Neptra 16.7 mg/ml florfenicol + 16.7 mg/ml terbinafine hydrochloride + 2.2 mg/ml mometasone furoate - Ear drops, solution in single-dose container
Neptra 16.7 mg/ml florfenicol + 16.7 mg/ml terbinafine hydrochloride + 2.2 mg/ml mometasone furoate - Ear drops, solution in single-dose container
Authorised
- Florfenicol
- Terbinafine hydrochloride
- Mometasone furoate
Product identification
Medicine name:
Neptra 16.7 mg/ml florfenicol + 16.7 mg/ml terbinafine hydrochloride + 2.2 mg/ml mometasone furoate - Ear drops, solution in single-dose container
Active substance:
- Florfenicol
- Terbinafine hydrochloride
- Mometasone furoate
Target species:
-
Dog
Route of administration:
-
Auricular use
Product details
Active substance and strength:
-
FlorfenicolPresentation_strength:16.7 mg Reference:Hse Index:0
-
Terbinafine hydrochloridePresentation_strength:16.7 mg Reference:Ph.Eur. Index:1
-
Mometasone furoatePresentation_strength:2.2 mg Reference:Ph.Eur. Index:2
Pharmaceutical form:
-
Ear drops, solution in single-dose container
Withdrawal period by route of administration:
-
Auricular use
- Dog
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QS02CA91
Legal status of supply:
-
Veterinary medicinal product subject to veterinary prescription
Authorisation status:
-
Valid
Authorised in:
-
Austria
-
Belgium
-
Bulgaria
-
Croatia
-
Cyprus
-
Czechia
-
Denmark
-
Estonia
-
Finland
-
France
-
Germany
-
Greece
-
Hungary
-
Iceland
-
Ireland
-
Italy
-
Latvia
-
Liechtenstein
-
Lithuania
-
Luxembourg
-
Malta
-
Netherlands
-
Norway
-
Poland
-
Portugal
-
Romania
-
Slovakia
-
Slovenia
-
Spain
-
Sweden
-
United Kingdom (Northern Ireland)
Available in:
-
Austria
-
Belgium
-
Bulgaria
-
Croatia
-
Cyprus
-
Czechia
-
Denmark
-
Estonia
-
Finland
-
France
-
Germany
-
Greece
-
Hungary
-
Ireland
-
Italy
-
Latvia
-
Lithuania
-
Luxembourg
-
Netherlands
-
Norway
-
Poland
-
Portugal
-
Romania
-
Slovakia
-
Slovenia
-
Spain
-
Sweden
-
United Kingdom (Northern Ireland)
Package description:
- Packaging:Tube (LDPE/Alu/LDPE), Package_size:1 tube, Content:1 ml
- Packaging:Tube (LDPE/Alu/LDPE), Package_size:20 tubes, Content:1 ml
- Packaging:Tube (LDPE/Alu/LDPE), Package_size:10 tubes, Content:1 ml
- Packaging:Tube (LDPE/Alu/LDPE), Package_size:2 tubes, Content:1 ml
Additional information
Entitlement type:
-
Marketing Authorisation
Legal basis of product authorisation:
-
Fixed combination application (Article 13b of Directive No 2001/82/EC)
Marketing authorisation holder:
- Elanco Animal Health GmbH
Marketing authorisation date:
Manufacturing sites for batch release:
- KVP Pharma+Veterinär Produkte GmbH
Responsible authority:
- European Commission
Authorisation number:
This information is not available for this product.
Date of authorisation status change:
To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet
Documents
Combined File of all Documents
English (PDF)
Download Published on: 19/10/2023
Bulgarian (PDF)
Published on: 19/10/2023
Croatian (PDF)
Published on: 19/10/2023
Czech (PDF)
Published on: 19/10/2023
Danish (PDF)
Published on: 19/10/2023
Dutch (PDF)
Published on: 19/10/2023
Estonian (PDF)
Published on: 19/10/2023
Finnish (PDF)
Published on: 19/10/2023
French (PDF)
Published on: 19/10/2023
German (PDF)
Published on: 19/10/2023
Greek (PDF)
Published on: 19/10/2023
Hungarian (PDF)
Published on: 19/10/2023
Icelandic (PDF)
Published on: 19/10/2023
Italian (PDF)
Published on: 19/10/2023
Latvian (PDF)
Published on: 19/10/2023
Lithuanian (PDF)
Published on: 19/10/2023
Maltese (PDF)
Published on: 19/10/2023
Norwegian (PDF)
Published on: 19/10/2023
Polish (PDF)
Published on: 19/10/2023
Portuguese (PDF)
Published on: 19/10/2023
Romanian (PDF)
Published on: 19/10/2023
Slovak (PDF)
Published on: 19/10/2023
Slovenian (PDF)
Published on: 19/10/2023
Spanish (PDF)
Published on: 19/10/2023
Swedish (PDF)
Published on: 19/10/2023
ema-puar-neptra-v-4735-par-en.pdf
English (PDF)
Download Published on: 21/03/2023
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