Pharmacovigilance

"Dear Doctor Letter" on spotted error in the package information leaflet for M-M-RVAXPRO vaccin

23.03.2012

Merck Sharp & Dohme d.o.o. Company, which is the marketing authorisation holder for M-M-RVAXPRO medicinal product, has sent a "Dear Doctor Letter" in collaboration with the Croatian Agency for Medicinal Products and Medical Devices on the spotted error in the patient information leaflet. The text incorrectly rendered "in subcutaneous muscle" as the route of administration instead of the correct text "intramuscular or subcutaneous application."

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