Gastazole 370 mg/g oral paste for horses
Gastazole 370 mg/g oral paste for horses
Authorised
- Omeprazole
Product identification
Medicine name:
Omeprogard 370 mg/g Pasta voor oraal gebruik
Omeprogard 370 mg/g Pâte orale
Omeprogard 370 mg/g Paste zum Einnehmen
Gastazole 370 mg/g oral paste for horses
Active substance:
- Omeprazole
Target species:
-
Horse
Route of administration:
-
Oral use
Product details
Active substance and strength:
-
Omeprazole370.00milligram(s)1.00gram(s)
Pharmaceutical form:
-
Oral paste
Withdrawal period by route of administration:
-
Oral use
-
Horse
-
Meat and offal1day
-
-
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QA02BC01
Legal status of supply:
-
Veterinary medicinal product subject to veterinary prescription
Authorisation status:
-
Valid
Authorised in:
-
Belgium
Package description:
- Immediate packageImmediate packaging: Opaque white pre-filled oral syringe containing 7.57g of paste composed of Barrel: HDPE & LLDPEBarrel Cap: LDPEPlunger: PolypropyleneRing: PolypropylenePlastic Seal: LDPEPackage sizesCarton box of 1 syringe
- Immediate packageImmediate packaging: Opaque white pre-filled oral syringe containing 7.57g of paste composed of Barrel: HDPE & LLDPEBarrel Cap: LDPEPlunger: PolypropyleneRing: PolypropylenePlastic Seal: LDPEPackage sizesCarton box of 7 syringes
- Immediate packageImmediate packaging: Opaque white pre-filled oral syringe containing 7.57g of paste composed of Barrel: HDPE & LLDPEBarrel Cap: LDPEPlunger: PolypropyleneRing: PolypropylenePlastic Seal: LDPEPackage sizesCarton box of 10 syringes
- Immediate packageImmediate packaging: Opaque white pre-filled oral syringe containing 7.57g of paste composed of Barrel: HDPE & LLDPEBarrel Cap: LDPEPlunger: PolypropyleneRing: PolypropylenePlastic Seal: LDPEPackage sizesCarton box of 14 syringes
- Immediate packageImmediate packaging: Opaque white pre-filled oral syringe containing 7.57g of paste composed of Barrel: HDPE & LLDPEBarrel Cap: LDPEPlunger: PolypropyleneRing: PolypropylenePlastic Seal: LDPEPackage sizesCarton box of 20 syringes
- Immediate packageImmediate packaging: Opaque white pre-filled oral syringe containing 7.57g of paste composed of Barrel: HDPE & LLDPEBarrel Cap: LDPEPlunger: PolypropyleneRing: PolypropylenePlastic Seal: LDPEPackage sizesCarton box of 56 syringes
- Immediate packageImmediate packaging: Opaque white pre-filled oral syringe containing 7.57g of paste composed of Barrel: HDPE & LLDPEBarrel Cap: LDPEPlunger: PolypropyleneRing: PolypropylenePlastic Seal: LDPEPackage sizesCarton box of 72 syringes
Additional information
Entitlement type:
-
Marketing Authorisation
Legal basis of product authorisation:
-
Generic application (Article 13(1) of Directive No 2001/82/EC)
Marketing authorisation holder:
- Chanelle Pharmaceuticals Manufacturing Limited
Marketing authorisation date:
Manufacturing sites for batch release:
- Chanelle Pharmaceuticals Manufacturing Limited
Responsible authority:
- Federal Agency For Medicines And Health Products
Authorisation number:
- BE-V660589
Date of authorisation status change:
Reference member state:
-
Ireland
Procedure number:
- IE/V/0658/001
Concerned member states:
-
Austria
-
Belgium
-
Czechia
-
Denmark
-
Finland
-
France
-
Germany
-
Greece
-
Hungary
-
Italy
-
Netherlands
-
Norway
-
Poland
-
Portugal
-
Romania
-
Spain
-
Sweden
To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet
Documents
Package Leaflet
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Labelling
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Combined File of all Documents
English (PDF)
Download Published on: 13/04/2025
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