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
TELMISARTAN, AMLODIPINE Twynsta BOEHRINGER INGELHEIM 3 years
VEMURAFENIB Zelboraf ROCHE Annual
Tiapride Tiapridal SANOFI PASTEUR 3 years
Interferon beta-1b Betaferon BAYER PHARMA AG 3 years
Alprostadil Prostin PFIZER 3 Years
Nonacog Alfa Nonacog Alfa PFIZER annual
Palbociclib IBRANCE PFIZER 6 Months
NAPHAZOLINE HYDROCHLORIDE, PHENIRAMINE MALEATE NAPHCON-A EYE DROPS ALCON annual
NAPHAZOLINE HYDROCHLORIDE NAPHCON FORTE 0.1% EYE DROPS ALCON annual
METFORMIN HEXAL METFORMIN HEXAL SANDOZ 2 Years


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