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
Ibuprofen, Ibuprofen-Lysine (not indicated in Ductus arteriosus) and Ibuprofen/Caffeine
PSUR-outcome
|
01/12/2023
Further information and amendments to the product information in all EU languages are available on the EMA website.
Beta-alanine
PSUR-outcome
|
01/12/2023
Further information and amendments to the product information in all EU languages are available on the EMA website.
Levosalbutamol, Salbutamol
PSUR-outcome
|
01/12/2023
Further information and amendments to the product information in all EU languages are available on the EMA website.
Etoposide
PSUR-outcome
|
01/12/2023
Further information and amendments to the product information in all EU languages are available on the EMA website.
Lomustine
PSUR-outcome
|
01/12/2023
Further information and amendments to the product information in all EU languages are available on the EMA website.
Valproate
Additional template
|
01/12/2023
Further information and amendments to the product information in all EU languages are available on the EMA website.
Topiramate
Referral
|
10/11/2023
Further information and amendments to the product information can be found on the EMA website.
Acebutolol
PSUR-outcome
|
10/11/2023
Further information and amendments to the product information in all EU languages are available on the EMA website.
Gemcitabine
PSUR-outcome
|
27/10/2023
Further information and amendments to the product information in all EU languages are available on the EMA website.
Paroxetine
PSUR-outcome
|
23/10/2023
Further information and amendments to the product information in all EU languages are available on the EMA website.
