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
Amitriptyline/Perphenazine
PSUR-outcome
|
30/11/2021
Further information and amendments to the product information in all EU languages are available on the EMA website.
Rosuvastatin
Additional template
|
30/11/2021
Further information is available in the CMDh press release (Report from the meeting held on 14-16 Sep 2021) on the HMA-Website.
Labetalol
PRAC signal recommendation
|
23/11/2021
Risk for nipple pain and suppressed lactation. Further information and the changes to the product information in all EU languages are available on the EMA website.
Ertapenem
PRAC signal recommendation
|
23/11/2021
Risk for toxic encephalopathy in patients with renal impairment. Further information and the changes to the product information in all EU languages are available on the EMA website.
Pregabalin
PSUR-outcome
|
16/11/2021
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.
Hydrochlorothiazide
Additional template
|
09/11/2021
Further information is available in the CMDh press release (Report from the meeting held on 14-16 Sep) on the HMA-Website.
Hydrochlorothiazide/Spironolacton
PSUR-outcome
|
09/11/2021
Further information and amendments to the product information in all EU languages are available on the EMA website.
Amitriptyline
PSUR-outcome
|
08/11/2021
Further information and amendments to the product information in all EU languages are available on the EMA website.
Cefoperazone
PSUR-outcome
|
08/11/2021
Further information and amendments to the product information in all EU languages are available on the EMA website.
Allopurinol
PSUR-outcome
|
05/11/2021
Further information and amendments to the product information in all EU languages are available on the EMA website.
