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
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Methylphenidate
PSUR-outcome
|
07/08/2020
Further information and amendments to the product information in all EU languages are available on the EMA website.
Midazolam (oromucosal solution, treatment of prolonged, acute, convulsive seizures)
PSUR-outcome
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06/08/2020
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.
Levosimendan
PSUR-outcome
|
06/08/2020
Further information and amendments to the product information in all EU languages are available on the EMA website.
Budesonide/Formoterol
PSUR-outcome
|
06/08/2020
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.
Carbidopa/Levodopa
PSUR-outcome
|
04/08/2020
Further information and amendments to the product information in all EU languages are available on the EMA website.
Artemether/Lumefantrine
PSUR-outcome
|
04/08/2020
Further information and amendments to the product information in all EU languages are available on the EMA website.
Methotrexate
PSUR-outcome
|
04/08/2020
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.
Hydrocortisone
PSUR-outcome
|
02/07/2020
Further information and amendments to the product information in all EU languages can be found on the EMA website.
Sotalol
PSUR-outcome
|
25/06/2020
Further information and amendments to the product information in all EU languages can be found on the EMA website.
Busulfan
PSUR-outcome
|
08/06/2020
Further information and the changes to the product information in all EU languages can be found on the EMA website.