Oncological products Kohne Pharma January 2015 * = Dossier in German language; MA = Marketing authorisation ** = Subject to commission; AT = Austria, DE = Germany, NL = The Netherlands, PL = Poland API 5-Fluorouracil* 5-Fluorouracil* 5-Fluorouracil* 5-Fluorouracil* Strength 250 500 1.000 5.000 mg mg mg mg Dosage form Status of product Solution Solution Solution Solution MA MA MA MA for for for for injection injection injection injection 2008 2008 2008 2008 in in in in DE DE DE DE Azacitidine 100 mg Powder for injection Development project Bicalutamide Bicalutamide 50 mg 150 mg Tablets Tablets MRP MA 2009 in DE MRP MA 2009 in DE Bortezomib Bortezomib 1 mg 3,5 mg Powder for injection Powder for injection Development project Development project Solution Solution Solution Solution Solution Solution Solution Dossier Dossier Dossier Dossier Dossier Dossier Dossier Calciumfolinate* Calciumfolinate* Calciumfolinate* Calciumfolinate* Calciumfolinate* Calciumfolinate* Calciumfolinate* 50 100 200 400 500 800 1.000 mg mg mg mg mg mg mg for for for for for for for injection injection injection injection injection injection injection 500 mg Powder for infusion Development project Doxorubicin Doxorubicin Doxorubicin Doxorubicin Doxorubicin 10 20 50 150 200 mg mg mg mg mg Solution Solution Solution Solution Solution for for for for for injection injection injection injection injection MA MA MA MA MA 2006 2006 2006 2006 2006 in in in in in NL NL NL NL NL Epirubicin** Epirubicin** Epirubicin** Epirubicin** Epirubicin** 10 20 50 100 200 mg mg mg mg mg Solution Solution Solution Solution Solution for for for for for injection injection injection injection injection MA MA MA MA MA 2002 2002 2002 2002 2002 in in in in in DE DE DE DE DE Kohne Pharma GmbH a ProductLife Group company Schallbruch 1 42781 Haan/Germany 25 mg Film-coated tablets Date of submission Time Slot RMS MRP/ DCP possible No No No No 2016-12 EUDossier/ Format No/CTD No/CTD No/CTD No/CTD Yes/CTD Yes/CTD Yes/CTD 1Q/2016 1Q/2016 Yes/CTD Yes/CTD No/CTD No/CTD No/CTD No/CTD No/CTD No/CTD No/CTD Dexrazoxane Erlotinib Dossier ready for submission Development project 4Q/2015 Yes/CTD Yes Yes Yes Yes Yes Yes/CTD Yes/CTD Yes/CTD Yes/CTD Yes/CTD Yes/CTD Yes/CTD Yes/CTD Yes/CTD Yes/CTD 1Q/2016 Fon: +49 (0) 2129 53 01 55 Fax: +49 (0) 2129 53 01 0 E-mail: [email protected] www.kohne-pharma.de Yes/CTD Oncology 1/2 Oncological products Kohne Pharma January 2015 * = Dossier in German language; MA = Marketing authorisation ** = Subject to commission; AT = Austria, DE = Germany, NL = The Netherlands, PL = Poland API Erlotinib Erlotinib 100 mg 150 mg Film-coated tablets Film-coated tablets Development project Development project Dossier ready for submission 1Q/2016 1Q/2016 Everolimus Everolimus Everolimus Everolimus 2,5 5 7,5 10 Film-coated Film-coated Film-coated Film-coated Development Development Development Development 2Q/2015 2Q/2015 2Q/2015 2Q/2015 Oxaliplatin** Oxaliplatin** 50 mg 100 mg Lyophilisat Lyophilisat MA 2011 in DE MA 2011 in DE Yes/CTD Yes/CTD Paclitaxel** Paclitaxel** Paclitaxel** 30 mg 100 mg 300 mg Solution for injection Solution for injection Solution for injection MA 2009 in DE MA 2009 in DE MA 2009 in DE Yes/CTD Yes/CTD Yes/CTD Palonosetron 250 mcg Solution for injection Development project 2Q/2015 Yes/CTD Film-coated tablets Development project 1Q/2016 Yes/CTD Capsules Capsules Capsules Capsules Development Development Development Development 1Q/2016 1Q/2016 1Q/2016 1Q/2016 Yes/CTD Yes/CTD Yes/CTD Yes/CTD Concentrate for infusion Solution for infusion DCP-MAs 2012 in DE, PL Development project 4Q/2014 Yes/CTD Yes/CTD Sorafenib Sunitinib Sunitinib Sunitinib Sunitinib Zoledronic acid Zoledronic acid Kohne Pharma GmbH a ProductLife Group company Schallbruch 1 42781 Haan/Germany Strength mg mg mg mg 200 mg 12,5 25 37,5 50 mg mg mg mg 4 mg/5 ml 4 mg/100 ml Dosage form Status of product tablets tablets tablets tablets project project project project project project project project Fon: +49 (0) 2129 53 01 55 Fax: +49 (0) 2129 53 01 0 E-mail: [email protected] www.kohne-pharma.de Date of submission Time Slot RMS MRP/ DCP possible EUDossier/ Format Yes/CTD Yes/CTD Yes/CTD Yes/CTD Yes/CTD Yes/CTD Oncology 2/2
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