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• 2023
  • IMBRUVICA®(Ibrutinib): Package Insert Updates to Dose Modifications for Adverse Reactions and to Special Warnings and Precautions for Use 2023-11-30
  • GLYPRESSIN® (Terlipressin): Serious or Fatal Respiratory Failure and Sepsis/Septic Shock in Patients with Type 1 Hepatorenal Syndrome (Type 1 HRS) 2023-06-13
• 2022
  • ALECENSA® (Alectinib): Risk of Haemolytic Anaemia (New Warning and Precaution and Dose Modification Guidance) 2022-09-28
  • MAVENCLAD® (Cladribine): Risk of Serious Liver Injury and New Recommendations About Liver Function Monitoring 2022-06-13
• 2021
  • TECENTRIQ® (Atezolizumab): Risk of Severe Cutaneous Adverse Reactions (SCARs) 2021-04-22
  • LEMTRADA® (Alemtuzumab): Revised indication, additional contraindications and risk minimisation measures 2021-01-20
• 2020
  • GILENYA® (fingolimod): New contraindication in pregnant women and in women of childbearing potential who are not using effective contraception 2020-09-08
  • PLAQUENIL® (hydroxycholoroquine): Risk of QT prolongation and other drug-drug interactions in the context of COVID-19 management 2020-08-14
  • KYPROLI® (Carfilzomib): (i) Risk of progressive multifocal leukoencephalopathy (PML); (ii) Risk of hepatitis B virus (HBV) reactivation  2020-04-06
  • ESBRIET® (Pirfenidone): Drug-Induced Liver Injury (DILI) 2020-04-06
• 2019
  • FEBURIC® (febuxostat): Increased risk of cardiovascular death and all-cause mortality in patients treated with febuxostat in the CARES study 2019-11-26
  • SMECTA® (dioctahedral smectite): Not recommended for use in children aged below 2 years and pregnant or breastfeeding women 2019-10-30
  • LEMTRADA® (alemtuzumab): (i) Risk of autoimmune hepatitis (ii) Other serious reactions temporally associated with alemtuzumab infusion (iii) Haemophagocytic lymphohistiocytosis 2019-09-03
  • ACTEMRA® (tocilizumab): New important identified risk of hepatotoxicity 2019-08-26
  • IMOVANE® (zopiclone): New restriction of the indication and additional warnings on abuse and dependence 2019-06-20
  • TECENTRIQ® (Atezolizumab): A new important identified risk – immune-related myositis 2019-06-20
  • BENLYSTA® (belimumab): Increased risk of serious psychiatric events 2019-06-12
  • EPILIM® (Sodium Valproate): Important new restrictions on use 2019-01-31
• 2018
  • TIVICAY® (dolutegravir): Reports of neural tube defects 2018-10-26
  • XGEVA® (denosumab): Risk of new primary malignancy 2018-10-26
  • TECENTRIQ® (Atezolizumab): Risk of nephritis 2018-10-26
  • ESMYA® (ulipristal acetate): New contraindication, restricted indication and liver function monitoring requirement 2018-10-26
  • STILNOX® 10 mg film-coated tablet (zolpidem): Restriction of indication 2018-07-30
  • ESMYA® 5 mg tablets (ulipristal acetate): Women taking Esmya® for uterine fibroids to have regular liver tests while safety review is ongoing; do not initiate treatment in new patients or those who have completed a previous treatment course 2018-04-24
  • OFEV® (nintedanib): Information on severe liver injury and the need for regular monitoring of liver function associated with the use in patients with idiopathic pulmonary fibrosis (IPF) 2018-02-22
• 2017
  • XOFIGO® (radium-223 dichloride): Important Safety Information Update Regarding Increased Incidence of Deaths and Fractures in a Randomized Clinical Trial with Xofigo® used in Combination with Abiraterone Acetate and Prednisolone/ Prednisone 2017-12-29
  • RIBOMUSTIN® (bendamustine): Increased Mortality Observed When Used in Non-approved Combination Treatments or Outside the Approved Indications; Monitor for Opportunistic Infections and Hepatitis B Reactivation 2017-10-06
  • XGEVA® (denosumab): Risk of Multiple Vertebral Fractures (MVF) Following Treatment Discontinuation 2017-10-06
  • KEYTRUDA® (pembrolizumab): Risk of Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN) 2017-07-03
  • ZELBORAF® (vemurafenib): Important Drug Warning – Risk of Dupuytren’s Contracture and Plantar Fascial Fibromatosis 2017-07-03
  • DOMIDE® (thalidomide): New important advice regarding viral reactivation and pulmonary hypertension 2017-06-05
  • REVLIMID® (lenalidomide): New important advice regarding viral reactivation 2017-06-05
  • MADONNA® (levonorgestrel): Levonorgestrel-containing emergency hormonal contraception ─ New advice on interactions with hepatic enzyme inducers and contraceptive efficacy 2017-04-11
  • ESCAPELLE® & POSTINOR-2® (levonorgestrel): Levonorgestrel-containing emergency hormonal contraception ─ New advice for users of hepatic-enzyme inducers 2017-04-11
  • POMALYST® (pomalidomide): New important advice- Hepatitis B Virus status to be established before initiating treatment with pomalidomide 2017-02-28