Dipharma gains European approval of generic Zavesca
Swiss generic drugmaker Dipharma today announced that the European Commission has granted Marketing Authorization of its generic miglustat.
This authorization comes after the European Medicines Agency’s the Committee for Medicinal Products for Human Use (CHMP) positive opinion last December in the frame of a centralized procedure. Miglustat Dipharma 100mg capsules has thus received authorization for all the 31 countries of the European Economic Area.
Miglustat Dipharma is a generic equivalent to Johnson & Johnson (NYSE: JNJ) company Actelion’s Zavesca (miglustat), and it can be stored at room temperature for 36 months. Dipharma owns IP rights on the miglustat active substance, notably in the USA and Europe.
This article is accessible to registered users, to continue reading please register for free. A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.
Login to your accountTry before you buy
Free
7 day trial access
- All the news that moves the needle in pharma and biotech
- Exclusive features, podcasts, interviews, data analyses and commentary from our global network of life sciences reporters.
- Receive The Pharma Letter daily news bulletin, free forever.
Become a subscriber
£820
Or £77 per month
- Unfettered access to industry-leading news, commentary and analysis in pharma and biotech.
- Updates from clinical trials, conferences, M&A, licensing, financing, regulation, patents & legal, executive appointments, commercial strategy and financial results.
- Daily roundup of key events in pharma and biotech.
- Monthly in-depth briefings on Boardroom appointments and M&A news.
- Choose from a cost-effective annual package or a flexible monthly subscription
The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed
Chairman, Sanofi Aventis UK
Today's issue
Company Spotlight
More Features in Generics
Copyright © The Pharma Letter 2024 | Headless Content Management with Blaze