Veterinary Medicines

Myodine 25 mg/ml solution for injection for dogs and cats

Authorised
  • Nandrolone laurate
Download as PDF

Product identification

Medicine name:
Myodine 25 mg/ml solution for injection for dogs and cats
Active substance:
  • Nandrolone laurate
Target species:
  • Dog
  • Cat
Route of administration:
  • Intramuscular use
  • Subcutaneous use

Product details

Active substance and strength:
  • Nandrolone laurate
    25.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QA14AB01
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Luxembourg
Package description:
  • Cardboard box with 1 clear type I glass vial containing 5 ml with a coated bromobutyl rubber stopper and aluminium cap.Pack size:Box with 1 vial of 5 ml
  • Cardboard box with 1 clear type II glass vial containing 10 ml with a coated bromobutyl rubber stopper and aluminium cap.Pack size:Box with 1 vial of 10 ml
  • Cardboard box with 1 clear type II glass vial containing 20 ml with a coated bromobutyl rubber stopper and aluminium cap.Pack size:Box with 1 vial of 20 ml
  • Cardboard box with 6 clear type I glass vials containing 5 ml with a coated bromobutyl rubber stopper and aluminium cap.Pack size:Multi-pack with 6 vials of 5 ml
  • Cardboard box with 6 clear type II glass vials containing 10 ml with a coated bromobutyl rubber stopper and aluminium cap.Pack size:Multi-pack with 6 vials of 10 ml
  • Cardboard box with 6 clear type II glass vials containing 20 ml with a coated bromobutyl rubber stopper and aluminium cap.Pack size:Multi-pack with 6 vials of 20 ml
  • Cardboard box with 10 clear type I glass vials containing 5 ml with a coated bromobutyl rubber stopper and aluminium cap.Pack size:Multi-pack with 10 vials of 5 ml
  • Cardboard box with 10 clear type II glass vials containing 10 ml with a coated bromobutyl rubber stopper and aluminium cap.Pack size:Multi-pack with 10 vials of 10 ml
  • Cardboard box with 10 clear type II glass vials containing 20 ml with a coated bromobutyl rubber stopper and aluminium cap.Pack size:Multi-pack with 10 vials of 20 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:
  • Dechra Regulatory B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Produlab Pharma B.V.
Responsible authority:
  • Ministere De La Sante Division De La Pharmacie Et Des Medicaments
Authorisation number:
  • V 914/18/09/1733
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0358/001
Concerned member states:
  • Austria
  • Belgium
  • Croatia
  • Cyprus
  • Czechia
  • Denmark
  • Estonia
  • Finland
  • France
  • Greece
  • Hungary
  • Iceland
  • Italy
  • Latvia
  • Lithuania
  • Luxembourg
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Spain
  • Sweden
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 3/05/2024
Download