Romefen PR 10%
Recall
|
Veterinary Medicines
|
15/11/2024
The marketing authorisation holder informed its customers on November 14, 2024, that there had been a mix-up between the veterinary medicinal product „Romefen PR 10%“ authorised in Germany and the „Romefen 100 mg/ml Injektionslösung für Rinder, Pferde und Schweine“ authorised in Austria. The two veterinary medicinal products are identical in composition and there is no impact on safety and efficacy. As the affected batch is not licensed for the Austrian market, it is being recalled.
| Name of the medicinal product | Romefen PR 10% |
|---|---|
| Marketing authorisation number(s) | DE-Zulassungsnummer: 26444.01.01 |
| Manufacturer | Ceva Sante Animale |
| Distributor | Richter Pharma AG |
| Batch number(s) | 508AA |
| Expiry date | 12/31/2025 |
| Classification of the recall | 3 |
| Depth of recall | Pharmacies |
| BASG reference number | INS-640.001-4989 |
Further inquiry note
Page last modified:
15/11/2024