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
Fentanyl (transmucosal)
Additional template
|
11/02/2022
Further information is available in the CMDh press release (Report from the meeting held on 14-16 December 2021) on the HMA-Website.
Chlororquine
Additional template
|
08/02/2022
Further information is available in the CMDh press release (Report from the meeting held on 14-16 December 2021) on the HMA-Website.
Promestriene (cream and vaginal capsules)
PSUR-outcome
|
08/02/2022
Further information and amendments to the product information in all EU languages are available on the EMA website.
Latanoprost (except for products with paediatric indication)
PSUR-outcome
|
04/02/2022
Further information and amendments to the product information in all EU languages are available on the EMA website.
Fentanyl (transdermal patches, solution for injection)
PSUR-outcome
|
04/02/2022
Further information and amendments to the product information in all EU languages are available on the EMA website.
Oxycodone
PSUR-outcome
|
03/02/2022
Further information and amendments to the product information in all EU languages are available on the EMA website.
Hydroxychloroquine
PSUR-outcome
|
03/02/2022
Further information and amendments to the product information in all EU languages are available on the EMA website.
Isotretinoin (oral formulations)
PSUR-outcome
|
03/02/2022
Further information and amendments to the product information in all EU languages are available on the EMA website.
Praziquantel
PSUR-outcome
|
03/02/2022
Further information and amendments to the product information in all EU languages are available on the EMA website.
Chloroquine
PSUR-outcome
|
03/02/2022
Further information and amendments to the product information in all EU languages are available on the EMA website.
