Veterinary Medicines

Arocenia, 10mg/ml, Solution for injection

Authorised
  • Maropitant
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Product identification

Medicine name:
Arocenia, 10mg/ml, Solution for injection
Arocenia, 10 mg/mL, otopina za injekciju, za pse i mačke
Active substance:
  • Maropitant
Target species:
  • Dog
  • Cat
Route of administration:
  • Intravenous use
  • Subcutaneous use

Product details

Active substance and strength:
  • Maropitant
    10.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Intravenous use
    • Dog
    • Cat
  • Subcutaneous use
    • Dog
    • Cat
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QA04AD90
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Croatia
Package description:
  • Glass Vial 1 x 20.0 millilitre(s)

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Generic application (Article 18 of Regulation (EU) 2019/6)
Marketing authorisation holder:
  • KRKA tovarna zdravil d.d. Novo mesto
Marketing authorisation date:
Manufacturing sites for batch release:
  • Krka d.d. Novo Mesto
  • Tad Pharma GmbH
Responsible authority:
  • Ministry Of Agriculture Veterinary And Food Safety Directorate
Authorisation number:
  • UP/I-322-05/23-01/643
Date of authorisation status change:
Reference member state:
  • Czechia
Procedure number:
  • CZ/V/0179/001
Concerned member states:
  • Belgium
  • Croatia
  • Estonia
  • Germany
  • Hungary
  • Latvia
  • Lithuania
  • Netherlands
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

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Croatian (PDF)
Published on: 2/01/2024
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