Scrip is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

EU Approval Delay for Janssen’s Spravato?

Third-Party Intervention Raises EU Approval Timing Question

Executive Summary

The EMA has received written interventions from third parties relating to its CHMP opinion that the controversial antidepressant should receive EU approval.

You may also be interested in...



J&J’s Spravato Gets EU Okay For Drug-Resistant Depression

Concerns that written interventions might delay the expected EU approval of the novel ketamine-based antidepressant have come to naught.

Axsome Soars After Depression Trial Success

Axsome is set to file for approval in the second half of 2020.

Global Medtech Guidance Tracker: June 2022

Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. More than 40 documents have been posted on the tracker since its last update.

Topics

Related Companies

Latest News
See All
UsernamePublicRestriction

Register

SC141361

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Thank you for submitting your question. We will respond to you within 2 business days. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel