Dabrafenib
Produktdetails
Indikation
Stärken
75mg
Darreichungsform
API
Dossier erwartet für
DCP-Slot
Umsatz
Entwickelt von:
Zusammenfassung
Midas Pharma entwickelt aktuell das 1:1 Generikum zum Originatorprodukt TAFINALR® von Norvatis.
Das Dossier wird in Q4/2026 fertig sein und ein Zulassungsslot ist bereits gebucht. Es wird zur Behandlung von erwachsenen Patienten mit inoperablem oder metastasiertem Melanom mit einer BRAF-V600-Mutation verwendet.
Ihr Kontakt für Fertigarzneimittel
Heike Sagi
Corporate Business Development & Licensing
Vice President
Rheinstraße 49
55218 Ingelheim
Deutschland
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The exploitation, including the development, sale and offer for sale of products and related processes is performed by Midas only in those territories where permissible by applicable patent law in particular, but not limited to EC Directive 2001/83 EC, Article 10, as amended by EC Directive 2004/27 EC. This document, therefore, does not and shall not constitute an offer for sale for the product in territories where an offer for sale or sale is not permissible by law. Midas expressly disclaims any liability for the information provided in this document as well as for damages resulting from or arising out of the use of the product and related process for purposes other than research and development in compliance with applicable laws.
Trametinib
Product details
Indication:
Strengths
2mg
Dosage form
API
Dossier expected
DCP-Slot
Turnover
Summary
Midas Pharma is currently developing the 1:1 generic version of the originator product MEKINIST® from Novartis.
The dossier will be ready in Q3/2026 and submission slot is confirmed. It will be used to treat adult patients with inoperable or metastatic melanoma with a BRAF V600 mutation.
Ihr Kontakt
Heike Sagi
Corporate Business Development & Licensing
Vice President
Rheinstraße 49
55218 Ingelheim
Deutschland
-
The exploitation, including the development, sale and offer for sale of products and related processes is performed by Midas only in those territories where permissible by applicable patent law in particular, but not limited to EC Directive 2001/83 EC, Article 10, as amended by EC Directive 2004/27 EC. This document, therefore, does not and shall not constitute an offer for sale for the product in territories where an offer for sale or sale is not permissible by law. Midas expressly disclaims any liability for the information provided in this document as well as for damages resulting from or arising out of the use of the product and related process for purposes other than research and development in compliance with applicable laws.