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
Erythromycin (systemic use)
PSUR-outcome
|
12/01/2023
Further information and amendments to the product information in all EU languages are available on the EMA website.
Fexofenadine
PSUR-outcome
|
09/01/2023
Further information and amendments to the product information in all EU languages are available on the EMA website.
Oxycodone
PSUR-outcome
|
22/12/2022
Further information and amendments to the product information in all EU languages are available on the EMA website.
Iohexol
PSUFU
|
15/12/2022
Further information is available on the HMA-Website.
Terlipressin
Referral
|
13/12/2022
Further information and amendments to the product information can be found on the EMA website.
Marketing authorisations of medicinal products for human use for which clinical part of bioequivalence studies were performed at Synchron Research Services
Referral
|
06/12/2022
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.
Levothyroxine
Additional template
|
02/12/2022
Further information is available in the CMDh press release (Report from the meeting held on 11-13 October 2022) on the HMA-Website.
Levothyroxine
PSUR-outcome
|
02/12/2022
Further information and amendments to the product information in all EU languages are available on the EMA website.
Mesterolone
PSUR-outcome
|
01/12/2022
Further information and amendments to the product information in all EU languages are available on the EMA website.
Gabapentin
PSUR-outcome
|
01/12/2022
Further information and amendments to the product information in all EU languages are available on the EMA website.
