DARZALEX
As listed in the register: DARZALEX 1800 mg, solution injectable
1 800 mg · solution injectable
- Prescription only
- Active substance
- Daratumumab
- Made by
- JANSSEN CILAG INTERNATIONAL NV
- Source
- Official label
Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.
What it is for
Mediclarum has not yet retrieved and stored the official label for this product, so none of its text is shown here. Open the official leaflet
Same active substance, strength and form in other countries
Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.
Medicine passport: one printable page to show a pharmacist abroad
United StatesNo exact match for this strength and form
European UnionNo exact match for this strength and form
SpainNo exact match for this strength and form
CanadaNo exact match for this strength and form
NetherlandsNo exact match for this strength and form
Details
| Made by | JANSSEN CILAG INTERNATIONAL NV |
|---|---|
| Active substance | Daratumumab |
| Strength | 1 800 mg |
| Form | solution injectable |
| Route | sous-cutanée |
| Dispensing (as stated by the register) | médicament nécessitant une surveillance particulière pendant le traitement · prescription réservée aux spécialistes et services ONCOLOGIE MEDICALE · prescription réservée aux spécialistes et services HEMATOLOGIE · prescription hospitalière · liste I · la première administration doit être effectuée en milieu hospitalier · prescription réservée aux médecins compétents en maladie du sang · prescription réservée aux médecins compétents en CANCEROLOGIE |
| Marketed | Yes, according to the register |
| Authorisation procedure | Procédure centralisée |
| EU number | EU/1/16/1101 |
| Name in the register | DARZALEX 1800 mg, solution injectable |
| Packs | 1 flacon(s) en verre de 15 ml |
| CIS | 60047225 |
| CIP13 | 3400930212202 |
Source: Base de données publique des médicaments · 2026-09-30 · not reviewed by a clinician
Source : Base de données publique des médicaments (ANSM / Ministère de la Santé), sous Licence Ouverte. Reuse terms: Licence Ouverte / Open Licence (Etalab).
Other strengths and forms
2 products are sold under this name. Grouped by form; a number on a strength means several companies make it.
- solution injectable1 products
- 1 800 mg
- solution à diluer pour perfusion1 products
Same active substance
These contain the same substance. That does not mean one can replace another — ask a pharmacist.