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 |
|---|---|---|---|---|---|---|---|
| Levonorgestrel | Mirena 52 Mg |
BAYER PHARMA AG | 1998 | 1990-05-09 | 3 years | 2017-12-23 | 2018-03-23 |
| Levonorgestrel | Microlut 0.03 Mg |
BAYER PHARMA AG | 1999 | 1971-12-23 | 3 years | 2017-12-23 | 2018-03-23 |
| Amiodarone | CORDARONE |
SANOFI PASTEUR | 1993 | 1966-12-20 | 3 years | 2017-12-20 | 2018-03-20 |
| Mannitoled freeze-dried allergen extract, or a glycerinated mannitoled allergen extract solution | Staloral Pollens 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 Pollens 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 Mites 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 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 |