Veterinary Medicines

Maprelin 75 µg/ml solution for injection for pigs

Authorised
  • Peforelin
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Product identification

Medicine name:
Maprelin 75 µg/ml solution for injection for pigs
MAPRELIN 75 µg/ml raztopina za injiciranje za prašiče
Active substance:
  • Peforelin
Target species:
  • Pig
Route of administration:
  • Intramuscular use

Product details

Active substance and strength:
  • Peforelin
    75.00
    microgram(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:
  • QH01CA95
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Slovenia
Available in:
  • Slovenia
Package description:
  • (ID4) 100 millilitre(s): unspecified outer container with 1 Vial (Glass) with 100 millilitre(s)
  • (ID3) 50 millilitre(s): unspecified outer container with 1 Vial (Glass) with 50 millilitre(s)
  • (ID2) 60 millilitre(s): unspecified outer container with 6 Vial (Glass) each with 10 millilitre(s)
  • (ID1) 10 millilitre(s): unspecified outer container with 1 Vial (Glass) with 10 millilitre(s)

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Full application (Article 12(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Veyx Pharma GmbH
Marketing authorisation date:
Manufacturing sites for batch release:
  • Veyx Pharma GmbH
Responsible authority:
  • Agency For Medicinal Products And Medical Devices Of The Republic Of Slovenia
Authorisation number:
  • MR/V/0196/001
Date of authorisation status change:
Reference member state:
  • Germany
Procedure number:
  • DE/V/0129/001
Concerned member states:
  • Austria
  • Belgium
  • Bulgaria
  • Czechia
  • Estonia
  • France
  • Hungary
  • Ireland
  • Italy
  • Latvia
  • Lithuania
  • Luxembourg
  • Netherlands
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Spain
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 14/02/2022
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Combined File of all Documents

This document does not exist in this language (English). You can find it in another language below.
Slovenian (PDF)
Published on: 2/03/2022
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