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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)

IDMP View

Structured regulatory data for this product mapped to the IDMP entity hierarchy (ISO 11615) — Marketing Authorisation, Medicinal Product, and Administrable Product.
Note: Wherever a type is listed as "Equivalent Term not known", we dont have the information available in public domain. However, this data is usually available in eAF (or equivalent) form and is stored by most regulators as strucutured data - albeit not always in same hierarchy as IDMP.

No IDMP data is linked to this authorisation number.

AI match to EMA Substance Dictionary

We analysed the SMPC composition text and searched for the closest equivalent in EMA's published substance dictionary. The suggested match and supporting details are shown below.

SMPC composition / active substance
Matched EMA substance
EMA SMS ID
Confidence
Higher confidence means the match is more likely to be correct.
Show AI rationale

FDA Approved Products —

Products approved by the FDA containing the matched EMA substance, sourced from OpenFDA Drugs@FDA.

No EMA substance match available — FDA lookup skipped.

Further information for:

Select a section below to read the detailed content extracted from the SMPC / Orphan Designation register.

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)
All Contraindications (SMPC)
Warnings/Precautions (SMPC)
Interactions (SMPC)
Pregnancy/Lactation (SMPC)
Driving/Machines (SMPC)
Undesirable effects (SMPC)
Overdose (SMPC)
Shelf life (SMPC)
Storage (SMPC)
Container description (SMPC)
Handling/Disposal (SMPC)
SMPC_URL

Link to SMPC: Not available