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, Article 38 of Directive 2001/82/EC or Article 5 of Regulation (EU) 2019/6 of the European Parliament and of the Council)
Date: 2023-03-31
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: EU Member State, drug surveillance, market approval, marketing standard, medicinal product








C_2023118EN.01000901.xml










31.3.2023   


EN


Official Journal of the European Union


C 118/9






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