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
Fluoroquinolone (systemic use) update
Additional template
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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
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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
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14/11/2019
Nähere Informationen und die Änderungen der Produktinformation in allen EU Sprachen finden Sie auf der Website der EMA.
Lithium
PRAC signal recommendation
|
05/11/2019
Risiko für Arzneimittelinduzierte lichenoide Hautreaktion.
Nähere Informationen und die Neufassung des Wortlauts der Produktinformationen in allen EU Sprachen finden Sie auf der Website der EMA (PRAC Meeting 2. bis 5. September 2019).
Testosteron (topische Anwendung)
PSUR-outcome
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31/10/2019
Nähere Informationen und die Änderungen der Produktinformation in allen EU Sprachen finden Sie auf der Website der EMA.
