Periodic safety reporting schedule

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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


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