Veterinary Medicines

Gleptoferron Labiana 200 mg/ml Solution for Injection

Authorised
  • Gleptoferron
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Product identification

Medicine name:
Gleptoferron Labiana 200 mg/ml Solution for Injection
Active substance:
  • Gleptoferron
Target species:
  • Pig
Route of administration:
  • Intramuscular use

Product details

Active substance and strength:
  • Gleptoferron
    532.60
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Pig
      • Meat and offal
        0
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QB03AC91
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • United Kingdom (Northern Ireland)
Package description:
  • Low-density polyethylene collapsible bottle (LDPE) with a nominal capacity of 100 ml closed with a chlorobutyl rubber closure and an aluminium ring seal. Each bottle is sealed in a sachet. The sachet is a polyester/polyethylene laminate. Do not open the sachet until ready to use the veterinary medicinal product. Presentation 1 x 100 ml
  • Low-density polyethylene collapsible bottle (LDPE) with a nominal capacity of 200 ml closed with a chlorobutyl rubber closure and an aluminium ring seal. Each bottle is sealed in a sachet. The sachet is a polyester/polyethylene laminate. Do not open the sachet until ready to use the veterinary medicinal product. Presentation 1 x 200 ml
  • Low-density polyethylene collapsible bottle (LDPE) with a nominal capacity of 100 ml closed with a chlorobutyl rubber closure and an aluminium ring seal. Each bottle is sealed in a sachet. The sachet is a polyester/polyethylene laminate. Do not open the sachet until ready to use the veterinary medicinal product. Presentation 10 x 100 ml
  • Low-density polyethylene collapsible bottle (LDPE) with a nominal capacity of 100 ml closed with a chlorobutyl rubber closure and an aluminium ring seal. Each bottle is sealed in a sachet. The sachet is a polyester/polyethylene laminate. Do not open the sachet until ready to use the veterinary medicinal product. Presentation 20 x 100 ml
  • Low-density polyethylene collapsible bottle (LDPE) with a nominal capacity of 100 ml closed with a chlorobutyl rubber closure and an aluminium ring seal. Each bottle is sealed in a sachet. The sachet is a polyester/polyethylene laminate. Do not open the sachet until ready to use the veterinary medicinal product. Presentation 40 x 100 ml
  • Low-density polyethylene collapsible bottle (LDPE) with a nominal capacity of 200 ml closed with a chlorobutyl rubber closure and an aluminium ring seal. Each bottle is sealed in a sachet. The sachet is a polyester/polyethylene laminate. Do not open the sachet until ready to use the veterinary medicinal product. Presentation 10 x 200 ml
  • Low-density polyethylene collapsible bottle (LDPE) with a nominal capacity of 200 ml closed with a chlorobutyl rubber closure and an aluminium ring seal. Each bottle is sealed in a sachet. The sachet is a polyester/polyethylene laminate. Do not open the sachet until ready to use the veterinary medicinal product. Presentation 20 x 200 ml
  • High-density polyethylene collapsible bottle (HDPE) with a nominal capacity of 100 ml closed with a chlorobutyl rubber closure and an aluminium ring seal.Presentation 1 x 100 ml
  • High-density polyethylene collapsible bottle (HDPE) with a nominal capacity of 100 ml closed with a chlorobutyl rubber closure and an aluminium ring seal.Presentation 10 x 100 ml
  • High-density polyethylene collapsible bottle (HDPE) with a nominal capacity of 100 ml closed with a chlorobutyl rubber closure and an aluminium ring seal.Presentation 20 x 100 ml
  • High-density polyethylene collapsible bottle (HDPE) with a nominal capacity of 100 ml closed with a chlorobutyl rubber closure and an aluminium ring seal. Presentation 40 x 100 ml
  • High-density polyethylene collapsible bottle (HDPE) with a nominal capacity of 200 ml closed with a chlorobutyl rubber closure and an aluminium ring seal.Presentation 1 x 200 ml
  • High-density polyethylene collapsible bottle (HDPE) with a nominal capacity of 200 ml closed with a chlorobutyl rubber closure and an aluminium ring seal Presentation 10 x 200 ml
  • High-density polyethylene collapsible bottle (HDPE) with a nominal capacity of 200 ml closed with a chlorobutyl rubber closure and an aluminium ring seal.Presentation 20 x 200 ml

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:
  • Labiana Life Sciences S.A.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Labiana Life Sciences S.A.
Responsible authority:
  • The Veterinary Medicines Directorate
Authorisation number:
  • VM 32112/4001
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0379/001
Concerned member states:
  • Cyprus
  • Greece
  • Portugal
  • Spain
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 3/05/2024
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