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Document 52021XC0226(07)
Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 January 2021 to 31 January 2021 (Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC)
Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 January 2021 to 31 January 2021 (Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC)
Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 January 2021 to 31 January 2021 (Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC)
PUB/2021/128
OJ C 67, 26.2.2021, pp. 15–24
(BG, ES, CS, DA, DE, ET, EL, EN, FR, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)
|
26.2.2021 |
EN |
Official Journal of the European Union |
C 67/15 |
Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 January 2021 to 31 January 2021
(Decisions taken pursuant to Article 34 of Directive 2001/83/EC (1) or Article 38 of Directive 2001/82/EC (2))
(2021/C 67/03)
— 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 |
|
18.1.2021 |
Valbazen |
Albendazole |
See Annex I |
See Annex I |
20.1.2021 |
|
11.1.2021 |
ulipristal acetate 5 mg |
ulipristal acetate 5 mg |
See Annex II |
See Annex II |
12.1.2021 |
ANNEX I
List of the names, pharmaceutical form, strengths of the veterinary medicinal products, animal species, route of administration, marketing authorisation holders in the Member States
|
Member State EU/EEA |
Marketing authorisation holders |
Name |
INN |
Strength |
Pharmaceutical form |
Animal species |
Route of administration |
||||||
|
Austria |
|
Valbazen 100 mg/ml-Suspension zum Eingeben für Rinder |
Albendazole |
100 mg/ml |
Oral suspension |
Cattle |
Oral use |
||||||
|
Austria |
|
Albendazol-aniMedica 100 mg/ml Suspension zum Eingeben für Rinder |
Albendazole |
100 mg/ml |
Oral suspension |
Cattle |
Oral use |
||||||
|
Austria |
|
Albex Gold 200 mg/ml Oral Suspension for Cattle |
Albendazole |
200 mg/ml |
Oral suspension |
Cattle |
Oral use |
||||||
|
Belgium |
|
Valbazen 10 % |
Albendazole |
100 mg/ml |
Oral suspension |
Cattle |
Oral use |
||||||
|
Belgium |
|
Albex 200 mg/ml oral suspension for cattle |
Albendazole |
200 mg/ml |
Oral suspension |
Cattle |
Oral use |
||||||
|
Bulgaria |
|
Gardal 10 % |
Albendazole |
100 mg/ml |
Oral suspension |
Cattle, sheep |
Oral use |
||||||
|
Bulgaria |
|
Albex BG 100 mg/ml oral suspension for cattle and sheep |
Albendazole |
100 mg/ml |
Oral suspension |
Cattle, sheep |
Oral use |
||||||
|
Croatia |
|
Albix 100 mg/ml, oralna suspenzija za goveda i ovce |
Albendazole |
100 mg/ml |
Oral suspension |
Cattle, sheep |
Oral use |
||||||
|
France |
|
Valbazen dix |
Albendazole |
100 mg/ml |
Oral suspension |
Cattle |
Oral use |
||||||
|
France |
|
Albex Gold 200 mg/ml suspension buvable pour bovins |
Albendazole |
200 mg/ml |
Oral suspension |
Cattle |
Oral use |
||||||
|
Germany |
|
Valbazen 10 % |
Albendazole |
100 mg/ml |
Oral suspension |
Cattle |
Oral use |
||||||
|
Germany |
|
Albex Gold 200 mg/ml Oral Suspension for Cattle |
Albendazole |
200 mg/ml |
Oral suspension |
Cattle |
Oral use |
||||||
|
Greece |
|
Albendazole/Provet, πόσιμο εναιώρημα 10 % w/v |
Albendazole |
100 mg/ml |
Oral suspension |
Calves, Sheep, Goats |
Oral use |
||||||
|
Greece |
|
Albex Πόσιμο εναιώρημα 10 % w/v/ |
Albendazole |
100 mg/ml |
Oral suspension |
