Promec 18.7 mg/g Oral Paste for Horses
Promec 18.7 mg/g Oral Paste for Horses
Authorised
- Ivermectin
Product identification
Medicine name:
Promec 18.7 mg/g Oral Paste for Horses
Promec 18.7 mg/g Oral Paste for Horses
Active substance:
- Ivermectin
Target species:
-
Horse
Route of administration:
-
Oral use
Product details
Active substance and strength:
-
Ivermectin18.70/milligram(s)1.00gram(s)
Pharmaceutical form:
-
Oral paste
Withdrawal period by route of administration:
-
Oral use
-
Horse
-
Meat and offal34day
-
-
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QP54AA01
Legal status of supply:
-
Veterinary medicinal product subject to veterinary prescription
Authorisation status:
-
Valid
Authorised in:
-
Ireland
Package description:
- High density polyethylene dose graduated syringes in an outer cardboard box.Pack size:Box containing 1 syringe of 6,42 g
- High density polyethylene dose graduated syringes in an outer cardboard box.Pack size:Box containing 1 syringe of 7,49 g
- High density polyethylene dose graduated syringes in an outer cardboard box.Pack size:Box containing 50 syringes of 7,49 g
Additional information
Entitlement type:
-
Marketing Authorisation
Legal basis of product authorisation:
-
Informed consent application (Article 13c of Directive No 2001/82/EC)
Marketing authorisation holder:
- Acme Drugs S.r.l.
Marketing authorisation date:
Manufacturing sites for batch release:
- Acme Drugs S.r.l.
Responsible authority:
- Health Products Regulatory Authority
Authorisation number:
- VPA25460/005/001
Date of authorisation status change:
Reference member state:
-
Ireland
Procedure number:
- IE/V/0474/001
Concerned member states:
-
Italy
-
Portugal
-
Spain
-
United Kingdom (Northern Ireland)
To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet
