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 |
|---|---|---|---|---|---|---|---|
| Atomoxetine | Strattera 25 |
Eli Lilly | 2008 | 2002-11-26 | 3 years | 2018-11-26 | 2019-02-26 |
| Atomoxetine | Strattera 60 |
Eli Lilly | 2008 | 2002-11-26 | 3 years | 2018-11-26 | 2019-02-26 |
| Atomoxetine | Strattera 40 |
Eli Lilly | 2008 | 2002-11-26 | 3 years | 2018-11-26 | 2019-02-24 |
| Bimatoprost 0.03%/Timolol maleate 0.5% | Ganfort Eye Drops |
Allergan | 2009 | 2006-06-19 | 3 Years | 2018-11-19 | 2019-02-17 |
| Econazole Nitrate/Triamcinolone Acetonide | PEVISONE |
JANSSEN-CILAG | 2002 | 1978-10-01 | 3 years | 2018-11-15 | 2019-02-13 |
| Levocabastine | LIVOSTIN |
JANSSEN-CILAG | 2005 | 1990-01-02 | 3 years | 2018-11-14 | 2019-02-12 |
| Doxorubicin Hydrochloride | ADRIBLASTINA |
PFIZER | 2013 | 1971-10-15 | 3 Years | 2018-11-12 | 2019-02-10 |
| Minoxidil | CILEST |
JANSSEN-CILAG | 2005 | 1986-11-03 | 3 years | 2018-11-12 | 2019-02-10 |
| Dextromethorphan | ROMIN |
Jazeera Pharmaceutical Industries (JPI) | 2002 | 1966-01-01 | 3 years | 2018-11-01 | 2019-01-30 |
| Benzydamine Hydrochlride | UNITUM 5% GEL |
BATTERJEE PHARMACETICAL FACTORY | 2009 | 1964-07-10 | 3 years | 2018-10-31 | 2019-01-29 |