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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 121 - 150 of 250 |
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Package
leaflet | Status for
supply | Name of the medicinal product |
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European Medicines Agency's website:
Ontozry - EMA: EPAR PI
Finnish Swedish
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European Medicines Agency's website:
Ontruzant - EMA: EPAR PI
Finnish Swedish
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European Medicines Agency's website:
Onureg - EMA: EPAR PI
Finnish Swedish
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PL
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Resepti
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Onytec 80 mg-g lääkekynsilakka SPC 2022-07-13
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PL
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Resepti
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Opamox 15 mg, 30 mg, 50 mg tabletti SPC 2021-05-07
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European Medicines Agency's website:
Opatanol - EMA: EPAR PI
Finnish Swedish
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European Medicines Agency's website:
Opdivo - EMA: EPAR PI
Finnish Swedish
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European Medicines Agency's website:
Opdualag - EMA: EPAR PI
Finnish Swedish
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European Medicines Agency's website:
Opfolda - EMA: EPAR PI
Finnish Swedish
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PL
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Resepti
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Ophtesic 20 mg-g silmägeeli, kerta-annospakkaus SPC 2024-01-15
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PL
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Resepti
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Ophthajod 50 mg-ml silmätipat, liuos SPC 2024-10-04
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European Medicines Agency's website:
Oprymea - EMA: EPAR PI
Finnish Swedish
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European Medicines Agency's website:
Opsumit - EMA: EPAR PI
Finnish Swedish
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PL
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Resepti
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Optinate Septimum 35 mg tabletti, kalvopäällysteinen SPC 2024-10-16
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PL
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Resepti
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Optipar 20 mg, 40 mg tabletti, kalvopäällysteinen SPC 2024-02-01
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PL
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Resepti
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Optiray 300 mg I-ml injektio-infuusioneste, liuos SPC 2023-04-19
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PL
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Resepti
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Optiray 300 mg I-ml injektio-infuusioneste, liuos, moniannospakkaus, SPC 2023-02-28
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PL
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Resepti
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Optiray 320 mg I-ml injektio-infuusioneste, liuos SPC 2023-02-28
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PL
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Resepti
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Optiray 320 mg I-ml injektio-infuusioneste, liuos, moniannospakkaus, SPC 2023-05-29
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PL
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Resepti
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Optiray 350 mg I-ml injektio-infuusioneste, liuos SPC 2023-04-19
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PL
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Resepti
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Optiray 350 mg I-ml injektio-infuusioneste, liuos, moniannospakkaus, SPC 2023-04-19
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European Medicines Agency's website:
Optison - EMA: EPAR PI
Finnish Swedish
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European Medicines Agency's website:
Optruma - EMA: EPAR PI
Finnish Swedish
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PL
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Resepti
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Oracea 40 mg säädellysti vapauttava kapseli, kova SPC 2021-04-27
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PL
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Resepti
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Oradexon 5 mgml injektioneste, liuos SPC 2022-08-29
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PL
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Resepti
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Oramet 500 mg, 850 mg tabletti, kalvopäällysteinen SPC 2023-06-26
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PL
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Resepti
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Oramet-hexal 1000 mg tabletti, kalvopäällysteinen SPC 2024-02-29
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PL
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Resepti
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Oramorph 2 mg-ml oraaliliuos kerta-annosampullissa SPC 2023-12-07
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PL
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Resepti
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Oramorph 2 mg-ml oraaliliuos SPC 2023-12-07
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PL
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Resepti
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Oramorph 20 mg-ml oraaliliuos kerta-annosampulissa SPC 2023-12-07
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