Detailed SMPC and OD register data for: Mozobil
Data as extracted from Orphan Designation Register
Product (OD)
Mozobil
PL number (OD)
PLGB 04425/0769
OD Designation ID (OD)
OD1
Active substance (OD)
plerixafor l, 1’-[1,4-phenylenebis (methylene)]-bis-1,4,8,11- tetraazacyclotetradecane
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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SMPC composition / active substance
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EMA SMS ID
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Further information for:
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OD Indication (OD)
Adult patients Mozobil is indicated in combination with granulocyte-colony stimulating factor (G-CSF) to enhance mobilisation of haematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in adult patients with lymphoma or multiple myeloma whose cells mobilise poorly. Paediatric patients (1 to less than 18 years) Mozobil is indicated in combination with G-CSF to enhance mobilisation of haematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in children with lymphoma or solid malignant tumours, either: - pre-emptively, when circulating stem cell count on the predicted day of collection after adequate mobilization with G-CSF (with or without chemotherapy) is expected to be insufficient with regards to desired hematopoietic stem cells yield, or - who previously failed to collect sufficient haematopoietic stem cells.
Full Designation Number(OD)
PLGB 04425/0769/OD1
Orphan Condition(OD)
Mobilization of progenitor cells prior to stem cell transplantation
All Indications (SMPC)
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Pregnancy/Lactation (SMPC)
Driving/Machines (SMPC)
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Overdose (SMPC)
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Container description (SMPC)
Handling/Disposal (SMPC)
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