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2012-11-15 - Male

481274

Adverse reaction report number 481274
Latest AER version number 0
Market authorization holder AER number ALL1201205479
Initial received date 2012-11-15
Latest received date 2012-11-15
Age N/A
Gender Male
Weight N/A
Type of report Spontaneous
Reporter type Pharmacist
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
CHAMPIXTABLETSuspectUnknown Smoking cessation therapy

Adverse reaction term information

MedDRA version: v.21.1
Adverse reaction terms Reaction duration
Drug interaction
Lip and/or oral cavity cancer
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