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
Buprenorphine (all formulations except implants)
PSUR-outcome
|
31/07/2024
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.
Teriflunomide
PSUR-outcome
|
31/07/2024
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.
Leflunomide
PSUR-outcome
|
29/07/2024
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.
Levofloxacin (i.v. and oral use)
PSUR-outcome
|
23/07/2024
Further information and amendments to the product information can be found on the EMA website.
Hydroxyprogesterone
Referral
|
17/07/2024
Further information can be found on the EMA website.
Duloxetine
PSUR-outcome
|
17/07/2024
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.
Zoledronic acid
PSUR-outcome
|
17/07/2024
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.
Baclofen (oral, for muscle spasticity indication)
PSUR-outcome
|
17/07/2024
Further information and amendments to the product information can be found on the EMA website.
Acitretin
PSUR-outcome
|
17/07/2024
Further information and amendments to the product information can be found on the EMA website.
Diclofenac (topical formulations)
PSUR-outcome
|
17/07/2024
Further information and amendments to the product information can be found on the EMA website.
