Date issuedProductSafety information
01/11/41 Hemlibra (Emicizumab)

Hemlibra® (Emicizumab) and it’s known interaction with certain laboratory assays in patients who become infected with the novel corona virus that causes COVID-19.CLICK HERE​

14/09/41 Megamox (Amoxicillin / Clavulanic acid)

Megamox® 625mg tablets is associated with a typographic error in the units for the weight of the product stated on the aluminum foil.CLICK HERE

08/09/41 XELJANZ (tofacitinib)

XELJANZ (tofacitinib): increased risk of venous thrombo-embolism and increased risk of serious and fatal infections.CLICK HERE

17/07/41 Ecalta (Anidulafungin)

Ecalta 100mg Powder for Concentrate for Solution for Infusion (Anidulafungin): Solution for Infusion must no longer be frozen.CLICK HERE​

17/07/41 Curam (Amoxicillin / Clavulanic acid)

Update on instruction for the preparation of Curam® (Amoxicillin Clavulanic Acid POS - powder for Oral Suspension) bottles.CLICK HERE​

16/06/41 Hydrochlorothiazide

Hydrochlorothiazide - Risk of non-melanoma skin cancer (basal cell carcinoma, squamous cell carcinoma)​.CLICK HERE

21/05/41 Olmepress (Olmesartan)

Restriction of combined use of medicines affecting the renin-angiotensin aldosterone system (RAAS) for medicinal products containing Olmepress (Olmesartan).CLICK HERE​

15/04/41 Kyprolis® ( Carfilzomib)

Kyprolis (carfilzomib) – New Safety Information: Risk of Progressive Multifocal Leukoencephalopathy (PML) and Hepatitis B Virus (HBV) Reactivation.CLICK HERE

11/04/41 Esbriet® (Pirfenidone)

Important Safety Update on ESBRIET® (pirfenidone) and Drug-Induced Liver Injury (DILI).CLICK HERE

17/03/41 FEGONA®

FEGONA (fingolimod) – New contraindication in pregnant women and in women of childbearing potential not using effective contraception ​. CLICK HERE​​​​​

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