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 250
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Package leaflet	Status for supply	Name of the medicinal product
		European Medicines Agency's website: Obgemsa - EMA: EPAR PI Finnish Swedish
		European Medicines Agency's website: Obizur - EMA: EPAR PI Finnish Swedish
PL	Itsehoito	Obsidan Fe++ 100 mg kapseli, kova SPC 2024-01-18
		European Medicines Agency's website: Ocaliva - EMA: EPAR PI Finnish Swedish
		European Medicines Agency's website: Ocrevus - EMA: EPAR PI Finnish Swedish
PL	Resepti	Octafil 50 IU-ml injektiokuiva-aine ja liuotin SPC 2016-03-16
PL	Resepti	Octafil Low 200 IU-ml injektiokuiva-aine ja liuotin, liuosta varten SPC 2023-11-20
PL	Resepti	Octagam 100 mg-ml infuusioneste, liuos SPC 2024-07-30
PL	Resepti	Octagam 50 mg-ml infuusioneste, liuos SPC 2024-07-30
PL	Resepti	Octanine 100 IU-ml injektiokuiva-aine ja liuotin, liuosta varten SPC 2021-12-20
PL	Resepti	octaplasLG infuusiokuiva-aine ja liuotin, liuosta varten SPC 2023-12-21
PL	Resepti	OctaplasLG infuusioneste, liuos SPC 2022-01-17
PL	Resepti	Octaplex 500 IU, 1000 IU infuusiokuiva-aine ja liuotin, liuosta varten SPC 2024-06-07
PL	Resepti	Octostim 15 mikrog-ml injektioneste, liuos SPC 2022-01-05
PL	Resepti	Octostim 150 mikrog-annos nenäsumute SPC 2019-06-18
PL	Resepti	Octreoscan 111 valmisteyhdistelmä radioaktiivista lääkettä varten SPC 2021-10-06
PL	Resepti	Octreotide ratiopharm 10 mg, 20 mg, 30 mg injektiokuiva-aine ja liuotin, depotsuspensiota varten SPC 2022-02-17
PL	Resepti	Oculac 50 mg-ml silmätipat, liuos SPC 2022-02-08
PL	Resepti	Oculac 50 mg-ml silmätipat, liuos, kerta-annospakkaus SPC 2022-02-08
PL	Resepti	Ocutifex 0,25 ml-ml silmätipat, liuos, kerta-annospakkaus SPC 2021-05-10
		European Medicines Agency's website: Odefsey - EMA: EPAR PI Finnish Swedish
		European Medicines Agency's website: Odomzo - EMA: EPAR PI Finnish Swedish
		European Medicines Agency's website: Ofev - EMA: EPAR PI Finnish Swedish
PL	Resepti	Oftagel 2,5 mg-g silmägeeli kerta-annospakkaus SPC 2024-01-12
PL	Resepti	Oftagel 2.5 mg-g silmägeeli SPC 2022-02-08
PL	Resepti	Oftan A-Pant silmävoide SPC 2019-08-19
PL	Resepti	Oftan Akvakol 5 mg-ml silmätipat, liuos SPC 2021-05-04
PL	Resepti	Oftan Akvakol 5 mg-ml silmätipat, liuos, kerta-annopakkaus SPC 2021-05-04
PL	Resepti	Oftan C-C 2 mg-ml + 5 mg-ml silmätipat, liuos SPC 2021-12-22
PL	Resepti	Oftan Chlora 10 mg-g silmävoide SPC 2024-03-04
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