- Application under evaluation
- CVMP opinion
- European Commission decision
Overview
The marketing authorisation for this product has been withdrawn at the request of the marketing authorisation holder.
Ingelvac PCV FLEX : EPAR - Summary for the public
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Product information
Ingelvac PCV FLEX : EPAR - Product Information
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Ingelvac PCV FLEX : EPAR - All Authorised presentations
English (EN) (280.17 KB - PDF)
български (BG) (336.55 KB - PDF)
español (ES) (278.67 KB - PDF)
čeština (CS) (308.83 KB - PDF)
dansk (DA) (281.18 KB - PDF)
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eesti keel (ET) (279.45 KB - PDF)
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français (FR) (278.12 KB - PDF)
hrvatski (HR) (296.78 KB - PDF)
íslenska (IS) (277.37 KB - PDF)
italiano (IT) (277.07 KB - PDF)
latviešu valoda (LV) (305.14 KB - PDF)
lietuvių kalba (LT) (299.06 KB - PDF)
magyar (HU) (289.49 KB - PDF)
Malti (MT) (304.2 KB - PDF)
Nederlands (NL) (277.85 KB - PDF)
norsk (NO) (278.69 KB - PDF)
polski (PL) (305.13 KB - PDF)
português (PT) (278.81 KB - PDF)
română (RO) (299.89 KB - PDF)
slovenčina (SK) (303.57 KB - PDF)
slovenščina (SL) (302.35 KB - PDF)
Suomi (FI) (275.1 KB - PDF)
svenska (SV) (277.71 KB - PDF)
Product details
- Name of medicine
- Ingelvac PCV FLEX
- Active substance
- porcine circovirus type 2 ORF2 protein
- International non-proprietary name (INN) or common name
- porcine circovirus vaccine (inactivated)
- Species
- Pigs
- Anatomical therapeutic chemical veterinary (ATCvet) code
- QI09AA07
Pharmacotherapeutic group
Immunologicals for suidaeTherapeutic indication
For active immunisation of pigs with no PCV2 maternally derived antibodies from the age of 2 weeks against porcine circovirus type 2 (PCV2)
Authorisation details
- EMA product number
- EMEA/V/C/004645
- Marketing authorisation holder
- Boehringer Ingelheim Vetmedica GmbH
Binger Strasse 173
55216 Ingelheim am Rhein
Germany - Opinion adopted
- 16/03/2017
- Marketing authorisation issued
- 24/05/2017
- Revision
- 2
Assessment history
Ingelvac PCV FLEX : EPAR - Procedural steps taken and scientific information after authorisation
English (EN) (184.03 KB - PDF)
Ingelvac PCV FLEX : EPAR - Public assessment report
English (EN) (278.66 KB - PDF)
CVMP summary of positive opinion for Ingelvac PCV FLEX
English (EN) (195.13 KB - PDF)