Pharmacovigilance

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Product Date Safety information Attachments
Cilest® - Ethinylestradiol, Norgestimate

The reason for the recall is that dissolution testing of norgestimate.  

 

TYKERB® - Lapatinib

Comparative data have shown that Lapatinib based regimens are less effective than trastuzumab based regimens in certain settings.  

 

Plavix® - Clopidogrel

Regarding Bleeding Risk with Plavix in Atrial Fibrillation Patients. 

 

Curacne® - Isotretinoin

Pregnancy Prevention Program   

 

ROACCUTANE®- Isotretinoin

Pregnancy Prevention Program    

 

Tysabri® - Connect

Risk of progressive multifocal leukoencephalopathy PML ​

Protelos® - Strontium ranelate

Increased risk of myocardial infarction ​

Miacalcic® - Calcitonin

increased risk of malignancies with long term calcitonin use  ​

Solpadeine® - Paracetamol, Caffeine, Codeine Phosphate

The use of codeine containing products for children after tonsillectomy and /or adenoidectomy surgery  

Vastarel® - Trimetazidine

Outcome of the Benefit-Risk Re-evaluation of Trimetazidine  ​



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