Comfortis
Withdrawn
This medicine's authorisation has been withdrawn
spinosad
MedicineVeterinaryWithdrawn
- Application under evaluation
- CVMP opinion
- European Commission decision
Overview
The marketing authorisation for Comfortis has been withdrawn at the request of the marketing authorisation holder
Comfortis : EPAR - Summary for the public
English (EN) (164.08 KB - PDF)
First published: Last updated:
български (BG) (236.57 KB - PDF)
First published: 22/08/2011Last updated: 26/06/2023
español (ES) (187.74 KB - PDF)
First published: 22/08/2011Last updated: 26/06/2023
čeština (CS) (226.05 KB - PDF)
First published: 22/08/2011Last updated: 26/06/2023
dansk (DA) (161.59 KB - PDF)
First published: 22/08/2011Last updated: 26/06/2023
Deutsch (DE) (171.6 KB - PDF)
First published: 22/08/2011Last updated: 26/06/2023
eesti keel (ET) (155.77 KB - PDF)
First published: 22/08/2011Last updated: 26/06/2023
ελληνικά (EL) (264.18 KB - PDF)
First published: 22/08/2011Last updated: 26/06/2023
français (FR) (189.24 KB - PDF)
First published: 22/08/2011Last updated: 26/06/2023
hrvatski (HR) (198.87 KB - PDF)
First published: 22/08/2011Last updated: 26/06/2023
italiano (IT) (161.61 KB - PDF)
First published: 22/08/2011Last updated: 26/06/2023
latviešu valoda (LV) (225.08 KB - PDF)
First published: 22/08/2011Last updated: 26/06/2023
lietuvių kalba (LT) (224.56 KB - PDF)
First published: 22/08/2011Last updated: 26/06/2023
magyar (HU) (217.9 KB - PDF)
First published: 22/08/2011Last updated: 26/06/2023
Malti (MT) (216.58 KB - PDF)
First published: 22/08/2011Last updated: 26/06/2023
Nederlands (NL) (191.07 KB - PDF)
First published: 22/08/2011Last updated: 26/06/2023
polski (PL) (205.46 KB - PDF)
First published: 22/08/2011Last updated: 26/06/2023
português (PT) (165.42 KB - PDF)
First published: 22/08/2011Last updated: 26/06/2023
română (RO) (234.04 KB - PDF)
First published: 22/08/2011Last updated: 26/06/2023
slovenčina (SK) (203.46 KB - PDF)
First published: 22/08/2011Last updated: 26/06/2023
slovenščina (SL) (219.22 KB - PDF)
First published: 22/08/2011Last updated: 26/06/2023
Suomi (FI) (179.48 KB - PDF)
First published: 22/08/2011Last updated: 26/06/2023
svenska (SV) (185.78 KB - PDF)
First published: 22/08/2011Last updated: 26/06/2023
Product information
Comfortis : EPAR - Product Information
English (EN) (762.08 KB - PDF)
First published: Last updated:
български (BG) (1 MB - PDF)
First published: 22/08/2011Last updated: 26/06/2023
español (ES) (788.73 KB - PDF)
First published: 22/08/2011Last updated: 26/06/2023
čeština (CS) (931.05 KB - PDF)
First published: 22/08/2011Last updated: 26/06/2023
dansk (DA) (761.7 KB - PDF)
First published: 22/08/2011Last updated: 26/06/2023
Deutsch (DE) (837.99 KB - PDF)
First published: 22/08/2011Last updated: 26/06/2023
eesti keel (ET) (986.97 KB - PDF)
First published: 22/08/2011Last updated: 26/06/2023
ελληνικά (EL) (1.1 MB - PDF)
First published: 22/08/2011Last updated: 26/06/2023
français (FR) (813.94 KB - PDF)
First published: 22/08/2011Last updated: 26/06/2023
hrvatski (HR) (961.72 KB - PDF)
First published: 22/08/2011Last updated: 26/06/2023
íslenska (IS) (733.62 KB - PDF)
First published: 22/08/2011Last updated: 26/06/2023
italiano (IT) (835.06 KB - PDF)
First published: 22/08/2011Last updated: 26/06/2023
latviešu valoda (LV) (1.1 MB - PDF)
First published: 22/08/2011Last updated: 26/06/2023
lietuvių kalba (LT) (1.05 MB - PDF)
First published: 22/08/2011Last updated: 26/06/2023
magyar (HU) (924.98 KB - PDF)
First published: 22/08/2011Last updated: 26/06/2023
Malti (MT) (1.01 MB - PDF)
First published: 22/08/2011Last updated: 26/06/2023
Nederlands (NL) (803.63 KB - PDF)
First published: 22/08/2011Last updated: 26/06/2023
norsk (NO) (762.11 KB - PDF)
First published: 22/08/2011Last updated: 26/06/2023
polski (PL) (993.24 KB - PDF)
First published: 22/08/2011Last updated: 26/06/2023
português (PT) (802.47 KB - PDF)
First published: 22/08/2011Last updated: 26/06/2023
română (RO) (969.27 KB - PDF)
First published: 22/08/2011Last updated: 26/06/2023
slovenčina (SK) (943.68 KB - PDF)
First published: 22/08/2011Last updated: 26/06/2023
slovenščina (SL) (925.44 KB - PDF)
First published: 22/08/2011Last updated: 26/06/2023
Suomi (FI) (789.17 KB - PDF)
