Periodic safety reporting schedule
| Active Substances | Trade Name | MAH | Year of registration in Saudi Arabia | International Birth Date (IBD) | PSUR Submission Frequency | Data Lock Point (DLP) | Submission Date |
|---|---|---|---|---|---|---|---|
| Glimepiride + Metformin HCL | Amaryl | SANOFI PASTEUR | 3 year | ||||
| Azacitidine | Vidaza | Algorithm | 3 years | ||||
| PERTUZUMAB | Perjeta | ROCHE | Annual | ||||
| DEXTRAN 70, HYPROMELLOSE | TEARS NATURALE II | ALCON | annual | ||||
| MINERAL OIL, ANHYDROUS LIQUID LANOLIN, WHIT PETROLATUM | DURATEARS OCULAR OINT. | ALCON | annual | ||||
| MOXIFLOXACIN | VIGAMOX 0.5% OPHTHALMIC SOLUTION | ALCON | annual | ||||
| DEXTRAN 70, HYPROMELLOSE | TEARS NATURAL FREE | ALCON | annual | ||||
| DEXTRAN 70, HYPROMELLOSE | TEARS NATURALE | ALCON | annual | ||||
| Quadrivalent human papillomavirus (types 6,11,16,18) recomb.vacc | GARDASIL RECOMBINANT VACCINE | MERCK SHARP & DOHME | annual | ||||
| Human normal Immunoglobulins | Flebogamma DIF | INSTITUTO GRIFOLS | annual |
