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Reporting quality defects in medicinal products via the FAMHP website

Quality defects in medicinal products can impact patients’ health or make it difficult for healthcare professionals to administer them. Quality defects can be reported via the FAMHP website.

Diabetes medicines with metformin: traces or nitrosamine contamination detected

The European Medicines Agency (EMA) and the competent medicine authorities of the European member states, including the FAMHP, have been notified that in a small number of diabetes medicines based on metformin outside of the European Union, a nitrosamine contamination (NDMA, N-nitrosodimethylamine) has been detected. Currently, analyses are being performed on the medicines within the European Union.

Simplified composition of preparations for treating coughs and colds from 1 January 2020

As of 1 January 2020, medicines with only one active ingredient can be sold for treating coughs and colds.

Watch out for identity theft for the illegal obtention of drug precursors

The FAMHP was confronted with a case of identity theft whereby company details where abused for the illegal obtention of drug precursors.

Ranitidine: recall of medicines

A nitrosamine impurity (NDMA, N-nitrosodimethylamine) has been detected in medicines based on ranitidine. The European Medicines Agency (EMA) has started a review. As a precautionary measure, the companies involved are recalling the medicine or placing the medicines in quarantine.

Information on the Falsified Medicines Directive available in the online medicines database

The Falsified Medicines Directive (FMD), sets forth a number of measures to prevent the introduction of falsified medicines on the market. Thus, all packages of medicines that fall under this regulation must have a unique code and an anti-tampering device (ATD). On packages that do not fall under this obligation, marketing authorization holders can voluntarily attach an ATD. This information is now available in the online medicines database.

Recall of batches of COCUNE brand mitt-type body wipes

The FAMHP would like to inform consumers and patients of a recall by Stöpler Medical B.V. concerning COCUNE brand mitt-type body wipes. This is a repeat of a safety alert previously issued by the FAMHP that may have escaped the attention of some consumers and patients.

EU and US reach milestone in mutual recognition of medicines manufacturers inspections

The U.S. Food and Drug Administration (U.S. FDA) has recognized all 28 EU member states. This means that starting 11 July 2019, the United States (US) and the European Union (EU) have fully implemented the mutual recognition agreement (MRA) for inspections of manufacturing sites for certain human medicines in their respective territories.

PRAC May 2019 – Start of referral: Xeljanz (tofacitinib)

During its meeting of May 2019, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has started a referral for Xeljanz (tofacitinib). PRAC has issued restrictions in use of Xeljanz while EMA reviews risk of blood clots in lungs.

Safety signal following early results from an ongoing study with Xeljanz (tofacitinib) in patients with rheumatoid arthritis – Increased risk of blood clots in lungs and death with higher dose of Xeljanz (tofacitinib) for rheumatoid arthritis

EMA is advising healthcare professionals and patients not to exceed the recommended dose of Xeljanz (tofacitinib) when treating rheumatoid arthritis. The advice follows early results from an ongoing study (study A3921133) in patients with rheumatoid arthritis which showed an increased risk of blood clots in the lungs and death when the normal dose of 5 mg twice daily was doubled.

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