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 31 - 60 of 111
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Package leaflet	Status for supply	Name of the medicinal product
PL	Itsehoito	Katapekt oraaliliuos SPC 2021-12-29
		European Medicines Agency's website: Kauliv - EMA: EPAR PI Finnish Swedish
PL	Resepti	Kefalex 500 mg, 750 mg tabletti, kalvopäällysteinen SPC 2023-03-13
PL	Resepti	Kefalex 500 mg, 750 mg tabletti, kalvopäällysteinen SPC 2023-03-13
PL	Resepti	Kefexin 100 mg-ml rakeet oraalisuspensiota varten SPC 2022-01-18
PL	Resepti	Kefexin 250 mg, 500 mg, 750 mg tabletti, kalvopäällysteinen SPC 2022-01-18
PL	Resepti	Kefexin 250 mg, 500 mg, 750 mg tabletti, kalvopäällysteinen SPC 2022-01-18
PL	Resepti	Kefexin 50 mg-ml rakeet oraalisuspensiota varten SPC 2022-01-18
		European Medicines Agency's website: Kengrexal - EMA: EPAR PI Finnish Swedish
		European Medicines Agency's website: Kentera (ent. Oxybutynin Nicobrand) - EMA: EPAR PI Finnish Swedish
		European Medicines Agency's website: Keppra - EMA: EPAR PI Finnish Swedish
		European Medicines Agency's website: Kerendia - EMA: EPAR PI Finnish Swedish
		European Medicines Agency's website: Kesimpta - EMA: EPAR PI Finnish Swedish
PL	Resepti/itsehoito	Kestine 10 mg tabletti, kalvopäällysteinen SPC 2023-07-06
PL	Resepti/itsehoito	Kestine 20 mg tabletti, kalvopäällysteinen SPC 2022-11-08
PL	Resepti/itsehoito	Kestine Lyo 10 mg tabletti, kylmäkuivattu SPC 2021-12-30
PL	Resepti/itsehoito	Kestine Lyo 20 mg tabletti, kylmäkuivattu SPC 2021-12-30
PL	Resepti/itsehoito	Kestox 10 mg tabletti, kalvopäällysteinen SPC 2022-06-15
PL	Resepti/itsehoito	Kestox 20 mg tabletti, kalvopäällysteinen SPC 2022-06-15
PL	Resepti	Ketamin Abcur 10 mg-ml, 50 mg-ml injektioneste, liuos SPC 2021-07-02
PL	Resepti	Ketanest-S 5mg-ml, 25 mg-ml injektioneste, liuos SPC 2021-03-17.doc
PL	Resepti	Ketazed 0,25 mg-ml silmätipat, liuos SPC 2024-03-14
PL	Resepti	Ketesse 25 mg oraaliliuos, annospussi SPC 2022-09-28
PL	Resepti	Ketesse 25 mg tabletti, kalvopäällysteinen SPC 2023-04-20
PL	Resepti	Ketesse 50 mg - 2 ml injektio-infuusioneste, liuos SPC 2023-03-27
PL	Resepti	Ketipinor 25 mg, 100 mg, 200 mg, 300 mg tabletti, kalvopäällysteinen SPC 2021-12-16
PL	Resepti	Ketipinor 25 mg, 100 mg, 200 mg, 300 mg tabletti, kalvopäällysteinen SPC 2021-12-16
PL	Resepti	Ketipinor 50 mg, 150 mg, 200 mg, 300 mg, 400 mg depottabletti SPC 2022-01-12
PL	Itsehoito	Keto 25 mg tabletti, kalvopäällysteinen SPC 2022-09-29
PL	Resepti	Keto 50 mg, 100 mg tabletti, kalvopäällysteinen SPC 2022-09-29
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