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
Baclofen (oral, for muscle spasticity indication)
PSUR-outcome
|
17/07/2024
Further information and amendments to the product information can be found on the EMA website.
Acitretin
PSUR-outcome
|
17/07/2024
Further information and amendments to the product information can be found on the EMA website.
Diclofenac (topical formulations)
PSUR-outcome
|
17/07/2024
Further information and amendments to the product information can be found on the EMA website.
Adapalene/Benzoyl Peroxide
PSUR-outcome
|
17/07/2024
Further information and amendments to the product information can be found on the EMA website.
Mercaptopurine
PSUR-outcome
|
25/06/2024
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.
Naproxen
PSUR-outcome
|
14/06/2024
Further information and amendments to the product information can be found on the EMA website.
Leuprorelin
PSUR-outcome
|
14/06/2024
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.
Lithium
PSUR-outcome
|
14/06/2024
Further information and amendments to the product information can be found on the EMA website.
Vincristine
PSUR-outcome
|
12/06/2024
Further information and amendments to the product information can be found on the EMA website.
Manidipine
PRAC signal recommendation
|
11/06/2024
Risk for Ascites. Further information and the changes to the product information in all EU languages are available on the EMA website.
