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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 241 - 265 of 265 |
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Package
leaflet | Status for
supply | Name of the medicinal product |
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PL
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Resepti
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Burana 200 mg, 400 mg, 600 mg, 800 mg tabletti, kalvopäällysteinen SPC 2023-12-12
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PL
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Resepti
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Burana 200 mg, 400 mg, 600 mg, 800 mg tabletti, kalvopäällysteinen SPC 2023-12-12
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PL
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Resepti
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Burana 200 mg, 400 mg, 600 mg, 800 mg tabletti, kalvopäällysteinen SPC 2023-12-12
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PL
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Resepti/itsehoito
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Burana 40 mg - ml oraalisuspensio SPC 2023-12-12
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PL
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Itsehoito
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Burana mustaherukka 400 mg jauhe oraaliliuosta varten, annospussi SPC 2023-12-12
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PL
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Itsehoito
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Burana sitruuna 400 mg jauhe oraaliliuosta varten, annospussi SPC 2023-12-12
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PL
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Resepti
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Burana Slow 800 mg depottabletti SPC 2023-12-12
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PL
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Itsehoito
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Burana-C tabletti, kalvopäällysteinen SPC 2023-12-12
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PL
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Resepti
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Burana-Caps 400 mg kapseli, pehmeä SPC 2023-12-12
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PL
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Itsehoito
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Burana-Caps 400 mg kapseli, pehmeä SPC 2023-12-12 OTC
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PL
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Itsehoito
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Buranagel 50 mg-g geeli SPC 2023-12-12
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PL
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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 SPC 2023-06-08
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PL
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Resepti
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Buscopan 20 mg-ml injektioneste, liuos SPC 2023-07-15
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European Medicines Agency's website:
Busilvex - EMA: EPAR PI
Finnish Swedish
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PL
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Resepti
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Buspiron ratiopharm 5 mg, 10 mg tabletti SPC 2019-08-27
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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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PL
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Resepti
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Buventol Easyhaler 100 mikrog-annos, 200 mikrog-annos inhalaatiojauhe SPC 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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