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)
Date: 2021-02-26
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: EU Member State, drug surveillance, market approval, marketing standard, medicinal product, veterinary medicinal product








C_2021067EN.01001501.xml










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






(1)  OJ L 311, 28.11.2001, p. 67.

(2)  OJ L 311, 28.11.2001, p. 1.




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







Zoetis Österreich GmbH




Floridsdorfer Hauptstraße 1




A- 1210 Wien




Österreich






Valbazen 100 mg/ml-Suspension zum Eingeben für Rinder


Albendazole


100 mg/ml


Oral suspension


Cattle


Oral use




Austria







AniMedica GmbH




Im Südfeld 9




48308 Senden-Bösensell




Germany






Albendazol-aniMedica 100 mg/ml Suspension zum Eingeben für Rinder


Albendazole


100 mg/ml


Oral suspension


Cattle


Oral use




Austria







Chanelle Pharmaceuticals Manufacturing Ltd




IDA Industrial Estate




Dublin Road, Loughrea




Co Galway H62 H771




Ireland






Albex Gold 200 mg/ml Oral Suspension for Cattle


Albendazole


200 mg/ml


Oral suspension


Cattle


Oral use




Belgium







Elanco GmbH




Heinz-Lohmann-Straβe 4




27472 Cuxhaven




Germany






Valbazen 10 %


Albendazole


100 mg/ml


Oral suspension


Cattle


Oral use




Belgium







Chanelle Pharmaceuticals Manufacturing Ltd




IDA Industrial Estate




Dublin Road, Loughrea




Co Galway H62 H771




Ireland






Albex 200 mg/ml oral suspension for cattle


Albendazole


200 mg/ml


Oral suspension


Cattle


Oral use




Bulgaria







Intervet International BV




Wim de Körverstraat 35




5831 AN Boxmeer




The Netherlands






Gardal 10 %


Albendazole


100 mg/ml


Oral suspension


Cattle, sheep


Oral use




Bulgaria







Asklep-Pharma Ltd.,




Lyulin 7, bl. 711A, shop 3,




Bulgaria






Albex BG 100 mg/ml oral suspension for cattle and sheep


Albendazole


100 mg/ml


Oral suspension


Cattle, sheep


Oral use




Croatia







Mount Trade d.o.o., Industrijska cesta 13, 43280 Garešnica




Croatia






Albix 100 mg/ml, oralna suspenzija za goveda i ovce


Albendazole


100 mg/ml


Oral suspension


Cattle, sheep


Oral use




France







Zoetis France




10 Rue Raymond David




92240 Malakoff




France






Valbazen dix


Albendazole


100 mg/ml


Oral suspension


Cattle


Oral use




France







Chanelle Pharmaceuticals Manufacturing Ltd




IDA Industrial Estate




Dublin Road, Loughrea




Co Galway H62 H771




Ireland






Albex Gold 200 mg/ml suspension buvable pour bovins


Albendazole


200 mg/ml


Oral suspension


Cattle


Oral use




Germany







Lilly Deutschland GmbH Abteilung Elanco Animal Health




Werner-Reimers-Straße 2-4




61352 Bad Homburg




Germany






Valbazen 10 %


Albendazole


100 mg/ml


Oral suspension


Cattle


Oral use




Germany







Chanelle Pharmaceuticals Manufacturing Ltd




IDA Industrial Estate




Dublin Road, Loughrea




Co Galway H62 H771




Ireland






Albex Gold 200 mg/ml Oral Suspension for Cattle


Albendazole


200 mg/ml


Oral suspension


Cattle


Oral use




Greece







Provet S.A.




77, Posidonos Avenue




174 55 Alimos, Attiki




Greece






Albendazole/Provet, πόσιμο εναιώρημα 10 % w/v


Albendazole


100 mg/ml


Oral suspension


Calves, Sheep, Goats


Oral use




Greece







Chanelle Pharmaceuticals Manufacturing Ltd




IDA Industrial Estate




Dublin Road, Loughrea




Co Galway H62 H771




Ireland






Albex Πόσιμο εναιώρημα 10 % w/v/


Albendazole


100 mg/ml


Oral suspension


Cattle, sheep, goats


Oral use




Ireland







Zoetis Belgium S.A.




2nd Floor, Building 10, Cherrywood Business Park, Loughlinstown, Co Dublin, Ireland






Valbazen 100 mg/ml Total Spectrum Wormer


Albendazole


100 mg/ml


Oral suspension


Cattle, sheep


Oral use




Ireland







Chanelle Pharmaceuticals Manufacturing Ltd




IDA Industrial Estate




Dublin Road, Loughrea




Co Galway H62 H771




Ireland






Albex Gold 200 mg/ml oral suspension for cattle


Albendazole


200 mg/ml


Oral suspension


Cattle


Oral use




Italy







Zoetis Italia S.r.l.




Via Andrea Doria 41M




00192 Roma




Italy






Valbazen 100 mg/ml sospensione per uso orale per bovini ed ovini


Albendazole


100 mg/ml


Oral suspension


Cattle, sheep


Oral use




Italy







Fatro S.p.A.




Via Emilia, 285




40064 Ozzano dell’Emilia (Bologna)




Italy






Sverminator 10, 100 mg/ml, sospensione orale per bovini ed ovini


Albendazole


100 mg/ml


Oral suspension


Cattle, sheep


Oral use




Italy







Chanelle Pharmaceuticals Manufacturing Ltd




IDA Industrial Estate




Dublin Road, Loughrea




Co Galway H62 H771




Ireland






Albex Gold 200 mg/ml sospensione orale per bovini


Albendazole


200 mg/ml


Oral suspension


Cattle


Oral use




Luxembourg







Elanco GmbH




Heinz-Lohmann-Straβe 4




27472 Cuxhaven




Germany






Valbazen 10 %


Albendazole


100 mg/ml


Oral suspension


Cattle


Oral use




Malta







Fatro S.p.A.




Via Emilia, 285




40064 Ozzano dell’Emilia (Bologna)




Italy






Sverminator 10


Albendazole


100 mg/ml


Oral suspension


Cattle, Sheep


Oral use




Poland







Chanelle Pharmaceuticals Manufacturing Ltd




IDA Industrial Estate




Dublin Road, Loughrea




Co Galway H62 H771




Ireland






Albex Gold 200 mg/ml oral suspension for cattle


Albendazole


200 mg/ml


Oral suspension


Cattle


Oral use




Poland







ZoetisPolska Sp. z.o.o




Postępu 17B, 02-676 Warszawa




Poland






Valbazen 10 %, 10 g/100 ml zawiesina doustna dla bydla i owiec


Albendazole


100 mg/ml


Oral suspension


Cattle, sheep


Oral use




Poland







C&H Generics Limited




c/o Michael McEvoy and Co




Seville House




New Dock Street




H91CKV0 Galway




Ireland






Albex 10 %


Albendazole


100 mg/ml


Oral suspension


Cattle, sheep


Oral use




Romania







Crida Pharm S.R.L.,




Str. Intrarea Vagonetului, Nr.2




Bl 101, Ap. 47, Sector 6,




RO-061151 Bucharest,




Romania






Cribendazol 10 %, 100 mg/ml


Albendazole


100 mg/ml


Oral suspension


Cattle


Oral use




The Netherlands







Chanelle Pharmaceuticals Manufacturing Ltd




IDA Industrial Estate




Dublin Road, Loughrea




Co Galway H62 H771




Ireland






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