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 61 - 90 of 257
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Package leaflet	Status for supply	Name of the medicinal product
PL	Resepti	Berinert 500 IU, 1500 IU injektioinfuusiokuiva-aine ja liuotin, liuosta varten SPC 2021-10-11
		European Medicines Agency's website: Beromun - EMA: EPAR PI Finnish Swedish
PL	Itsehoito	Bertolix 3 mg-ml sumute suuonteloon, liuos SPC 2024-09-12
		European Medicines Agency's website: Besponsa - EMA: EPAR PI Finnish Swedish
		European Medicines Agency's website: Besremi - EMA: EPAR PI Finnish Swedish
PL	Itsehoito	Betadine 10 mg-ml suuvesi SPC 2022-02-01
PL	Itsehoito	Betadine 100 mg-g voide SPC 2022-02-02
PL	Itsehoito	Betadine 100 mg-ml paikallisantiseptiliuos SPC 2022-04-21
		European Medicines Agency's website: Betaferon - EMA: EPAR PI Finnish Swedish
PL	Resepti	Betahistin Orifarm Generics 8 mg, 16 mg, 24 mg tabletti SPC 2022-02-21
PL	Resepti	Betahistine Accord 24 mg tabletti SPC 2019-08-27.doc
PL	Resepti	Betahistine Stada 8 mg, 16 mg, 24 mg tabletti SPC 2021-11-15
PL	Resepti	Betaklav 500 mg-125 mg, 875 mg-125 mg tabletti, kalvopäällysteinen SPC 2024-04-17
PL	Resepti	Betapred 4 mg-ml injektioneste, liuos valmisteyhteenveto 2023-07-05
PL	Resepti	Betaserc 24 mg tabletti, suussa hajoava SPC 2022-10-17
PL	Resepti	Betaserc 8 mg, 16 mg, 24 mg tabletti SPC 2022-01-17
		European Medicines Agency's website: Betmiga - EMA: EPAR PI Finnish Swedish
PL	Resepti	Betnovat 1 mg-ml liuos iholle SPC 2023-05-01
PL	Resepti	Betnovat Scalp 1 mg-ml liuos iholle SPC 2023-06-20
PL	Resepti	Betolo 6 mg-ml + 2,23 mg-ml + 4,46 mg-ml sumute suuonteloon, liuos SPC 2024-08-19
PL	Resepti/itsehoito	Betolo mint, appelsiini, hunaja & sitruuna 2 mg - 0,6 mg - 1,2 mg imeskelytabletti SPC 2023-09-14
PL	Resepti	Betoptic 5 mg-ml silmätipat, liuos SPC 2022-10-01
PL	Resepti	Betoptic S 2.5 mg-ml silmätipat, suspensio SPC 2022-10-01
		European Medicines Agency's website: Bevespi Aerosphere - EMA: EPAR PI Finnish Swedish
PL	Resepti	Bevitrio 0,5 mg-0,8 mg-3 mg tabletti SPC 2023-09-08
PL	Resepti	Bexarotene Amdipharm 75 mg kapseli, pehmeä SPC 2024-10-21
		European Medicines Agency's website: Bexsero - EMA: EPAR PI Finnish Swedish
		European Medicines Agency's website: Beyfortus - EMA: EPAR PI Finnish Swedish
PL	Resepti	Bezalip 400 mg depottabletti SPC 2022-09-29
PL	Resepti	Bicain Pond Spinal 5 mg-ml injektioneste, liuos SPC 2021-01-26
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