Veterinary Medicines

AdTab 112 mg - Chewable tablet

Authorised
  • Lotilaner
Download as PDF

Product identification

Medicine name:
AdTab 112 mg - Chewable tablet
Active substance:
  • Lotilaner
Target species:
  • Dog
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Lotilaner
    Presentation_strength:112.5 mg Reference:Hse Index:0
Pharmaceutical form:
  • Chewable tablet
Withdrawal period by route of administration:
  • Oral use
    • Dog
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QP53BE04
Legal status of supply:
  • Veterinary medicinal product not 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)
Package description:
  • Packaging:Blister (Alu/Alu), Package_size:3 tablets
  • Packaging:Blister (Alu/Alu), Package_size:1 tablet

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Informed Consent application (Article 21 of Regulation (EU) 2019/6)
Marketing authorisation holder:
  • Elanco GmbH
Marketing authorisation date:
Manufacturing sites for batch release:
  • Elanco France S.A.S
Responsible authority:
  • European Commission
Authorisation number:
This information is not available for this product.
Date of authorisation status change:
Informed consent reference:

Documents

Combined File of all Documents

English (PDF)
Published on: 19/02/2024
Download
Bulgarian (PDF)
Published on: 19/02/2024
Download
Croatian (PDF)
Published on: 19/02/2024
Download
Czech (PDF)
Published on: 19/02/2024
Download
Danish (PDF)
Published on: 19/02/2024
Download
Dutch (PDF)
Published on: 19/02/2024
Download
Estonian (PDF)
Published on: 19/02/2024
Download
Finnish (PDF)
Published on: 19/02/2024
Download
French (PDF)
Published on: 19/02/2024
Download
German (PDF)
Published on: 19/02/2024
Download
Greek (PDF)
Published on: 19/02/2024
Download
Hungarian (PDF)
Published on: 19/02/2024
Download
Icelandic (PDF)
Published on: 19/02/2024
Download
Italian (PDF)
Published on: 19/02/2024
Download
Latvian (PDF)
Published on: 19/02/2024
Download
Lithuanian (PDF)
Published on: 19/02/2024
Download
Maltese (PDF)
Published on: 19/02/2024
Download
Norwegian (PDF)
Published on: 19/02/2024
Download
Polish (PDF)
Published on: 19/02/2024
Download
Portuguese (PDF)
Published on: 19/02/2024
Download
Romanian (PDF)
Published on: 19/02/2024
Download
Slovak (PDF)
Published on: 19/02/2024
Download
Slovenian (PDF)
Published on: 19/02/2024
Download
Spanish (PDF)
Published on: 19/02/2024
Download
Swedish (PDF)
Published on: 19/02/2024
Download

ema-puar-lotilaner-elanco-v-006030-par-en.pdf

English (PDF)
Published on: 21/03/2023
Download
How useful was this page?:
No votes yet
"Please do not include any personal data, such as your name or contact details. If you do, you consent to the processing of that data in accordance with EMA’s Privacy Statement concerning requests for information or access to documents. If you would like a reply from EMA, please Send a question to EMA instead."