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
Methotrexate Methotrexate PFIZER 3 Years
9-2- XALACOM PFIZER 3 Years
CANDESARTAN CILEXETIL DICERAN SANDOZ 2 Years
Rabeprazole Sodium PARIET JANSSEN-CILAG 3 years
Sufentanil Citrate SUFENTA JANSSEN-CILAG 3 years
DESFLURANE SUPRANE INHALATION ANAESTHITIC - 240mL Baxter 3 years
Vigabatrin Sabril SANOFI PASTEUR 3 years
Leflunomide Arava SANOFI PASTEUR 3 years
Sirolimus RAPAMUNE PFIZER 3 Years
Diphtheria, Tetanus Toxoids, Acellular Pertussis &
Haemophilus b Conjugate Vaccine
Actacel SANOFI PASTEUR 3 years


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