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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Ethinylestradiol / Levonorgestrel
PSUR-outcome
|
30/01/2020
Further information and amendments to the product information in all EU languages can be found on the EMA website.
Dexmedetomidine
PSUR-outcome
|
24/01/2020
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.
Botulinum neurotoxin type a (150 kD) free from complexing proteins
PSUR-outcome
|
24/01/2020
Further information and amendments to the product information in all EU languages can be found on the EMA website.
Isotretinoin (oral formulations)
PSUR-outcome
|
24/01/2020
Further information and amendments to the product information in all EU languages can be found on the EMA website.
Tenofovirdisoproxil
PSUR-outcome
|
17/01/2020
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.
Lisdexamfetamine
PSUR-outcome
|
16/01/2020
Further information and amendments to the product information in all EU languages can be found on the EMA website.
Erythromycin
PSUR-outcome
|
15/01/2020
Further information and amendments to the product information in all EU languages can be found on the EMA website.
Ezetimibe/Simvastatin
PSUR-outcome
|
15/01/2020
Further information and amendments to the product information in all EU languages can be found on the EMA website.
Vardenafil
PSUR-outcome
|
10/01/2020
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.
Acetylsalicylic acid
PSUR-outcome
|
13/12/2019
Further information and amendments to the product information in all EU languages can be found on the EMA website.
