Healixia News - page 13

January 20, 2022

PRAC January 2022 – Review of terlipressin medicines started, update of COVID-19 vaccins and new safety information for Mavenclad

During its January 2022 meeting, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has started a referral of terlipressin medicines. The PRAC also has recommended a change to the product information for Vaxzevria and COVID-19 Vaccine Janssen. The PRAC discussed direct healthcare professional communication (DHPC) containing important safety information for Mavenclad.

Source: FAMHP

January 20, 2022

Manufacturers, importers and distributors of human and veterinary medicines must check their data in the Organisation Management Service database of the EMA

From 28 January 2022, new regulations will come into force for manufacturers, importers and distributors of medicines for human and veterinary use. The FAMHP is asking them to check from 28 January 2022 onwards whether their organisation's data are correctly registered in the Organisation Management Service of the European Medicines Agency (EMA).

Source: FAMHP

January 18, 2022

Give your opinion on a genetically modified medicine for the treatment of Duchenne muscular dystrophy

The FPS Public Health and the FAMHP invite you to participate in the public consultation on a clinical trial of the genetically modified medicine SRP-9001 for the treatment of Duchenne muscular dystrophy. The public consultation runs from 17 January 2022 to 16 February 2022.

Source: FAMHP

January 13, 2022

Give your opinion on a genetically modified medicine for the treatment of various types of advanced cancer

The FPS Public Health and the FAMHP invite you to participate in the public consultation on a clinical trial testing the genetically modified oncolytic virus VSV-GP (BI 1831169), for the treatment of patients with various types of advanced cancer (solid tumours). The public consultation runs from 11 January 2022 to 10 February 2022.

Source: FAMHP

January 11, 2022

COVID-19 webinar update from Brazil: Critical Retrospective of the COVID-19 Pandemic in Brazil (2020-2021)

After the first webinar of its kind in December 2020, SBMF, the IFAPP member association from Brazil will provide a “Critical Retrospective of the COVID-19 Pandemic in Brazil” on 20 January 2022, 12:00-13:30 CET.

December 23, 2021

Limited availability of RoActemra (Roche): new situation update

The availability of RoActemra (tocilizumab), a drug used for certain rheumatological and hematological disorders, can still not be fully guaranteed. Currently, there is a stock for both the intravenous and subcutaneous form of administration, taking into account the previously approved indications, i.e. exclusive use in COVID-19 patients. At present, Roche has only confirmed a limited number of deliveries for early January 2022.

Source: FAMHP

December 22, 2021

Limited availability of subcutaneous immunoglobulins

Due to a decrease in the availability of subcutaneous immunoglobulins around the world, there is also a critical level of limited availability in Belgium. The FAMHP issues several recommendations for hospital and retail pharmacists, medical doctors (specialists), and patients.

Source: FAMHP

December 17, 2021

Coronavirus: monthly update of COVID-19 vaccines 16 December 2021

Coronavirus: maandelijks overzicht bijwerkingen COVID-19-vaccins van 16 december 2021

Coronavirus : aperçu mensuel des effets indésirables des vaccins contre la COVID-19 du 16 decembre 2021

Source: FAMHP

December 16, 2021

Reiteration of the recommendations for the rational use of benzodiazepines and “Z-drugs” in sleep disorders

Volgend op de publicatie van de resultaten van de vijfde COVID-19 gezondheidsbevraging van Sciensano en de FAGG-bevraging over het gebruik van slaapmiddelen, wil het FAGG patiënten en gezondheidszorgbeoefenaars aanmoedigen om benzodiazepines en "Z-drugs" correct te gebruiken bij slaapstoornissen.

Suite à la publication des résultats de la 5ème enquête de santé COVID-19 de Sciensano ainsi que de ceux de l’enquête de l’AFMPS sur l’utilisation des somnifères, l’AFMPS souhaite encourager patients et professionnels de la santé au bon usage des benzodiazépines et « Z-drugs » dans le cadre des troubles du sommeil.

Source: FAMHP

December 16, 2021

Operation Shield II: Belgian authorities seize 87 241 tablets and 99 549 ampoules in action against counterfeit medicines and doping

De douane, de federale politie, het Federaal Agentschap voor Geneesmiddelen en Gezondheidsproducten (FAGG) en het Federaal Agentschap voor de Veiligheid van de Voedselketen (FAVV) hebben deelgenomen aan operatie SHIELD II, gecoördineerd door Europol.

La Douane, la Police fédérale, l’Agence fédérale des médicaments et des produits de santé (AFMPS) et l’Agence fédérale pour la sécurité de la chaîne alimentaire (AFSCA) ont participé à l'opération SHIELD II, coordonnée par Europol.

Source: FAMHP