Veterinary Medicines

Milteforan 20 mg/ml oral solution for dogs

Authorised
  • Miltefosine
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Product identification

Medicine name:
Milteforan 20 mg/ml orale oplossing voor honden
Milteforan 20 mg/ml oral solution for dogs
Active substance:
  • Miltefosine
Target species:
  • Dog
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Miltefosine
    20.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Oral solution
Withdrawal period by route of administration:
  • Oral use
    • Dog
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QP51DX07
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Netherlands
Package description:
  • Carton box containing a 90 ml Polyethylene terephthalate (PET) bottle equipped with a sampling polypropylene (PP) snap cap with silicone stopper and a 3 ml polypropylene (PP) syringe graduated every 0.1 ml
  • Carton box containing a 60 ml Polyethylene terephthalate (PET) bottle equipped with a sampling polypropylene (PP) snap cap with silicone stopper and a 3 ml polypropylene (PP) syringe graduated every 0.1 ml
  • Carton box containing a 30 ml Polyethylene terephthalate (PET) bottle equipped with a sampling polypropylene (PP) snap cap with silicone stopper and a 3 ml polypropylene (PP) syringe graduated every 0.1 ml

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Generic application (Article 18 of Regulation (EU) 2019/6)
Marketing authorisation holder:
  • Virbac
Marketing authorisation date:
Manufacturing sites for batch release:
  • Virbac
Responsible authority:
  • Medicines Evaluation Board
Authorisation number:
  • REG NL 130834
Date of authorisation status change:
Reference member state:
  • Netherlands
Procedure number:
  • NL/V/0405/001
Concerned member states:
  • Bulgaria
  • Croatia
  • Cyprus
  • France
  • Greece
  • Italy
  • Portugal
  • Romania
  • Slovenia
  • Spain
Generic of:

Documents

Combined File of all Documents

English (PDF)
Published on: 26/02/2024
Download
Dutch (PDF)
Published on: 26/02/2024
Download

NLV0405001DC Milteforan final PuAR.pdf

English (PDF)
Published on: 3/04/2024
Download
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