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
Levonorgestrel Mirena 52 Mg BAYER PHARMA AG 3 years
Amiodarone CORDARONE SANOFI PASTEUR 3 years
Mannitoled freeze-dried allergen extract, or a glycerinated mannitoled allergen extract solution Staloral Pollens Initial STALLERGENS 3 years
Mannitoled freeze-dried allergen extract, or a glycerinated mannitoled allergen extract solution Staloral Pollens Maintenance STALLERGENS 3 years
Mannitoled freeze-dried allergen extract, or a glycerinated mannitoled allergen extract solution Staloral Mites Initial STALLERGENS 3 years
Mannitoled freeze-dried allergen extract, or a glycerinated mannitoled allergen extract solution Staloral Moulds Initial STALLERGENS 3 years
Mannitoled freeze-dried allergen extract, or a glycerinated mannitoled allergen extract solution Staloral Mites Maintenance STALLERGENS 3 years
Mannitoled freeze-dried allergen extract, or a glycerinated mannitoled allergen extract solution Staloral Moulds Maintenance STALLERGENS 3 years
Mannitoled freeze-dried allergen extract, or a glycerinated mannitoled allergen extract solution Staloral Animal Origin Initial STALLERGENS 3 years
Mannitoled freeze-dried allergen extract, or a glycerinated mannitoled allergen extract solution Staloral Animal Origin Maintenance STALLERGENS 3 years


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