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DARZALEX 20 mg/ml, concentrate for solution for infusion bottle, 5 ml

Active ingredients: Daratumumab

Commercialized according to BDPMDispensing in France: Prescription only, hospital use
Concentrate for solution for infusionbottle, 5 mlintraveineuse

No current ANSM shortage notice is included

Package details

Original BDPM fields are shown in French.

Official name
DARZALEX 20 mg/mL, solution à diluer pour perfusion
Pharmaceutical form
solution à diluer pour perfusion
Route of administration
intraveineuse
Presentation description
1 flacon(s) en verre de 5 ml
Marketing authorisation holder
JANSSEN CILAG INTERNATIONAL NV
Reimbursement according to BDPM
—
Approval for use in healthcare institutions
oui
Commercialization declaration date
20 Jun 2016
Prescription and dispensing conditions
Prescription only, hospital use
  • List I: prescription-only medicine
  • Requires special monitoring during treatment
  • Prescribed by specialists only
  • Hospital use only
Original BDPM wording: liste I · médicament nécessitant une surveillance particulière pendant le traitement · prescription réservée aux médecins compétents en CANCEROLOGIE · prescription réservée aux médecins compétents en maladie du sang · prescription réservée aux spécialistes et services HEMATOLOGIE · prescription réservée aux spécialistes et services ONCOLOGIE MEDICALE · réservé à l'usage HOSPITALIER
Enhanced ANSM monitoring
No

BDPM identifiers

CIS67352140CIP75502180CIP133400955021803

Composition in BDPM

Composition in BDPM
ComponentAmount per unitSource type
DARATUMUMABsolution20 mg · 1 ml de solutionSA

Information is based on BDPM data and is for reference only. Consult a doctor before use.

Other packages of this medicine

The same medicine in another pack size, according to BDPM.

Similar medicines

Similar medicines are listed using the official BDPM catalog. Availability must be checked separately. Consult a doctor or pharmacist before switching medicines.

The current BDPM data does not list similar medicines for this product.