# C_2021105EN.01001101.xml

| 26.3.2021 | EN | Official Journal of the European Union | C 105/11 |
| --- | --- | --- | --- |

26.3.2021

EN

Official Journal of the European Union

C 105/11

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Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 February 2021 to 28 February 2021

(Decisions taken pursuant to Article 34 of Directive 2001/83/EC (1) or Article 38 of Directive 2001/82/EC (2))

(2021/C 105/02)

—   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 |
| --- | --- | --- | --- | --- | --- |
| 25.2.2021 | Adjusol tmp sulfa liquide and its associated names | Sulfadiazine and trimethoprim | See Annex | See Annex | 26.2.2021 |
| 19.2.2021 | Angiotensin-II-receptor antagonists (sartans) containing a tetrazole group | candesartan, irbesartan, losartan, olmesartan, valsartan | Not applicable | Not applicable | 22.2.2021 |

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

25.2.2021

Adjusol tmp sulfa liquide and its associated names

Sulfadiazine and trimethoprim

See Annex

See Annex

26.2.2021

19.2.2021

Angiotensin-II-receptor antagonists (sartans) containing a tetrazole group

candesartan, irbesartan, losartan, olmesartan, valsartan

Not applicable

Not applicable

22.2.2021

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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

List of the names, pharmaceutical form, strength of the veterinary medicinal product, animal species, route of administration, marketing authorisation holder in the Member States

| Member State EU/EEA | Marketing authorisation holder | Name | INN | Strength | Pharmaceutical form | Animal species | Route of administration |
| --- | --- | --- | --- | --- | --- | --- | --- |
| France | Virbac |
| 1ere Avenue 2065M LID |
| 06516 Carros Cedex |
| France |

Member State EU/EEA

Marketing authorisation holder

Name

INN

Strength

Pharmaceutical form

Animal species

Route of administration

France

Virbac

1ere Avenue 2065M LID

06516 Carros Cedex

France

Adjusol TMP Sulfa Liquide

Trimethoprim

Sulfadiazine

16,65  mg/ml

83,35  mg/ml

Oral solution

Cattle (calves), sheep (lambs), pigs, rabbits, poultry (chickens, turkeys, ducks)

Oral use

Greece

| Virbac |
| --- |
| 1ere Avenue 2065M LID |
| 06516 Carros Cedex |
| France |

Virbac

1ere Avenue 2065M LID

06516 Carros Cedex

France

ADJUSOL TMP SULFA πόσιμο διάλυμα (1,665 +8,335 )g/100ml

Trimethoprim

Sulfadiazine

16,65  mg/ml

83,35  mg/ml

Oral solution

Broilers

Oral use

Luxembourg

| Virbac |
| --- |
| 1ere Avenue 2065M LID |
| 06516 Carros Cedex |
| France |

Virbac

1ere Avenue 2065M LID

06516 Carros Cedex

France

ADJUSOL TMP SULFA LIQUIDE

Trimethoprim

Sulfadiazine

16,65  mg/ml

83,35  mg/ml

Oral solution

Cattle (calves), sheep (lambs), pigs, rabbits, poultry (chickens, turkeys, ducks)

Oral use

Portugal

| Virbac |
| --- |
| 1ere Avenue 2065M LID |
| 06516 Carros Cedex |
| France |

Virbac

1ere Avenue 2065M LID

06516 Carros Cedex

France

ADJUSOL TMP SULFA LIQUIDO, solução oral para administração na água de bebida para frangos de carne

Trimethoprim

Sulfadiazine

16,65  mg/ml

83,35  mg/ml

Oral solution

Broilers

Oral use

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