Assessment report
22iIUw4
22iIUw4
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Manufacture of the product and process controls<br />
Detailed descriptions of the manufacturing process which is conducted by direct compression and<br />
performed in-process controls have been provided.<br />
Product specification<br />
The release and shelf-life specifications of the drug products contain adequate parameters for a tablet<br />
respectively for an orodispersible tablet.<br />
Stability of the product<br />
Aripiprazole Mylan tablets<br />
Stability studies have been performed on batches of all strengths packed in HDPE bottles, cold form<br />
blister and simulated bulk shipment pack (which only differ in dimensions with respect to bulk<br />
shipment pack).<br />
Long-term stability data of 24 months have been provided. For the drug product packed in bulk<br />
shipment pack a shelf life of 12 months is declared without any special storage condition which is<br />
accepted.<br />
A shelf-life of 36 months has been proposed for the drug product packed in HDPE bottles and cold form<br />
blister pack without any special storage condition. Based on available stability data the extrapolation of<br />
the shelf-life to 36 months is acceptable. For the drug product packed in bulk shipment pack a shelf life<br />
of 12 months is declared without any special storage condition which is accepted.<br />
According to results of the in-use stability study Aripiprazole Mylan tablets are stable up to 100 days<br />
after opening the HDPE bottle pack. According to the application form/SmPC/package leaflet/labelling a<br />
package size of 500 tablets in HDPE bottles is intended for the tablet strengths 10 mg, 15 mg and 30<br />
mg. The in-use stability study only covers 100 days and the dose range of aripiprazole is 10 to 30 mg<br />
per day. Taken this into consideration the discrepancy between the covered period of the performed inuse<br />
stability study and the proposed package size of 500 tablets in HDPE bottles should be explained.<br />
Aripiprazole Mylan orodispersible tablets<br />
Stability studies have been performed on batches of all strengths packed in cold form blister and<br />
simulated bulk shipment pack (which only differ in dimensions with respect to bulk shipment pack).<br />
Long-term stability data of 24 months have been provided. For the drug product packed in bulk<br />
shipment pack a shelf life of 12 months is declared without any special storage condition which is<br />
accepted.<br />
A shelf-life of 36 months has been proposed for the drug product packed in cold form blister pack<br />
without any special storage condition. Based on available stability data the extrapolation of the shelflife<br />
to 36 months is acceptable.<br />
Comparability exercise for Finished Medicinal Drug Product<br />
Not applicable.<br />
Adventitious agents<br />
Not applicable.<br />
<strong>Assessment</strong> <strong>report</strong><br />
EMA/49072/2016 Page 11/37
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