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
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Lactulose
PSUR-outcome
|
24/03/2022
Further information and amendments to the product information in all EU languages are available on the EMA website.
Pholcodine
PSUR-outcome
|
22/03/2022
Further information and amendments to the product information in all EU languages are available on the EMA website.
Loperamide, Loperamide/Simeticone
PSUR-outcome
|
22/03/2022
Further information and amendments to the product information in all EU languages are available on the EMA website.
Levonorgestrel (all indications except emergency contraception)
PSUR-outcome
|
22/03/2022
Further information and amendments to the product information in all EU languages are available on the EMA website.
Remifentanil
PSUR-outcome
|
18/03/2022
Further information and amendments to the product information in all EU languages are available on the EMA website.
Paracetamol (IV formulation)
PSUR-outcome
|
18/03/2022
Further information and amendments to the product information in all EU languages are available on the EMA website.
Tacrolimus (systemic formulations)
PSUR-outcome
|
25/02/2022
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.
Mycophenolate mofetil or Mycophenolic acid
PSUR-outcome
|
24/02/2022
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.
Ulipristalacetate
PSUR-outcome
|
24/02/2022
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.
Azithromycin
PSUR-outcome
|
22/02/2022
Further information and amendments to the product information in all EU languages are available on the EMA website.
