# C_2020033EN.01001101.xml

| 31.1.2020 | EN | Official Journal of the European Union | C 33/11 |
| --- | --- | --- | --- |

31.1.2020

EN

Official Journal of the European Union

C 33/11

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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 |
| --- | --- |

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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 |

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

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(1)  OJ L 311, 28.11.2001, p. 67.

(2)  OJ L 311, 28.11.2001, p. 1.

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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 |

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 |

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 |

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 |

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 |

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

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