Safety Information

Description Publish Date LINKS
Important safety information on vaccines in Ukraine
10/10/2018

Important safety information on Seretide in Ukraine
10/10/2018

Important safety information on Dolutegravir in Ukraine
10/10/2018

Important safety information on Belimumab in Ukraine 02/04/2019
Important safety information on Abacavir: Hypersensitivity reaction - educational slide deck 15/02/2024
Important safety information on Volibris in Ukraine (Information for Healthcare Professionals) 14/07/2023
Important safety information on Volibris in Ukraine (Patient booklet) 14/07/2023
Important safety information on Volibris in Ukraine (Memo for female patients taking Volibris) 14/07/2023
Important safety information on Volibris in Ukraine (Information for male partners of women taking Volibris) 14/07/2023
Reminder information for patients taking Volibris (Reminder card) 14/07/2023
Important safety information on Cephalosporins in Ukraine (Safety Notification_Cephalosporins and risk of seizure) 01/03/2023

Important safety information on Cephalosporins in Ukraine (Safety Notification_Cephalosporins and risk of neurotoxicity)

07/03/2023

Important safety information on Amoxicillin / Amoxicillin and clavulanic acid containing products in Ukraine

09/09/2023
Important safety information on Lamotrigine containing products in Ukraine 09/09/2023
Important safety information on Paroxetine containing products in Ukraine 27-10-2023
Important safety information on Cefuroxime sodium containing products in Ukraine 30-10-2023
Important safety information on Dolutegravir containing products in Ukraine (Safety Notification_Korean label update for Dolutegravir containing products) 31-10-2023
Important safety information on Topical Corticosteroids containing products in Ukraine 20-11-2023
Important safety information on Hepatitis B surface antigen recombinant vaccine in Ukraine (Initial Safety Notification Engerix-B and Myelitis_November 2023) 20-11-2023
Important safety information on Hepatitis B surface antigen recombinant vaccine in Ukraine (Updated Safety Notification Engerix-B and Myelitis_December 2023) 27-12-2023

Important safety information on Amoxicillin/clavulanic acid containing products - MedSafe communication regarding labelling updates

18/12/2023

Important safety information on Zanamivir containing products - Precautions for prescribing and administering flu medications (zanamivir)

22/12/2023

Important safety information on Paroxetine containing products - Modifications of the information of medicines authorized by national procedure that contain Paroxetine

22/12/2023

Important safety information on Acyclovir containing products - Safety Notification EMA-PRAC: The MAH has been requested to provide cumulative reviews of the below-mentioned issues in the next PBRER to be submitted for acyclovir

02/01/2024

Important safety information on Dolutegravir containing products - Dolutegravir and sexual dysfunction

11/01/2024

Important safety information on Hepatitis B surface antigen recombinant vaccine (Updated Safety Notification Engerix-B and Myelitis_January 2024_1st upd)

08/01/2024

Important safety information on Hepatitis B surface antigen recombinant vaccine (Updated Safety Notification Engerix-B and Myelitis_January 2024_2nd upd)

26/01/2024

Important safety information on Lamotrigine containing products - Safety Signal received from Swissmedic: Lamictal - Interaction with hormone replacement therapies (HRT)

18/03/2024

Important safety information on Lamotrigine containing products - El Salvador safety alert-LAMICTAL 5 mg, LAMICTAL 25 mg, LAMICTAL 50 MG, LAMICTAL 100 MG

18/03/2024

Important safety information on Valaciclovir containing products - Adaptation of the medicinal product information for Valaciclovir containing products

18/03/2024

Important safety information on Umeclidinium bromide/vilanterol trifenatate containing products - Minutes from French HA (ANSM) meeting / signal for umeclidinium bromide/vilanterol trifenatate (ANORO)

20/03/2024

Important safety information on Lamotrigine containing products - Safety Signal received from Swissmedic: Lamictal - Interaction with hormone replacement therapies (HRT), updated information, April 2024

05/04/2024

Important safety information on Amoxicillin/clavulanic acid containing products - Drug-induced gastroenteritis syndrome

10/04/2024

Important safety information on Mepolizumab containing products - PBRER final assessment report (fAR) for EU PBRER 24 March 2023 to 23 September 2023

15/04/2024

Important safety information on Acyclovir containing products - ACYCLOVIR/VALACYCLOVIR – RISK OF DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS (DRESS)

17/04/2024

Important safety information on Paroxetine containing products - Modifications of the information of medicines authorized by national procedure that contain: PAROXETINE, updated information, April 2024

19/04/2024

Important safety information on Hepatitis B surface antigen recombinant vaccine - Updated Safety Notification Engerix-B and Myelitis_May 2024

07/05/2024

emo for female patients taking Volibris