MHRAsafety guidance72% confidence
Class 4 Medicines Defect Notification: Relonchem Limited, Gabapentin Relonchem 50mg/ml Oral Solution, EL(26)A/31
Source: MHRA
Why This Matters
Why this matters: illustrates how regulators handled a comparable safety guidance decision relevant to Apoquel.
Regulatory Analysis
Relonchem Limited have informed the MHRA that particles have been observed inside some bottles of Gabapentin Relonchem Oral Solution, identified through a customer complaint.
Supporting Context
- Therapeutic area
- Veterinary Medicine · Allergy
- Sub-indication
- General
Related signal: FDA Reports Increase in Accidental Overdoses of Apoquel Chewable in Dogs