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 (HRT)
PRAC signal recommendation
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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
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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
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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.
Busulfan
PSUR-outcome
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08/06/2020
Further information and the changes to the product information in all EU languages can be found on the EMA website.
Ibuprofen, ketoprofen and fixed-dose combinations for systemic use
PRAC signal recommendation
|
05/06/2020
Risk for serious exacerbation of infections. Further information and amendments to the product information in all EU languages can be found on the EMA website.