Human medicinal products | | SPC PL | | Veterinary medicinal
products | SPC PL | | Herbal medicinal products | | SPC PL | | Name of the medicinal
product |
| |
|
|
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 1 - 30 of 343 |
|
|
SPC | Status for supply | Name of the medicinal product |
SPC
|
Resepti
|
D-Calsor 500 mg-10 mikrog (400 IU), 500 mg-20 mikrog (800IU) tabletti, kalvopäällysteinen PL 2021-04-28
|
SPC
|
Itsehoito
|
D-Calsor 500 mg-10 mikrog (400 IU), 500 mg-20 mikrog (800IU) tabletti, kalvopäällysteinen PL 2021-04-28 OTC
|
|
|
European Medicines Agency's website: Dabigatran etexilate Accord - EMA: EPAR PI
Finnish Swedish
|
SPC
|
Resepti
|
Dabigatran etexilate Glenmark 110 mg kapseli, kova PL 2024-03-07
|
SPC
|
Resepti
|
Dabigatran etexilate Glenmark 150 mg kapseli, kova PL 2024-03-07
|
SPC
|
Resepti
|
Dabigatran etexilate Glenmark 75 mg kapseli, kova PL 2024-02-26
|
SPC
|
Resepti
|
Dabigatran etexilate Krka 110 mg kapseli, kova PL 2023-10-20.docx
|
SPC
|
Resepti
|
Dabigatran etexilate Krka 150 mg kapseli, kova PL 2023-10-20.docx
|
SPC
|
Resepti
|
Dabigatran etexilate Krka 75 mg kapseli, kova PL 2023-10-20.docx
|
|
|
European Medicines Agency's website: Dabigatran etexilate Leon Farma - EMA: EPAR PI
Finnish Swedish
|
SPC
|
Resepti
|
Dabigatran etexilate Orion 110 mg kapseli, kova PL 2023-11-13.docx
|
SPC
|
Resepti
|
Dabigatran etexilate Orion 150 mg kapseli, kova PL 2023-11-13.docx
|
SPC
|
Resepti
|
Dabigatran etexilate Orion 75 mg kapseli, kova PL 2023-11-13.docx
|
SPC
|
Resepti
|
Dabigatran etexilate Sandoz 110 mg kapseli, kova PL 2024-10-09
|
SPC
|
Resepti
|
Dabigatran etexilate Sandoz 150 mg kapseli, kova PL 2024-10-09
|
SPC
|
Resepti
|
Dabigatran etexilate Sandoz 75 mg kapseli, kova PL 2024-10-09
|
SPC
|
Resepti
|
Dabigatran etexilate STADA 110 mg kapseli, kova PL 2023-11-09.docx
|
SPC
|
Resepti
|
Dabigatran etexilate STADA 150 mg kapseli, kova PL 2023-11-09.docx
|
SPC
|
Resepti
|
Dabigatran etexilate STADA 75 mg kapseli, kova PL 2023-11-09.docx
|
SPC
|
Resepti
|
Dabigatran etexilate STADA Nordic 110 mg kapseli, kova PL 2024-04-23.docx
|
SPC
|
Resepti
|
Dabigatran etexilate STADA Nordic 150 mg kapseli, kova PL 2024-04-23.docx
|
SPC
|
Resepti
|
Dabigatran etexilate STADA Nordic 75 mg kapseli, kova PL 2024-04-23.docx
|
SPC
|
Resepti
|
Dabigatran etexilate Viatris 110 mg kapseli, kova PL 2024-04-10
|
SPC
|
Resepti
|
Dabigatran etexilate Viatris 150 mg kapseli, kova PL 2024-04-10
|
SPC
|
Resepti
|
Dabigatran etexilate Viatris 75 mg kapseli, kova PL 2024-01-25
|
SPC
|
Resepti
|
DacarbaDacarbazine Lipomed 200 mg injektio-infuusiokuiva-aine, liuosta varten PL 2024-04-10
|
SPC
|
Resepti
|
Dacarbazine Lipomed 500 mg, 1000 mg infuusiokuiva-aine, liuosta varten PL 2024-04-10
|
SPC
|
Resepti
|
Dacarbazine medac 100 mg, 200 mg injektio-infuusiokuiva-aine liuosta varten PL 2023-08-31
|
SPC
|
Resepti
|
Dacarbazine medac 500 mg, 1000 mg infuusiokuiva-aine liuosta varten PL 2023-08-31
|
SPC
|
Resepti
|
Dacepton 10 mg-ml injektioneste PL 2023-09-29
|
|
| |