Veterinary Medicines

Pyrocam 15 mg/ml oral suspension for pigs

Authorised
  • Meloxicam
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Product identification

Medicine name:
Pyrocam 15 mg/ml oral suspension for pigs
Pyrocam, 15mg/ml, Perorální suspenze
Active substance:
  • Meloxicam
Target species:
  • Pig
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Meloxicam
    15.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Oral suspension
Withdrawal period by route of administration:
  • Oral use
    • Pig
      • Meat and offal
        5
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QM01AC06
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Czechia
Package description:
  • Cardboard box with HDPE bottle of 1000 ml closed with a two-part tamper evident closure consisting of an outer white cap (PP), an internal natural colour screw closure (HDPE) and a mounted plug (LDPE) + plastic measuring syringe
  • Cardboard box with HDPE bottle of 250 ml closed with a two-part tamper evident closure consisting of an outer white cap (PP), an internal natural colour screw closure (HDPE) and a mounted plug (LDPE) + plastic measuring syringe
  • Cardboard box with HDPE bottle of 125 ml closed with a two-part tamper evident closure consisting of an outer white cap (PP), an internal natural colour screw closure (HDPE) and a mounted plug (LDPE) + plastic measuring syringe

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Hybrid application – bioavailability studies cannot be used to demonstrate bioequivalence (Article 19(1)(b) of Regulation (EU) 2019/6)
Marketing authorisation holder:
  • HuVepharma
Marketing authorisation date:
Manufacturing sites for batch release:
  • Biovet J.S.C.
Responsible authority:
  • Institute For State Control Of Veterinary Biologicals And Medicaments
Authorisation number:
  • 96/059/23-C
Date of authorisation status change:
Reference member state:
  • Belgium
Procedure number:
  • BE/V/0048/001
Concerned member states:
  • Austria
  • Bulgaria
  • Croatia
  • Cyprus
  • Czechia
  • Denmark
  • Estonia
  • Finland
  • France
  • Germany
  • Greece
  • Hungary
  • Ireland
  • Italy
  • Latvia
  • Lithuania
  • Luxembourg
  • Malta
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Spain
  • Sweden
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
Czech (PDF)
Published on: 13/12/2023
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Czech (PDF)
Published on: 13/12/2023
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Labelling

This document does not exist in this language (English). You can find it in another language below.
Czech (PDF)
Published on: 13/12/2023
Download

Combined File of all Documents

English (PDF)
Published on: 27/07/2023
Updated on: 1/12/2023
Download
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