Veterinary Medicines

FACILPART 10 U.I./ ml SOLUCION INYECTABLE

Authorised
  • OXYTOCIN SYNTHETIC
Download as PDF

Product identification

Medicine name:
FACILPART 10 U.I./ ml SOLUCION INYECTABLE
Active substance:
  • OXYTOCIN SYNTHETIC
Target species:
  • Horse (mare)
  • Cattle (cow)
  • Pig (female)
  • Sheep
  • Goat (adult female)
  • Cat (adult female)
  • Dog (bitch)
Route of administration:
  • Intramuscular use
  • Intravenous use
  • Subcutaneous use

Product details

Active substance and strength:
  • OXYTOCIN SYNTHETIC
    10.00
    international unit(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Horse (mare)
      • Meat and offal
        0
        day
      • Milk
        0
        day
    • Cattle (cow)
      • Meat and offal
        0
        day
      • Milk
        0
        day
    • Pig (female)
      • Meat and offal
        0
        day
    • Sheep
      • Meat and offal
        0
        day
      • Milk
        0
        day
    • Goat (adult female)
      • Meat and offal
        0
        day
      • Milk
        0
        day
    • Cat (adult female)
    • Dog (bitch)
  • Intravenous use
    • Horse (mare)
      • Meat and offal
        0
        day
      • Milk
        0
        day
    • Cattle (cow)
      • Meat and offal
        0
        day
      • Milk
        0
        day
    • Pig (female)
      • Meat and offal
        0
        day
    • Sheep
      • Meat and offal
        0
        day
      • Milk
        0
        day
    • Goat (adult female)
      • Meat and offal
        0
        day
      • Milk
        0
        day
    • Cat (adult female)
    • Dog (bitch)
  • Subcutaneous use
    • Horse (mare)
      • Meat and offal
        0
        day
      • Milk
        0
        day
    • Cattle (cow)
      • Meat and offal
        0
        day
      • Milk
        0
        day
    • Pig (female)
      • Meat and offal
        0
        day
    • Sheep
      • Meat and offal
        0
        day
      • Milk
        0
        day
    • Goat (adult female)
      • Meat and offal
        0
        day
      • Milk
        0
        day
    • Cat (adult female)
    • Dog (bitch)
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QH01BB02
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Spain
Available in:
  • Spain
Package description:

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Full application - Known active substance (Article 12(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Laboratorios Syva S.A.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Laboratorios Syva S.A.U.
Responsible authority:
  • The Spanish Agency Of Medicines And Medical Devices
Authorisation number:
  • 528 ESP
Date of authorisation status change:

Documents

Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
Spanish (PDF)
Published on: 28/11/2023
Download

Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Spanish (PDF)
Published on: 28/11/2023
Download

Labelling

This document does not exist in this language (English). You can find it in another language below.
Spanish (PDF)
Published on: 28/11/2023
Download
How useful was this page?:
No votes yet
"Please do not include any personal data, such as your name or contact details. If you do, you consent to the processing of that data in accordance with EMA’s Privacy Statement concerning requests for information or access to documents. If you would like a reply from EMA, please Send a question to EMA instead."