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
Hydroxycarbamide New
PSUR-outcome
|
30/08/2024
Further information and amendments to the product information can be found on the EMA website.
Posaconazole New
PSUR-outcome
|
23/08/2024
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.
Atorvastatin New
PSUR-outcome
|
19/08/2024
Further information and amendments to the product information can be found on the EMA website.
Minoxidil (topical formulation) New
PSUR-outcome
|
14/08/2024
Further information and amendments to the product information can be found on the EMA website.
Clevidipine New
PSUR-outcome
|
14/08/2024
Further information and amendments to the product information can be found on the EMA website.
Nimodipine New
PSUR-outcome
|
14/08/2024
Further information and amendments to the product information can be found on the EMA website.
Ceftazidime New
PSUR-outcome
|
14/08/2024
Further information and amendments to the product information can be found on the EMA website.
Buprenorphine/Naloxone New
PSUR-outcome
|
06/08/2024
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.
Levofloxacin (i.v. and oral use) New
PSUR-outcome
|
23/07/2024
Further information and amendments to the product information can be found on the EMA website.
Baclofen (oral, for muscle spasticity indication) New
PSUR-outcome
|
17/07/2024
Further information and amendments to the product information can be found on the EMA website.