Summaries of Product Characteristics (SPC) for Human medicinal products

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 121 - 150 of 257
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Package leaflet	Status for supply	Name of the medicinal product
		European Medicines Agency's website: BiResp Spiromax - EMA: EPAR PI Finnish Swedish
PL	Itsehoito	Biseltoc 2,13 mg-ml oraaliliuos SPC 2023-07-15
PL	Resepti/itsehoito	Bisolaclar 600 mg poretabletti SPC 2023-07-15
PL	Itsehoito	Bisolvon 0,8 mg-ml oraaliliuos SPC 2023-07-15
PL	Itsehoito	Bisolvon 8 mg liukeneva tabletti SPC 2023-07-15
PL	Itsehoito	Bisolvon 8 mg oraaliliuos, annospussi SPC 2016-10-26
PL	Itsehoito	Bisolvon 8 mg tabletti SPC 2023-07-15
PL	Itsehoito	Bisolvon Strong 1.6 mg-ml oraaliliuos SPC 2024-04-26
PL	Resepti	Bisoproact 2.5 mg, 5 mg, 10 mg tabletti SPC 2021-06-04
PL	Resepti	Bisoprolol Accord 2.5 mg, 5 mg, 10 mg tabletti, kalvopäällysteinen SPC 2023-10-18
PL	Resepti	Bisoprolol comp ratiopharm 5 mg-12.5 mg, 10 mg-25 mg tabletti, kalvopäällysteinen SPC 2021-12-02
PL	Resepti	Bisoprolol Krka 2.5 mg, 5 mg, 10 mg tabletti, kalvopäällysteinen SPC 2022-06-14
PL	Resepti	Bisoprolol Orion 2.5 mg, 5 mg, 10 mg tabletti SPC 2023-03-21
PL	Resepti	Bisoprolol ratiopharm 2.5 mg tabletti SPC 2022-08-05
PL	Resepti	Bisoprolol ratiopharm 5 mg, 10 mg tabletti SPC 2019-11-27
PL	Resepti	Bisoprolol Sandoz 2.5 mg tabletti, kalvopäällysteinen SPC 2021-06-25
PL	Resepti	Bisoprolol Sandoz 5 mg, 10 mg tabletti, kalvopäällysteinen SPC 2021-06-25
PL	Resepti	Bisoprolol Vitabalans 5 mg, 10 mg tabletti SPC 2022-05-05
PL	Resepti	Bitifrin 0,3 mg-ml + 5 mg-ml silmätipat, liuos SPC 2024-03-11
PL	Resepti	Bivalirudin Reig Jofre 250 mg kuiva-aine välikonsentraatiksi injektio-infuusionestettä varten, liuos SPC 2022-09-12
PL	Resepti	Bleomycin Accord 15000 IU injektio-infuusiokuiva-aine, liuosta varten SPC 2023-03-21
PL	Resepti	Bleomycin Baxter injektio-infuusiokuiva-aine, liuosta varten SPC 2024-07-23
		European Medicines Agency's website: Blincyto - EMA: EPAR PI Finnish Swedish
PL	Resepti	Blissel 50 mikrog-g emätingeeli SPC 2024-01-25
		European Medicines Agency's website: Blitzima - EMA: EPAR PI Finnish Swedish
		European Medicines Agency's website: Blitzima - EMA: EPAR PI Finnish Swedish
PL	Itsehoito	Bloctil 100 mg kapseli, kova SPC 2024-03-13
PL	Resepti	Bocouture 50, 100 yksikköä injektiokuiva-aine, liuosta varten SPC 2019-11-22
		European Medicines Agency's website: Bondronat - EMA: EPAR PI Finnish Swedish
PL	Resepti	Bonjesta 20 mg - 20 mg säädellysti vapauttava tabletti SPC 2023-03-03
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