Veterinary Medicines

Zolvix 25 mg/ml - Oral solution

Authorised
  • Monepantel
Download as PDF

Product identification

Medicine name:
Zolvix 25 mg/ml - Oral solution
Active substance:
  • Monepantel
Target species:
  • Sheep
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Monepantel
    Presentation_strength:25 mg Reference:Hse Index:0
Pharmaceutical form:
  • Oral solution
Withdrawal period by route of administration:
  • Oral use
    • Sheep
      • Meat and offal
        7
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QP52AX09
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
  • France
  • Germany
  • Ireland
  • Luxembourg
  • Netherlands
  • United Kingdom (Northern Ireland)
Package description:
  • Packaging:Bottle (HDPE), Package_size:1 bottle, Content:2.5 l
  • Packaging:Bottle (HDPE), Package_size:1 bottle, Content:1 l
  • Packaging:Bottle (HDPE), Package_size:1 bottle, Content:0.5 l
  • Packaging:Bottle (HDPE), Package_size:1 bottle, Content:0.25 l
  • Packaging:Bottle (HDPE), Package_size:1 bottle, Content:5 l

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Full application (Article 12(3) of Directive No 2001/82/EC)
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:

Documents

Combined File of all Documents

English (PDF)
Published on: 26/05/2023
Download
Bulgarian (PDF)
Published on: 26/05/2023
Download
Croatian (PDF)
Published on: 26/05/2023
Download
Czech (PDF)
Published on: 26/05/2023
Download
Danish (PDF)
Published on: 26/05/2023
Download
Dutch (PDF)
Published on: 26/05/2023
Download
Estonian (PDF)
Published on: 26/05/2023
Download
Finnish (PDF)
Published on: 26/05/2023
Download
French (PDF)
Published on: 26/05/2023
Download
German (PDF)
Published on: 26/05/2023
Download
Greek (PDF)
Published on: 26/05/2023
Download
Hungarian (PDF)
Published on: 26/05/2023
Download
Icelandic (PDF)
Published on: 26/05/2023
Download
Italian (PDF)
Published on: 26/05/2023
Download
Latvian (PDF)
Published on: 26/05/2023
Download
Lithuanian (PDF)
Published on: 26/05/2023
Download
Maltese (PDF)
Published on: 26/05/2023
Download
Norwegian (PDF)
Published on: 26/05/2023
Download
Polish (PDF)
Published on: 26/05/2023
Download
Portuguese (PDF)
Published on: 26/05/2023
Download
Romanian (PDF)
Published on: 26/05/2023
Download
Slovak (PDF)
Published on: 26/05/2023
Download
Slovenian (PDF)
Published on: 26/05/2023
Download
Spanish (PDF)
Published on: 26/05/2023
Download
Swedish (PDF)
Published on: 26/05/2023
Download

ema-puar-zolvix-v-154-var-ii-0004-en.pdf

English (PDF)
Published on: 16/03/2023
Download

ema-puar-zolvix-v-154-var-ii-0001-g-en.pdf

English (PDF)
Published on: 16/03/2023
Download

ema-puar-zolvix-epar-scientific-discussion-en.pdf

English (PDF)
Published on: 16/03/2023
Download