Scientific Name | Trade Name | Updated Section | Safety-Related Labeling Changes | Date |
---|---|---|---|---|
Measles Virus (SCHWARZ) Live Attenuated,Mumps Virus (JERYL LYNN, STRAIN RIT 4385) Live Attenuated,Rubella Virus (WISTAR RA 27/3) Live Attenuated | M.M.R II | 4.6 Pregnancy, lactation and fertility | Safety information during pregnancy | Nov,2024 |
Sodium Alginate,Calcium Carbonate,Sodium Bicarbonate | Gaviscon Double Action | 4.4 Special warnings and precautions for use. 4.6 Pregnancy, lactation and fertility | Soidum content. Safety information in breastfeeding women and effect on fertility | Nov,2024 |
Vinorelbine tartrate | Navelbine | 4.4 Special warnings and precautions for use | Pulmonary embolism, posterior reversible encephalopathy syndrome and Skin hyperpigmentation | Nov,2024 |
Alirocumab | Praluent | 4.8 Undesirable effects | Added safety information in pediatrics | Nov,2024 |
Terlipressin Diacetate Pentahydrate | Glypressin | "4.4 Special warnings and precautions for use. 4.8 Undesirable effects" | Hepatorenal syndrome and advanced renal or liver disease. Adverse events associated with use of Terlipressin in hepatorenal syndrome (i.e. sepsis/septic shock, respiratory failure, respiratory distress) | Nov,2024 |
Triptorelin | Diphereline P.R. | 4.4 Special warnings and precautions for use | Idiopathic intracranial hypertension | Nov,2024 |