Medicinal Products

Instructions for Variation Applications Following the Outcome of the PSUSA Procedure

When the outcome of the PSUSA procedure leads to a variation of marketing authorisations, marketing authorisation holders (MAHs) for medicinal products containing the active substance covered by the procedure, should submit a variation to align the information of the medicinal product with the outcome of the PSUSA assessment, even if their product was not in the direct scope of the procedure (generic medicine or a medicine authorised on the basis of well established use), conforming with Article 50 of the Medicinal Products Act (Official Gazette 76/13, 90/14 and 100/18) and article 16 of regulation (EC) No. 726/2004.

  • PSUSA CAPs and PSUSA CAPs / NAPs

The outcomes of the PSUSA procedures for active substances found only in centrally authorised medicines (PSUSA CAPs), as well as the outcomes of the PSUSA procedures covering nationally authorised medicinal products where centrally authorised products were also involved (PSUSA CAPs/NAPs), are published by the European Commission (EC).

For nationally authorised medicinal products included in the PSUSA CAPs / NAPs procedure, MAHs should submit a variation application to the national competent authority, within 10 days after the Commission Decision in accordance with "Guidelines on the details of the various categories of variations, on the operation of the procedures laid down in Chapters II, IIa, III and IV of Commission Regulation (EC) No 1234/2008 of 24 November 2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products and on the documentation to be submitted pursuant to those procedures", available here.

For generic medicines and other medicines which are not in direct scope of the PSUSA procedure itself, MAHs should submit a variation application to the national competent authority within 60 days after the Commission Decision.

  • PSUSA NAPs

For PSUSA procedures which involve only nationally authorised medicinal products (PSUSA NAPs), a deadline for submitting a variation application is specified in the document "CMDh Scientific conclusions and grounds for the variation, amendments to the Product Information and timetable for the implementation" in section "Annex III. Timetable for the implementation of this position” which is published in all EU languages on the EMA website, i.e. here.

The outcomes of PSUSA procedures, related to medicinal products authorised in Croatia, are available in the table below.

For more information on how to submit a variation application, please refer to the information published on the HMA and CMDh websites available under the following links:

More information about PSUR and PSUSA procedure is available on the HALMED website, i.e. here (in Croatian).

PSUSA procedure outcomes that require variation application

The table below provides information on PSUSA procedure outcomes that require variation application and relates to medicinal products authorised in Croatia. The outcome of the PSUSA procedure is available in English, as well as a translation in Croatian (the drop down menu Available languages). The table contains the outcomes of PSUSA procedures completed after 1/1/2020. The outcomes of the previously completed PSUSA procedures are available on the EMA or EC website, as described in the text which can be accessed here (in Croatian).

The variation should be classified as follows:

• Type IAIN C.I.3.a - implementing the agreed wording in Croatian language in the product information does not require additional adjustments to the latest approved version
• Type IB C.I.3.z - the last approved version of the product information needs to be adapted to the agreed wording which is being implemented
• Type II - implementation of the agreed wording, with the submission of additional data that needs to be evaluated.

