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
Metronidazole (except for external use on the skin)
Additional template
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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
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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
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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
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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
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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
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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
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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.
Ciclosporin (systemic use)
PSUR-outcome
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20/10/2022
Further information and amendments to the product information in all EU languages are available on the EMA website.
