The summaries of product characteristics (SPC) contain the information relevant to the use of the medicinal products and of importance to health care professionals. The SPCs are published in Finnish; the use of Finnish key words in the search fields is therefore recommended.
Some of the medicinal products contain a condition relevant to the prescribing of the product and not always found in the SPC. The conditions for prescribing and the products covered by this condition are found in the FimeaWeb search.
The SPCs 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.
Summaries of Product Characteristics 1 - 30 of 80 |
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Package leaflet | Status for supply | Name of the medicinal product |
PL
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Resepti
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Haemate 250 IU FVIII - 600 IU VWF, 500 IU FVIII - 1200 IU VWF, 1000 IU FVIII - 2400 IU VWF injektio-infuusiokuiva-aine ja liuotin, liuosta varten SPC 2023-10-02
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European Medicines Agency's website: Halaven - EMA: EPAR PI
Finnish Swedish
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PL
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Resepti
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Halcion 0.25 mg tabletti SPC 2022-11-21
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PL
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Resepti
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Harmonet 75 mikrog-20 mikrog tabletti, päällystetty SPC 2022-10-12
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European Medicines Agency's website: Harvoni - EMA: EPAR PI
Finnish Swedish
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PL
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Resepti
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Havrix 1440 Elisa U-ml injektioneste suspensio SPC 2023-06-27
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European Medicines Agency's website: HBVaxPro - EMA: EPAR PI
Finnish Swedish
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European Medicines Agency's website: Hefiya - EMA: EPAR PI
Finnish Swedish
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PL
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Resepti/itsehoito
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Heinix 10 mg imeskelytabletti SPC 2022-06-27
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PL
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Resepti
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Heinix 10 mg tabletti, kalvopäällysteinen SPC 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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PL
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Resepti
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Hemosol B0 hemodialyysi-hemofiltraationeste SPC 2023-03-20
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PL
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Resepti
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Heparin LEO 100 IU-ml injektioneste, liuos SPC 2020-08-28.docx
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PL
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Resepti
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Heparin LEO 5000 IU-ml injektioneste, liuos SPC 2020-08-28.docx
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PL
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Resepti
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Hepatect 50 IU-ml infuusioneste, liuos SPC 2021-11-18
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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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PL
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Resepti/itsehoito
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Herpolips 50 mg-g emulsiovoide SPC 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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European Medicines Agency's website: Hetlioz - EMA: EPAR PI
Finnish Swedish
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PL
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Resepti
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Hevascol 480 mg I/ml injektioneste, liuos SPC 2024-05-02
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PL
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Resepti
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Hevicain Spinal Tung 5 mg-ml injektioneste, liuos SPC 2023-02-17
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European Medicines Agency's website: Hexacima - EMA: EPAR PI
Finnish Swedish
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