Veterinary Medicines

Thyrotab 400 �g Tablets for dogs and cats

Authorised
  • Levothyroxine sodium
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Product identification

Medicine name:
Thyrocep Vet 400 microgram Tablets for dogs and cats
Thyrotab 400 �g Tablets for dogs and cats
Active substance:
  • Levothyroxine sodium
Target species:
  • Dog
  • Cat
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Levothyroxine sodium
    400.00
    microgram(s)
    /
    1.00
    Tablet
Pharmaceutical form:
  • Tablet
Withdrawal period by route of administration:
  • Oral use
    • Dog
    • Cat
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QH03AA01
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Ireland
Package description:
  • Cardboard box with 250 tablets (25 Aluminium-PVC/Alu/oPA blisters of 10 tablets)
  • Cardboard box with 100 tablets (10 Aluminium-PVC/Alu/oPA blisters of 10 tablets)
  • Cardboard box with 30 tablets (3 Aluminium-PVC/Alu/oPA blisters of 10 tablets)

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Hybrid application – change in strength (Article 19(1)(a) of Regulation (EU) 2019/6)
Marketing authorisation holder:
  • CP-Pharma Handelsgesellschaft mbH
Marketing authorisation date:
Manufacturing sites for batch release:
  • Cp-Pharma Handelsgesellschaft mbH
Responsible authority:
  • Health Products Regulatory Authority
Authorisation number:
  • VPA10810/029/002
Date of authorisation status change:
Reference member state:
  • Netherlands
Procedure number:
  • NL/V/0404/002
Concerned member states:
  • Austria
  • Belgium
  • Czechia
  • Denmark
  • Estonia
  • Finland
  • France
  • Germany
  • Greece
  • Hungary
  • Ireland
  • Italy
  • Latvia
  • Lithuania
  • Norway
  • Poland
  • Portugal
  • Slovakia
  • Spain
  • Sweden
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