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2026
- ALECENSA® (Alectinib): Guidance for Management of Severe Hypertriglyceridaemia 2026-06-15
- POLIVY® (Polatuzumab Vedotin): Identified Risk – Severe Infusion Site Extravasation Events 2026-06-15
- COLUMVI® (Glofitamab): New Important Identified Risk of Haemophagocytic Lymphohistiocytosis 2026-05-25
- CELLCEPT® (Mycophenolate mofetil): New Important Identified Risk – Anaphylactic Reaction 2026-03-19
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2025
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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
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2022
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2021
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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
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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
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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
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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
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2016
- Zaltrap® (aflibercept): Information on the risk of osteonecrosis of the jaw 2016-12-30
- Implanon NXT® (etonogestrel): Implants have been found rarely in the vasculature and lung. An update on possible risks and complications regarding insertion, localisation, removal and migration 2016-11-24
- Invokana® (canagliflozin): Advice on the risk of lower limb amputation (primarily of the toe) during treatment with canagliflozin-containing medicines 2016-11-24
- Tarceva® (erlotinib): First-line maintenance indication now restricted to treatment of patients whose tumours harbour an EGFR-activating mutation 2016-08-24
- Adempas® (Riociguat): New Contraindication for Patients with Pulmonary Hypertension Associated with Idiopathic Interstitial Pneumonias (PH-IIP) 2016-08-03
- Locabiotal® Solution (fusafungine): Withdrawal of registration following European Medicines Agency’s benefit-risk assessment 2016-06-08
- Glivec® (imatinib) & Tasigna® (nilotinib): Risk of Hepatitis B reactivation 2016-06-08
- Xalkori® (crizotinib): Inclusion of a new warning regarding cardiac failure 2016-06-08
- Viekirax® (ombitasvir/ paritaprevir/ ritonavir) with or without Exviera® (dasabuvir): Not recommended in Child-Pugh B Patients 2016-06-08
- Xgeva® 120mg & Prolia® 60mg (denosumab): Clinically Significant Cases of Hypercalcaemia after Cessation of Treatment with Denosumab in Paediatric Patients 2016-06-08
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2015
- Cellcept® (mycophenolate mofetil): Teratogenic risk – important new pregnancy prevention advice for women and men 2015-12-31
- Forxiga® (dapagliflozin): Risk of Diabetic Ketoacidosis During Treatment With Sodium Glucose Co-transporter 2 (SGLT2)Inhibitor - Dapagliflozin 2015-09-04
- Motilium® (domperidone): New recommendations to minimise cardiac risks 2015-09-04
- Xgeva®120mg Solution for Injection (denosumab): Updated recommendations to minimise the risk of severe symptomatic hypocalcaemia (SSH) and osteonecrosis of the jaw (ONJ) 2015-03-23
- Artrodar®50mg (diacerein): New restrictions of use to limit the risk of severe diarrhoea and effects on the liver 2015-02-12
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2014
- Reminyl® (galantamine hydrobromide): New Warning: Serious skin reactions (Stevens Johnson Syndrome [SJS] and acute generalised exanthematous pustulosis [AGEP]) 2014-12-31
- Revatio® (sildenafil citrate): Safety Information regarding Revatio® tablets for the treatment of pulmonary arterial hypertension (PAH) 2014-10-21
- Topamax® (topiramate): Updated Warnings and Precautions on Visual Field Defects 2014-10-21
- Protaxos® (strontium ranelate): New restricted indication and contraindications for use 2014-08-27
- Neupogen® (filgrastim) & Neulastim® (pegfilgrastim): Risk of capillary leak syndrome in patients with cancer (filgastrim & pegfilgastrim) and in healthy donors (filgastrim only) 2014-08-27
- Gran® (filgrastim) & Peglasta® (pegfilgrastim): Risk of capillary leak syndrome in patients with cancer (filgastrim & pegfilgastrim) and in healthy donors (filgastrim only) 2014-08-19
- Vectibix® (panitumumab): Rare cases of Stevens-Johnson syndrome (SJS) and Toxic Epidermal Necrolysis (TEN) have been reported in patients treated with Vectibix® 2014-07-15
- Mencevax ACWY™ (meningococcal vaccine): New antibody persistence data 2014-07-15
- Ritalin and Ritalin LA® (methylphenidate hydrochloride): New warning on priapism in patients treated for Attention Deficit Hyperactivity Disorder (ADHD) 2014-07-15
- Risperidone and Paliperidone: Risk of Intraoperative Floppy Iris Syndrome (IFIS) in Patients Undergoing Cataract Surgery 2014-06-17
- Dilatrend® (carvedilol): Warning on Severe Adverse Cutaneous Reactions 2014-05-30
- Combination Products containing Cyproterone Acetate 2mg and Ethinylestradiol 0.035mg: Restriction of Indication and Measures to Reduce Risk of Thromboembolism 2014-05-20
- Tykerb® (Lapatinib): Comparative data have shown that lapatinib based regimens are less effective than trastuzumab based regimens for metastatic breast cancer in certain settings 2014-04-30
- Concerta® (Methylphenidate hydrochloride): New warning on priapism in patients treated for Attention Deficit Hyperactivity Disorder (ADHD) 2014-04-30
- Zofran® (Ondansetron): Dose-dependent QT interval prolongation – updated information on posology for intravenous (IV) use in the prevention of Chemotherapy-Induced Nausea And Vomiting (CINV) 2014-04-30
- Erbitux® (Cetuximab): Importance of establishing wild type RAS status (exons 2,3,4 of KRAS and NRAS) before treatment in metastatic colorectal cancer (mCRC) 2014-04-30
- Ultracet® Tablet (tramadol and paracetamol): Association with Serious Skin Reactions–Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN) 2014-04-30
- Frisium® (clobazam): Update to include serious skin reactions in package insert for Malaysia 2014-04-30
