Veterinary Medicines

Cepedex 0.5 mg/ml - Solution for injection

Authorised
  • Dexmedetomidine hydrochloride
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Product identification

Medicine name:
Cepedex 0.5 mg/ml - Solution for injection
Active substance:
  • Dexmedetomidine hydrochloride
Target species:
  • Dog
  • Cat
Route of administration:
  • Intramuscular use
  • Intravenous use

Product details

Active substance and strength:
  • Dexmedetomidine hydrochloride
    Presentation_strength:0.5 mg Reference:HSE Comments:equivalent to 0.42 mg dexmedetomidine Index:0
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Dog
    • Cat
  • Intravenous use
    • Dog
    • Cat
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QN05CM18
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:
  • Belgium
  • Croatia
  • Denmark
  • Estonia
  • Finland
  • Germany
  • Greece
  • Italy
  • Latvia
  • Lithuania
  • Netherlands
  • Norway
  • Poland
  • Slovenia
  • Sweden
Package description:
  • Packaging:Vial (glass), Package_size:1 vial, Content:20 ml
  • Packaging:Vial (glass), Package_size:5 vials, Content:10 ml
  • Packaging:Vial (glass), Package_size:1 vial, Content:10 ml
  • Packaging:Vial (glass), Package_size:1 vial, Content:5 ml

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Generic application (Article 13(1) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • CP-Pharma Handelsgesellschaft mbH
Marketing authorisation date:
Manufacturing sites for batch release:
  • CP-Pharma Handelsgesellschaft mbH
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: 24/07/2023
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Bulgarian (PDF)
Published on: 24/07/2023
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Croatian (PDF)
Published on: 24/07/2023
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Czech (PDF)
Published on: 24/07/2023
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Danish (PDF)
Published on: 24/07/2023
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Dutch (PDF)
Published on: 24/07/2023
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Estonian (PDF)
Published on: 24/07/2023
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Finnish (PDF)
Published on: 24/07/2023
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French (PDF)
Published on: 24/07/2023
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German (PDF)
Published on: 24/07/2023
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Greek (PDF)
Published on: 24/07/2023
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Hungarian (PDF)
Published on: 24/07/2023
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Italian (PDF)
Published on: 24/07/2023
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Latvian (PDF)
Published on: 24/07/2023
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Lithuanian (PDF)
Published on: 24/07/2023
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Maltese (PDF)
Published on: 24/07/2023
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Norwegian (PDF)
Published on: 24/07/2023
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Polish (PDF)
Published on: 24/07/2023
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Portuguese (PDF)
Published on: 24/07/2023
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Romanian (PDF)
Published on: 24/07/2023
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Slovak (PDF)
Published on: 24/07/2023
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Slovenian (PDF)
Published on: 24/07/2023
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Spanish (PDF)
Published on: 24/07/2023
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Swedish (PDF)
Published on: 24/07/2023
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ema-puar-cepedex-v-4376-par-en.pdf

English (PDF)
Published on: 17/03/2023
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