Pink Sheet 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

PPI in EMEA’s centralized switch

This article was originally published in The Tan Sheet

Executive Summary

The European Medicines Agency's Committee for Medicinal Products for Human Use recommends selling the proton pump inhibitor Pantozol Control (pantoprazole 20 mg) OTC, according to a Feb. 19 release. The Nycomed GmbH product is the first PPI recommended for OTC status across Europe and is the second product recommended for OTC sale through Europe's centralized switch process. The first centrally switched nonprescription product in Europe is GlaxoSmithKline's weight-loss drug alli (1"The Tan Sheet" Oct. 27, 2008, p. 3)

You may also be interested in...



Nycomed Prepares To Launch First Nonprescription PPI With EU-Wide Approval

Nycomed is gearing up to launchPantozol Control (pantoprazole 20 mg) later this year when the firm expects an approval for European Union nonprescription marketing authorization

Alli Pioneers EU Centralized Process For Nonprescription Switch

The European Medicines Agency's clearance of GlaxoSmithKline's weight-loss drug alli for nonprescription status across the European Union marks the first success for a centralized Rx-to-OTC switch process

Color Additive Risk Evaluation Tool Qualified As New Medical Device Development Tool

A color additive evaluation tool for polymeric medical devices was approved as an MDDT under the FDA’s voluntary program.

Topics

Latest News
See All
UsernamePublicRestriction

Register

PS102644

Ask The Analyst

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

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