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Veterinary Medicines

Mirataz 20 mg/ml - Transdermal ointment

Authorised
  • Mirtazapine hemihydrate

Product identification

Medicine name:
Mirataz 20 mg/ml - Transdermal ointment
Active substance:
  • Mirtazapine hemihydrate
Target species:
  • Cat
Route of administration:
  • Transdermal use

Product details

Active substance and strength:
  • Mirtazapine hemihydrate
    0.02
    gram(s)
    /
    1.00
    Tube
Pharmaceutical form:
  • Transdermal ointment
Withdrawal period by route of administration:
  • Transdermal use
    • Cat
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QN06AX11
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:Tube (PE child resistant within cardboard carton), Package_size:1 tube, Content:3 g

Additional information

Entitlement type:
  • Marketing Authorisation
Marketing authorisation holder:
  • Dechra Regulatory B.V
Marketing authorisation date:
Manufacturing sites for batch release:
  • GENERA Inc., Chemopharmaceutical Production, Solid Dosage Forms Facility
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: 15/07/2025
Download
Bulgarian (PDF)
Published on: 15/07/2025
Croatian (PDF)
Published on: 15/07/2025
Czech (PDF)
Published on: 15/07/2025
Danish (PDF)
Published on: 15/07/2025
Dutch (PDF)
Published on: 15/07/2025
Estonian (PDF)
Published on: 15/07/2025
Finnish (PDF)
Published on: 15/07/2025
French (PDF)
Published on: 15/07/2025
German (PDF)
Published on: 15/07/2025
Greek (PDF)
Published on: 15/07/2025
Hungarian (PDF)
Published on: 15/07/2025
Icelandic (PDF)
Published on: 15/07/2025
Italian (PDF)
Published on: 15/07/2025
Latvian (PDF)
Published on: 15/07/2025
Lithuanian (PDF)
Published on: 15/07/2025
Maltese (PDF)
Published on: 15/07/2025
Norwegian (PDF)
Published on: 15/07/2025
Polish (PDF)
Published on: 15/07/2025
Portuguese (PDF)
Published on: 15/07/2025
Romanian (PDF)
Published on: 15/07/2025
Slovak (PDF)
Published on: 15/07/2025
Slovenian (PDF)
Published on: 15/07/2025
Spanish (PDF)
Published on: 15/07/2025
Swedish (PDF)
Published on: 15/07/2025

ema-puar-mirataz-v-4733-par-en.pdf

English (PDF)
Published on: 15/03/2023
Download
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