DHPC (Rote-Hand-Brief) on Profact Depot 9.45 mg 3-month implant: Risk of premature implant dissolution/future adjustment of the storage temperature
2023.11.17
Active substance: Buserelin
The company Cheplapharm Arzneimittel GmbH informs about an insufficient release of the active substance in the last time fraction (day 78 - 91) of the in vitro dissolution test. To ensure that the therapeutic goal of permanently reducing the testosterone concentration below the castration level is achieved, the company recommends close testosterone monitoring with individual adjustment of the dosing interval or, alternatively, a reduction of the dosing interval to 10 weeks. A reduced storage temperature of 2 - 8 °C is required for new batches.
2023.11.17 Further Information:
There are several parallel imports of the medicinal product Profact Depot 9.45 mg 3-month implant from Cheplapharm Arzneimittel GmbH with the trade name Suprefact.
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