PSUSA Procedure Number Date of outcome Active substance(s) Link at PSUSA outcome (EMA or EC) Additional information
EMEA/H/C/PSUSA/00001255/202111 19.09.2022. erlotinib EK
PSUSA/00000679/202111 05.09.2022. klormadinonacetat/etinilestradiol EMA
PSUSA/00002849/202111 05.09.2022. tapentadol EMA
PSUSA/00001048/202109 08.08.2022. diklofenak (sistemske formulacije) EMA
PSUSA/00002024/202110 05.08.2022. metilfenidat EMA
PSUSA/00002878/202111 05.08.2022. teikoplanin EMA
PSUSA/00000997/202110 01.08.2022. deksketoprofen EMA
PSUSA/00002601/202110 01.08.2022. rabeprazol EMA
EMEA/H/C/PSUSA/00001702/202106 25.07.2022. ibandronatna kiselina EK
EMEA/H/C/PSUSA/00000432/202108 24.06.2022. brinzolamid EK
EMEA/H/C/PSUSA/00010029/202110 14.06.2022. dapagliflozin EK
EMEA/H/C/PSUSA/00001816/202108 14.06.2022. lakozamid EK
PSUSA/00010440/202108 09.06.2022. estradiol EMA
PSUSA/00002235/202108 02.06.2022. okskarbazepin EMA
PSUSA/00010242/202108 31.05.2022. modafinil EMA
EMEA/H/N/PSR/S/0035 30.05.2022. deksketoprofen i tramadol EMA
EMEA/H/C/PSUSA/00000962/202107 30.05.2022. desloratadin EK
EMEA/H/C/PSUSA/00000476/202106 30.05.2022. kabazitaksel EK
PSUSA/00010434/202107 16.05.2022. amlodipin/rosuvastatin, perindopril/amlodipin/rosuvastatin EMA
PSUSA/00010877/202107 11.05.2022. leuprorelin (depo formulacije) EMA
EMEA/H/C/PSUSA/00001725/202105 22.03.2022. imatinib EK
PSUSA/00001821/202105 14.03.2022. laktuloza EMA
PSUSA/00002396/202105 14.03.2022. folkodin EMA
PSUSA/00010665/202105 14.03.2022. loperamid i loperamid/simetikon EMA
PSUSA/00010828/202105 11.03.2022. levonorgestrel (sve indikacije osim hitne kontracepcije) EMA
PSUSA/00002617/202105 08.03.2022. remifentanil EMA
EMEA/H/C/PSUSA/00001267/202104 04.03.2022. eslikarbazepinacetat EK
PSUSA/00002311/202105 04.03.2022. paracetamol (formulacija za intravensku primjenu) EMA CMDh PR 01/2022
EMEA/H/C/PSUSA/00000226/202105 16.02.2022. apiksaban EK
PSUSA/00002104/202103 16.02.2022. nadroparin EMA
EMEA/H/C/PSUSA/00010550/202105 16.02.2022. mofetilmikofenolat, mikofenolatna kiselina EK
EMEA/H/C/PSUSA/00002839/202103 21.02.2022. takrolimus EK
PSUSA/00001370/202104 31.1.2022. fentanil EMA
PSUSA/00001693/202104 31.1.2022. hidroksiklorokin EMA
PSUSA/00001832/202104 30.1.2022. latanoprost (osim lijekova odobrenih za pedijatrijsku indikaciju) EMA
PSUSA/00002254/202104 30.1.2022. oksikodon EMA
PSUSA/00010488/202105 30.1.2022. izotretinoin EMA
PSUSA/00001151/202103 3.1.2022. dobutamin EMA
PSUSA/00002780/202103 26.12.2021. spironolakton EMA
PSUSA/00002217/202102 26.12.2021. ondanzetron EMA
PSUSA/00001997/202103 26.12.2021. metamizol EMA
EMEA/H/C/PSUSA/00010833/202104 20.12.2021. enoksaparin EK
EMEA/H/C/PSUSA/00000413/202103 20.12.2021. bimatoprost EK
EMEA/H/C/PSUSA/3127/202102 20.12.2021. vorikonazol EK
EMEA/H/C/PSUSA/00000998/202103 17.12.2021. deksmedetomidin EK
EMEA/H/C/PSUSA/00000918/202103 09.12.2021. dabigatran EK
EMEA/H/C/PSUSA/00002435/202102 09.12.2021. pirfenidon EK
PSUSA/00000973/202101 30.11.2021. deksametazon EMA
PSUSA/00003090/202101 29.11.2021. valproat EMA
PSUSA/00003175/202103 26.11.2021. lantan EMA
EMEA/H/C/PSUSA/00002948/202012 15.11.2021. tikagrelor EK
EMEA/H/C/PSUSA/00002511/202101 12.11.2021. pregabalin EK
PSUSA/00001662/202101 3.11.2021. hidroklorotiazid/spironolakton EMA CMDh PR 09/2021
PSUSA/00010374/202101 3.11.2021. amitriptilin EMA CMDh PR 09/2021
PSUSA/00000391/202101 29.10.2021. betametazon EMA
PSUSA/00000095/202012 29.10.2021. alopurinol EMA
PSUSA/00000539/202012 27.10.2021. karbamazepin EMA
PSUSA/00000007/202012 27.10.2021. fluorouracil (za intravenoznu primjenu) EMA
EMEA/H/N/PSR/J/0026 26.10.2021. željezo (za intravenoznu primjenu) EMA
PSUSA/00000166/202012 26.10.2021. amiodaron EMA
PSUSA-00010800-202011 22.9.2021. etanolni ekstrakt iz.. (Iberogast oralne kapi, tekućina) EMA
EMEA/H/C/PSUSA/00001838/202012 16.9.2021. lenalidomid EK
PSUSA/00001731/202011 6.9.2021. indapamid EMA
PSUSA/00001529/202011 6.9.2021. glatiramer EMA
PSUSA-00010800-202011 5.9.2021. etanolni ekstrakti iz: Iberis amara L., planta tota recens / Angelica archangelica L., radix / Matricaria recutita L., flos / Carum carvi L., fructus / Silybum marianum (L.) Gaertn., fructus / Melissa officinalis L., folium / Mentha piperita L., folium / Chelidonium majus L., herba /
Glycyrrhiza glabra L., radix
EMA
PSUSA/00009182/202012 5.9.2021. hidroksikarbamid EMA
EMEA/H/C/PSUSA/00002480/202010 18.8.2021. posakonazol EK
PSUSA/00002472/202010 8.8.2021. polistirensulfonat EMA
PSUSA/00002354/202010 8.8.2021. perindopril EMA

