Veterinary Medicines

Gastazole 370 mg/g oral paste for horses

Authorised
  • Omeprazole
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Product identification

Medicine name:
Gastazole 370 mg/g oral paste for horses
Gastazole 370 mg/g Paste zum Eingeben für Pferde
Active substance:
  • Omeprazole
Target species:
  • Horse
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Omeprazole
    370.00
    milligram(s)
    /
    1.00
    gram(s)
Pharmaceutical form:
  • Oral paste
Withdrawal period by route of administration:
  • Oral use
    • Horse
      • Meat and offal
        1
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QA02BC01
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Germany
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 Ltd
Responsible authority:
  • Federal Office Of Consumer Protection And Food Safety
Authorisation number:
  • V7002855.00.00
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

Documents

Summary of Product Characteristics

English (PDF)
Published on: 13/04/2025
Download

Combined File of all Documents

English (PDF)
Published on: 13/04/2025
Download
German (PDF)
Published on: 10/01/2025
Download
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