Publications, both in English and in Dutch, by the Netherlands Pharmacovigilance Centre Lareb

Signals as submitted to Lareb to the Dutch Medicines Evaluation Board. Some of the articles are in Dutch only.

#	Title	Year	Download
1	M-M-RVAXPRO® and crying	2016

To ensure a correct interpretation of the results, the data shown may only be used for publications or other media after consulting Lareb. Please read the disclaimer.

The reports shown on this website were received directly by the Netherlands Pharmacovigilance Centre Lareb. If you enter a brand name or generic name, all reports of products will be shown that contain the corresponding active substance. The selection that is shown is based on the ATC classification system of the World Health Organization.

The fact that a possible side effect of a drug or vaccine is reported, does not imply that the reported symptoms are actually caused by the drug or vaccine. Since the aim of a voluntary reporting centre is to detect new adverse drug reactions, we ask healthcare professionals and consumers to report suspicions of ADRs, even if the causal relationship has not been proven.

One single report may refer to multiple ADRs For this reason, the number of reports may be higher than the number of reports shown in the overview.

The number of reports shown does not necessarily reflect the actual change for an ADR to occur. It is therefore not possible to calculate an incidence rate of these ADRs based on these data.

MAZELEN MET BOF EN RUBELLA, LEVEND VERZWAKT

Overview of reported side effects

VigiBase® data

This data is sourced from VigiBase, the World Health Organization’s (the “WHO”) global database for suspected adverse drug reactions “ADRs”, maintained by Uppsala Monitoring Centre (“UMC”). UMC is the WHO Collaborating Centre for International Drug Monitoring based in Uppsala, Sweden providing scientific leadership and operative support to the WHO Program for International Drug Monitoring (www.who-umc.org).

The data contains reports of suspected ADRs, so called Individual Case Safety Reports (ICSRs), collected by national drug authorities in over 120 countries and span over more than 100 000 different medicinal products. Thus, this database is only a repository of ICSRs provided for VigiBase, and shall not be considered as a systematic register of ADRs that have occurred or may occur.

The volume of ICSRs for a particular medicinal product may be influenced by many different factors, including but not limited to the extent of use of the product, publicity and the nature of the reactions. No information is provided on the number of patients exposed to a particular product, and it is therefore, based on the ICSRs, not possible to calculate frequency of any ADR. Moreover, collection of data is, due to e.g. differing national legislation and policies, heterogeneous between different countries. For these reasons, any interpretation of ADR data, and particularly those based on comparisons between various medicinal products, may be misleading.

Information on a suspected ADR should not be interpreted as meaning that the medicinal product in question, or the active substance(s), generally causes the observed effect or is unsafe to use. Any robust conclusion with regard to benefits and risks of a specific medicinal product always requires detailed evaluation and scientific assessment of all available data. The balance between benefit and risk of a specific medicinal product also varies between individual patients.

If you think that you may be experiencing a side-effect from a medicinal product, please seek advice from a health professional as soon as possible. Never stop or change the dose for prescription medicines without consulting your physician.

About the release of this data:
UMC takes great care to ensure that the data contained herein is an accurate record of data collected by the national drug authorities and transmitted to UMC. UMC does, however, not guarantee, warrant or make any representation whatsoever regarding the data contained herein, including but not limited to guarantees, warranties or representations of accuracy, reliability, completeness, currency, suitability, fitness or usefulness for any particular purpose or with respect to non-infringement of any third-party rights. In no event shall UMC be liable for any loss, damage, cost or other expense whatsoever (whether direct, indirect, punitive, incidental, special or consequential) arising out of or in any way connected with the use of or reference to any data contained herein. In no event shall UMC be liable other than i) under Swedish substantive law and ii) subject to the courts of Sweden with the district court of Uppsala as first instance.

MAZELEN MET BOF EN RUBELLA, LEVEND VERZWAKT

Overview of reported side effects