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 1 - 30 of 121
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Package leaflet	Status for supply	Name of the medicinal product
PL	Resepti	Gabapentin Accord 300 mg, 400 mg kapseli, kova SPC 2023-01-16
PL	Resepti	Gabapentin Accord 600 mg, 800 mg tabletti, kalvopäällysteinen SPC 2023-02-17
PL	Resepti	Gabapentin Actavis 300 mg, 400 mg kapseli, kova SPC 2023-05-16
PL	Resepti	Gabapentin Actavis 600 mg, 800 mg tabletti, kalvopäällysteinen SPC 2023-01-12
PL	Resepti	Gabapentin Orion 300 mg, 400 mg kapseli, kova SPC 2023-10-17
PL	Resepti	Gabapentin Orion 600 mg, 800 mg tabletti, kalvopäällysteinen SPC 2023-03-06
PL	Resepti	Gabapentin ratiopharm 300 mg, 400 mg kapseli, kova SPC 2024-02-15
PL	Resepti	Gabapentin Sandoz 300 mg, 400 mg kapseli, kova SPC 2023-11-22
PL	Resepti	Gabapentin Sandoz 600 mg, 800 mg tabletti, kalvopäällysteinen SPC 2023-01-08
PL	Resepti	Gabapentin Strides 100 mg, 300 mg, 400 mg kapseli, kova SPC 2024-02-20
PL	Resepti	Gabrion 300 mg, 400 mg kapseli, kova SPC 2023-10-20
PL	Resepti	Gabrion 600 mg, 800 mg tabletti, kalvopäällysteinen SPC 2023-10-20
PL	Resepti	Gadovist 1 mmol-ml injektioneste, liuos SPC 2022-08-18
PL	Resepti	Gadovist 1 mmol-ml injektioneste, liuos, esitäytetty ruisku SPC 2022-09-06
		European Medicines Agency's website: Galafold - EMA: EPAR PI Finnish Swedish
PL	Resepti	Galantamin Krka 8 mg, 16 mg, 24 mg depotkapseli, kova SPC 2022-04-28
PL	Resepti	Galantamin Mylan 8, 16, 24 mg depotkapseli SPC 2016-03-07
PL	Resepti	Galantamin Orion 8 mg, 16 mg, 24 mg depotkapseli, kova SPC 2023-03-03
PL	Resepti	Galantamin Stada 8 mg, 16 mg, 24 mg depotkapseli, kova SPC 2021-01-18
PL	Itsehoito	Galieve 500 mg - 213 mg - 325 mg oraalisuspensio, annospussi SPC 2021-11-08
PL	Itsehoito	Galieve Mint oraalisuspensio SPC 2021-11-08
PL	Itsehoito	Galieve Mint oraalisuspensio, annospussi SPC 2022-08-30
PL	Itsehoito	Galieve Peppermint purutabletti SPC 2021-11-08
PL	Resepti	Galli Ad 0,74 - 1,85 GBq radionuklidigeneraattori SPC 2022-03-04
PL	Resepti	GalliaPharm 0,74 - 1,85 GBq, radionuklidigeneraattori SPC 2023-05-17
		European Medicines Agency's website: Galvus - EMA: EPAR PI Finnish Swedish
PL	Resepti	Gammagard S-D infuusiokuiva-aine ja liuotin, liuosta varten SPC 2023-04-28
PL	Resepti	Gamunex 100 mg-ml infuusioneste, liuos SPC 2022-10-24
PL	Resepti	Ganciclovir Oresund Pharma 500 mg kuiva-aine välikonsentraatiksi infuusionestettä varten, liuos SPC 2022-11-01
		European Medicines Agency's website: Ganfort - EMA: EPAR PI Finnish Swedish
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