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Overview of approved compassionate use programmes

The MEB can give permission for bringing a medicinal product on the market that has not (yet) been granted a marketing...

Publication | 10-04-2017

Assessment report Chia seed, applicant Fruity-Line B.V.

A report on the assessment of chia seed by the company Fruity-Line B.V. for substantial equivalence to chia seed, which has...

Report | 13-03-2017

The MEB Regulatory Science Program 2016 and beyond

Leaflet | 31-01-2017

CHCs containing ethinylestradiol: Dutch translation of SmPC and package leaflet

Publication | 25-01-2017

Drug therapy for onchocerciasis - A. Klink

Worldwide roughly 18 million people are infected with Onchocerca volculus, of which 3 to 4 million people have skin disease and...

Publicatie | 20-01-2017

Additional Monitoring of Medicines & Social Media - M. van der Sar

The list of medicines under additional monitoring was published 25 April 2013 by the European Medicines Agency and consist of...

Publicatie | 20-01-2017

Interchangeability of Generic Anti-epileptic Drugs: a Quantitative Analysis - N. Banishki

Authorization of generic products depends on proof of bioequivalence comparing generics with the innovator. Regulations do not...

Publicatie | 20-01-2017

The development of a test battery to study the relationship between older people’s hand-eye function - L. Donkerbroek

Tablet subdivision is an inaccurate practice, due to the often purely aesthetic division lineresulting in potential medication...

Publicatie | 20-01-2017

Conditions of historical-controlled trials for anticancer treatments publication - Y. Yang

The difficulties of assessing historical controlled trials (HCTs) is noticed by regulators, thus investigation is warranted for...

Publicatie | 20-01-2017

On the Predictive Validity of Pre-Clinical Assessment of Dependence Potential - H. Lamberink

Animal studies on self-administration, physical dependence and drug discrimination are well established with high predictive...

Publicatie | 20-01-2017