CMDh PR 06/2021

PSUSA/00000294/202009 5.7.2021. baklofen EMA
EMEA/H/C/PSUSA/00002653/202009 21.6.2021. rivaroksaban EK
EMEA/H/C/PSUSA/00010007/202007 1.6.2021. ribavirin EK
EMEA/H/C/PSUSA/00000459/202007 19.5.2021. buprenorfin EK
PSUSA/00010271/202007 10.5.2021.

ezetimib, rosuvastatin (PSUSA)

rosuvastatin, ticagrelor (CMDh PR 03/2021 i CMDh PR 06/2021)

EMA

CMDh PR 03/2021 CMDh PR 06/2021

PSUSA/00002109/202008 9.5.2021. naftifin EMA
PSUSA/00001708/202007 9.5.2021. ibuprofen, levomentol EMA
PSUSA/00002589/202007 9.5.2021. kvetiapin EMA
PSUSA/00000777/202007 30.4.2021. cisatrakurij EMA
PSUSA/00002060/202005 23.4.2021. mifepriston EMA
PSUSA/00001773/202006 23.4.2021. jopromid EMA
PSUSA/00001768/202006 23.4.2021. joheksol EMA
PSUSA/00002846/202004 23.4.2021. tamoksifen EMA
PSUSA/00001307/202007 15.4.2021.

etinilestradiol/etonogestrel (PSUSA)

etinilestradiol (CMDh PR)

EMA CMDh PR 02/2021
PSUSA/00002201/202006 11.4.2021. oktreotid EMA
PSUSA/00010390/202007 7.4.2021. lidokainklorid/fenilefrinklorid/tropikamid EMA
EMEA/H/C/PSUSA/00000226/202005 31.3.2021. apiksaban EK
PSUSA/00001766/202004 16.3.2021. jodiksanol EMA
PSUSA/00001769/202004 16.3.2021. jomeprol EMA
PSUSA/00003134/202005 16.3.2021. ksilometazolin EMA
PSUSA/00001783/202005 15.3.2021. irinotekan EMA
PSUSA/00003002/202005 10.3.2021.

tramadol (PSUSA)

tramadol/paracetamol i tramadol/deksketoprofen (CMDh PR)

