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
Amfepramone
Referral
|
19/01/2023
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.
Amoxicillin / Clavulanate
PSUR-outcome
|
17/01/2023
Further information and amendments to the product information in all EU languages are available on the EMA website.
Combined medicinal products containing amoxicillin
Additional template
|
17/01/2023
Further information is available in the CMDh press release (Report from the meeting held on 8-10 November 2022) on the HMA-Website.
Methotrexate; Probenecid
Additional template
|
13/01/2023
Further information is available in the CMDh press release (Report from the meeting held on 8-10 November 2022) on the HMA-Website.
Amoxicillin
PSUR-outcome
|
13/01/2023
Further information and amendments to the product information in all EU languages are available on the EMA website.
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.
