BRUKINSA
As listed in the register: BRUKINSA 80 mg, gélule
80 mg · gélule
- Prescription only
- Active substance
- Zanubrutinib
- Made by
- BEONE MEDICINES IRELAND (IRLANDE)
- 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
European UnionNo exact match for this strength and form
Details
| Made by | BEONE MEDICINES IRELAND (IRLANDE) |
|---|---|
| Active substance | Zanubrutinib |
| Strength | 80 mg |
| Form | gélule |
| Route | orale |
| Dispensing (as stated by the register) | médicament nécessitant une surveillance particulière pendant le traitement · prescription réservée aux spécialistes et services HEMATOLOGIE · prescription hospitalière · liste I · prescription réservée aux médecins compétents en maladie du sang |
| Marketed | Yes, according to the register |
| Reinforced monitoring | Yes — under reinforced monitoring, according to the register |
| Authorisation procedure | Procédure centralisée |
| EU number | EU/1/21/1576 |
| Name in the register | BRUKINSA 80 mg, gélule |
| Packs | 1 flacon(s) polyéthylène haute densité (PEHD) avec fermeture de sécurité enfant de 120 gélule(s) |
| CIS | 65919841 |
| CIP13 | 3400930242391 |
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).