EMA CMDh PR 02/2021
EMEA/H/C/PSUSA/00010550/202005 18.2.2021. mofetilmikofenolat, mikofenolatna kiselina EK
EMEA/H/C/PSUSA/00002772/202003 18.2.2021. somatropin EK
EMEA/H/C/PSUSA/00000424/202004 11.2.2021. bortezomib EK
PSUSA/00002438/202004 27.1.2021. piroksikam EMA
PSUSA/00000788/202004 27.1.2021. klaritromicin EMA
PSUSA/00010525/202004 22.1.2021. deoksikolatna kiselina EMA
EMEA/H/C/PSUSA/00002892/202003 21.1.2021. tenofovirdizoproksil EK CMDh PR 11/2020
EMEA/H/N/PSR/S/0025 18.1.2021. teikoplanin EMA
EMEA/H/C/PSUSA/00003152/202003 11.1.2021. zonisamid EK
PSUSA/00001402/202003 11.1.2021. flukloksacilin EMA
PSUSA/00001404/202003 21.12.2020. flukonazol EMA
PSUSA/00001997/202003 18.12.2020. metamizol EMA CMDh PR 11/2020
PSUSA/00001990/202002 15.12.2020. mesalazin EMA
PSUSA/00010649/202002 3.12.2020. ibuprofen, ibuprofen lizin (koji nemaju indikaciju ductus arteriosus), ibuprofen/kofein EMA
PSUSA/00003097/202001 3.12.2020. vankomicin EMA
PSUSA/00003105/202001 3.12.2020. verapamil EMA
PSUSA/00002370/202001 29.11.2020. fenobarbital EMA
EMEA/H/C/PSUSA/00002511/202001 20.11.2020. pregabalin EK
PSUSA/00003162/202001 10.11.2020. bendamustinklorid EMA
PSUSA/00001771/201912 6.11.2020. jopamidol EMA
PSUSA/00010442/202001 4.11.2020. levonorgestrel/etinilestradiol, etinilestradiol (kombinirano pakiranje) EMA
EMEA/H/C/PSUSA/00000805/201912 24.9.2020. klofarabin EK
EMEA/H/C/PSUSA/00001838/201912 24.9.2020. lenalidomid EK
PSUSA/00010236/202001 7.9.2020. željezo (pripravci za parenteralnu primjenu, osim željezovog dekstrana) EMA
EMEA/H/C/PSUSA/00002014/201910 23.7.2020. metotreksat EK
EMEA/H/C/PSUSA/00002321/201910 22.7.2020. pazopanibum EK
EMEA/H/C/PSUSA/00010585/201908 16.7.2020. budezonid/formoterol EK
PSUSA/00002832/201909 15.7.2020. sumatriptan EMA
PSUSA/00010670/201909 12.7.2020.

opijum (PSUSA)

morfin (CMDh PR)

EMA CMDh PR 05/2020
PSUSA/00000548/201910 7.7.2020. karbidopa / levodopa EMA
EMEA/H/C/PSUSA/00010480/201909 25.06.2020. deksametazon EK
EMEA/H/C/PSUSA/00001180/201907 17.6.2020. dronedaron EK
PSUSA/00010328/201908 10.6.2020. hidrokortizon EMA
PSUSA/00002774/201908 9.6.2020. sotalol EMA
PSUSA/00000464/201907 19.5.2020. busulfan EMA
PSUSA-00002661201907 8.5.2020. ropinirol EMA
EMEA/H/C/PSUSA/00001180/201907 28.4.2020. aripiprazol EK
PSUSA/00001711/201907 7.4.2020.

ibuprofen / pseudoefedrin (PSUSA)

pseudoefedrin (CMDh PR)

EMA CMDh PR 02/2020
PSUSA/00002396/201905 3.4.2020. folkodin EMA
PSUSA-00001761-201904 3.4.2020. jobitridol EMA
EMEA/H/C/PSUSA/00000234/201907 24.3.2020.

sofosbuvir/velpatasvir (PSUSA)

amiodaron (CMDh PR)

EK CMDh PR 02/2020
PSUSA/00002004/201905 17.3.2020. metadon EMA
PSUSA/00001855/201905 12.3.2020. levometadon EMA
PSUSA/00001856/201905 10.3.2020. levonorgestrel EMA
PSUSA/00009231/201905 10.3.2020. moksifloksacin (sistemska primjena) EMA
EMEA/H/C/PSUSA/00010540/201903 3.3.2020. olanzapin EK
EMEA/H/C/PSUSA/00002491/201904 28.2.2020. pramipeksol EK
PSUSA/00002656/201902 14.2.2020. rokuronijev bromid EMA
PSUSA/00010593/201903 13.2.2020. sulfametrol/trimetoprim, sulfadiazin/trimetoprim, sulfametoksazol/trimetoprim (kotrimoksazol) EMA
PSUSA/00001821/202105 13.2.2020. sulfametrol/trimetoprim, sulfadiazin/trimetoprim, sulfametoksazol/trimetoprim (kotrimoksazol) EMA
PSUSA/00001309/201904 27.1.2020. etinilestradiol/levonorgestrel EMA
EMEA/H/C/PSUSA/00000998/201903 20.1.2020. deksmedetomidin EK
PSUSA/00010488/201905 20.1.2020. izotretinoin EMA
PSUSA/00001257/201903 14.1.2020. eritromicin EMA
EMEA/H/C/PSUSA/00002892/201903 13.1.2020. tenofovirdizoproksil EK
PSUSA/00001347/201903 10.1.2020. ezetimib / simvastatin EMA
PSUSA/00009084/201812 28.10.2019. botulinski neurotoksin tip A (150 kD) EMA
PSUSA/00000426/201812 25.10.2019. botulinski toksin tip A EMA

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