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

(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.

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

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

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

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

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

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

TIMOLOL SIFI 1 MG/G GEL OFTALMICO

1 mg/g

Eye gel in single-dose container

Ocular use

1 mg/g

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

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

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

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