Nivolumab
Pd-1/Pd-L1 (Programmed Cell Death Protein 1/Death Ligand 1) Inhibitors
Sold as OPDIVO · OPDUALAG · OPDIVO SC
- Drug class
- Pd-1/Pd-L1 (Programmed Cell Death Protein 1/Death Ligand 1) Inhibitors
- Availability
- See label
- Routes
- Subcutaneous, Intravenous
- Markets covered
- 3
- Products on record
- 19
Overview
Nivolumab is an active pharmaceutical ingredient in the Pd-1/Pd-L1 (Programmed Cell Death Protein 1/Death Ligand 1) Inhibitors group (L01FF). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.
Regulatory status by market
| Market | Regulator | Products | Last revision |
|---|---|---|---|
| GB United Kingdom | MHRA | 13 | May 22, 2026 |
| CA Canada | Health Canada | 5 | March 27, 2026 |
| EU European Union | EMA | 1 | June 2, 2026 |
GBUnited Kingdom· MHRA
13 products
Uses
1). OPDIVO as monotherapy or in combination with ipilimumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older. 1). 1). 1). OPDIVO in combination with ipilimumab and 2 cycles of platinum-based chemotherapy is indicated for the first-line treatment of metastatic non-small cell lung cancer in adults whose tumours have no sensitising EGFR mutation or ALK translocation.
OPDIVO as monotherapy is indicated for the treatment of locally advanced or metastatic non-small cell lung cancer after prior chemotherapy in adults. Malignant pleural mesothelioma (MPM) OPDIVO in combination with ipilimumab is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma.
1). 1). OPDIVO as monotherapy is indicated for the treatment of advanced renal cell carcinoma after prior therapy in adults. 3 Classical Hodgkin lymphoma (cHL) OPDIVO as monotherapy is indicated for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma after autologous stem cell transplant (ASCT) and treatment with brentuximab vedotin.
CACanada· Health Canada
5 products
Uses
3 Pharmacokinetics, Special Populations and Conditions, Pediatrics). 4. Geriatrics No overall differences in safety or efficacy were reported between elderly patients (≥ 65 years) and younger patients (< 65 years). Limited safety and efficacy information is available for Opdivo in cHL ≥ 65 years of age (n=7/266).
Unresectable or Metastatic Melanoma:
Of the 210 patients randomized to Opdivo in CHECKMATE-066, 50% were 65 years of age or older. Of the 272 patients randomized to Opdivo in CHECKMATE-037, 35% were 65 years of age or older. Of the 316 patients randomized to Opdivo in CHECKMATE-067, 37% were 65 years of age or older and of the 314 patients randomized to Opdivo administered with ipilimumab, 41% were 65 years of age or older.
Adjuvant Treatment of Melanoma:
Of the 453 patients randomized to Opdivo in CHECKMATE-238, 27% were 65 years of age or older and 4% were 75 years or older. Data from patients 75 years of age or older are too limited to draw conclusions. 4% were 75 years or older. Data from patients 75 years of age or older are too limited to draw conclusions.
EUEuropean Union· EMA
1 product
Uses
1). OPDIVO as monotherapy or in combination with ipilimumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older. 1). 1 for selection criteria). 1 for selection criteria).
OPDIVO in combination with ipilimumab and 2 cycles of platinum-based chemotherapy is indicated for the first-line treatment of metastatic non-small cell lung cancer in adults whose tumours have no sensitising EGFR mutation or ALK translocation.
OPDIVO as monotherapy is indicated for the treatment of locally advanced or metastatic non-small cell lung cancer after prior chemotherapy in adults. Malignant pleural mesothelioma (MPM) OPDIVO in combination with ipilimumab is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma.
1). 1). OPDIVO as monotherapy is indicated for the treatment of advanced renal cell carcinoma after prior therapy in adults. Classical Hodgkin lymphoma (cHL) OPDIVO in combination with doxorubicin, vinblastine and dacarbazine (AVD) is indicated for adults and adolescents 12 years of age and older with previously untreated Stage III or IV classical Hodgkin lymphoma.
Drug interactions
Known interactions involving Nivolumab. Select one for details. This list is informational and not a complete interaction checker.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
Sources & citations
- [1]MHRA (UK) · PLGB151050133 · revised April 24, 2026
- [2]Health Canada (DPD) · 02446626 · revised March 4, 2026
- [3]European Medicines Agency · EMEA/H/C/003985 · revised June 2, 2026
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.