystemic wasting syndrome.
Authorisation details
- EMA product number
- EMEA/V/C/000149
- Marketing authorisation holder
- Zoetis Belgium SA
Rue Laid Burniat 1
1348 Louvain-la-Neuve
Belgium - Marketing authorisation issued
- 24/07/2009
- Revision
- 13
Assessment history
Suvaxyn PCV : EPAR - Procedural steps taken and scientific information after authorisation
English (EN) (315.8 KB - PDF)
First published: Last updated:
CVMP post-authorisation summary of negative opinion for Suvaxyn PCV
AdoptedReference Number: EMA/CVMP/686504/2013
English (EN) (233.58 KB - PDF)
First published: Last updated:
CVMP post-authorisation summary of negative opinion for Suvaxyn PCV
AdoptedReference Number: EMA/CVMP/404045/2013
English (EN) (656.01 KB - PDF)
First published: Last updated:
Suvaxyn PCV : EPAR - Scientific Discussion
Reference Number: EMEA/352270/2009
English (EN) (372.78 KB - PDF)
First published: Last updated:
Suvaxyn PCV : EPAR - Procedural steps taken before authorisation
English (EN) (198.98 KB - PDF)
First published: Last updated:
Committee for medicinal products for veterinary use summary of opinion: Suvaxyn PCV: International Non-proprietary Names (INN): Gamithromycin
AdoptedReference Number: EMEA/CVMP/257211/2009
English (EN) (194.85 KB - PDF)
First published: Last updated:
News on Suvaxyn PCV
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