| - |
Nivolumab |
Opdivo® |
Is licensed for the treatment of advanced renal cell carcinoma after prior therapy in adults |
Assessment Process Complete |
28th March 2017 |
 |
| - |
Nivolumab |
Opdivo® |
As monotherapy is indicated for the treatment of relapsed or refractory classical Hodgkin lymphoma after autologous stem cell transplant and treatment with brentuximab vedotin. |
Rapid Review Complete |
18th January 2017 |
|
| - |
Nivolumab |
Opdivo® |
For the treatment of squamous cell carcinoma of the head and neck (SCCHN) in adults progressing on or after platinum-based therapy. |
Rapid Review Complete |
30th May 2017 |
|
| - |
Nivolumab |
Opdivo® |
Is indicated as for monotherapy treatment for patients diagnosed with unresectable metastatic melanoma. Rapid Review |
Assessment Process Complete |
18th March 2016 |
|
| 22046 |
Nivolumab |
Opdivo® |
Is indicated for the adjuvant treatment of adults with muscle invasive urothelial carcinoma (MIUC) with tumour cell PD-L1 expression ≥1%, who are at high risk of recurrence after undergoing radical resection of MIUC. |
NCPE Assessment Process Complete |
10th March 2025 |
|
| - |
Nivolumab |
Opdivo® |
Is indicated for the treatment of adults with locally advanced or metastatic non-squamous NSCLC after prior chemotherapy. |
Assessment Process Complete |
12th October 2016 |
|
| - |
Nivolumab |
Opdivo® |
Opdivo® is indicated for the treatment of locally advanced or metastatic squamous NSCLC after prior chemotherapy in adults. |
Assessment Process Complete |
10th March 2016 |
|
| 22045 |
Nivolumab |
Opdivo® |
Nivolumab in combination with fluoropyrimidine- and platinum-based combination chemotherapy is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma (OSCC) with tumour cell PD-L1 (programmed death ligand 1) expression ≥1%. |
Rapid Review Complete |
20th October 2023 |
|
| - |
Nivolumab |
Opdivo® |
As monotherapy is indicated for the treatment of locally advanced unresectable or metastatic urothelial carcinoma in adults after failure of prior platinum-containing therapy. |
Assessment Process Complete |
12th September 2018 |
|
| - |
Nivolumab |
Opdivo® |
Nivolumab in combination with ipilimumab for the first-line treatment of adult patients with intermediate/poor-risk advanced renal cell carcinoma (RCC) for RCC. |
Assessment Process Complete |
8th January 2020 |
|
| 21023 |
Nivolumab |
Opdivo® |
Nivolumab (Opdivo®) in combination with ipilimumab (Yervoy®) is indicated for the treatment of adult patients with mismatch repair deficient or microsatellite instability-high metastatic colorectal cancer after prior fluoropyrimidine-based combination chemotherapy. |
NCPE Assessment Process Complete |
6th July 2023 |
|
| 26011 |
Nivolumab in combination with ipilimumab |
Opdivo® in combination with Yervoy® |
Nivolumab (Opdivo®) in combination with ipilimumab (Yervoy®) is indicated for the first-line treatment of adult patients with unresectable or advanced hepatocellular carcinoma. |
Rapid Review Complete |
16th April 2026 |
|
| 25036 |
Nivolumab (Opdivo®) |
Opdivo® |
Nivolumab (Opdivo®) for subcutaneous (SC) use co-formulated with recombinant human hyaluronidase (rHuPH20), is indicated across multiple previously approved adult solid tumours as monotherapy, monotherapy maintenance following completion of nivolumab plus ipilimumab (Yervoy®) combination therapy, or in combination with chemotherapy or cabozantinib. |
Rapid Review Complete |
18th June 2025 |
|
| 25003 |
Nivolumab with Ipilimumab |
Opdivo® with Yervoy® |
Nivolumab (Opdivo®) with Ipilimumab (Yervoy®) is indicated for the first-line treatment of adult patients with unresectable or metastatic mismatch repair deficient or microsatellite instability-high colorectal cancer. |
Rapid Review Complete |
14th February 2025 |
|
| 23050 |
Nivolumab |
Opdivo® |
In combination with platinum-based chemotherapy for the neoadjuvant treatment of resectable non-small cell lung cancer at high risk of recurrence in adult patients whose tumours have PD-L1 expression ≥ 1%. |
Rapid Review Complete |
5th June 2024 |
|
| 21018 |
Nivolumab in combination with ipilimumab |
Opdivo® plus Yervoy® |
Nivolumab in combination with ipilimumab is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma. |
NCPE Assessment Process Complete |
7th September 2022 |
|
| - |
Nivolumab plus ipilimumab |
Opdivo® plus Yervoy® |
For the treatment of advanced melanoma. |
Rapid Review Complete |
9th November 2016 |
|
| 21014 |
Nivolumab plus ipilimumab plus platinum-doublet chemotherapy |
Opdivo® plus Yervoy® |
