|
SMC2880
|
13/07/2026
|
durvalumab (Imfinzi)
|
Full
|
IMFINZI in combination with gemcitabine and cisplatin as neoadjuvant treatment, followed by IMFINZI as monotherapy adjuvant treatment after radical cystectomy, is indicated for the treatment of adults with resectable muscle invasive bladder cancer (MIBC).
|
|
|
SMC2846
|
13/07/2026
|
glofitamab (Columvi)
|
Full
|
In combination with gemcitabine and oxaliplatin is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma not otherwise specified (DLBCL NOS) who are ineligible for autologous stem cell transplant (ASCT).
|
|
|
SMC2726
|
07/10/2024
|
nivolumab (Opdivo)
|
Non submission
|
In combination with cisplatin and gemcitabine for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma.
|
|
|
SMC2683
|
10/06/2024
|
pembrolizumab (Keytruda)
|
Non submission
|
In combination with gemcitabine and cisplatin for the first-line treatment of locally advanced unresectable or metastatic biliary tract carcinoma in adults.
|
|
|
SMC2582
|
13/11/2023
|
durvalumab (Imfinzi)
|
Full
|
In combination with gemcitabine and cisplatin for the first-line treatment of adults with locally advanced, unresectable, or metastatic biliary tract cancer (BTC).
|
|
|
1217/17
|
13/03/2017
|
liposomal irinotecan (Onivyde)
|
Full
|
Treatment of metastatic adenocarcinoma of the pancreas, in combination with fluorouracil (5-FU) and leucovorin (folinic acid), in adult patients who have progressed following gemcitabine based therapy.
|
|
|
1184/16
|
08/08/2016
|
necitumumab (Portrazza)
|
Non submission
|
In combination with gemcitabine and cisplatin chemotherapy for the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor (EGFR) expressing squamous non-small cell lung cancer who have not received prior chemotherapy for this condition.
|
|
|
968/14
|
09/02/2015
|
paclitaxel albumin (Abraxane)
|
Resubmission
|
In combination with gemcitabine for the first-line treatment of adult patients with metastatic adenocarcinoma of the pancreas.
|
|
|
853/13
|
11/03/2013
|
bevacizumab (Avastin)
|
Full
|
Bevacizumab, in combination with carboplatin and gemcitabine, is indicated for treatment of adult patients with first recurrence of platinum-sensitive epithelian ovarian, fallopian tube or primary peritoneal cancer who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor–targeted agents.
|
|
|
642/10
|
11/10/2010
|
pemetrexed (Alimta)
|
Full
|
Non-small cell lung cancer
|
|
|
382/07
|
09/07/2007
|
Erlotinib (Tarceva)
|
Non submission
|
metastatic pancreatic cancer
|
|
|
154/05
|
11/12/2006
|
gemcitabine 200mg and 1g powder for solution for infusion (Gemzar)
|
Resubmission
|
Metastatic breast cancer who have relapsed following adjuvant/neoadjuvant chemotherapy
|
|
|
154/05
|
07/03/2005
|
Gemcitabine/paclitaxel (Gemzar®)
|
Full
|
In combination with paclitaxel for the treatment of metastatic breast cancer
|
|
