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
Cyproterone
Referral
|
19/05/2020
For further information and changes to the product information please visit the EMA website.
Pseudoephedrine
Additional template
|
08/04/2020
Further information is available in the CMDh press release (Report from the meeting held on 25-27 February 2020) on the HMA-Website.
Ibuprofen/Pseudoephedrine
PSUR-outcome
|
08/04/2020
Further information and amendments to the product information in all EU languages can be found on the EMA website.
Pitavastatin
PSUR-outcome
|
08/04/2020
Further information and amendments to the product information in all EU languages can be found on the EMA website.
Thiazide, thiazide-like diuretics and combinations
PRAC signal recommendation
|
07/04/2020
Choroidal effusion. Further information and amendments to the product information in all EU languages can be found on the EMA website.
Paroxetine
PRAC signal recommendation
|
07/04/2020
Microscopic colitis. Further information and amendments to the product information in all EU languages can be found on the EMA website.
Pholcodine
PSUR-outcome
|
06/04/2020
Further information and amendments to the product information in all EU languages can be found on the EMA website.
Iobitridol
PSUR-outcome
|
06/04/2020
Further information and amendments to the product information in all EU languages can be found on the EMA website.
Estradiol-containing (0.01% w/w) medicinal products for topical use
Referral
|
24/03/2020
Further information and amendments to the product information can be found on the EMA website.
Methadone
PSUR-outcome
|
24/03/2020
Further information and amendments to the product information in all EU languages can be found on the EMA website.
