GALCES PLUS, Tablet
GALCES PLUS, Tablet
Authorised
- Febantel
- Pyrantel embonate
- Praziquantel
Product identification
Medicine name:
GALCES PLUS, Tablet
GALCES PLUS, Tableta
Active substance:
- Febantel
- Pyrantel embonate
- Praziquantel
Target species:
-
Dog
Route of administration:
-
Oral use
Product details
Active substance and strength:
-
Febantel150.00/milligram(s)1.00Tablet
-
Pyrantel embonate144.00/milligram(s)1.00Tablet
-
Praziquantel50.00/milligram(s)1.00Tablet
Pharmaceutical form:
-
Tablet
Withdrawal period by route of administration:
-
Oral use
-
Dog
-
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QP52AC55
Legal status of supply:
-
Veterinary medicinal product not subject to veterinary prescription
Authorisation status:
-
Valid
Authorised in:
-
Czechia
Package description:
- Plastic Blister 10 x 10.0 Tablet
- Plastic Blister 5 x 10.0 Tablet
- Plastic Blister 1 x 10.0 Tablet
- Plastic Blister 1 x 4.0 Tablet
Additional information
Entitlement type:
-
Marketing Authorisation
Legal basis of product authorisation:
-
Well-established use application (Article 13a of Directive No 2001/82/EC)
Marketing authorisation holder:
- Pharmagal spol. s r.o.
Marketing authorisation date:
Manufacturing sites for batch release:
- Pharmagal spol. s r.o.
Responsible authority:
- Institute For State Control Of Veterinary Biologicals And Medicaments
Authorisation number:
- 96/038/10-C
Date of authorisation status change:
Reference member state:
-
Czechia
Procedure number:
- CZ/V/0113/001
Concerned member states:
-
Poland
To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet
Documents
Summary of Product Characteristics
English (PDF)
Download Published on: 24/05/2022
Czech (PDF)
Published on: 24/05/2022
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