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
Sugammadex New
PSUR-outcome
|
19/12/2024
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.
Hormone Replacement Therapy New
Additional template
|
29/11/2024
Update of the Core SmPC/PL.
Terazosin
PSUR-outcome
|
27/11/2024
Further information and amendments to the product information in all EU languages are available on the EMA website.
Angiotensin II receptor blockers (ARBs) New
PRAC signal recommendation
|
27/11/2024
Risk for intestinal angioedema. Further information and amendments to the product information can be found on the EMA website.
Metamizole New
Referral
|
26/11/2024
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.
Mesalazine New
PSUR-outcome
|
25/11/2024
Further information and amendments to the product information in all EU languages are available on the EMA website.
Zofenopril New
PSUR-outcome
|
25/11/2024
Further information and amendments to the product information in all EU languages are available on the EMA website.
Amiodarone New
PSUR-outcome
|
22/11/2024
Further information and amendments to the product information in all EU languages are available on the EMA website.
Vancomycin-containing medicinal products (parenteral formulations for intravenous use)
Additional template
|
19/11/2024
Further information is available in the CMDh press release (Report from the meeting held on 17-18 September 2024) on the HMA-Website.
Levonorgestrel/Ethinylestradiol, Ethinylestradiol (combination pack) New
PSUR-outcome
|
14/11/2024
Further information and amendments to the product information in all EU languages are available on the EMA website.
