Periodic safety reporting schedule
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 |
|---|---|---|---|---|---|---|---|
| CALCITRIOL | Rocaltrol |
ROCHE | 1980 | 2078-01-01 | 3 years | 2018-01-01 | 2018-04-01 |
| FERROUS FUMARATE | FUMAFER |
SANOFI PASTEUR | 1990 | 1963-06-28 | 3 years | 2018-01-01 | 2018-04-01 |
| Furosemide | Lasix |
SANOFI PASTEUR | 1987 | 1961-01-01 | 3 years | 2018-01-01 | 2018-04-01 |
| Tetanus vaccine | Tetavax |
SANOFI PASTEUR | 2007 | 1987-07-25 | 3 years | 2018-01-01 | 2018-04-01 |
| Pseudoephedrine / triprolidine | COLFED |
APM | 2000 | 3 years | 2017-12-31 | 2018-03-31 | |
| Betahistine | BETASERC |
ABBOTT Laboratories | 1985 | 3 years | 2017-12-31 | 2018-03-31 | |
| Pseudoephedrine / triprolidine | RINOFED |
Jazeera Pharmaceutical Industries (JPI) | 1999 | 3 years | 2017-12-31 | 2018-03-31 | |
| Cyproheptadine | CIPTADINE |
Hikma Pharmaceuticals PLC | 1987 | 3 years | 2017-12-31 | 2018-03-31 | |
| Pseudoephedrine / triprolidine | TRIFED |
Hikma Pharmaceuticals PLC | 1993 | 3 years | 2017-12-31 | 2018-03-31 | |
| Azelastine hydrochloride | Allergodil |
MEDA PHARMA GmbH & Co KG | 1997 | 1990-11-20 | 3 years | 2017-12-31 | 2018-03-31 |