Veterinary Medicines

Osteopen 100 mg/ml Solution for injection for dogs

Authorised
  • Pentosan polysulfate sodium
Download as PDF

Product identification

Medicine name:
Osteopen 100 mg/ml Solution for injection for dogs
Osteopen 100 mg/ml oldatos injekció kutyáknak A.U.V.
Active substance:
  • Pentosan polysulfate sodium
Target species:
  • Dog
Route of administration:
  • Subcutaneous use

Product details

Active substance and strength:
  • Pentosan polysulfate sodium
    100.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Subcutaneous use
    • Dog
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QM01AX90
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Hungary
Package description:
  • Colourless glass vial fitted with a grey chlorobutyl stopper and sealed by a lacquered aluminium cap.Package size:1 x 10ml
  • Colourless glass vial fitted with a grey chlorobutyl stopper and sealed by a lacquered aluminium cap.Package size:1 x 20ml

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:
  • Chanelle Pharmaceuticals Manufacturing Limited
Marketing authorisation date:
Manufacturing sites for batch release:
  • Chanelle Pharmaceuticals Manufacturing Limited
  • Labiana Life Sciences S.A.
Responsible authority:
  • Directorate Of Veterinary Medicinal Products
Authorisation number:
  • 4238/X/21 NÉBIH ÁTI
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0382/001
Concerned member states:
  • Austria
  • Belgium
  • Cyprus
  • Czechia
  • Denmark
  • Finland
  • France
  • Germany
  • Greece
  • Hungary
  • Iceland
  • Italy
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Spain
  • Sweden
  • United Kingdom (Northern Ireland)
How useful was this page?:
No votes yet
"Please do not include any personal data, such as your name or contact details. If you do, you consent to the processing of that data in accordance with EMA’s Privacy Statement concerning requests for information or access to documents. If you would like a reply from EMA, please Send a question to EMA instead."