Veterinary Medicines

Osteopen 100 mg/ml Solution for injection for dogs

Authorised
  • Pentosan polysulfate sodium
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Product identification

Medicine name:
Osteopen 100 mg/ml Solution for injection for dogs
Osteopen 100 mg/ml Oplossing voor injectie
Osteopen 100 mg/ml Solution injectable
Osteopen 100 mg/ml Injektionslösung
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:
  • Belgium
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:
  • Federal Agency For Medicines And Health Products
Authorisation number:
  • BE-V579457
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)

Documents

Summary of Product Characteristics

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Dutch (PDF)
Published on: 22/03/2022
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French (PDF)
Published on: 22/03/2022
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Dutch (PDF)
Published on: 22/03/2022
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French (PDF)
Published on: 22/03/2022
Download
German (PDF)
Published on: 22/03/2022
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