Veterinary Medicines

Uriphex 50 mg/ml, oral solution for dogs

Authorised
  • Phenylpropanolamine hydrochloride
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Product identification

Medicine name:
Uriphex 50 mg/ml, oral solution for dogs
Uriphex 50 mg/ml Lösung zum Eingeben für Hunde
Active substance:
  • Phenylpropanolamine hydrochloride
Target species:
  • Dog (bitch)
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Phenylpropanolamine hydrochloride
    50.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Oral solution
Withdrawal period by route of administration:
  • Oral use
    • Dog (bitch)
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QG04BX91
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Germany
Package description:
  • HDPE bottle closed with white polypropylene child-resistant cap and LDPE syringe adaptor. A 1 mL HDPE/polypropylene graduated syringe is supplied with each bottle. Bottle of 100 mL.
  • HDPE bottle closed with white polypropylene child-resistant cap and LDPE syringe adaptor. A 1 mL HDPE/polypropylene graduated syringe is supplied with each bottle. Bottle of 60 mL.
  • HDPE bottle closed with white polypropylene child-resistant cap and LDPE syringe adaptor. A 1 mL HDPE/polypropylene graduated syringe is supplied with each bottle. Bottle of 30 mL.

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Generic application (Article 18 of Regulation (EU) 2019/6)
Marketing authorisation holder:
  • Alfasan Nederland B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Alfasan Nederland B.V.
Responsible authority:
  • Federal Office Of Consumer Protection And Food Safety
Authorisation number:
  • V7009322.00.00
Date of authorisation status change:
Reference member state:
  • Netherlands
Procedure number:
  • NL/V/0383/001
Concerned member states:
  • Austria
  • Belgium
  • Bulgaria
  • Croatia
  • Cyprus
  • Czechia
  • Denmark
  • Estonia
  • Finland
  • France
  • Germany
  • Greece
  • Hungary
  • Iceland
  • Ireland
  • Italy
  • Latvia
  • Lithuania
  • Luxembourg
  • Norway
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Spain
  • Sweden
  • United Kingdom (Northern Ireland)
Generic of:

Documents

Combined File of all Documents

English (PDF)
Published on: 31/08/2023
Updated on: 3/09/2023
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German (PDF)
Published on: 3/01/2025
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