الجدول الزمني لتقديم تقارير السلامة الدورية المحدثة
الجدول الزمني لتقديم تقارير السلامة الدورية المحدثة
| المادة الفعالة | الاسم التجاري | MAH | تاريخ التسجيل في السعودية | تاريخ الميلاد العالمي (IBD) | PSUR التكرار | نقطة قفل البيانات (DLP) | تاريخ التقديم |
|---|---|---|---|---|---|---|---|
| Mannitoled freeze-dried allergen extract, or a glycerinated mannitoled allergen extract solution | Staloral Mites Maintenance |
STALLERGENS | 2008 | 1998-12-21 | 3 years | 2017-12-18 | 2018-03-18 |
| Mannitoled freeze-dried allergen extract, or a glycerinated mannitoled allergen extract solution | Staloral Moulds Initial |
STALLERGENS | 2008 | 1998-12-21 | 3 years | 2017-12-18 | 2018-03-18 |
| Mannitoled freeze-dried allergen extract, or a glycerinated mannitoled allergen extract solution | Staloral Moulds Maintenance |
STALLERGENS | 2008 | 1998-12-21 | 3 years | 2017-12-18 | 2018-03-18 |
| Mannitoled freeze-dried allergen extract, or a glycerinated mannitoled allergen extract solution | Staloral Animal Origin Initial |
STALLERGENS | 2008 | 1998-12-21 | 3 years | 2017-12-18 | 2018-03-18 |
| Mannitoled freeze-dried allergen extract, or a glycerinated mannitoled allergen extract solution | Staloral Animal Origin Maintenance |
STALLERGENS | 2008 | 1998-12-21 | 3 years | 2017-12-18 | 2018-03-18 |
| Bendamustin Hydrochloride | RIBOMUSTIN |
ASTELLAS PHARMA | 2016 | 1971-11-10 | annual | 2018-01-06 | 2018-03-17 |
| ALECTINIB | Alecensa |
ROCHE | 2017 | 2014-07-04 | 6 months | 2018-01-03 | 2018-03-14 |
| Tobramycin | Tobi Podhaler |
NOVARTIS | 2013 | 2010-11-25 | 2 years | 2017-12-31 | 2018-03-11 |
| Omalizumab | Xolair |
NOVARTIS | 2006 | 2002-06-13 | annual | 2017-12-31 | 2018-03-11 |
| PHYTOMENADION | Konakion |
ROCHE | 1980 | 3 years | 2017-12-31 | 2018-03-11 |