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 217
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Package leaflet	Status for supply	Name of the medicinal product
PL	Resepti	Valsartan-Hydrochlorothiazide Krka 80 mg-12.5 mg, 160 mg-12.5 mg, 160 mg-25 mg, 320 mg-12.5 mg, 320 mg-25 mg tabletti, kalvopäällysteinen SPC 2023-11-28
PL	Resepti	Valsartan-Hydrochlorothiazide Sandoz 80 mg-12.5 mg, 160 mg-12.5 mg tabletti, kalvopäällysteinen SPC 2022-03-31
PL	Resepti	Valsartan-Hydroklortiazid Actavis 320 mg-12.5 mg, 320 mg-25 mg tabletti, kalvopäällysteinen SPC 2023-04-04
PL	Resepti	Valsartan/Hydroklortiazid Actavis 80mg/12.5mg, 160mg/12.5mg, 160mg/25mg tabletti, kalvopäällysteinen SPC 2023-05-11
PL	Resepti	Valsartore Comp 80 mg-12,5 mg, 160 mg-12,5 mg, 160 mg-25 mg kalvopäällysteinen tabletti SPC 2022-03-28
PL	Resepti	Valtrex 250 mg, 500 mg tabletti, kalvopäällysteinen SPC 2023-09-13
PL	Resepti	Valtrex 250 mg, 500 mg tabletti, kalvopäällysteinen SPC 2023-09-13
PL	Resepti	Vaminolac infuusioneste, liuos SPC 2020-07-15.docx
PL	Resepti	Vamtexar 500 mg-20 mg säädellysti vapauttavat tabletit SPC 2024-09-25
PL	Resepti	Vancomycin hameln 500 mg, 1000 mg kuiva-aine välikonsentraatiksi infuusionestettä varten, liuos SPC 2024-09-24
PL	Resepti	Vancomycin MIP Pharma 500 mg, 1000 mg infuusiokuiva-aine, liuosta varten SPC 2023-10-31
PL	Resepti	Vancomycin Orion 500 mg, 1000 mg kuiva-aine välikonsentraatiksi infuusionestettä varten, liuos SPC 2023-11-20
PL	Resepti	Vancomycin Strides 125 mg, 250 mg kapseli, kova SPC 2023-06-21
PL	Resepti	Vancomycin Xellia 125 mg ja 250 mg kapseli, kova SPC 2023-07-05
PL	Resepti	Vancosan 500 mg, 1000 mg infuusiokuiva-aine, liuosta varten SPC 2020-12-15
		European Medicines Agency's website: Vaniqa - EMA: EPAR PI Finnish Swedish
		European Medicines Agency's website: Vantavo (ent. Alendronate Sodium And Colecalciferol, MSD) - EMA: EPAR PI Finnish Swedish
PL	Resepti	Vaqta 25 U-0.5 ml injektioneste, suspensio SPC 2024-05-10
PL	Resepti	Vaqta 25 U-0.5 ml injektioneste, suspensio, esitäytetty ruisku SPC 2024-05-10
PL	Resepti	Vaqta 50 U-1 ml injektioneste, suspensio SPC 2024-05-10
PL	Resepti	Vaqta 50 U-1 ml injektioneste, suspensio, esitäytetty ruisku SPC 2024-05-10
PL	Resepti	Vardenafil Accord 5 mg, 10 mg, 20 mg kalvopäällysteiset tabletit SPC 2023-07-11
PL	Resepti	Vardenafil Accord 5 mg, 10 mg, 20 mg tabletit SPC 2020-02-14
PL	Resepti	Vardenafil Krka 5 mg, 10 mg, 20 mg tabletti, kalvopäällysteinen SPC 2022-02-03
PL	Resepti	Vardenafil Stada 5 mg, 10 mg, 20 mg tabletti, kalvopäällysteinen SPC 2021-08-23
PL	Resepti	Varenicline Glenmark 0,5 mg, 1 mg tabletti, kalvopäällysteinen SPC 2024-08-29
PL	Resepti	Varenicline ratiopharm 0,5 mg tabletti, kalvopäällysteinen SPC 2024-03-15
PL	Resepti	Varenicline ratiopharm 0,5 mg+1 mg tabletti, kalvopäällysteinen SPC 2024-03-15
PL	Resepti	Varenicline ratiopharm 1 mg tabletti, kalvopäällysteinen SPC 2024-03-15
		European Medicines Agency's website: Vargatef - EMA: EPAR PI Finnish Swedish
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