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
Dorzolamide
PSUR-outcome
|
22/11/2022
Further information and amendments to the product information in all EU languages are available on the EMA website.
Metronidazole (except for external use on the skin)
Additional template
|
11/11/2022
Metronidazole-containing medicinal products (either as mono-component or in combination) approved only for H. pylori eradication. Further information is available in the CMDh press release (Report from the meeting held on 11-13 October 2022) on the…
Nomegestrol or Chlormadinone
Referral
|
10/11/2022
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.
Dexlansoprazole, Lansoprazole
PSUR-outcome
|
10/11/2022
Further information and amendments to the product information in all EU languages are available on the EMA website.
Dexketoprofen / Tramadol
PSUR-outcome
|
28/10/2022
Further information and amendments to the product information in all EU languages are available on the EMA website.
Bupropion
PSUR-outcome
|
28/10/2022
Further information and amendments to the product information in all EU languages are available on the EMA website.
Botulinumtoxin Typ A
PSUR-outcome
|
28/10/2022
Further information and amendments to the product information in all EU languages are available on the EMA website.
Valaciclovir
PSUR-outcome
|
28/10/2022
Further information and amendments to the product information in all EU languages are available on the EMA website.
Terbutaline
PSUR-outcome
|
28/10/2022
Further information and amendments to the product information in all EU languages are available on the EMA website.
Codeine/Ibuprofen
PRAC signal recommendation
|
25/10/2022
Risk for renal tubular acidosis and hypokalaemia. Further information and the changes to the product information in all EU languages are available on the EMA website.
