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
Sertraline
PRAC signal recommendation
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06/07/2020
Risk for Microscopic colitis. Further information and the changes to the product information in all EU languages can be found on the EMA website.
Mirtazapine
PRAC signal recommendation
|
06/07/2020
Risk for amnesia and drug effects with eosinophilia and systemic symptoms (DRESS). Further information and the changes to the product information in all EU languages can be found on the EMA website.
Hormone replacement therapy (HRT)
PRAC signal recommendation
|
03/07/2020
The following updates of the CMDh Core summary of product characteristics (SmPC) and Package Leaflet (PL) for post-menopausal HRT products have been endorsed by the PRAC.
Hydrocortisone
PSUR-outcome
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02/07/2020
Further information and amendments to the product information in all EU languages can be found on the EMA website.
Serotonergic medicinal products
PRAC signal recommendation
|
01/07/2020
The MAHs of serotonergic medicinal products ( (ATC Codes N06AA, N06AB, N06AF, N06AG, N06AX) should ensure that the possible interaction with buprenorphine/opioids is reflected in their product information.
Buprenorphine; Buprenorphine, Naloxone
PRAC signal recommendation
|
01/07/2020
Drug-drug interaction with serotonergic drugs leading to serotonin syndrome. Further information and amendments to the product information in all EU languages can be found on the EMA website.
Sotalol
PSUR-outcome
|
25/06/2020
Further information and amendments to the product information in all EU languages can be found on the EMA website.
Fosfomycin
Referral
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18/06/2020
Amiodarone
Additional template
|
09/06/2020
Further information is available in the CMDh press release (Report from the meeting held on 28-30 January 2020) on the HMA-Website.
Insulin
PRAC signal recommendation
|
09/06/2020
Risiko für kutane Amyloidose. Nähere informationen und die Änderungen der Produktinformationen in allen EU Sprachen finden Sie auf der Website der EMA.
