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CMDh Scientific conclusions and grounds for the variation, amendments to the Product Information and

Taking into account the PRAC Assessment Report on the PSUR(s) for technetium (99mtc) mebrofenin, the scientific conclusions are as follows: Cumulatively, there were 2 cases of hypersensitivity reported following use of technetium (99mtc) mebrofenin, as well as literature reports suggesting the possibility of hypersensitivity after use of technetium (99mtc) mebrofenin. In addition, prescribing information of other technetium (99mtc) mebrofenin radiopharmaceutical products include hypersensitivity as a rare undesirable effect.

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