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,
EMA.
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.
Search with the first character of the name of the medicinal product: h
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supply | Name of the medicinal product |
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SPC
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Resepti
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Haemate 250 IU FVIII-600 IU VWF injektio-infuusiokuiva-aine ja liuotin, liuosta varten PL 2023-10-02
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SPC
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Resepti
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Haemate 500 IU FVIII - 1200 IU VWF, 1000 IU FVIII - 2400 IU VWF injektio-infuusiokuiva-aine ja liuotin, liuosta varten PL 2023-10-02
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European Medicines Agency's website:
Halaven - EMA: EPAR PI
Finnish Swedish
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SPC
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Resepti
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Halcion 0.25 mg tabletti PL 2022-11-21
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SPC
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Resepti
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Harmonet 75 mikrog-20 mikrog tabletti, päällystetty PL 2022-10-12
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European Medicines Agency's website:
Harvoni - EMA: EPAR PI
Finnish Swedish
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SPC
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Resepti
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Havrix 1440 Elisa U-ml injektioneste suspensio PL 2023-06-26
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European Medicines Agency's website:
HBVaxPro - EMA: EPAR PI
Finnish Swedish
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SPC
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Itsehoito
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Hedexin, siirappi pakkausseloste 2024-07-18.docx
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European Medicines Agency's website:
Hefiya - EMA: EPAR PI
Finnish Swedish
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SPC
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Itsehoito
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Heinix 10 mg imeskelytabletti PL OTC 2022-06-27
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SPC
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Resepti
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Heinix 10 mg imeskelytabletti PL Rx 2022-06-27
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SPC
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Resepti
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Heinix 10 mg tabletti, kalvopäällysteinen PL 2022-06-27
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SPC
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Itsehoito
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Heinix 10 mg tabletti, kalvopäällysteinen PL OTC 2022-06-27
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European Medicines Agency's website:
Helicobacter Test INFAI - EMA: EPAR PI
Finnish Swedish
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European Medicines Agency's website:
Hemangiol - EMA: EPAR PI
Finnish Swedish
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European Medicines Agency's website:
Hemgenix - EMA: EPAR PI
Finnish Swedish
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European Medicines Agency's website:
Hemlibra - EMA: EPAR PI
Finnish Swedish
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European Medicines Agency's website:
Hemlibra - EMA: EPAR PI
Finnish Swedish
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SPC
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Resepti
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Hemosol B0 hemodialyysi-hemofiltraationeste PL 2024-04-04
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SPC
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Resepti
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Heparin LEO 100 IU-ml injektioneste, liuos PL 2020-08-28.docx
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SPC
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Resepti
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Heparin LEO 5000 IU-ml injektioneste, liuos PL 2024-02-21.docx
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SPC
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Resepti
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Hepatect 50 IU-ml infuusioneste, liuos PL 2023-11-07
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European Medicines Agency's website:
Hepcludex - EMA: EPAR PI
Finnish Swedish
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European Medicines Agency's website:
HEPLISAV B - EMA: EPAR PI
Finnish Swedish
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European Medicines Agency's website:
Hepsera - EMA: EPAR PI
Finnish Swedish
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European Medicines Agency's website:
Herceptin - EMA: EPAR PI
Finnish Swedish
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SPC
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Resepti
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Herpolips 50 mg-g emulsiovoide PL 2024-01-30
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European Medicines Agency's website:
Herwenda - EMA: EPAR PI
Finnish Swedish
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European Medicines Agency's website:
Herzuma - EMA: EPAR PI
Finnish Swedish
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