What's new
Information from the previous month appears monthly in the newsletter “What'sNew” (link to registration page).
For the RSS feed with daily notifications of updates, use the link: RSS feed for “What'sNew”.
Diamorphine New
PSUR-outcome
|
03/10/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
Recall
|
Medicines
|
30/09/2025
Recall due to incorrectly sealed blister packs
Diazoxide New
PRAC signal recommendation
|
30/09/2025
Risk for necrotising enterocolitis neonatal. Further information and amendments to the product information can be found on the EMA website.
Azathioprine New
PSUR-outcome
|
19/09/2025
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.
Hydromorphone New
PSUR-outcome
|
15/09/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
Phosphocreatine New
PSUR-outcome
|
15/09/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
Acetylsalicylic acid / Bisoprolol New
PSUR-outcome
|
12/09/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
Tapentadol New
PSUR-outcome
|
09/09/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
Nicotine (Amendments of the product information for oral and oromucosal formulations) New
PSUR-outcome
|
08/09/2025
Further information and amendments to the product information in all EU languages are available on the EMA website.
Clozapine New
PRAC signal recommendation
|
03/09/2025
New aspect of the known risk of neutropenia/agranulocytosis with potential impact on the risk minimisation measures. Further information and amendments to the product information can be found on the EMA website.