do-me/EUR-LEX huggingface dataset:
Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 December 2019 to 31 December 2019 (Decisions taken pursuant to Article 34 of Directive 2001/83/EC 11 or Article 38 of Directive 2001/82/EC 22 )
Date: 2020-01-31
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: EU Member State, drug surveillance, market approval, marketing standard, medicinal product








C_2020033EN.01001101.xml










31.1.2020   


EN


Official Journal of the European Union


C 33/11






Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 December 2019 to 31 December 2019
(Decisions taken pursuant to Article 34 of Directive 2001/83/EC (1) or Article 38 of Directive 2001/82/EC (2))
(2020/C 33/02)






—



Issuing, maintenance or modification of a national marketing authorisation















Date of the decision


Name(s) of the medicinal product


INN (International Non-Proprietary Name)


Holder(s) of the marketing authorisation


Member State concerned


Date of notification




16.12.2019


Flurbiprofen Geiser 8,75 mg oromucosal spray, solution and associated names


flurbiprofen


See Annex


See Annex


17.12.2019






(1)  OJ L 311, 28.11.2001, p. 67.

(2)  OJ L 311, 28.11.2001, p. 1.




ANNEX

List of medicinal products and presentations












Member State EU/EEA


Applicant company name, address


(Invented) Name


Strength


Pharmaceutical form


Route of administration


Content
(concentration)




Czechia







Geiser Pharma, S.L.




Camino Labiano 45B




31192 Mutilva Alta,




Navarra, Spain






Flurbiprofen Sejmet


8,75 mg/dose


Oromucosal spray, solution


Oromucosal use


17,16 mg/ml




The Netherlands







Geiser Pharma, S.L.




Camino Labiano 45B




31192 Mutilva Alta,




Navarra, Spain






Flurbiprofen Sejmet 8,75 mg keelspray


8,75 mg/dose


Oromucosal spray, solution


Oromucosal use


17,16 mg/ml




Portugal







Geiser Pharma, S.L.




Camino Labiano 45B




31192 Mutilva Alta,




Navarra, Spain






Mentocaína Spray


8,75 mg/dose


Oromucosal spray, solution


Oromucosal use


17,16 mg/ml




Slovakia







Geiser Pharma, S.L.




Camino Labiano 45B




31192 Mutilva Alta,




Navarra, Spain






Flurbiprofen Sejmet 8,75 mg orálna roztoková aerodisperzia


8,75 mg/dose


Oromucosal spray, solution


Oromucosal use


17,16 mg/ml




Spain







Geiser Pharma, S.L.




Camino Labiano 45B




31192 Mutilva Alta,




Navarra, Spain






Flurbiprofeno Geiser 8,75 mg/dosis solución para pulverización bucal


8,75 mg/dose


Oromucosal spray, solution


Oromucosal use


17,16 mg/ml