Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

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
UsernamePublicRestriction

EMEA on cough drug risks

This article was originally published in The Tan Sheet

Executive Summary

The European Medicines Agency concludes the risks of OTC clobutinol-containing cough medicines are greater than their benefits and on Oct. 18 recommends the European Commission withdraw the products' marketing authorizations. Most of these medicines were marketed in Europe by Boehringer Ingelheim under the brand Silomat, but the firm on Aug. 31 withdrew the product from all its markets after regulators in Germany suspended marketing authorization there. Following Germany's decision, EMEA's Committee for Medicinal Products for Human Use concluded the use of clobutinol is linked to a risk of fainting and disruption of the heart rhythm, especially when taken in higher doses. EMEA says clobutinol-containing cough medicines also are available in Austria, Belgium, the Czech Republic, Finland, France and Greece. The EC has not set a schedule for rendering a decision on the recommendation...

Topics

UsernamePublicRestriction

Register

PS101018

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. 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