For the first-line treatment of metastatic non-small cell lung cancer (NSCLC) in adult patients whose tumours have no sensitising EGFR mutation or ALK translocation. |
Rapid Review Complete |
30th April 2021 |
|
| 24009 |
Nivolumab+relatlimab |
Opdualag® |
Nivolumab+relatlimab (Opdualag® ) is indicated for the first-line treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older with tumour cell PD-L1 expression < 1%. |
Awaiting response from Applicant |
21st April 2026 |
|
| - |
Nomegestrol acetate/estradiol |
Zoely® |
Nomegestrol acetate/estradiol (Zoely®) oral contraception |
Rapid Review Complete |
3rd January 2012 |
|
| 20044 |
Nusinersen |
Spinraza® |
For the treatment of 5q spinal muscular atrophy (SMA) in adults patients (>18 years). |
Rapid Review Complete |
29th October 2020 |
|
| - |
Nusinersen |
Spinraza® |
Is indicated for the treatment of 5q spinal muscular atrophy (SMA) |
Assessment Process Complete |
19th December 2017 |
|
| - |
Obeticholic acid |
Ocaliva® |
For the treatment of primary biliary cirrhosis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA or as monotherapy in adults unable to tolerate UDCA. |
NCPE Assessment Process Complete |
6th February 2026 |
|
| - |
Obinutuzumab |
Gazyvaro® |
In combination with bendamustine followed by obinutuzumab maintenance for the treatment of patients with follicular lymphoma who did not respond or who progressed during or up to 6 months after treatment with rituximab or a rituximab-containing regimen. |
Assessment process complete |
26th January 2017 |
|
| - |
Obinutuzumab |
Gazyvaro® |
In combination with chlorambucil for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia and with comorbidities making them unsuitable for full-dose fludarabine based therapy. |
Assessment process complete |
2nd April 2015 |
|
| - |
Obinutuzumab |
Gazyvaro® |
In combination with chemotherapy, followed by obinutuzumab maintenance therapy in patients achieving a response, for the treatment of patients with previously untreated advanced follicular lymphoma. |
Assessment process complete |
3rd May 2018 |
|
| 25065 |
Obinutuzumab |
Gazyvaro® |
Obinutuzumab (Gazyvaro®) in combination with mycophenolate mofetil, is indicated for the treatment of adult patients with active Class III or IV, with or without concomitant Class V, lupus nephritis. |
Rapid Review Complete |
8th December 2025 |
|
| - |
Ocrelizumab |
Ocrevus® |
For the treatment of adult patients with early primary progressive multiple sclerosis (PPMS) in terms of disease duration and level of disability, and with imaging features characteristic of inflammatory activity. |
Assessment process complete |
4th October 2018 |
|
| - |
Ocrelizumab |
Ocrevus® |
For the treatment of adult patients with relapsing forms of multiple sclerosis (RMS) with active disease defined by clinical or imaging features. |
Assessment process complete |
29th August 2018 |
|
| 25015 |
Ocrelizumab |
Ocrevus SC® |
Ocrelizumab SC is indicated • For the treatment of adult patients with relapsing forms of multiple sclerosis (RMS) with active disease defined by clinical or imaging features. • For the treatment of adult patients with early primary progressive multiple sclerosis (PPMS) in terms of disease duration and level of disability, and with imaging features characteristic of inflammatory activity. |
Rapid Review Complete |
20th March 2025 |
|
| - |
Ocriplasmin |
Jetrea® |
For the treatment of vitreomacular traction (VMT), including when associated with macular hole of diameter less than or equal to 400 microns. |
Rapid Review Complete |
11th July 2013 |
|
| 21058 |
Odevixibat |
Bylvay® |
For the treatment of progressive familial intrahepatic cholestasis (PFIC) in patients aged 6 months or older. |
NCPE Assessment Process Complete |
11th March 2025 |
|
| 26005 |
Odevixibat |
Kayfanda® |
Odevixibat (Kayfanda®) is indicated for the treatment of cholestatic pruritus in Alagille Syndrome (ALGS) in patients aged six months or older. |
Rapid Review Complete |
26th February 2026 |
|
| - |
Ofatumumab |
Arzerra® |
In combination with chlorambucil or bendamustine for the treatment of patients with chronic lymphocytic leukaemia (CLL) who have not received prior therapy and who are not eligible for fludarabine-based therapy. |
Rapid Review Complete |
18th December 2014 |
|
| - |
Ofatumumab |
Arzerra® |
For the treatment of CLL in patients who are refractory to fludarabine and alemtuzumab. |
Rapid Review Complete |
22nd June 2010 |
|
| 21008 |
Ofatumumab |
Kesimpta® |
For the treatment of adult patients with relapsing forms of multiple sclerosis (RMS) with active disease defined by clinical or imaging features. |
Assessment process complete |
