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 373
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Package leaflet	Status for supply	Name of the medicinal product
PL	Resepti	Silkis 3 mikrog-g voide SPC 2021-04-15
		European Medicines Agency's website: Silodosin Recordati - EMA: EPAR PI Finnish Swedish
		European Medicines Agency's website: Silodyx - EMA: EPAR PI Finnish Swedish
PL	Itsehoito	Silotoc 50 mg tabletti, kalvopäällysteinen SPC 2023-07-15
		European Medicines Agency's website: Simbrinza - EMA: EPAR PI Finnish Swedish
		European Medicines Agency's website: Simbrinza - EMA: EPAR PI Finnish Swedish
PL	Resepti	Simdax 2.5 mg-ml infuusiokonsentraatti, liuosta varten SPC 2021-11-12
		European Medicines Agency's website: Simponi - EMA: EPAR PI Finnish Swedish
		European Medicines Agency's website: Simulect - EMA: EPAR PI Finnish Swedish
PL	Resepti	Simvastatin Krka 10 mg, 20 mg, 40 mg tabletti, kalvopäällysteinen SPC 2023-03-15
PL	Resepti	Simvastatin Mylan 10 mg, 20 mg, 40 mg, 80 mg tabletti, kalvopäällysteinen SPC 2023-03-16
PL	Resepti	Simvastatin Orion 10 mg, 20 mg, 40 mg, 80 mg tabletti, kalvopäällysteinen SPC 2023-03-21
PL	Resepti	Simvastatin ratiopharm 10 mg, 20 mg, 40 mg tabletti, kalvopäällysteinen SPC 2023-03-24
PL	Resepti	Simvastatin ratiopharm 80 mg tabletti, kalvopäällysteinen SPC 2023-03-24
PL	Resepti	Simvastatin SanoSwiss 10 mg, 20 mg, 40 mg tabletti, kalvopäällysteinen SPC 2023-04-03
PL	Resepti	Sinafex 30 mg, 60 mg, 90 mg tabletti, kalvopäällysteinen SPC 2020-09-14
PL	Resepti	Sinemet 12.5 mg - 50 mg, 25 mg - 100 mg tabletti SPC 2023-09-07
PL	Resepti	Sinemet depot 50 mg - 200 mg depottabletti SPC 2022-01-14
PL	Resepti	Singulair 10 mg tabletti, kalvopäällysteinen SPC 2023-04-21
PL	Resepti	Singulair 4 mg purutabletti SPC 2023-04-21
PL	Resepti	Singulair 4 mg rakeet SPC 2023-04-21
PL	Resepti	Singulair 5 mg purutabletti SPC 2023-04-21
PL	Resepti	Sinmelan 5 mg-ml, 25 mg-ml injektioneste, liuos SPC 2021-03-23
PL	Resepti	Sir. Ephedrin oraalineste SPC 2022-03-31
PL	Resepti	Sir. Ephedrin Paediatr. oraalineste SPC 2022-04-01
PL	Resepti	Sirdalud 2 mg, 4 mg tabletti SPC 2022-12-09
PL	Resepti	Sirdalud Retard 6 mg depotkapseli, kova SPC 2022-12-09
		European Medicines Agency's website: SIRTURO - EMA: EPAR PI Finnish Swedish
PL	Resepti	Sislaf 2,5 mg tabletti, kalvopäällysteinen SPC 2024-07-02
PL	Resepti	Sislaf 5 mg tabletti, kalvopäällysteinen SPC 2024-07-02
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