Package Leaflets (PL) for Human medicinal products

The package leaflet (PL) provides users with information about the medicinal product and its correct use. The package leaflets contain instructions in both Finnish and Swedish.

The package leaflets can be searched from alphabetical list, with the name, marketing authorisation number and the Anatomical Therapeutic Chemical, i.e. ATC Code of the Summary of Product Characteristics, SPC.

The package leaflets 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.

Product Information Leaflets 211 - 240 of 255
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SPC	Status for supply	Name of the medicinal product
SPC	Resepti	Rosamera 10mg-5mg-4mg, 10mg-5mg-8mg, 10mg-10mg-8mg, 20mg-5mg-4mg, 20mg-5mg-8mg, 20mg-10mg-8mg tabletti, kalvopäällysteinen PL 2023-05-30
SPC	Resepti	Rosazol 1 % emulsiovoide PL 2019-10-09
SPC	Itsehoito	Rosazol 1 % emulsiovoide PL OTC 2019-10-09
SPC	Resepti	Rosuvastatin Actavis 15 mg, 30 mg tabletti, kalvopäällysteinen PL 2024-08-16
SPC	Resepti	Rosuvastatin Actavis 5 mg, 10 mg, 20 mg, 40 mg tabletti, kalvopäällysteinen PL 2024-08-23
SPC	Resepti	Rosuvastatin Krka 15 mg, 30 mg tabletti, kalvopäällysteinen PL 2023-03-15
SPC	Resepti	Rosuvastatin Krka 5 mg, 10 mg, 20 mg, 40 mg tabletti, kalvopäällysteinen PL 2023-03-15
SPC	Resepti	Rosuvastatin Orion 5 mg, 10 mg, 20 mg, 40 mg tabletti, kalvopäällysteinen PL 2024-06-13
SPC	Resepti	Rosuvastatin ratiopharm 5 mg, 10 mg, 20 mg, 40 mg tabletti, kalvopäällysteinen PL 2024-05-23
SPC	Resepti	Rosuvastatin Sandoz 5 mg, 10 mg, 20 mg, 40 mg tabletti, kalvopäällysteinen PL 2023-03-20
SPC	Resepti	Rosuvastatin Stada 5 mg, 10 mg, 20 mg, 40 mg, tabletti, kalvopäällysteinen PL 2024-02-26
SPC	Resepti	Rosuvastatin Xiromed 5mg, 10mg, 20mg, 40 mg tabletti kalvopäällysteinen PL 2023-02-28
SPC	Resepti	Rosuvastatin-Ezetimib Krka 5 mg-10 mg, 10 mg-10 mg, 20 mg - 10 mg tabletti , kalvopäällysteinen PL 2023-10-23
SPC	Resepti	Rosuvastatin-Ezetimibe ratiopharm 5 mg - 10 mg, 10 mg - 10 mg tabletti PL 2023-08-21
		European Medicines Agency's website: Rotarix - EMA: EPAR PI Finnish Swedish
		European Medicines Agency's website: RotaTeq - EMA: EPAR PI Finnish Swedish
		European Medicines Agency's website: Roteas - EMA: EPAR PI Finnish Swedish
		European Medicines Agency's website: Roteas - EMA: EPAR PI Finnish Swedish
SPC	Resepti	Rotigotine Medical Valley 1 mg-24 tuntia, 3 mg-24 tuntia depotlaastari PL 2024-10-03
SPC	Resepti	Rotigotine Medical Valley 2 mg-24 tuntia depotlaastari PL 2024-10-03
SPC	Resepti	Rotigotine Medical Valley 4 mg-24 tuntia, 6 mg-24 tuntia, 8 mg-24 tuntia depotlaastari PL 2024-10-03
SPC	Resepti	ROTOP-NanoHSA 0.5 mg valmisteyhdistelmä radioaktiivista lääkettä varten PL 2022-09-30
SPC	Itsehoito	Rowiren emulsiovoide PL 2021-07-20
SPC	Resepti	Roxiper 10 mg-4 mg-1.25 mg, 20 mg-4 mg-1.25 mg, 10 mg-8 mg-2.5 mg, 20 mg-8 mg-2.5 mg tabletti, kalvopäällysteinen PL 2023-05-23
SPC	Resepti	Roxithromycin Orifarm 150, 300 mg tabletti, kalvopäällysteinen PL 2018-06-18
SPC	Resepti	Roxithromycin Sandoz 150 mg, 300 mg tabletti, kalvopäällysteinen PL 2019-04-16
SPC	Resepti/itsehoito	Rozex 0.75 prosenttinen emulsiovoide PL OTC 2021-07-09
SPC	Resepti/itsehoito	Rozex 0.75 prosenttinen emulsiovoide PL Rx 2021-07-09
SPC	Resepti/itsehoito	Rozex 0.75 prosenttinen geeli PL OTC 2021-07-09
SPC	Resepti/itsehoito	Rozex 0.75 prosenttinen geeli PL Rx 2021-07-09
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