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SMC ID Date Medicine Submission Type Indication
SMC2812 09/06/2025 pegylated liposomal irinotecan (Onivyde) Non submission

In combination with oxaliplatin, 5-fluorouracil (5-FU) and leucovorin (LV) for the first-line treatment of adult patients with metastatic adenocarcinoma of the pancreas
SMC2435 08/11/2021 olaparib (Lynparza) Non submission

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.
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.
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.
698/11 09/05/2011 sunitinib (Sutent) Full Treatment of unresectable or metastatic, well-differentiated pancreatic neuroendocrine tumours with disease progression in adults.

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