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
Hormone Replacement Therapy New
Additional template
|
29/11/2024
Update of the Core SmPC/PL.
Terazosin New
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.
Liothyronine New
PSUR-outcome
|
13/11/2024
Further information and amendments to the product information in all EU languages are available on the EMA website.
