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Suggestions

Pharmacovigilance

Product Date Safety information Attachments
Procoralan® (Ivabradine)

​Reminder 

on the Procoralan® (Ivabradine) conditions of use for the symptomatic treatment 

of chronic stable angina pectoris to avoid potentially dangerous 

bradycardia 

Carvidol® (Carvedilol)

​Important 

safety update of prescribing information for  

Carvidol® 

(Carvedilol) 

Vectibix® (Panitumumab)

​Rare 

cases of Stevens-Johnson syndrome and Toxic Epidermal Necrolysis that have been 

reported in patients treated with Vectibix® (Panitumumab) 

Benlysta® (Belimumab)

​Two Post Marketing Reports, One Fatal, of Progressive Multifocal Leukoencephalopathy (PML) in Patients with Systemic Lupus Erythematosus (SLE) . 

Plasmex 6%® (Hydroxyethyl starch)

​New 

safety guidance for  Plasmex 

6%® (Hydroxyethyl starch) 

Plasmex 6%® (Hydroxyethyl starch)

 

New 

safety guidance for  Plasmex 

6%® (Hydroxyethyl starch) 

Valdoxan® - Agomelatine

New contraindication for use and a reminder of importance of liver function monitoring. CLICK HERE​

Roaccutane® - Isotretinoin

Pregnancy Prevention Program and Safety Information about  Roaccutane®. ​

VIREAD ® - Tenofovir

Possible presence of silicone rubber in the above listed product and lots.

Zelboraf® - Vemurafenib

Risk of liver injury reported with  Zelboraf®. ​