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Document 52023XC0331(05)
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)
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)
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)
PUB/2023/326
OJ C 118, 31.3.2023, p. 9–11
(BG, ES, CS, DA, DE, ET, EL, EN, FR, GA, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)
|
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.
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 |
|
GENOPTOL |
1 mg/g |
Eye gel in single-dose container |
Ocular use |
1 mg/g |
||||
|
Germany |
|
Gelisia |
1 mg/g |
Eye gel in single-dose container |
Ocular use |
1 mg/g |
||||
|
Italy |
|
GELISIA |
1 mg/g |
Eye gel in single-dose container |
Ocular use |
1 mg/g |
||||
|
The Netherlands |
|
Gelisia |
1 mg/g |
Eye gel in single-dose container |
Ocular use |
1 mg/g |
||||
|
Romania |
|
GELISIA |
1 mg/g |
Eye gel in single-dose container |
Ocular use |
1 mg/g |
||||
|
Spain |
|
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 |
|
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 |
|
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 |
|
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 |