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Hormone Replacement Therapy (HRT): duration of gestagen addition in sequential HRT
2010.09.10
Active substance: gestagen
In a Notice (Bescheid) of 23 August 2010 relating to medicinal products for sequential HRT with gestagen addition on less than 12 days per treatment cycle, the BfArM ruled that the product information be supplemented. It is stated that there is no clear evidence of endometrial safety similar to that when gestagen is added on 12 days.
To the graduated plan procedure (available in German only)