Human medicinal products
SPC PL
Veterinary medicinal
products
SPC PL
Herbal medicinal products
SPC PL
Name of the medicinal
product
A B C D E F G
H I J K L M N
O P Q R S T U
V W X Y Z Å Ä Ö
Name of the medicinal
product

Marketing authorisation
holder

Marketing authorisation
number

ATC Code Codes

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Active agent

Pharmaceutical form

Adverse effect

Therapeutic indication

Contraindication

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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 31 - 53 of 53
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Package
leaflet
Status for
supply
Name of the medicinal product

European Medicines Agency's website:
Xigduo - EMA: EPAR PI
Finnish Swedish

European Medicines Agency's website:
Xiliarx - EMA: EPAR PI
Finnish Swedish

PL

Resepti

Xilmac 1000mg-200mg injektio-infuusiokuiva-aine, liuosta varten SPC 2023-11-07

European Medicines Agency's website:
Ximluci - EMA: EPAR PI
Finnish Swedish

European Medicines Agency's website:
Xofigo - EMA: EPAR PI
Finnish Swedish

European Medicines Agency's website:
Xofluza - EMA: EPAR PI
Finnish Swedish

European Medicines Agency's website:
Xolair - EMA: EPAR PI
Finnish Swedish

PL

Resepti

Xonvea 10 mg - 10 mg enterotabletti SPC 2024-02-08

PL

Resepti

Xorox 30 mg-g silmävoide SPC 2021-02-03

European Medicines Agency's website:
Xospata - EMA: EPAR PI
Finnish Swedish

European Medicines Agency's website:
Xoterna Breezhaler - EMA: EPAR PI
Finnish Swedish

European Medicines Agency's website:
Xromi - EMA: EPAR PI
Finnish Swedish

European Medicines Agency's website:
Xtandi - EMA: EPAR PI
Finnish Swedish

European Medicines Agency's website:
Xultophy - EMA: EPAR PI
Finnish Swedish

European Medicines Agency's website:
Xydalba - EMA: EPAR PI
Finnish Swedish

PL

Resepti

Xylocain 100 mg-ml sumute iholle, liuos SPC 2018-06-29

PL

Resepti

Xylocain 100 mg/ml sumute iholle, liuos SPC 2022-01-13.doc

PL

Resepti

Xylocain 2% geeli, SPC 2023-11-06

PL

Resepti

Xylocain Dental Adrenalin 20 mg-ml + 12.5 mikrog-ml injektioneste, liuos SPC 2015-08-18.doc

European Medicines Agency's website:
Xyrem - EMA: EPAR PI
Finnish Swedish

PL

Resepti

Xyzal 0.5 mg-ml oraaliliuos SPC 2022-07-14

PL

Resepti/itsehoito

Xyzal 5 mg tabletti, kalvopäällysteinen SPC 2022-07-14

PL

Resepti/itsehoito

Xyzal 5 mg-ml tipat, liuos SPC 2022-07-14

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