Bactrimel: end of commercialisation of Bactrim 80 mg/5 ml + 400 mg/5 ml oral suspension (AIC 021978061) and new availability of Bactrimel 40 mg + 8 mg/ml oral suspension (AIC 048950012).

Summary Information:

• The current formulation of BACTRIM 80 MG/5 ML + 400 MG/5 ML ORAL SUSPENSION can no longer be produced due to a long-term unavailability of one of its components.
• A new formulation is now available: BACTRIMEL 40 MG/ML + 8 MG/ML ORAL SUSPENSION
• The active substance strength of the new formulation is halvened when compared to the previous formulation. A particular attention should be drawn as to the new product concentration so that the patient is still receiving the appropriate regimen.
• For a limited time, it is anticipated that there will be an overlap in availability of the new formulation with the old one. In the interest of good practice and to avoid medication error, this situation requires attention.
• The packs of the two formulations on the market will be easily distinguished in that the packs of BACTRIM will continue to show Roche S.p.A as the marketing authorization holder, while the packs of BACTRIMEL with the new formulation will be placed on the market under Eumedica Pharmaceuticals GmbH as the marketing authorization holder.

Published on: 12 May 2022