# C_2021067EN.01001501.xml

| 26.2.2021 | EN | Official Journal of the European Union | C 67/15 |
| --- | --- | --- | --- |

26.2.2021

EN

Official Journal of the European Union

C 67/15

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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 |

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

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(1)  OJ L 311, 28.11.2001, p. 67.

(2)  OJ L 311, 28.11.2001, p. 1.

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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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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

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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 |

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

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