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
iron (parenteral preparations, except for iron dextran)
PSUR-outcome
|
24/09/2020
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.
Pancuronium
PSUR-outcome
|
24/09/2020
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.
Lenograstim
PSUR-outcome
|
14/08/2020
Further information and amendments to the product information in all EU languages are available on the EMA website.
Sumatriptan
PSUR-outcome
|
14/08/2020
Further information and amendments to the product information in all EU languages are available on the EMA website.
Leuproreline
Referral
|
11/08/2020
Further information and amendments to the product information in all EU languages can be found on the EMA website.
Lisdexamfetamine
PRAC signal recommendation
|
07/08/2020
Risk for QT-prolongation and cardiac arrhythmia. Further information and the changes to the product information in all EU languages can be found on the EMA website.
Morphine/Cyclizine
Additional template
|
07/08/2020
Further information is available in CMDh press release (Report from the meeting held on 26-27 May 2020) at HMA-Website.
Opium
PSUR-outcome
|
07/08/2020
Further information and amendments to the product information in all EU languages are available on the EMA website.
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
|
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.