Veterinary Medicines

Sedan, 35mg/ml, Oral gel

Authorised
  • Acepromazine
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Product identification

Medicine name:
Sedan, 35mg/ml, Oral gel
Sedan 35 mg/ml gel voor oraal gebruik voor paarden en honden
Active substance:
  • Acepromazine
Target species:
  • Horse
  • Dog
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Acepromazine
    35.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Oral gel
Withdrawal period by route of administration:
  • Oral use
    • Horse
      • Meat and offal
        no withdrawal period
      • Milk
        no withdrawal period
    • Dog
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QN05AA04
Legal status of supply:
This information is not available for this product.
Authorisation status:
  • Valid
Authorised in:
  • Netherlands
Package description:
  • Plastic Applicator 1 x 10.0 millilitre(s)
  • Plastic Applicator 1 x 1.0 millilitre(s)

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:
  • Bioveta a.s.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Bioveta a.s.
Responsible authority:
  • Medicines Evaluation Board
Authorisation number:
  • REG NL 129523
Date of authorisation status change:
Reference member state:
  • Czechia
Procedure number:
  • CZ/V/0174/001
Concerned member states:
  • Austria
  • Belgium
  • Bulgaria
  • Croatia
  • Cyprus
  • Denmark
  • Estonia
  • France
  • Germany
  • Greece
  • Hungary
  • Italy
  • Latvia
  • Lithuania
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Spain
  • Sweden

Documents

Combined File of all Documents

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Dutch (PDF)
Published on: 17/08/2022
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