Pyrocam 15 mg/ml oral suspension for pigs
Pyrocam 15 mg/ml oral suspension for pigs
Authorised
- Meloxicam
Product identification
Medicine name:
Pyrocam 15 mg/ml oral suspension for pigs
Pyrocam 15 mg/ml suspensie voor oraal gebruik voor varkens
Pyrocam 15 mg/ml suspension buvable pour porcins
Pyrocam 15 mg/ml Suspension zum Eingeben für Schweine
Active substance:
- Meloxicam
Target species:
-
Pig
Route of administration:
-
Oral use
Product details
Active substance and strength:
-
Meloxicam15.00milligram(s)1.00millilitre(s)
Pharmaceutical form:
-
Oral suspension
Withdrawal period by route of administration:
-
Oral use
-
Pig
-
Meat and offal5day
-
-
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QM01AC06
Legal status of supply:
-
Veterinary medicinal product subject to veterinary prescription
Authorisation status:
-
Valid
Authorised in:
-
Belgium
Available in:
-
Belgium
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 AD
Responsible authority:
- Federal Agency For Medicines And Health Products
Authorisation number:
- BE-V661874
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)
To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet
Documents
Summary of Product Characteristics
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Labelling
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Package Leaflet
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