23.12.2025
To the attention of interested persons
Considering the information received from the representative of the MAH and given the need to ensure availability of Augmentin FP 400 mg/57 mg/5 ml powder for oral suspension (INN: Amoxicillinum + Acidum Clavulanicum, MAH: GlaxoSmithKline Trading Services Limited, Ireland, MA no. 11562/2019/01-08) for patients, batches no. L86Y, HN6R, MJ8C, NR5L, which already are in the therapeutic circuit in the stock of pharmacies, the ANMDMR communicated to the MAH the obligation to disseminate a communication to healthcare professionals, pharmacists and physicians, through the Romanian College of Pharmacists, the Romanian College of Physicians, the Romanian Society of Family Medicine, the Romanian Society of Paediatrics, etc., as well as to the public, regarding the quality non-compliance concerning the lack of instructions for reconstitution of the suspension in the Package Leaflet. Thus, medicinal products from the above-mentioned batches shall be dispensed to patients accompanied by the printed version with the full information from the “Reconstitution Instructions” section, according to Annex 1 to MA no. 11562/2019/01-08.