Cattle, sheep, goats |
Oral use |
||||||
|
Ireland |
|
Valbazen 100 mg/ml Total Spectrum Wormer |
Albendazole |
100 mg/ml |
Oral suspension |
Cattle, sheep |
Oral use |
||||||
|
Ireland |
|
Albex Gold 200 mg/ml oral suspension for cattle |
Albendazole |
200 mg/ml |
Oral suspension |
Cattle |
Oral use |
||||||
|
Italy |
|
Valbazen 100 mg/ml sospensione per uso orale per bovini ed ovini |
Albendazole |
100 mg/ml |
Oral suspension |
Cattle, sheep |
Oral use |
||||||
|
Italy |
|
Sverminator 10, 100 mg/ml, sospensione orale per bovini ed ovini |
Albendazole |
100 mg/ml |
Oral suspension |
Cattle, sheep |
Oral use |
||||||
|
Italy |
|
Albex Gold 200 mg/ml sospensione orale per bovini |
Albendazole |
200 mg/ml |
Oral suspension |
Cattle |
Oral use |
||||||
|
Luxembourg |
|
Valbazen 10 % |
Albendazole |
100 mg/ml |
Oral suspension |
Cattle |
Oral use |
||||||
|
Malta |
|
Sverminator 10 |
Albendazole |
100 mg/ml |
Oral suspension |
Cattle, Sheep |
Oral use |
||||||
|
Poland |
|
Albex Gold 200 mg/ml oral suspension for cattle |
Albendazole |
200 mg/ml |
Oral suspension |
Cattle |
Oral use |
||||||
|
Poland |
|
Valbazen 10 %, 10 g/100 ml zawiesina doustna dla bydla i owiec |
Albendazole |
100 mg/ml |
Oral suspension |
Cattle, sheep |
Oral use |
||||||
|
Poland |
|
Albex 10 % |
Albendazole |
100 mg/ml |
Oral suspension |
Cattle, sheep |
Oral use |
||||||
|
Romania |
|
Cribendazol 10 %, 100 mg/ml |
Albendazole |
100 mg/ml |
Oral suspension |
Cattle |
Oral use |
||||||
|
The Netherlands |
|
Albex Gold 200 mg/ml, orale suspensie voor runderen |
Albendazole |
200 mg/ml |
Oral suspension |
Cattle |
Oral use |
ANNEX II
List of nationally authorised medicinal products
|
Member State (EEA) |
Marketing Authorisation Holder |
Product name |
INN/Active substance + Strength (per unit) |
Pharmaceutical form |
Route of administration |
|
Croatia |
Alvogen Pharma Trading Europe Eood |
Ulipristalacetat Alvogen |
Ulipristal Acetate 5 mg Tablet |
Tablet |
Oral Use |
|
Czech Republic |
Aristo Pharma Gmbh (Art 57) |
Ulimyo |
Ulipristal Acetate 5 mg Tablet |
Tablet |
Oral Use |
|
Czech Republic |
Zentiva, K.S. |
Stillupra |
Ulipristal Acetate 5 mg Tablet |
Tablet |
Oral Use |
|
France |
Accord Healthcare France Sas |
Ulipristal Acetate Accord |
Ulipristal Acetate 5 mg Tablet |
Tablet |
Oral Use |
|
France |
Eg Labo Laboratoires Eurogenerics |
Ulipristal Acetate Eg |
Ulipristal Acetate 5 mg Tablet |
Tablet |
Oral Use |
|
France |
Helm Ag |
Ulipristal Acetate Helm |
Ulipristal Acetate 5 mg Tablet |
Film-Coated Tablet |
Oral Use |
|
France |
Zentiva France |
Ulipristal Acetate Zentiva |
Ulipristal Acetate 5 mg Tablet |
Tablet |
Oral Use |
|
Germany |
Accord Healthcare B.V. |
Ulipristal Accord |
Ulipristal Acetate 5 mg Tablet |
Tablet |
Oral Use |
|
Germany |
Aliud Pharma Gmbh |
Ulipristal Al |
Ulipristal Acetate 5 mg Tablet |
Tablet |
Oral Use |
|
Germany |
Aristo Pharma Gmbh (Art 57) |
Ulimyo |
Ulipristal Acetate 5 mg Tablet |
Tablet |
Oral Use |
|
Germany |
Cipla Europe Nv |
Ulipristal Cipla |
Ulipristal Acetate 5 mg Tablet |
Tablet |
Oral Use |
|
Germany |
Cyndea Pharma S.L |
Ulipristal Cyndea |
Ulipristal Acetate 5 mg Tablet |
Tablet |
Oral Use |
|
Germany |
Heumann Pharma Gmbh & Co. Generica Kg |
Ulipristal Heumann |
Ulipristal Acetate 5 mg Tablet |
Tablet |
Oral Use |
|
