Reason for request

Renewal of inclusion

-


Clinical Benefit

Substantial

Prevention of recurrence of major depressive episodes
In adults, the actual benefit remains substantial for ZOLOFT 50 mg and is substantial for ZOLOFT 25 mg in hard capsules.

Major depressive episodes
In adults, the actual benefit remains substantial for ZOLOFT 25 and 50 mg.

Obsessive compulsive disorder (OCD) in adults as well as in paediatric patients aged 6 to 17 years
In adults and children aged 6 to 17 years, the actual benefit remains substantial for
ZOLOFT 25 mg and 50 mg.

Panic disorder with or without agoraphobia
In adults, the actual benefit is substantial for ZOLOFT 25 and 50 mg.

Post traumatic stress disorder
In adults, the actual benefit is substantial for ZOLOFT 25 and 50 mg.

Moderate

Social Anxiety Disorder
In adults, the actual benefit is moderate for ZOLOFT 25 and 50 mg.


Clinical Added Value

no clinical added value

In panic disorder with or without agoraphobia, social anxiety disorder and post traumatic stress disorder, ZOLOFT does not provide any improvement in actual benefit (IAB V) compared with the other medicines available in these indications.