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
BUDESONIDE, FORMOTEROL SYMBICORT AstraZeneca 3 years
Infliximab REMICADE JANSSEN-CILAG 3 years
Paricalcitol ZEMPLAR ABBVIE 3 years
Oxcarbazepine Trileptal NOVARTIS 2 years
Telbivudine Sebivo NOVARTIS 3 years
Catridecacog NovoThirteen 2500 IU NOVO NORDISK 3 years
Agalsidase Beta Fabrazyme SANOFI PASTEUR 3 years
Meloxicam MELOXI JAMJOOM PHARMACEUTICALS COMPANY 3 years
MELOXICAM Mobic BOEHRINGER INGELHEIM 3 years
Meloxicam meloxicam APM 3 years


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