PHV-wordings
Here you will find safety-relevant information that must be implemented in the corresponding product information due to a PHV (pharmacovigilance) 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
Vardenafil
PSUR-outcome
|
10/01/2020
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.
Acetylsalicylic acid
PSUR-outcome
|
13/12/2019
Further information and amendments to the product information in all EU languages can be found on the EMA website.
Fluoroquinolone (systemic use) update
Additional template
|
09/12/2019
Further information is available in the CMDh press release (Report from the meeting held on 15-17 October 2018) on the HMA-Website.
Cabergoline
PSUR-outcome
|
05/12/2019
Further information and amendments to the product information in all EU languages can be found on the EMA website.
Ciprofloxacin (systemic use) update
PSUR-outcome
|
29/11/2019
Further information and amendments to the product information in all EU languages can be found on the EMA website.
Iron sucrose; iron carboxymaltose; iron isomaltoside; iron dextran; sodium ferric gluconate (i.v.)
PRAC signal recommendation
|
28/11/2019
Arteriospasm coronary. Further information and amendments to the product information in all EU languages can be found on the EMA website. (PRAC Meeting 28-31 October 2019).
Levothyroxine
PSUR-outcome
|
28/11/2019
Further information and amendments to the product information in all EU languages can be found on the EMA website.
Dorzolamide
PSUR-outcome
|
27/11/2019
Further information and amendments to the product information in all EU languages can be found on the EMA website.
Fluorouracil (topical application)
PSUR-outcome
|
22/11/2019
Further information and amendments to the product information in all EU languages can be found on the EMA website.
Botulinum-Toxin Typ A – Hämagglutinin-Komplex
PSUR-outcome
|
14/11/2019
Nähere Informationen und die Änderungen der Produktinformation in allen EU Sprachen finden Sie auf der Website der EMA.
