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2015-09-03 - Male - 18 Years old

900465425

Adverse reaction report number 900465425
Latest AER version number 0
Market authorization holder AER number CA201510565
Initial received date 2015-09-03
Latest received date 2015-09-03
Age 18 Years
Gender Male
Weight N/A
Type of report Spontaneous
Reporter type Consumer Or Other Non Health Professional
Source of report MAH
Report outcome Unknown
Serious report? Yes

Reason for seriousness

Death
Disability
Cogenital anomaly
Life threateting
Hospitalization
Other medically important Yes

Product information

Product description Dosage form Health product role Route of administration Dose Frequency Therapy duration Indication(s)
ADDERALL XRCAPSULE, EXTENDED RELEASESuspectOral Product used for unknown indication

Adverse reaction term information

MedDRA version: v.21.1
Adverse reaction terms Reaction duration
Tourette's disorder
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