Situation in Austria Imurek-50 mg Film-Coated Tablets are currently temporarily unavailable due to increased demand beyond national borders, and associated capacity constraints at the manufacturer. This information is publicly available on the…

address of the manufacturer(s) of the dosage form***) |_| In the CPP only active substances should be stated |_| In the CPP active substances and excipients should be stated |_| The medicinal product is

Referenced at:

• Certificate for a Pharmaceutical Product (CPP)

Competent Authority the notification of approval by the BMASGKFurther information on harmonization activities for clinical trials with genetically modified organismsInformation der Europäischen can be found [...] stoppage of the trial not envisaged in the approved protocol and where there is an intention to resume activities. A temporary halt can be a substantial amendment (IV.1) or part of an urgent safety measure (IV [...] means a biological medicinal product which has the following characteristics: (a) it contains an active substance which contains or consists of a recombinant nucleic acid used in or administered to human

Referenced at:

• Clinical trials with medicinal products - DIR 2001/20/EC

Competent Authority the notification of approval by the BMASGKFurther information on harmonization activities for clinical trials with genetically modified organismsInformation der Europäischen can be found [...] stoppage of the trial not envisaged in the approved protocol and where there is an intention to resume activities. A temporary halt can be a substantial amendment (IV.1) or part of an urgent safety measure (IV [...] means a biological medicinal product which has the following characteristics: (a) it contains an active substance which contains or consists of a recombinant nucleic acid used in or administered to human

Referenced at:

• Clinical trials with medicinal products - DIR 2001/20/EC

Symptoms associated with Zika virus (ZIKV) infection are generally mild and most people who become infected do not develop any symptoms. However, since the 2015‒2017 epidemic in the Americas, ZIKVhas been recognised asbeingassociated with severe neurological disorders

Referenced at:

• Zika virus transmission worldwide

Zusammenfassung der jährlichen Berichterstattung über ernste unerwünschte Reaktionen und Zwischenfälle bei Blut und Blutbestandteilen (2017) - Bericht nur auf englisch verfügbar

Referenced at:

• Haemovigilance

During the transitional phase, strict limits are already in place for these impurities.

During the transitional phase, strict limits are already in place for these impurities.

The EMA published a revision of the “Guideline on the environmental risk assessment (ERA) of human medicines” on 30 November 2018. The guideline is now open for public consultation until 30 June 2019. The purpose of the ‚Guideline on Environmental…

No acute danger, all packages available in Austria have already been recalled by BASG.