Veterinary Medicines

Doxybactin 200 mg tablets for dogs

Authorised
  • Doxycycline hyclate
Download as PDF

Product identification

Medicine name:
Doxybactin 200 mg
Doxybactin 200 mg tablets for dogs
Active substance:
  • Doxycycline hyclate
Target species:
  • Dog
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Doxycycline hyclate
    230.83
    milligram(s)
    /
    1.00
    Tablet
Pharmaceutical form:
  • Tablet
Withdrawal period by route of administration:
  • Oral use
    • Dog
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QJ01AA02
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Ireland
Package description:
  • Cardboard box of 3 Aluminium - PVC/PE/PVDC blisters of 10 tablets
  • Cardboard box of 2 Aluminium - PVC/PE/PVDC blisters of 10 tablets
  • Cardboard box of 1 Aluminium - PVC/PE/PVDC blister of 10 tablets
  • Cardboard box containing 10 separate cardboard boxes, each containing 1 Aluminium - PVC/PE/PVDC blister of 10 tablets
  • Cardboard box of 10 Aluminium - PVC/PE/PVDC blisters of 10 tablets

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Hybrid application (Article 13(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Dechra Regulatory B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Lelypharma B.V.
  • Genera d.d.
Responsible authority:
  • Health Products Regulatory Authority
Authorisation number:
  • VPA22622/044/002
Date of authorisation status change:
Reference member state:
  • Netherlands
Procedure number:
  • NL/V/0218/003
Concerned member states:
  • Austria
  • Belgium
  • Croatia
  • Cyprus
  • Czechia
  • Denmark
  • Estonia
  • Finland
  • France
  • Germany
  • Greece
  • Hungary
  • Iceland
  • Ireland
  • Italy
  • Latvia
  • Lithuania
  • Luxembourg
  • Norway
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Spain
  • Sweden
  • United Kingdom (Northern Ireland)

Documents

Combined File of all Documents

English (PDF)
Published on: 30/01/2023
Download
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."