Grifols Gets FDA Approval For Thrombate III In Pediatric Patients In U.S.

Reuters
2025.11.18 09:08
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Nov 18 (Reuters) - Grifols SA (GRLS.MC) :RECEIVES EXPANDED INDICATION FOR THROMBATE III LABEL IN U.S., STRENGTHENING TREATMENT OPTIONS FOR PEDIATRIC PATIENTSEXPANDED LABEL FOR THROMBATE III INDICATES IT CAN BE SAFELY AND EFFECTIVELY USED IN PEDIATRIC PATIENTS WITH HATD, A RARE PATIENT POPULATIONFDA APPROVAL WAS BASED ON SUBMITTED DATA EXTRAPOLATION FROM TWO CLINICAL TRIALS IN ADULT PATIENTS ADDRESSING CRITICAL GAPS IN CLINICAL COMPREHENSION AND TREATMENT OF PEDIATRIC HATDSource text Further company coverage: (GRLS.MC)(Gdansk Newsroom)

Nov 18 (Reuters) - Grifols SA (GRLS.MC) :

  • RECEIVES EXPANDED INDICATION FOR THROMBATE III LABEL IN U.S., STRENGTHENING TREATMENT OPTIONS FOR PEDIATRIC PATIENTS
  • EXPANDED LABEL FOR THROMBATE III INDICATES IT CAN BE SAFELY AND EFFECTIVELY USED IN PEDIATRIC PATIENTS WITH HATD, A RARE PATIENT POPULATION
  • FDA APPROVAL WAS BASED ON SUBMITTED DATA EXTRAPOLATION FROM TWO CLINICAL TRIALS IN ADULT PATIENTS ADDRESSING CRITICAL GAPS IN CLINICAL COMPREHENSION AND TREATMENT OF PEDIATRIC HATD

Source text Further company coverage: (GRLS.MC)

(Gdansk Newsroom)

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