PHV-wordings
Here you will find safety-relevant information that must be implemented in the corresponding product information due to a PHV (pharmacovigilance) 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
Tapentadol
PSUR-outcome
|
09/09/2022
Further information and amendments to the product information in all EU languages are available on the EMA website.
NSAID-containing medicinal products (for systemic use)
Additional template
|
09/09/2022
Further information is available in the CMDh press release (Report from the meeting held on 13-14 September 2022 and Report from the meeting held on 19-20 July 2022) on the HMA-Website.
NSAIDs Ibuprofen (for systemic use)
Additional template
|
26/08/2022
Further information is available in the CMDh press release (Report from the meeting held on 19-20 July 2022) on the HMA-Website.
Dexketoprofen
PSUR-outcome
|
16/08/2022
Further information and amendments to the product information in all EU languages are available on the EMA website.
Soybean phospholipids (oral use)
PSUR-outcome
|
16/08/2022
Further information and amendments to the product information in all EU languages are available on the EMA website.
Diclofenac systemisch
PSUR-outcome
|
11/08/2022
Further information and amendments to the product information in all EU languages are available on the EMA website.
Teicoplanin
PSUR-outcome
|
08/08/2022
Further information and amendments to the product information in all EU languages are available on the EMA website.
Methylphenidate
PSUR-outcome
|
08/08/2022
Further information and amendments to the product information in all EU languages are available on the EMA website.
Rabeprazole
PSUR-outcome
|
08/08/2022
Further information and amendments to the product information in all EU languages are available on the EMA website.
Alfentanil
PSUR-outcome
|
05/07/2022
Further information and amendments to the product information in all EU languages are available on the EMA website.
