PHV-wordings
Here you will find safety-relevant information that must be implemented in the corresponding product information due to a PHV issues.
Due to the relaunch of the EMA website in December 2023, you will find the current links to the entries prior to December 01, 2023 at https://www.ema.europa.eu
Buprenorphine; Buprenorphine, Naloxone
PRAC signal recommendation
|
01/07/2020
Drug-drug interaction with serotonergic drugs leading to serotonin syndrome. Further information and amendments to the product information in all EU languages can be found on the EMA website.
Sotalol
PSUR-outcome
|
25/06/2020
Further information and amendments to the product information in all EU languages can be found on the EMA website.
Fosfomycin
Referral
|
18/06/2020
Amiodarone
Additional template
|
09/06/2020
Further information is available in the CMDh press release (Report from the meeting held on 28-30 January 2020) on the HMA-Website.
Insulin
PRAC signal recommendation
|
09/06/2020
Risiko für kutane Amyloidose. Nähere informationen und die Änderungen der Produktinformationen in allen EU Sprachen finden Sie auf der Website der EMA.
Busulfan
PSUR-outcome
|
08/06/2020
Further information and the changes to the product information in all EU languages can be found on the EMA website.
Ibuprofen, ketoprofen and fixed-dose combinations for systemic use
PRAC signal recommendation
|
05/06/2020
Risk for serious exacerbation of infections. Further information and amendments to the product information in all EU languages can be found on the EMA website.
Ropinirol
PSUR-outcome
|
20/05/2020
Further information and amendments to the product information in all EU languages can be found on the EMA website.
Brivudine
PSUR-outcome
|
19/05/2020
Further information and amendments to the product information in all EU languages can be found on the EMA website.
Aripiprazole
PSUR-outcome
|
19/05/2020
Further information can be found in the Commission Decision and its annexes, which are available in all EU languages on the European Commission's (EC) website.
