Detailed SMPC and OD register data for: PREVYMIS 240 mg film-coated tablets
Data as extracted from Orphan Designation Register
Product (OD)
PREVYMIS 240 mg film-coated tablets
PL number (OD)
PLGB 53095/0048
OD Designation ID (OD)
OD1
Active substance (OD)
Letermovir
Data as extracted from SMPC. (PS: More information at bottom of the page)
Product (SMPC)
PL Number (SMPC)
Composition/ Active Substance (SMPC)
Dose form (SMPC)
Marketing Authorisation holder details (SMPC)
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Further information for:
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OD Indication (OD)
PREVYMIS is indicated for prophylaxis of cytomegalovirus (CMV) reactivation and disease in adult and paediatric patients weighing at least 15 kg who are CMV-seropositive recipients [R+] of an allogeneic haematopoietic stem cell transplant (HSCT). PREVYMIS is indicated for prophylaxis of CMV disease in CMV-seronegative adults and paediatric patients weighing at least 40 kg who have received a kidney transplant from a CMV-seropositive donor [D+/R-]. Consideration should be given to official guidance on the appropriate use of antiviral agents.
Full Designation Number(OD)
PLGB 53095/0048/OD1
Orphan Condition(OD)
Cytomegalovirus disease reactivation in patients with impaired cell-mediated immunity
All Indications (SMPC)
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Undesirable effects (SMPC)
Overdose (SMPC)
Shelf life (SMPC)
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Container description (SMPC)
Handling/Disposal (SMPC)
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