#52026XC01842Summary of European Union Decisions on Marketing Authorisations for Medicinal Products from 1 February 2026 to 28 February 2026
AI-generated summary for informational purposes only. Not legal advice. See the original source for the authoritative text.
This law summarizes the European Union's decisions regarding marketing authorisations for medicinal products within a specified timeframe. It includes details of decisions made under various directives and regulations, highlighting the issuance, maintenance, or modification of marketing authorisations for specific medicinal products during February 2026. Notably, it provides information about certain veterinary medicinal products approved for use in chickens.
AI-generated summary. May contain errors. Refer to official sources for legal decisions.
Key Changes
- Approval of the veterinary medicinal product Phenoxypen WSP for use in chickens
- Marketing authorisations maintained for Melatomed and associated names
- Details provided about the pharmaceutical forms and routes of administration
Obligations
What this law requires
Dopharma Research B.V. must maintain marketing authorisation for Phenoxypen WSP (Phenoxymethylpenicillin 325 mg/g powder for use in drinking water) across all EU member states and Northern Ireland as per the issued authorisations
Dopharma Research B.V. must ensure Phenoxypen WSP is only administered to chickens via drinking water at the authorized strength of 325 mg/g in powder form
Fairmed Healthcare GmbH must maintain marketing authorisation for Melatomed (melatonin 2 mg prolonged-release tablet) in Austria, Denmark, Germany, and Sweden as per the issued authorisations
Fairmed Healthcare GmbH must ensure Melatomed/Melozostrin (melatonin 2 mg) is only distributed as a prolonged-release tablet formulation for oral use
Marketing authorisation holders must comply with the applicable provisions of Directive 2001/83/EC, Directive 2001/82/EC, or Regulation (EU) 2019/6, depending on which authorisation framework applies to their product