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Suggestions

Pharmacovigilance

Product Date Safety information Attachments
XELJANZ (tofacitinib)

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

Curam (Amoxicillin / Clavulanic acid)

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

Ecalta (Anidulafungin)

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

Hydrochlorothiazide

Hydrochlorothiazide - Risk of non-melanoma skin cancer (basal cell carcinoma, squamous cell carcinoma)

Depakine (Valproate)

Restrictions on use; pregnancy prevention programme to be put in place.

Olmepress (Olmesartan)

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

Kyprolis® ( Carfilzomib)

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

Esbriet® (Pirfenidone)

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

FEGONA®

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

Zofran®

Direct Healthcare Professional Communication on the risk of birth defects from the recently published epidemiological studies for Zofran® (Ondansetron)