16th April 2021 |
|
| - |
Oladaterol |
Striverdi®, Respimat® |
As a maintenance bronchodilator treatment in patients with chronic obstructive pulmonary disease (COPD). |
Rapid Review Complete |
6th May 2014 |
|
| - |
Olaparib |
Lynparza® |
For the maintenance treatment of adult patients with advanced (FIGO stages III and IV) BRCA1/2-mutated (germline and/or somatic) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy. |
Assessment process complete |
30th March 2020 |
|
| 22065 |
Olaparib |
Lynparza® |
As monotherapy or in combination with endocrine therapy for the adjuvant treatment of adult patients with germline BRCA1/2-mutations who have HER2-negative high risk early breast cancer previously treated with neoadjuvant or adjuvant chemotherapy. |
NCPE Assessment Process Complete |
24th September 2024 |
|
| - |
Olaparib |
Lynparza® |
As monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed BRCA-mutated (germline and/or somatic) high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete response or partial response) to platinum-based chemotherapy. |
Assessment process complete |
17th December 2015 |
|
| - |
Olaparib |
Lynparza® |
For the treatment of adult patients with germline BRCA1/2 mutations, who have HER2-negative locally advanced or metastatic breast cancer. Patients should have previously been treated with an anthracycline and a taxane in the (neo)adjuvant or metastatic setting unless patients were not suitable for these treatments. |
Rapid Review Complete |
10th April 2019 |
|
| 21019 |
Olaparib |
Lynparza® |
As monotherapy for the treatment of adult patients with metastatic castration-resistant prostate cancer and BRCA1/2-mutations (germline and/or somatic) who have progressed following prior therapy that included a new hormonal agent. |
Rapid Review Complete |
15th June 2021 |
|
| - |
Olaparib |
Lynparza® |
As monotherapy for the maintenance treatment of adult patients with PSR high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy. |
Assessment process complete |
2nd February 2020 |
|
| 23029 |
Olaparib |
Lynparza® |
Olaparib in combination with abiraterone and prednisone or prednisolone is indicated for the treatment of adult patients with mCRPC in whom chemotherapy in not clinically indicated |
NCPE Assessment Process Complete |
10th May 2025 |
|
| 21011 |
Olaparib |
Lynparza® |
Olaparib in combination with bevacizumab is indicated for the maintenance treatment of adult patients with advanced (FIGO stages III and IV) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy in combination with bevacizumab and whose cancer is associated with homologous recombination deficiency (HRD) positive status defined by either a BRCA1/2 mutation and/or genomic instability. |
NCPE Assessment Process Complete |
20th October 2023 |
|
| - |
Olaparib |
Lynparza® |
As monotherapy for the maintenance treatment of adult patients with BRCA-mutated platinum sensitive relapsed ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete response or partial response) to platinum-based chemotherapy. This is a sub-group of the entire licensed population. |
Rapid Review Complete |
6th August 2019 |
|
| 24029 |
Olaparib |
Lynparza® |
Olaparib (Lynparza®) is indicated as monotherapy for the maintenance treatment of adult patients with germline BRCA1/2-mutations who have metastatic adenocarcinoma of the pancreas and have not progressed after a minimum of 16 weeks of platinum treatment within a first-line chemotherapy regimen |
Rapid Review Complete |
13th August 2024 |
|
| 23014 |
Olipudase alfa |
Xenpozyme® |
As an enzyme replacement therapy for the treatment of non-Central Nervous System (CNS) manifestations of Acid Sphingomyelinase Deficiency (ASMD) in paediatric and adult patients with type A/B or type B. |
Rapid Review Complete |
12th February 2026 |
|
| - |
Omalizumab |
Xolair® |
As an add-on therapy for the treatment of chronic spontaneous urticaria (CSU) in adult and adolescent (12 years and above) patients with inadequate response to H1-antihistamine treatment. |
Rapid Review Complete |
25th June 2014 |
|
| - |
Omalizumab |
Xolair® |
As an add-on therapy to improve asthma control in patients with severe persistent allergic asthma who have a positive skin test or in vitro reactivity to a perennial aeroallergen and who have reduced lung function (FEV1<80%) as well as frequent daytime symptoms or night-time awakenings and who have had multiple documented severe asthma exacerbations despite daily high-dose inhaled corticosteroids, plus a long-acting inhaled beta2-agonist. |
Assessment process complete |
25th June 2015 |
|
