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 151 - 180 of 250
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Package leaflet	Status for supply	Name of the medicinal product
PL	Resepti	Oramorph 20 mg-ml oraaliliuos SPC 2023-12-07
PL	Resepti	Oramorph 6 mg-ml oraaliliuos kerta-annosampullissa 2023-12-07
PL	Resepti	Oraqix geeli ientaskuun SPC 2017-02-15
PL	Resepti	Orbeos 10 mg, 20 mg purutabletti SPC 2023-05-08
PL	Resepti	Orbeos 10 mg, 20 mg, 40 mg, 80 mg tabletti, kalvopäällysteinen SPC 2024-05-20
		European Medicines Agency's website: Ordspono - EMA: EPAR PI Finnish Swedish
		European Medicines Agency's website: Orencia - EMA: EPAR PI Finnish Swedish
		European Medicines Agency's website: Orfadin - EMA: EPAR PI Finnish Swedish
PL	Resepti	Orfiril 100 mg-ml injektioneste, liuos SPC 2024-05-03
PL	Resepti	Orfiril long 150 mg, 300 mg depotkapseli, kova SPC 2024-10-01
PL	Resepti	Orfiril long 500 mg depotrakeet SPC 2024-10-01
		European Medicines Agency's website: Orgalutran - EMA: EPAR PI Finnish Swedish
PL	Resepti	Orgametril 5 mg tabletti SPC 2021-04-27
PL	Resepti	Orgaran 1250 anti-Xa U - ml injektioneste, liuos SPC 2022-02-01
		European Medicines Agency's website: Orgovyx - EMA: EPAR PI Finnish Swedish
PL	Resepti	Oribamide 500 mg, kapseli, kova SPC 2024-08-19
PL	Resepti	Oricyclin 500 mg tabletti, kalvopäällysteinen SPC 2019-04-30
PL	Resepti	Oricyclin 500 mg tabletti, kalvopäällysteinen SPC 2021-06-28
PL	Resepti	Oridip 10 mg, 20 mg tabletti, kalvopäällysteinen SPC 2020-07-01
PL	Resepti	Orimelan 3 mg, 5 mg tabletti SPC 2024-05-22
PL	Resepti/itsehoito	Oriptan 50 mg, 100 mg tabletti, kalvopäällysteinen SPC 2024-09-02
PL	Resepti	Orisantin 200 mg - 25 mg säädellysti vapauttava kapseli, kova SPC 2021-07-12
PL	Resepti	Orisild 20 mg tabletti, kalvopäällysteinen SPC 2022-07-01
		European Medicines Agency's website: Orkambi - EMA: EPAR PI Finnish Swedish
		European Medicines Agency's website: Orladeyo - EMA: EPAR PI Finnish Swedish
PL	Resepti/itsehoito	Orlistat Sandoz 60 mg kapseli, kova SPC 2021-05-17
PL	Resepti	Orlistat STADA 120 mg kapseli, kova Rx PL 2020-12-10.docx
PL	Resepti	Orlistat Stada 120 mg kapseli, kova SPC 2021-12-01
PL	Resepti	Orloc 5 mg, 10 mg tabletti, kalvopäällysteinen SPC 2023-07-06
PL	Resepti	Ormox 10 mg, 20 mg tabletti SPC 2021-07-15
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