Veterinary Medicines

Duramune Puppy DP + C

Suspended
  • Canine distemper virus, strain Onderstepoort, Live
  • Canine parvovirus, strain SAH, Live
  • Canine coronavirus, strain TN449, Inactivated
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Product identification

Medicine name:
Duramune Puppy DP + C
DURAMUNE CACHORROS DP+C
Active substance:
  • Canine distemper virus, strain Onderstepoort, Live
  • Canine parvovirus, strain SAH, Live
  • Canine coronavirus, strain TN449, Inactivated
Target species:
  • Dog
Route of administration:
  • Subcutaneous use

Product details

Active substance and strength:
  • Canine distemper virus, strain Onderstepoort, Live
    4.80
    tissue culture infective dose 50
    /
    1.00
    millilitre(s)
  • Canine parvovirus, strain SAH, Live
    6.50
    tissue culture infective dose 50
    /
    1.00
    millilitre(s)
  • Canine coronavirus, strain TN449, Inactivated
    2.00
    relative potency
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Lyophilisate and solvent for suspension for injection
Withdrawal period by route of administration:
  • Subcutaneous use
    • Dog
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QI07AH04
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Suspended
Authorised in:
  • Spain
Package description:
  • Pack with 100 x 1 ml doses
  • Pack with 50 x 1 ml doses
  • Pack with 25 x 1 ml doses
  • Pack with 10 x 1 ml doses

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Full application - Known active substance (Article 12(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Zoetis Spain S.L.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Zoetis Belgium
Responsible authority:
  • (AEMPS)
Authorisation number:
  • 1656 ESP
Date of authorisation status change:
Reference member state:
  • Spain
Procedure number:
  • ES/V/0289/001
Concerned member states:
  • Cyprus
  • Italy
  • Lithuania
  • Malta

Documents

Summary of Product Characteristics

English (PDF)
Published on: 23/03/2023
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Spanish (PDF)
Published on: 17/03/2023
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Spanish (PDF)
Published on: 17/03/2023
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Labelling

This document does not exist in this language (English). You can find it in another language below.
Spanish (PDF)
Published on: 17/03/2023
Download
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