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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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/Spironolacton
PSUR-outcome
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09/11/2021
Further information and amendments to the product information in all EU languages are available on the EMA website.
Amitriptyline
PSUR-outcome
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08/11/2021
Further information and amendments to the product information in all EU languages are available on the EMA website.
Cefoperazone
PSUR-outcome
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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.
Betamethasone
PSUR-outcome
|
05/11/2021
Further information and amendments to the product information in all EU languages are available on the EMA website.
Carbamazepine
PSUR-outcome
|
05/11/2021
Further information and amendments to the product information in all EU languages are available on the EMA website.
5-Fluorouracil
PSUR-outcome
|
05/11/2021
Further information and amendments to the product information in all EU languages are available on the EMA website.
Amiodaron
PSUR-outcome
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29/10/2021
Further information and amendments to the product information in all EU languages are available on the EMA website.
Ethanol extracts of: Iberis amara L., planta tota recens / Angelica archangelica L., radix / Matricaria recutita L., flos / Carum carvi L., fructus / Silybum marianum (L.) Gaertn., fructus / Melissa officinalis L., folium / Mentha piperita
PSUR-outcome
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22/10/2021
Further information and amendments to the product information in all EU languages are available on the EMA website.
