Obligation to submit a variation application following PSUSA procedure
15.04.2024
Agency for Medicinal Products and Medical Devices of Croatia (HALMED) has published information on the outcomes of the PSUSA procedures, which include medicinal products authorised in the Republic of Croatia. Stated information is available in the Medicinal products/ Variation applications - referrals, PSUSA procedures and PRAC signals/ Instructions for variation applications following the outcome of the PSUSA procedure section of the HALMED's website.
The table is updated with the PSUSA outcomes for the following active substances
- doxorubicin hydrochloride liposomal
- rivaroxaban
- vortioxetine
- tadalafil
- etoposide
- abacavir / lamivudine
- pramipexole
- etoposide
- levosalbutamol, salbutamol
- gemcitabine
- paroxetine
- ibuprofen, ibuprofen lysine (not indicated in ductus arteriosus), ibuprofen / caffeine
- gentamicin (systemic use)
- racecadotril
- piroxicam
- clarithromycin
- venlafaxine
- fluconazole
- furosemide-spironolactone
- oxycodone
- emtricitabine / tenofovir disoproxil fumarate
- tacrolimus
- gadoteridol
- gadoxetic acid disodium
- gadobutrol
- moxifloxacin (systemic use)
- gadobenic acid
- ceftriaxone
- gadoteric acid (IV and intravascular formulations)
- mifepristone
- misoprostol (gynaecological indication - termination of pregnancy)
- fentanyl (transmucosal route of administration)
- sunitinib
- mycophenolate mofetil or mycophenolic acid
In accordance with Art. 50 of the Medicinal Products Act (Official Gazette No. 76/13., 90/14. and 100/18.) and Art. 16 of Regulation (EC) No. 726/2004, marketing authorisation holders are required to ensure that information on the medicinal product is in accordance with the latest scientific knowledge. In cases where the outcomes of the PSUSA procedure require a regulatory procedure, such as the introduction of new information in the Summary of Product Characteristics (SmPC) and the Package Leaflet (PL), marketing authorisation holders are required to submit a variation to the marketing authorisation.
The PSUSA procedure number should be stated at the variation application.