First published: 22/08/2011Last updated: 26/06/2023
svenska (SV) (753.4 KB - PDF)
First published: 22/08/2011Last updated: 26/06/2023
Latest procedure affecting product information:
IB/0025/G
10/09/2021
Comfortis : EPAR - All Authorised presentations
English (EN) (289.71 KB - PDF)
First published: Last updated:
български (BG) (351.84 KB - PDF)
First published: 22/08/2011Last updated: 26/06/2023
español (ES) (294.94 KB - PDF)
First published: 22/08/2011Last updated: 26/06/2023
čeština (CS) (261.47 KB - PDF)
First published: 22/08/2011Last updated: 26/06/2023
dansk (DA) (280.02 KB - PDF)
First published: 22/08/2011Last updated: 26/06/2023
Deutsch (DE) (288.43 KB - PDF)
First published: 22/08/2011Last updated: 26/06/2023
eesti keel (ET) (287.9 KB - PDF)
First published: 22/08/2011Last updated: 26/06/2023
ελληνικά (EL) (326.3 KB - PDF)
First published: 22/08/2011Last updated: 26/06/2023
français (FR) (295.94 KB - PDF)
First published: 22/08/2011Last updated: 26/06/2023
hrvatski (HR) (329.99 KB - PDF)
First published: 22/08/2011Last updated: 26/06/2023
íslenska (IS) (296.28 KB - PDF)
First published: 22/08/2011Last updated: 26/06/2023
italiano (IT) (291.52 KB - PDF)
First published: 22/08/2011Last updated: 26/06/2023
latviešu valoda (LV) (321.16 KB - PDF)
First published: 22/08/2011Last updated: 26/06/2023
lietuvių kalba (LT) (267.62 KB - PDF)
First published: 22/08/2011Last updated: 26/06/2023
magyar (HU) (305.68 KB - PDF)
First published: 22/08/2011Last updated: 26/06/2023
Malti (MT) (310.01 KB - PDF)
First published: 22/08/2011Last updated: 26/06/2023
Nederlands (NL) (288.83 KB - PDF)
First published: 22/08/2011Last updated: 26/06/2023
norsk (NO) (282.34 KB - PDF)
First published: 22/08/2011Last updated: 26/06/2023
polski (PL) (310.43 KB - PDF)
First published: 22/08/2011Last updated: 26/06/2023
português (PT) (284.42 KB - PDF)
First published: 22/08/2011Last updated: 26/06/2023
română (RO) (294.1 KB - PDF)
First published: 22/08/2011Last updated: 26/06/2023
slovenčina (SK) (310.17 KB - PDF)
First published: 22/08/2011Last updated: 26/06/2023
slovenščina (SL) (345.29 KB - PDF)
First published: 22/08/2011Last updated: 26/06/2023
Suomi (FI) (287.08 KB - PDF)
First published: 22/08/2011Last updated: 26/06/2023
svenska (SV) (286.33 KB - PDF)
First published: 22/08/2011Last updated: 26/06/2023
Product details
- Name of medicine
- Comfortis
- Active substance
- spinosad
- International non-proprietary name (INN) or common name
- spinosad
- Species
- Dogs
- Cats
- Anatomical therapeutic chemical veterinary (ATCvet) code
- QP53BX03
Pharmacotherapeutic group
Other ectoparasiticides for systemic useTherapeutic indication
Treatment and prevention of flea infestations (Ctenocephalides felis).
The preventive effect against re-infestations is a result of the adulticidal activity and the reduction in egg production and persists for up to 4 weeks after a single administration of the product.
The veterinary medicinal product can be used as part of a treatment strategy for the control of flea allergy dermatitis (FAD).
Authorisation details
- EMA product number
- EMEA/V/C/002233
- Marketing authorisation holder
- Elanco GmbH
Heinz-Lohmann-Str. 4
27472 Cuxhaven
Germany - Opinion adopted
- 08/12/2010
- Marketing authorisation issued
- 11/02/2011
- Revision
- 12
Assessment history
Comfortis : EPAR - Procedural steps taken and scientific information after authorisation
English (EN) (634.97 KB - PDF)
First published: Last updated:
Comfortis-V-C-2233-X-10 : EPAR - Assessment Report - Extension
AdoptedReference Number: EMA/CVMP/615967/2013
English (EN) (349.36 KB - PDF)
First published: Last updated:
CVMP post-authorisation summary of positive opinion for Comfortis
AdoptedReference Number: EMA/CVMP/490575/2013
English (EN) (125.74 KB - PDF)
First published: Last updated:
Comfortis-V-C-2233-X-06-G : EPAR - Assessment Report - Extension
AdoptedReference Number: EMA/CVMP/700676/2012
English (EN) (256.63 KB - PDF)
First published: Last updated:
CVMP post-authorisation summary of positive opinion for Comfortis
AdoptedReference Number: EMA/CVMP/676652/2012
English (EN) (82.62 KB - PDF)
First published: Last updated:
News on Comfortis
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