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 241 - 264 of 264 |
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| SPC | Status for
supply | Name of the medicinal product |
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SPC
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Resepti
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Burana 200 mg, 400 mg, 600 mg, 800 mg tabletti, kalvopäällysteinen PL 2023-12-12
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SPC
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Resepti
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Burana 40 mg - ml oraalisuspensio PL 2024-04-08
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SPC
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Itsehoito
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Burana 40 mg - ml oraalisuspensio PL 2024-04-08 OTC
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SPC
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Itsehoito
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Burana mustaherukka 400 mg jauhe oraaliliuosta varten, annospussi PL 2023-12-12
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SPC
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Itsehoito
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Burana sitruuna 400 mg jauhe oraaliliuosta varten, annospussi PL 2023-12-12
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SPC
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Resepti
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Burana Slow 800 mg depottabletti PL 2023-12-12
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SPC
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Itsehoito
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Burana-C tabletti, kalvopäällysteinen PL 2023-12-12
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SPC
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Resepti
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Burana-Caps 400 mg kapseli, pehmeä PL 2023-12-12
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SPC
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Itsehoito
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Burana-Caps 400 mg kapseli, pehmeä PL OTC 2023-12-12
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SPC
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Itsehoito
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Buranagel 50 mg-g geeli PL 2023-12-12
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SPC
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Resepti
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Burpenorphine-Naloxone G.L. Pharma 2 mg-0.5 mg, 4 mg-1 mg, 8 mg-2 mg resoribletti PL 2023-06-08
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SPC
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Resepti
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Buscopan 20 mg-ml injektioneste, liuos PL 2023-07-15
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European Medicines Agency's website:
Busilvex - EMA: EPAR PI
Finnish Swedish
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SPC
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Resepti
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Buspiron ratiopharm 5 mg, 10 mg tabletti PL 2021-05-21
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European Medicines Agency's website:
Busulfan Frasenius Kabi - EMA: EPAR PI
Finnish Swedish
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European Medicines Agency's website:
Busulfan Fresenius Kabi - EMA: EPAR PI
Finnish Swedish
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SPC
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Resepti
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Buventol Easyhaler 100 mikrog-annos, 200 mikrog-annos inhalaatiojauhe PL 2023-12-19
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European Medicines Agency's website:
Buvidal - EMA: EPAR PI
Finnish Swedish
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European Medicines Agency's website:
BYANNLI (ent. Paliperidone Janssen-Cilag International) - EMA: EPAR PI
Finnish Swedish
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European Medicines Agency's website:
Bydureon - EMA: EPAR PI
Finnish Swedish
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European Medicines Agency's website:
Byetta - EMA: EPAR PI
Finnish Swedish
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European Medicines Agency's website:
Byfavo - EMA: EPAR PI
Finnish Swedish
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European Medicines Agency's website:
Bylvay - EMA: EPAR PI
Finnish Swedish
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European Medicines Agency's website:
Byooviz - EMA: EPAR PI
Finnish Swedish
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