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
Mesalazin
PSUR-outcome
|
11/01/2021
Further information and amendments to the product information in all EU languages are available on the EMA website.
Fluconazole
PSUR-outcome
|
11/01/2021
Further information and amendments to the product information in all EU languages are available on the EMA website.
Galantamine
PSUR-outcome
|
11/01/2021
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.
Verapamil
PSUR-outcome
|
04/01/2021
Further information and amendments to the product information in all EU languages are available on the EMA website.
Kalium-4-Aminobenzoat
PSUR-outcome
|
21/12/2020
Further information and amendments to the product information in all EU languages are available on the EMA website.
Vancomycine
PSUR-outcome
|
21/12/2020
Further information and amendments to the product information in all EU languages are available on the EMA website.
Bupropion
Additional template
|
10/12/2020
Further information is available in the CMDh press release (Report from the meeting held on 13-14 Oct 20) on the HMA-Website
Ibuprofen, Ibuprofen-Lysin (not indicated in Ductus arteriosus), Ibuprofen/Coffein
PSUR-outcome
|
10/12/2020
Further information and amendments to the product information in all EU languages are available on the EMA website.
Verapamil
PSUR-outcome
|
10/12/2020
Further information and amendments to the product information in all EU languages are available on the EMA website.
Vancomycin
PSUR-outcome
|
10/12/2020
Further information and amendments to the product information in all EU languages are available on the EMA website