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Description: There is a potential safety issue related to cases of Neural Tube Defects (NTD) in infants born to women who were treated with antiretroviral regimens containing dolutegravir at the time…
Description: Healthcare professionals are informed of the new important identified risk of nephritis with use of Tecentriq® (atezolizumab). Atezolizumab is indicated for the treatment of patients…
Description: Healthcare professionals are informed of the new contraindication, restricted indication and liver function monitoring requirement for Esmya 5mg Tablets® (ulipristal acetate). Esmya® is…
Description: The risk of developing abuse and dependence with zolpidem has been found to increase with a treatment duration above 28 days and in patients with previous or concomitant history of…
Date: 12 April 2018 Description: The Pharmacovigilance Risk Assessment Committee (PRAC), European Medicines Agency (EMA) started a review of Esmya®, to assess the link between Esmya® and cases of…
Date: 5 January 2018 Description: Cases of drug-induced liver injury (DILI) in patients treated with Ofev® have been reported worldwide in the post-marketing period, including a case of severe liver…
Date: 8 December 2017 Description: Preliminary data from a randomised clinical trial showed an increased incidence of fractures (24% vs. 7%) and deaths (27% vs. 20%) in patients with…
Date: 25 September 2017 Description: Increased mortality was observed in recent clinical studies when bendamustine was used in non-approved combination treatments (obinutuzumab and rituximab) or…
Date: 8 September 2017 Description: Cases of multiple vertebral fractures (MVF) have occurred rarely following discontinuation of Xgeva® in patients participating in ongoing clinical trials…
Date: 11 May 2017 Description: Cases of Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported internationally in patients treated with Keytruda® (pembrolizumab) in…
Date: 26 April 2017 Description: Zelboraf® is indicated for the treatment of unresectable or metastatic melanoma specifically with V600 mutation in the BRAF gene. Cases of Dupuytren’s contracture…
Date: 8 May 2017 Description: Cases of viral reactivation, some serious, have been reported following treatment with thalidomide, particularly in patients previously infected with the…
Date: 13 April 2017 Description: Cases of viral reactivation have been reported following treatment with lenalidomide, particularly in patients previously infected with the varicella zoster or…
Date: 5 April 2017 Description: Concomitant use of liver enzyme inducers - mainly inducers of CYP3A4 enzymes - increases the metabolism of levonorgestrel. This results in a decrease in plasma…
Date: 15 March 2017 Description: The metabolism of levonorgestrel is known to be increased by concomitant use of liver enzyme inducers, mainly inducers of CYP3A4 enzymes. This resulting reduction in…
Date: 19 January 2017 Description: Reactivation of hepatitis B has been reported rarely following treatment with pomalidomide plus dexamethasone in patients previously infected with the hepatitis B…
Date: 14 December 2016 Description: Cases of osteonecrosis of the jaw (ONJ) have been reported in cancer patients who have been treated with Zaltrap® (aflibercept). Patients who have also previously…
Date: 14 November 2016 Description: There have been post-marketing reports of etonogestrel implants (non-radiopaque and radiopaque) found in the vasculature (including the pulmonary artery) and the…
Date: 25 August 2016 Description: Tarceva® (erlotinib) is no longer indicated for the first-line maintenance treatment in patients without an epidermal growth factor receptor (EGFR)-activating…
Date: 1 July 2016 Description: Tarceva® (erlotinib) is no longer indicated for the first-line maintenance treatment in patients without an epidermal growth factor receptor (EGFR)-activating mutation…
Date: 22 July 2016 Description: Adempas® (riociguat) should not be used in patients with pulmonary hypertension associated with idiopathic interstitial pneumonias (PH-IIP). Riociguat is not approved…
Date: 18 May 2016 Description: Locabiotal® Solution (oromucosal/nasal spray containing fusafungine) will no longer be available in Malaysia and worldwide following a review which concluded that the…
Date: 25 April 2016 Description: A Direct Healthcare Professional Communication (DHPC) has been approved by NPCB to inform healthcare professionals of the risk of HBV reactivation in patients who are…
Date: 30 March 2016 Description: The package inserts of Xalkori® will be updated with safety information on the risk of cardiac failure following a safety review of clinical trial data and…
