Dalmaprost 0.075 mg/ml solution for injection for cattle, pigs and horses
  • d-Cloprostenol sodium
  • Valid
Authorised in these countries:
  • European Union
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Product identification

Medicine name:
Dalmaprost 0.075 mg/ml solution for injection for cattle, pigs and horses
Dalmazin SYNCH 0,075 mg/ml инжекционен разтвор за говеда, свине и коне
Active substance and strength:
  • d-Cloprostenol sodium
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QG02AD90
Authorisation number:
  • 0022-2921
Product identification number:
  • cbb4eac9-ecf8-4d43-a414-31c067d9e5d8
Permanent identification number:
  • 600000038876

Product details

Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Cattle (cow)
      • Meat and offal
        no withdrawal period
      • Milk
        no withdrawal period
    • Pig (female)
      • Meat and offal
        1
        day
    • Horse (mare)
      • Meat and offal
        2
        day
      • Milk
        no withdrawal period

Availability

Package description:
  • box containing 1 HDPE container of 100 ml
  • box containing 1 vial of 20 ml
  • box containing 1 vial of 10 ml
  • box containing 60 vials of 2 ml
  • box containing 15 vials of 2 ml
Manufacturing sites for batch release:
  • Fatro S.p.A.
Source wholesaler:
This information is not available for this product.
Destination wholesaler:
This information is not available for this product.

Authorisation details

Authorisation status:
  • Valid
Authorisation procedure type:
  • Marketing Authorisation
Procedure number:
  • ES/V/0305/001
Date of authorisation status change:
Legal basis of product authorisation:
  • Generic application (Article 13(1) of Directive No 2001/82/EC)
Authorisation country:
  • Bulgaria
Responsible authority:
  • BFSA
Marketing authorisation holder:
  • Fatro S.p.A.
Marketing authorisation issued:
Reference member state:
  • Spain
Concerned member states:
  • Austria
  • Belgium
  • Bulgaria
  • Croatia
  • Cyprus
  • Czechia
  • Denmark
  • Estonia
  • Finland
  • France
  • Germany
  • Greece
  • Hungary
  • Iceland
  • Ireland
  • Italy
  • Latvia
  • Lithuania
  • Luxembourg
  • Malta
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Sweden
  • United Kingdom (Northern Ireland)
Reference product identifier:
This information is not available for this product.
Source product identifier:
This information is not available for this product.

Additional information

To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet

Documents

Summary of Product Characteristics (PDF)
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Last updated:
Package Leaflet and Labelling (PDF)
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Summary of Product Characteristics (PDF)
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Package Leaflet (PDF)
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Last updated:
Labelling (PDF)
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Last updated:
eu-PUAR-dalmaprost-0.075-mg-ml-solution-for-injection-for-cattle--pigs-and-horses-en.pdf (PDF)
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Last updated:
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