| - |
Zanamivir |
Dectova® |
For the treatment of complicated and potentially life-threatening influenza A or B virus infection in adult and paediatric patients (aged ≥6 months) when the patient's influenza virus is known or suspected to be resistant to anti-influenza medicinal products other than zanamivir, and/or other anti-viral medicinal products for treatment of influenza, including inhaled zanamivir, are not suitable for the individual patient |
Rapid review complete |
18th October 2019 |
 |
| 23072 |
Zanubrutinib |
Brukinsa® |
Zanubrutinib monotherapy is indicated for adult patients with relapsed/refractory marginal zone lymphoma with at least one prior anti-CD20-based therapy. |
Pre submission consultation scheduled |
7th March 2024 |
|
| 21044 |
Zanubrutinib |
Brukinsa® |
Monotherapy for the treatment of adult patients with Waldenström’s macroglobulinaemia who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo-immunotherapy |
Rapid review complete |
16th November 2021 |
|
| 23010 |
Zanubrutinib |
Brukinsa® |
Zanubrutinib as monotherapy is indicated for the treatment of adult patients with chronic lymphocytic leukaemia (CLL). The place in therapy for zanubrutinib, proposed by the Applicant, is narrower than the licensed population i.e. as monotherapy for patients with CLL, who are treatment naïve and have del(17p) and/or TP53 mutations or for patients that have relapsed and/or refractory disease |
Rapid Review Complete |
20th October 2023 |
|
