The package leaflet (PL) provides users with information about the medicinal product and its correct use. The package leaflets contain instructions in both Finnish and Swedish.
The package leaflets can be searched from alphabetical list, with the name, marketing authorisation number and the Anatomical Therapeutic Chemical, i.e. ATC Code of the Summary of Product Characteristics, SPC.
The package leaflets processed as part of the EU centralised marketing authorisation procedure are published by the European Medicines Agency,
.
Fimea's service contains links to the documents on medicinal products (EPAR PI) on the EMA website.
Drugs belonging to the centralised authorisation procedure can be searched in Fimea's service by using an alphabetical list or by entering the product name or ATC code.
The material being published is not necessarily complete or up-to-date due to the technical quality of files submitted to the Finnish Medicines Agency Fimea or earlier to the National Agency for Medicines and the delays in delivery. For this reason, Fimea cannot guarantee that the document on the Internet fully complies with the summary of product characteristics and package leaflet officially approved by a desicion for a marketing authorisation. Only the hard copies of the SPCs and the PLs, which are in accordance with the marketing authorisation, are conclusive.
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| SPC | Status for
supply | Name of the medicinal product |
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SPC
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Itsehoito
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Ebastin Orion 10 mg suussa hajoava tabletti PL OTC 2019-05-07
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SPC
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Resepti
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Ebastin Orion 10mg suussa hajoava tabletti PL (Rx) 2021-09-16
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SPC
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Itsehoito
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Ebastin Orion 20 mg suussa hajoava tabletti PL OTC 2019-05-07
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SPC
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Resepti
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Ebastin Orion 20mg suussa hajoava tabletti PL (Rx) 2021-09-16
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SPC
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Resepti
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Ebetrex 20 mg-ml injektioneste, liuos, esitäytetty ruisku, ilman turvaneulaa PL 2024-09-06
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SPC
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Resepti
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Ebetrex 20 mg-ml injektioneste, liuos, esitäytetty ruisku, turvaneulalla PL 2024-09-06
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European Medicines Agency's website:
Ebilfumin - EMA: EPAR PI
Finnish Swedish
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European Medicines Agency's website:
Ebixa - EMA: EPAR PI
Finnish Swedish
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European Medicines Agency's website:
Ebvallo - EMA: EPAR PI
Finnish Swedish
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European Medicines Agency's website:
Ebymect - EMA: EPAR PI
Finnish Swedish
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European Medicines Agency's website:
Ecalta - EMA: EPAR PI
Finnish Swedish
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European Medicines Agency's website:
Ecansya (ent. Capecitabine Krka) - EMA: EPAR PI
Finnish Swedish
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SPC
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Itsehoito
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Echinaforce tipat, liuos PL 2023-01-03
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European Medicines Agency's website:
Edarbi - EMA: EPAR PI
Finnish Swedish
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European Medicines Agency's website:
Edistride - EMA: EPAR PI
Finnish Swedish
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SPC
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Resepti
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Edluar 5 mg, 10 mg resoribletti PL 2023-11-23
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European Medicines Agency's website:
Edurant - EMA: EPAR PI
Finnish Swedish
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SPC
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Resepti
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Efavirenz Aurobindo 600 mg tabletti, kalvopäällysteinen PL 2024-07-15
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SPC
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Resepti
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Efavirenz Sandoz 600 mg tabletti, kalvopäällysteinen PL 2024-08-07
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European Medicines Agency's website:
Efavirenz Teva - EMA: EPAR PI
Finnish Swedish
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European Medicines Agency's website:
Efavirenz/Emtricitabine/Tenofovir disoproxil Krka - EMA: EPAR PI
Finnish Swedish
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European Medicines Agency's website:
Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan - EMA: EPAR PI
Finnish Swedish
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European Medicines Agency's website:
Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva - EMA: EPAR PI
Finnish Swedish
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SPC
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Resepti
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Efedrin Abboxia 5 mg-ml, 50 mg-ml injektioneste, liuos PL 2023-09-05
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SPC
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Resepti
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Efedrin Aguettant 3 mg-ml injektioneste, liuos, esitäytetty ruisku PL 2020-11-13
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SPC
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Resepti
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Efedrin Unimedic 5 mg-ml injektioneste, liuos PL 2019-11-29.doc
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SPC
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Resepti
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Efexor Depot 37,5 mg, 75 mg, 150 mg depotkapseli, kova PL 2023-04-25
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European Medicines Agency's website:
Effentora - EMA: EPAR PI
Finnish Swedish
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European Medicines Agency's website:
Efficib - EMA: EPAR PI
Finnish Swedish
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SPC
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Resepti
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Effortil 10 mg-ml injektioneste, liuos PL 2021-12-01
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