Pharmacovigilance
| Product | Date | Safety information | Attachments |
|---|---|---|---|
| Motilium (Domperidone) |
Removal of the paediatric posology and reminder of indication and contraindications related to serious cardiac side-effects |
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| Levofloxacin Sandoz (Levofloxacin) |
Systemic fluoroquinolones: risk of heart valve regurgitation |
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| Hydrochlorothiazide |
Hydrochlorothiazide - Association with non-melanoma skin cancer (basal cell carcinoma, squamous cell carcinoma) |
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| Curacne (Isotretinoin) |
Isotretinoin - update on teratogenicity and neuropsychiatric disorders |
||
| Co-olmepress / Co-cinfaval |
Hydrochlorothiazide - Risk of non-melanoma skin cancer (basal cell carcinoma, squamous cell carcinoma) |
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| 5-Fluorouracil Capecitabine |
<p style="direction: ltr;">5-Fluorouracil (i.v.) and capecitabine containing products: Pre-treatment testing to identify DPD-deficient patients at increased risk of severe toxicity. |
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| Verorab (Rabies Vaccine, Inactivated) |
Updated information on the reconstitution and administration of rabies vaccine, inactivated (VERORAB) |
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| 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 |
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| Zofran® (Ondansetron) |
Direct Healthcare Professional Communication on the recently published epidemiological studies evaluating the risk of birth defects with Zofran® (Ondansetron) |
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| Megamox (Amoxicillin / Clavulanic acid) |
<p dir="RTL">Megamox® 625mg tablets is associated with a typographic error in the units for the weight of the product stated on the aluminum foil. |
