Malta - English - Medicines Authority

mylan ireland limited unit 35/36, grange parade, baldoyle industrial estate, dublin 13, ireland - irinotecan hydrochloride, trihydrate - concentrate for solution for infusion - irinotecan hydrochloride trihydrate 20 mg/ml - antineoplastic agents

Australia - English - Department of Health (Therapeutic Goods Administration)

sanofi-aventis australia pty ltd - cemiplimab, quantity: 350 mg - injection, intravenous infusion - excipient ingredients: sucrose; histidine; histidine hydrochloride monohydrate; water for injections; proline; polysorbate 80 - cutaneous squamous cell carcinoma,libtayo as monotherapy is indicated for the treatment of adult patients with metastatic or locally advanced cutaneous squamous cell carcinoma (mcscc or lacscc) who are not candidates for curative surgery or curative radiation. non-small cell lung cancer,libtayo as monotherapy is indicated for the first-line treatment of adult patients with non-small cell lung cancer (nsclc) expressing pd-l1 tumour proportion score (tps) greater than and equal to 50% as determined by a validated test, with no egfr, alk or ros1 aberrations, who have:,? locally advanced nsclc and who are not candidates for surgical resection or definitive chemoradiation, or ? metastatic nsclc.,libtayo in combination with platinum-based chemotherapy is indicated for the first-line treatment of patients with nsclc whose tumours have no egfr, alk or ros1 aberrations and is:,? locally advanced where patients are not candidates for surgical resection or definitive chemoradiation, or,? metastatic. basal cell carcinoma,libtayo as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic basal cell carcinoma (bcc) previously treated with a hedgehog pathway inhibitor or for whom a hedgehog pathway inhibitor is not appropriate.

Ireland - English - HPRA (Health Products Regulatory Authority)

actavis group ptc ehf - docetaxel - concentrate for solution for infusion - 20 milligram(s)/millilitre - taxanes; docetaxel

Malta - English - Medicines Authority

pfizer hellas s.a. 243 messoghion ave., neo psychiko 15451, athens, greece - irinotecan - concentrate for solution for infusion - irinotecan 20 mg/ml - antineoplastic agents

Malta - English - Medicines Authority

pfizer hellas s.a. 243 messoghion ave., neo psychiko 15451, athens, greece - irinotecan - concentrate for solution for infusion - irinotecan 20 mg/ml - antineoplastic agents

Malta - English - Medicines Authority

pfizer hellas s.a. 243 messoghion ave., neo psychiko 15451, athens, greece - irinotecan - concentrate for solution for infusion - irinotecan 20 mg/ml - antineoplastic agents

Ireland - English - HPRA (Health Products Regulatory Authority)

pfizer healthcare ireland - irinotecan hydrochloride trihydrate - concentrate for solution for infusion - 20 milligram(s)/millilitre - other antineoplastic agents; irinotecan

Malta - English - Medicines Authority

accord healthcare ireland ltd euro house, euro business park, little island cork, t45 k857, ireland - mitoxantrone - concentrate for solution for infusion - mitoxantrone 2 mg/ml - antineoplastic agents

Malta - English - Medicines Authority

accord healthcare ireland ltd euro house, euro business park, little island cork, t45 k857, ireland - mitoxantrone - concentrate for solution for infusion - mitoxantrone 2 mg/ml - antineoplastic agents

Malta - English - Medicines Authority

accord healthcare ireland ltd euro house, euro business park, little island cork, t45 k857, ireland - mitoxantrone - concentrate for solution for infusion - mitoxantrone 2 mg/ml - antineoplastic agents