Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Opdivo   
Auth. number : EU/1/15/1014
Active substance : nivolumab
ATC: Anatomical main group: L - Antineoplastic and immunomodulating agents
Therapeutic subgroup: L01 - Antineoplastic agents
Pharmacological subgroup: L01X - Other antineoplastic agents
Chemical subgroup: L01XC - Monoclonal antibodies
Chemical substance: L01XC17 - fluciclovine (18F)
(See WHO ATC Index)
Indication: Melanoma

OPDIVO as monotherapy or in combination with ipilimumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults.

Relative to nivolumab monotherapy, an increase in progression-free survival (PFS) and overall survival (OS) for the combination of nivolumab with ipilimumab is established only in patients with low tumour PD-L1 expression.

Adjuvant treatment of melanoma

OPDIVO as monotherapy is indicated for the adjuvant treatment of adults with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection.

Non-Small Cell Lung Cancer (NSCLC)

OPDIVO as monotherapy is indicated for the treatment of locally advanced or metastatic non-small cell lung cancer after prior chemotherapy in adults.

Renal Cell Carcinoma (RCC)

OPDIVO as monotherapy is indicated for the treatment of advanced renal cell carcinoma after prior therapy in adults.

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.

Squamous Cell Cancer of the Head and Neck (SCCHN)

OPDIVO as monotherapy is indicated for the treatment of recurrent or metastatic squamous cell cancer of the head and neck in adults progressing on or after platinum-based therapy).

Urothelial Carcinoma

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.
Marketing Authorisation Holder: Bristol-Myers Squibb Pharma EEIG
Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom
EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Community Register.

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
24/06/2015 Centralised - Authorisation EMEA/H/C/3985 (2015)4299 of 19/06/2015
30/10/2015 Centralised - 2-Monthly update EMEA/H/C/3985/II/1 (2015)7592 of 28/10/2015
17/12/2015 Centralised - Variation EMEA/H/C/3985/II/4
Updated with Decision(2016)2080 of 04/04/2016
25/02/2016 Centralised - Variation EMEA/H/C/3985/II/2
Updated with Decision(2016)2080 of 04/04/2016
6/04/2016 Centralised - 2-Monthly update EMEA/H/C/3985/II/8 (2016)2080 of 4/04/2016
13/05/2016 Centralised - 2-Monthly update EMEA/H/C/3985/II/3 (2016)2952 of 11/05/2016
20/06/2016 Centralised - Variation EMEA/H/C/3985/IB/16
Updated with Decision(2016)7684 of 21/11/2016
14/07/2016 Centralised - Variation EMEA/H/C/3985/II/11/G
Updated with Decision(2016)7684 of 21/11/2016
28/07/2016 Centralised - Variation EMEA/H/C/3985/II/14
Updated with Decision(2016)7684 of 21/11/2016
23/11/2016 Centralised - 2-Monthly update EMEA/H/C/3985/II/12 (2016)7684 of 21/11/2016
21/12/2016 Centralised - Variation EMEA/H/C/3985/IB/28
Updated with Decision(2017)2127 of 24/03/2017
31/01/2017 Centralised - 2-Monthly update EMEA/H/C/3985/II/18 (2017)581 of 27/01/2017
23/02/2017 Centralised - Variation EMEA/H/C/3985/II/23
Updated with Decision(2017)2970 of 28/04/2017
28/03/2017 PSUSA - Modification EMEA/H/C/3985/PSUSA/10379/201607 (2017)2127 of 24/03/2017
30/03/2017 Centralised - Variation EMEA/H/C/3985/II/31/G
Updated with Decision(2017)3946 of 02/06/2017
21/04/2017 Centralised - Variation EMEA/H/C/3985/II/24
Updated with Decision(2017)3946 of 02/06/2017
3/05/2017 Centralised - 2-Monthly update EMEA/H/C/3985/II/17 (2017)2970 of 28/04/2017
16/05/2017 Centralised - Variation EMEA/H/C/3985/IB/35
Updated with Decision(2017)6432 of 18/09/2017
7/06/2017 Centralised - 2-Monthly update EMEA/H/C/3985/II/19 (2017)3946 of 2/06/2017
20/09/2017 PSUSA - Modification EMEA/H/C/PSUSA/10379/201701 (2017)6432 of 18/09/2017
23/10/2017 Centralised - 2-Monthly update EMEA/H/C/3985/II/32 (2017)7167 of 19/10/2017
9/11/2017 Centralised - Variation EMEA/H/C/3985/II/38
Updated with Decision(2018)1958 of 23/03/2018
22/12/2017 Centralised - Variation EMEA/H/C/3985/IB/45G
Updated with Decision(2018)1958 of 23/03/2018
12/01/2018 Centralised - Variation EMEA/H/C/3985/IB/46
Updated with Decision(2018)1958 of 23/03/2018
21/02/2018 Centralised - Variation EMEA/H/C/3985/IB/48
Updated with Decision(2018)2591 of 23/04/2018
27/03/2018 PSUSA - Modification EMEA/H/C/3985/PSUSA/10379/201707 (2018)1958 of 23/03/2018
25/04/2018 Centralised - 2-Monthly update EMEA/H/C/3985/II/36/G (2018)2591 of 23/04/2018
26/04/2018 Centralised - Variation EMEA/H/C/3985/II/47
Updated with Decision(2018)5204 of 30/07/2018
17/05/2018 Centralised - Variation EMEA/H/C/3985/II/51/G
Updated with Decision(2018)5204 of 30/07/2018
1/08/2018 Centralised - 2-Monthly update EMEA/H/C/3985/II/41 (2018)5204 of 30/07/2018
24/09/2018 PSUSA - Modification EMEA/H/C/3985/PSUSA/10379/201801 (2018)6232 of 20/09/2018