Profen Equine 100 mg/ml oral suspension for horses.
Profen Equine 100 mg/ml oral suspension for horses.
Authorised
- Fenbendazole
Product identification
Medicine name:
Profen Equine 100 mg/ml oral suspension for horses.
Active substance:
- Fenbendazole
Target species:
-
Horse
Route of administration:
-
Oral use
Product details
Active substance and strength:
-
Fenbendazole100.00/milligram(s)1.00millilitre(s)
Pharmaceutical form:
-
Oral suspension
Withdrawal period by route of administration:
-
Oral use
-
Horse
-
Meat and offal31day
-
-
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QP52AC13
Legal status of supply:
-
Veterinary medicinal product subject to veterinary prescription
Authorisation status:
-
Valid
Authorised in:
-
Ireland
Package description:
- 1 L (jerrican) HDPE white rigid container closed with a polypropylene screw cap with an induction heat seal liner.
- 2.5 L (back pack) HDPE white rigid container closed with a polypropylene screw cap with an induction heat seal liner.
- 5 L (jerrican) HDPE white rigid container closed with a polypropylene screw cap with an induction heat seal liner.
- 1 L (flat bottom flexi) HDPE white rigid container closed with a polypropylene screw cap with an induction heat seal liner.
- 2.5 L (jerrican) HDPE white rigid container closed with a polypropylene screw cap with an induction heat seal liner.
Additional information
Entitlement type:
-
Marketing Authorisation
Legal basis of product authorisation:
-
Informed Consent application (Article 21 of Regulation (EU) 2019/6)
Marketing authorisation holder:
- Interchem (Ireland) Limited
Marketing authorisation date:
Manufacturing sites for batch release:
- Univet Limited
Responsible authority:
- Health Products Regulatory Authority
Authorisation number:
- VPA10555/012/001
Date of authorisation status change:
To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet
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