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
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.
Macrogol for bowel preparaion for colonoscopy
PRAC signal recommendation
|
06/08/2020
Risk for ischaemic colitis. Further information and the changes to the product information in all EU languages are available on the EMA 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.
