Pharmaceuticals - Union Register

  

Union Register of medicinal products for human use


AUTHORISED  

Product information

Invented name: KEYTRUDA   
Auth. number : EU/1/15/1024
Active substance : pembrolizumab
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: L01XC18 - pembrolizumab
(See WHO ATC Index)
Indication: KEYTRUDA as monotherapy is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults.
KEYTRUDA as monotherapy is indicated for the adjuvant treatment of adults with Stage III melanoma and lymph node involvement who have undergone complete resection (see section 5.1).
KEYTRUDA as monotherapy is indicated for the first-line treatment of metastatic non-small cell lung carcinoma (NSCLC) in adults whose tumours express PD-L1 with a ≥ 50% tumour proportion score (TPS) with no EGFR or ALK positive tumour mutations.
KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of metastatic non-squamous NSCLC in adults whose tumours have no EGFR or ALK positive mutations.
KEYTRUDA, in combination with carboplatin and either paclitaxel or nab-paclitaxel, is indicated for the first-line treatment of metastatic squamous NSCLC in adults.
KEYTRUDA as monotherapy is indicated for the treatment of locally advanced or metastatic NSCLC in adults whose tumours express PD-L1 with a ≥ 1% TPS and who have received at least one prior chemotherapy regimen. Patients with EGFR or ALK positive tumour mutations should also have received targeted therapy before receiving KEYTRUDA.
KEYTRUDA as monotherapy is indicated for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL) who have failed autologous stem cell transplant (ASCT) and brentuximab vedotin (BV), or who are transplant-ineligible and have failed BV.
KEYTRUDA as monotherapy is indicated for the treatment of locally advanced or metastatic urothelial carcinoma in adults who have received prior platinum-containing chemotherapy (see section 5.1).
KEYTRUDA as monotherapy is indicated for the treatment of locally advanced or metastatic urothelial carcinoma in adults who are not eligible for cisplatin-containing chemotherapy and whose tumours express PD L1 with a combined positive score (CPS) ≥ 10 (see section 5.1).
KEYTRUDA as monotherapy is indicated for the treatment of recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) in adults whose tumours express PD-L1 with a ≥ 50% TPS and progressing on or after platinum-containing chemotherapy (see section 5.1).
Marketing Authorisation Holder: Merck Sharp & Dohme B.V.
Waarderweg 39, 2031 BN Haarlem, Nederland
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 Union Register.

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
21/07/2015 Centralised - Authorisation EMEA/H/C/3820 (2015)5144 of 17/07/2015
3/02/2016 Centralised - Variation EMEA/H/C/3820/IB/5
Updated with Decision(2016)5075 of 29/07/2016
1/04/2016 Centralised - Variation EMEA/H/C/3820/II/2
Updated with Decision(2016)5075 of 29/07/2016
2/08/2016 Centralised - 2-Monthly update EMEA/H/C/3820/II/7 (2016)5075 of 29/07/2016
22/08/2016 Centralised - Variation EMEA/H/C/3820/X/1/G (2016)5441 of 18/08/2016
31/01/2017 Centralised - Variation EMEA/H/C/3820/II/11 (2017)574 of 27/01/2017
2/02/2017 Centralised - Variation EMEA/H/C/3820/II/13
Updated with Decision(2017)3058 of 02/05/2017
20/04/2017 Centralised - Variation EMEA/H/C/3820/IB/24/G
Updated with Decision(2017)4304 of 16/06/2017
21/04/2017 Centralised - Variation EMEA/H/C/3820/II/18/G
Updated with Decision(2017)4304 of 16/06/2017
4/05/2017 Centralised - 2-Monthly update EMEA/H/C/3820/II/14 (2017)3058 of 2/05/2017
12/06/2017 Centralised - Variation EMEA/H/C/3820/IB/33
Updated with Decision(2017)5943 of 24/08/2017
19/06/2017 Centralised - Variation EMEA/H/C/3820/IA/34
Updated with Decision(2017)5943 of 24/08/2017
20/06/2017 PSUSA - Modification EMEA/H/C/3820/PSUSA/10403/201609 (2017)4304 of 16/06/2017
27/06/2017 Centralised - 2-Monthly update EMEA/H/C/3820/II/25 (2017)4467 of 23/06/2017
20/07/2017 Centralised - Variation EMEA/H/C/3820/II/28
Updated with Decision(2017)5943 of 24/08/2017
29/08/2017 Centralised - 2-Monthly update EMEA/H/C/3820/II/23/G (2017)5943 of 24/08/2017
13/12/2017 PSUSA - Modification EMEA/H/C/3820/PSUSA/10403/201703 (2017)8615 of 8/12/2017
27/03/2018 Centralised - 2-Monthly update EMEA/H/C/3820/II/37/G (2018)1949 of 23/03/2018
15/05/2018 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/3820/T/45 (2018)3003 of 8/05/2018
25/06/2018 PSUSA - Modification EMEA/H/C/3820/PSUSA/10403/201709 (2018)4015 of 21/06/2018
28/06/2018 Centralised - Variation EMEA/H/C/3820/II/44
Updated with Decision(2018)5376 of 02/08/2018
10/07/2018 Centralised - 2-Monthly update EMEA/H/C/3820/II/52 (2018)4464 of 6/07/2018
6/08/2018 Centralised - 2-Monthly update EMEA/H/C/3820/II/48 (2018)5376 of 2/08/2018
8/08/2018 Centralised - Variation EMEA/H/C/3820/IB/55
Updated with Decision(2018)8907 of 12/12/2018
6/09/2018 Centralised - 2-Monthly update EMEA/H/C/3820/II/43, EMEA/H/C/3820/II42 (2018)5902 of 4/09/2018
4/10/2018 Centralised - Variation EMEA/H/C/3820/II/58
Updated with Decision(2018)8907 of 12/12/2018
8/11/2018 Centralised - Variation EMEA/H/C/3820/II/54
Updated with Decision(2019)2054 of 11/03/2019
14/12/2018 Centralised - 2-Monthly update EMEA/H/C/3820/II/47 (2018)8907 of 12/12/2018
15/01/2019 PSUSA - Modification EMEA/H/C/PSUSA/10403/201803 (2019)190 of 11/01/2019
13/03/2019 Centralised - 2-Monthly update EMEA/H/C/003820/II/0060 (2019)2054 of 11/03/2019