"Valsartan/HCT ratiopharm 80 mg/12.5 mg Film-Coated Tablets" and "Valsartan/HCT ratiopharm 160 mg/25 mg Film-Coated Tablets" (active ingredient: valsartan) have been approved for the treatment of hypertension since August 16, 2013. In the course of…

Recall of certain lots of "Valsartan/HCT ratiopharm 80 mg/12.5 mg Film-Coated Tablets" and "Valsartan/HCT ratiopharm 160 mg/25 mg Film-Coated Tablets" containing valsartan active ingredient manufactured by "Mylan Laboratory Limited".

The spread of the Zika virus epidemic in the Americas is likely to continue as the competent vectors Aedes aegypti and Aedes albopictus mosquitoes are widely distributed there. There is also a significant increase in the number of babies born with microcephaly in the north-eastern states of Brazil, however, the magnitude and geographical spread of the increase have not yet been well characterised.

Referenced at:

• Zika virus disease epidemic: potential association with microcephaly and Guillain-Barré syndrome (first update)

are responsible for weighing the benefits of a given vaccine (i.e., its potential to prevent a disease) against its risks (i.e., its potential side effects). A marketing authorisation is granted only if [...] which both a children’s and an adult version are available are the TBE vaccines FSME-Immun® and Encepur®, the hepatitis A vaccine Havrix®, the hepatitis B vaccine Engerix®, the hepatitis A + B combination [...] pregnancy and breast-feeding? 15. Which side effects may occur after vaccination? 16. Does aluminium contained in vaccines pose a risk? 1. Frequently asked questions about vaccinations - Federal Ministry of

Zusammenfassung der jährlichen Berichterstattung über ernste unerwünschte Reaktionen und Zwischenfälle bei Blut und Blutbestandteilen (2019) - Bericht nur auf englisch verfügbar

Referenced at:

• Haemovigilance

Questions and answers about the stolen vials of Herceptin and other affected products

which consists of 6 dots. Each letter, number, or punctuation mark is represented by a specific pattern of dots. Braille is a writing system read by using the fingers’ tactile sense. Therefore, to enable reading [...] be included in the labelling of the outer packaging of a proprietary medicinal product. In justified exceptional cases, when only one strength of a given proprietary medicinal product is authorised, it [...] request of the BASG, a specimen of the outer packaging. The responsibility for checking the legibility of the texts presented in Braille rests with the MAH. Applicants who wish to invoke a derogation have to

Questions and answers about the stolen vials of Herceptin and other affected products

Assessment of the Advisory Board on Classification regarding Lipid Control Pflanzlicher Fettbinder (German only)

Referenced at:

• Decisions of the AGBR

Reaktionen Reaktion BioNTech/Pfizer Moderna AstraZeneca Jannsen Fieber 1.936 397 10.079 16 Kopfweh 2.161 360 9.433 16 Schmerzen an der Impfstelle 1.577 434 6.244 8 Müdigkeit 1.643 305 5.104 9 Gelenkschmerzen [...] Nebenwirkungen Alter in Jahren Anzahl Personen unbekannt 521 über 75 753 65-75 756 45-64 7.968 18-44 14.043 16-17 32 Geschlechterverteilung Abbildung 2. Geschlechterverteilung der Personen mit vermuteten Nebenwirkungen [...] Geschlechterverteilung der Personen mit vermuteten Nebenwirkungen Geschlecht Anzahl Personen Weiblich 16.678 Männlich 7.313 unbekannt 82 Bericht über Meldungen vermuteter Nebenwirkungen nach Impfungen zum

Referenced at:

• Reports COVID-19 Vaccination