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
Tacrolimus (systemic formulations)
PSUR-outcome
|
25/02/2022
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.
Mycophenolate mofetil or Mycophenolic acid
PSUR-outcome
|
24/02/2022
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.
Ulipristalacetate
PSUR-outcome
|
24/02/2022
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.
Azithromycin
PSUR-outcome
|
22/02/2022
Further information and amendments to the product information in all EU languages are available on the EMA website.
Pregabalin
PRAC signal recommendation
|
22/02/2022
Risk for Toxic epidermal necrolysis. Further information and the changes to the product information in all EU languages are available on the EMA website.
Nadroparin
PSUR-outcome
|
17/02/2022
Further information and amendments to the product information in all EU languages are available on the EMA website.
Hydrochlorothiazide/Quinapril
PSUR-outcome
|
11/02/2022
Further information and amendments to the product information in all EU languages are available on the EMA website.
Quinapril
PSUR-outcome
|
11/02/2022
Further information and amendments to the product information in all EU languages are available on the EMA website.
Efavirenz
Additional template
|
11/02/2022
Further information is available in the CMDh press release (Report from the meeting held on 14-16 December 2021) on the HMA-Website.
Latanoprost
Additional template
|
11/02/2022
Further information is available in the CMDh press release (Report from the meeting held on 14-16 December 2021) on the HMA-Website.
