# C_2023118EN.01000901.xml

| 31.3.2023 | EN | Official Journal of the European Union | C 118/9 |
| --- | --- | --- | --- |

31.3.2023

EN

Official Journal of the European Union

C 118/9

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Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 February 2023 to 28 February 2023

(Decisions taken pursuant to Article 34 of Directive 2001/83/EC (1), Article 38 of Directive 2001/82/EC (2) or Article 5 of Regulation (EU) 2019/6 of the European Parliament and of the Council (3))

(2023/C 118/02)

—   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 |
| --- | --- | --- | --- | --- | --- |
| 27.2.2023 | Gelisia and associated names | timolol maleate | See Annex I | See Annex I | 27.2.2023 |
| 15.2.2023 | Rambis and associated names | ramipril/bisoprolol fumarate | See Annex II | See Annex II | 16.2.2023 |

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

27.2.2023

Gelisia and associated names

timolol maleate

See Annex I

See Annex I

27.2.2023

15.2.2023

Rambis and associated names

ramipril/bisoprolol fumarate

See Annex II

See Annex II

16.2.2023

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

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

(3)  OJ L 4, 7.1.2019, p. 43.

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ANNEX I

List of medicinal products and presentations

| Member State EU/EEA | Applicant | Invented name | INN + Strength | Pharmaceutical form | Route of administration | Content (concentration) |
| --- | --- | --- | --- | --- | --- | --- |
| France | SIFI S.p.A. |
| Via Ercole Patti 36 |
| 95025 — Aci Sant’Antonio (CT) |
| Italy |

Member State EU/EEA

Applicant

Invented name

INN + Strength

Pharmaceutical form

Route of administration

Content (concentration)

France

SIFI S.p.A.

Via Ercole Patti 36

95025 — Aci Sant’Antonio (CT)

Italy

GENOPTOL

1 mg/g

Eye gel in single-dose container

Ocular use

1 mg/g

Germany

| SIFI S.p.A. |
| --- |
| Via Ercole Patti 36 |
| 95025 — Aci Sant’Antonio (CT) |
| Italy |

SIFI S.p.A.

Via Ercole Patti 36

95025 — Aci Sant’Antonio (CT)

Italy

Gelisia

1 mg/g

Eye gel in single-dose container

Ocular use

1 mg/g

Italy

| SIFI S.p.A. |
| --- |
| Via Ercole Patti 36 |
| 95025 — Aci Sant’Antonio (CT) |
| Italy |

SIFI S.p.A.

Via Ercole Patti 36

95025 — Aci Sant’Antonio (CT)

Italy

GELISIA

1 mg/g

Eye gel in single-dose container

Ocular use

1 mg/g

The Netherlands

| SIFI S.p.A. |
| --- |
| Via Ercole Patti 36 |
| 95025 — Aci Sant’Antonio (CT) |
| Italy |

SIFI S.p.A.

Via Ercole Patti 36

95025 — Aci Sant’Antonio (CT)

Italy

Gelisia

1 mg/g

Eye gel in single-dose container

Ocular use

1 mg/g

Romania

| SIFI S.p.A. |
| --- |
| Via Ercole Patti 36 |
| 95025 — Aci Sant’Antonio (CT) |
| Italy |

SIFI S.p.A.

Via Ercole Patti 36

95025 — Aci Sant’Antonio (CT)

Italy

GELISIA

1 mg/g

Eye gel in single-dose container

Ocular use

1 mg/g

Spain

| SIFI S.p.A. |
| --- |
| Via Ercole Patti 36 |
| 95025 — Aci Sant’Antonio (CT) |
| Italy |

SIFI S.p.A.

Via Ercole Patti 36

95025 — Aci Sant’Antonio (CT)

Italy

TIMOLOL SIFI 1 MG/G GEL OFTALMICO

1 mg/g

Eye gel in single-dose container

Ocular use

1 mg/g

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ANNEX II

List of medicinal products and presentations

| Member State EU/EEA | Applicant | (Invented) Name | Strength | Pharmaceutical form | Route of administration |
| --- | --- | --- | --- | --- | --- |
| Czech Republic | Adamed Pharma S.A. |
| ul. Mariana Adamkiewicza 6A |
| 05-152 Pieńków/Czosnów |
| Poland |

Member State EU/EEA

Applicant

(Invented) Name

Strength

Pharmaceutical form

Route of administration

Czech Republic

Adamed Pharma S.A.

ul. Mariana Adamkiewicza 6A

05-152 Pieńków/Czosnów

Poland

RALBIOR

2,5  mg/1,25  mg (ramipril/bisoprolol fumarate)

2,5  mg/2,5  mg (ramipril/bisoprolol fumarate)

5 mg/2,5  mg (ramipril/bisoprolol fumarate)

5 mg/5 mg (ramipril/bisoprolol fumarate)

10mg/5 mg (ramipril/bisoprolol fumarate)

10 mg/10 mg

(ramipril/bisoprolol fumarate)

Capsule, hard

Oral use

Poland

| Adamed Pharma S.A. |
| --- |
| ul. Mariana Adamkiewicza 6A |
| 05-152 Pieńków/Czosnów |
| Poland |

Adamed Pharma S.A.

ul. Mariana Adamkiewicza 6A

05-152 Pieńków/Czosnów

Poland

RAMBIS

2,5  mg/1,25  mg (ramipril/bisoprolol fumarate)

2,5  mg/2,5  mg (ramipril/bisoprolol fumarate)

5 mg/2,5  mg

(ramipril/bisoprolol fumarate)

5 mg/5 mg (ramipril/bisoprolol fumarate)

10mg/ 5mg (ramipril/bisoprolol fumarate)

10 mg/ 10mg (ramipril/bisoprolol fumarate)

Capsule, hard

Oral use

Slovak Republic

| Adamed Pharma S.A. |
| --- |
| ul. Mariana Adamkiewicza 6A |
| 05-152 Pieńków/Czosnów |
| Poland |

Adamed Pharma S.A.

ul. Mariana Adamkiewicza 6A

05-152 Pieńków/Czosnów

Poland

RALBIOR 2,5  mg/1,25  mg tvrdé kapsuly;

RALBIOR 5 mg/2,5 mg tvrdé kapsuly

RALBIOR 5 mg/2,5  mg tvrdé kapsuly;

RALBIOR 5 mg/5 mg tvrdé kapsuly;

RALBIOR 10 mg/5 mg tvrdé kapsuly;

RALBIOR 10 mg/10 mg tvrdé kapsuly

2,5  mg/1,25  mg (ramipril/bisoprolol fumarate)

2,5  mg/2,5  mg (ramipril/bisoprolol fumarate)

5 mg/2,5  mg (ramipril/bisoprolol fumarate)

5 mg/5 mg (ramipril/bisoprolol fumarate)

1 0mg/ 5mg (ramipril/bisoprolol fumarate)

10 mg/ 10mg (ramipril/bisoprolol fumarate)

Capsule, hard

Oral use

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