Germany |
Zentiva Pharma Gmbh |
Ulipristal Zentiva |
Ulipristal Acetate 5 mg Tablet |
Tablet |
Oral Use |
|
Greece |
Faran S.A. |
Boled |
Ulipristal Acetate 5 mg Tablet |
Tablet |
Oral Use |
|
Hungary |
Alvogen Pharma Trading Europe Eood |
Uliprisztál-Acetát Alvogen |
Ulipristal Acetate 5 mg Tablet |
Tablet |
Oral Use |
|
Hungary |
Aristo Pharma Gmbh (Art 57) |
Ulimyo |
Ulipristal Acetate 5 mg Tablet |
Tablet |
Oral Use |
|
Iceland |
Alvogen Pharma Trading Europe Eood |
Ulipristal Asetat Alvogen |
Ulipristal Acetate 5 mg Tablet |
Tablet |
Oral Use |
|
Malta |
G.L. Pharma Gmbh |
Ulipristal G.L. |
Ulipristal Acetate 5 mg Tablet |
Tablet |
Oral Use |
|
Netherlands |
Helm Ag |
Ulipristal Helm |
Ulipristal Acetate 5 mg Tablet |
Film-Coated Tablet |
Oral Use |
|
Netherlands |
Sandoz B.V. |
Elyoma |
Ulipristal Acetate 5 mg Tablet |
Tablet |
Oral Use |
|
Poland |
Alvogen Pharma Trading Europe Eood |
Ulipristal Alvogen |
Ulipristal Acetate 5 mg Tablet |
Tablet |
Oral Use |
|
Poland |
Aristo Pharma Gmbh (Art 57) |
Ulimyo |
Ulipristal Acetate 5 mg Tablet |
Tablet |
Oral Use |
|
Portugal |
Ciclum Farma Unipessoal Lda. |
Ulipristal Ciclum |
Ulipristal Acetate 5 mg Tablet |
Tablet |
Oral Use |
|
Portugal |
G.L. Pharma Gmbh |
Ulipristal G.L |
Ulipristal Acetate 5 mg Tablet |
Tablet |
Oral Use |
|
Portugal |
Sumar Pharma Ehf |
Karevonal |
Ulipristal Acetate 5 mg Tablet |
Tablet |
Oral Use |
|
Portugal |
Sumar Pharma Ehf |
Selavona |
Ulipristal Acetate 5 mg Tablet |
Tablet |
Oral Use |
|
Portugal |
Sumar Pharma Ehf |
Ulipristal Sumar |
Ulipristal Acetate 5 mg Tablet |
Tablet |
Oral Use |
|
Portugal |
Sumar Pharma Ehf |
Varinam |
Ulipristal Acetate 5 mg Tablet |
Tablet |
Oral Use |
|
Portugal |
Zentiva Portugal, Lda |
Stillupra |
Ulipristal Acetate 5 mg Tablet |
Tablet |
Oral Use |
|
Portugal |
Zentiva Portugal, Lda |
Ulipristal Zentiva |
Ulipristal Acetate 5 mg Tablet |
Tablet |
Oral Use |
|
Slovakia |
Aristo Pharma Gmbh (Art 57) |
Ulimyo |
Ulipristal Acetate 5 mg Tablet |
Tablet |
Oral Use |
|
Slovakia |
Zentiva, K.S. |
Stillupra |
Ulipristal Acetate 5 mg Tablet |
Tablet |
Oral Use |
|
Spain |
Adamed Laboratorios, S.L.U. |
Missitel |
Ulipristal Acetate 5 mg Tablet |
Tablet |
Oral Use |
|
Spain |
Cipla Europe Nv |
Ulipristal Cipla |
Ulipristal Acetate 5 mg Tablet |
Tablet |
Oral Use |
|
Spain |
Cyndea Pharma S.L |
Ulipristal Cyndea |
Ulipristal Acetate 5 mg Tablet |
Tablet |
Oral Use |
|
Spain |
Helm Ag |
Ulipristal Acetate Helm |
Ulipristal Acetate 5 mg Tablet |
Film-Coated Tablet |
Oral Use |
|
United Kingdom |
Accord Healthcare Limited |
Ulipristal Acetate Accord Healthcare |
Ulipristal Acetate 5 mg Tablet |
Tablet |
Oral Use |
|
United Kingdom |
Cipla (Eu) Limited |
Ulipristal Acetate Cipla |
Ulipristal Acetate 5 mg Tablet |
Tablet |
Oral Use |
|
United Kingdom |
Creo Pharma Ltd |
Ulipristal Acetate Creo Pharma |
Ulipristal Acetate 5 mg Tablet |
Tablet |
Oral Use |
|
United Kingdom |
Helm Ag |
Ulipristal Helm |
Ulipristal Acetate 5 mg Tablet |
Film-Coated Tablet |
Oral Use |
|
United Kingdom |
Mercury Pharmaceuticals Ltd. |
Ulipristal Acetate Mercury Pharmaceuticals |
Ulipristal Acetate 5 mg Tablet |
Tablet |
Oral Use |
|
United Kingdom |
Zentiva Pharma Uk Limited |
Ulipristal Acetate Zentiva |
Ulipristal Acetate 5 mg Tablet |
Tablet |
Oral Use |