FDA Adverse Event Reporting System (AERS) Freedom of ...
FDA Adverse Event Reporting System (AERS) Freedom of Information (FOI) Report:
Date: 08/07/06
ISR (Individual Safety Report) Number: 5076371-2
Report Type: Expedited (15-Day)
Company Report #: TACI2006A03117
Age: 35 YR
Gender: Female
Outcome: Other
Preferred Term: Haemorrhagic Ovarian Cyst, Ovarian Cyst Ruptured
Report Source: Study, Health Professional
Product: Leuplin For Injection Kit 1.88 (Leuprolide Acetate Injection)
Role: Primary Suspect
Manufacturer: TAKEDA PHARMACEUTICAL
Route: SUBCUTANEOUS
Dose: 1.88 MG (1.88 MG, 1 IN 28 D) SUBCUTANEOUS
Duration: 2 MON
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