PMCPA Case
| Case | AUTH/3509/5/21 |
| Company | Tillotts Pharma UK Limited |
| Complainant | Anonymous |
| Material | BMJ advertisement (ref EO-00328, April 2021) framed as acquisition/corporate announcement |
| Medicine | Dificlir (fidaxomicin) |
| Indication referenced | Treatment of Clostridioides difficile infections (noted as adults and children with body weight ≥12.5 kg) |
| Main issue | Promotional content presented as corporate announcement; missing prescribing information and AE reporting statement |
| Applicable Code year | 2019 |
| Breach clauses | 4.1, 4.9 |
| Sanctions | Undertaking received; additional sanctions: Not stated |
| Complaint received | 11 May 2021 |
| Case completed | 14 January 2022 |
| Appeal | No appeal |
Download the full case report (PDF)
Reviewed by Dr Anzal Qurbain (FFPM) — ABPI Final Signatory
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