Veterinary Medicines

Neoleish (--) - Nasal spray, solution

Authorised
  • Bacterial DNA plasmid containing LACK gene from Leishmania infantum
Download as PDF

Product identification

Medicine name:
Neoleish (--) - Nasal spray, solution
Active substance:
  • Bacterial DNA plasmid containing LACK gene from Leishmania infantum
Target species:
  • Dog
Route of administration:
  • Nasal use

Product details

Active substance and strength:
  • Bacterial DNA plasmid containing LACK gene from Leishmania infantum
    Presentation_strength:212.5-250 µg Index:0
Pharmaceutical form:
  • Nasal spray, solution
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QI07AX
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)
Package description:
  • Packaging:Vial (glass), Package_size:10 vials, Content:10 x 1 ml
  • Packaging:Vial (glass), Package_size:1 vial, Content:1 ml

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Full application - New active substance (Article 12(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • CZ Vaccines S.A.U.
Marketing authorisation date:
Manufacturing sites for batch release:
  • CZ Vaccines S.A.U.
Responsible authority:
  • European Commission
Authorisation number:
This information is not available for this product.
Date of authorisation status change:

Documents

Combined File of all Documents

English (PDF)
Published on: 13/05/2025
Download
Bulgarian (PDF)
Published on: 13/05/2025
Download
Croatian (PDF)
Published on: 13/05/2025
Download
Czech (PDF)
Published on: 13/05/2025
Download
Danish (PDF)
Published on: 13/05/2025
Download
Dutch (PDF)
Published on: 13/05/2025
Download
Estonian (PDF)
Published on: 13/05/2025
Download
Finnish (PDF)
Published on: 13/05/2025
Download
French (PDF)
Published on: 13/05/2025
Download
German (PDF)
Published on: 13/05/2025
Download
Greek (PDF)
Published on: 13/05/2025
Download
Hungarian (PDF)
Published on: 13/05/2025
Download
Icelandic (PDF)
Published on: 13/05/2025
Download
Italian (PDF)
Published on: 13/05/2025
Download
Latvian (PDF)
Published on: 13/05/2025
Download
Lithuanian (PDF)
Published on: 13/05/2025
Download
Maltese (PDF)
Published on: 13/05/2025
Download
Norwegian (PDF)
Published on: 13/05/2025
Download
Polish (PDF)
Published on: 13/05/2025
Download
Portuguese (PDF)
Published on: 13/05/2025
Download
Romanian (PDF)
Published on: 13/05/2025
Download
Slovak (PDF)
Published on: 13/05/2025
Download
Slovenian (PDF)
Published on: 13/05/2025
Download
Spanish (PDF)
Published on: 13/05/2025
Download
Swedish (PDF)
Published on: 13/05/2025
Download

ema-puar-neoleish-emea-puar-v-005538-en.pdf

English (PDF)
Published on: 20/04/2023
Download