Periodic safety reporting schedule
Active Substances | Trade Name | MAH | Year of registration in Saudi Arabia | International Birth Date (IBD) | PSUR Submission Frequency | Data Lock Point (DLP) | Submission Date |
---|---|---|---|---|---|---|---|
Atomoxetine | Strattera 18 | Eli Lilly | 3 years | ||||
Atomoxetine | Strattera 25 | Eli Lilly | 3 years | ||||
Atomoxetine | Strattera 40 | Eli Lilly | 3 years | ||||
Bimatoprost 0.03%/Timolol maleate 0.5% | Ganfort Eye Drops | Allergan | 3 Years | ||||
Econazole Nitrate/Triamcinolone Acetonide | PEVISONE | JANSSEN-CILAG | 3 years | ||||
Levocabastine | LIVOSTIN | JANSSEN-CILAG | 3 years | ||||
Doxorubicin Hydrochloride | ADRIBLASTINA | PFIZER | 3 Years | ||||
Minoxidil | CILEST | JANSSEN-CILAG | 3 years | ||||
Dextromethorphan | ROMIN | Jazeera Pharmaceutical Industries (JPI) | 3 years | ||||
Cinnarizine | STUGERON | JANSSEN-CILAG | 3 years |