# C_2016154EN.01000801.xml

| 29.4.2016 | EN | Official Journal of the European Union | C 154/8 |
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29.4.2016

EN

Official Journal of the European Union

C 154/8

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Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 March 2016 to 31 March 2016

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

1

2

(2016/C 154/02)

—   Issuing, maintenance or modification of a national marketing authorisation

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 |
| --- | --- | --- | --- | --- | --- |
| 22.3.2016 | Closamectin Pour-On Solution and associated names — Art. 78 | Closantel and ivermectin | See Annex | See Annex | 29.3.2016 |
| 7.3.2016 | Rivastigmine Rectificative Decision PSUSA 2654 201501 | Rivastigmine | Not applicable | Not applicable | 8.3.2016 |

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

22.3.2016

Closamectin Pour-On Solution and associated names — Art. 78

Closantel and ivermectin

See Annex

See Annex

29.3.2016

7.3.2016

Rivastigmine Rectificative Decision PSUSA 2654 201501

Rivastigmine

Not applicable

Not applicable

8.3.2016

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

1

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

2

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ANNEX

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

| Member State (EU/EEA) | Marketing authorisation holder | Product name | INN | Strength | Pharmaceutical form | Animal species | Route of administration |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Austria | Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Northern Ireland | Closamectin 5 mg/ml + 200 mg/ml Pour-On Lösung für Rinder | Ivermectin Closantel | 5 mg/ml 200 mg/ml | Pour-On solution | Cattle | Topical use |
| Belgium | Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Northern Ireland | Closamectin 5 mg/ml + 200 mg/ml pour-on oplossing voor rundvee | Ivermectin Closantel | 5 mg/ml 200 mg/ml | Pour-On solution | Cattle | Topical use |
| Czech Republic | Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Northern Ireland | Closamectin 5 mg/ml + 200 mg/ml roztok pro nalévání na hřbet — pour-on | Ivermectin Closantel | 5 mg/ml 200 mg/ml | Pour-On solution | Cattle | Topical use |
| Denmark | Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Northern Ireland | Closamectin Pour-On | Ivermectin Closantel | 5 mg/ml 200 mg/ml | Pour-On solution | Cattle | Topical use |
| France | Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Northern Ireland | CLOSAMECTIN POUR-ON SOLUTION POUR BOVINS | Ivermectin Closantel | 5 mg/ml 200 mg/ml | Pour-On solution | Cattle | Topical use |
| Germany | Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Northern Ireland | Closamectin 5 mg/ml + 200 mg/ml Pour-On Lösung zum Übergießen für Rinder | Ivermectin Closantel | 5 mg/ml 200 mg/ml | Pour-On solution | Cattle | Topical use |
| Greece | Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Northern Ireland | Closamectin 5 mg/ml + 200 mg/ml διάλυμα επίχυσης για Βοοειδή | Ivermectin Closantel | 5 mg/ml 200 mg/ml | Pour-On solution | Cattle | Topical use |
| Ireland | Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Northern Ireland | Closamectin 5 mg/ml + 200 mg/ml Pour-On Solution for Cattle | Ivermectin Closantel | 5 mg/ml 200 mg/ml | Pour-On solution | Cattle | Topical use |
| Ireland | Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Northern Ireland | Closivet Pour-On Solution for Cattle | Ivermectin Closantel | 5 mg/ml 200 mg/ml | Pour-On solution | Cattle | Topical use |
| Italy | Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Northern Ireland | Closamectin 5 mg/ml + 200 mg/ml Soluzione Pour-On per bovini | Ivermectin Closantel | 5 mg/ml 200 mg/ml | Pour-On solution | Cattle | Topical use |
| Italy | Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Northern Ireland | Vermax Pour-On 5 mg/ml + 200 mg/ml Soluzione Pour-On per bovini | Ivermectin Closantel | 5 mg/ml 200 mg/ml | Pour-On solution | Cattle | Topical use |
| Poland | Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Northern Ireland | Closamectin Pour-On 5 mg/ml + 200 mg/ml, roztwór do polewania dla bydła | Ivermectin Closantel | 5 mg/ml 200 mg/ml | Pour-On solution | Cattle | Topical use |
| Portugal | Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Northern Ireland | Closamectin FF 5 mg/ml + 200 mg/ml solução para unção contínua para bovinos | Ivermectin Closantel | 5 mg/ml 200 mg/ml | Pour-On solution | Cattle | Topical use |
| Romania | Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Northern Ireland | Closamectin 5 mg/ml + 200 mg/ml Soluţie Pour-On pentru bovine | Ivermectin Closantel | 5 mg/ml 200 mg/ml | Pour-On solution | Cattle | Topical use |
| Spain | Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Northern Ireland | CLOSAMECTIN 5 mg/ml + 200 mg/ml SOLUCION POUR-ON PARA BOVINO | Ivermectin Closantel | 5 mg/ml 200 mg/ml | Pour-On solution | Cattle | Topical use |
| Spain | Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Northern Ireland | Closivet Solución Pour-On | Ivermectin Closantel | 5 mg/ml 200 mg/ml | Pour-On solution | Cattle | Topical use |
| Sweden | Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Northern Ireland | Closamectin vet 5 mg/ml+200 mg/ml Pour-on lösning till nöt | Ivermectin Closantel | 5 mg/ml 200 mg/ml | Pour-On solution | Cattle | Topical use |
| Slovenia | Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Northern Ireland | Closamectin 5 mg/ml + 200 mg/ml Pour-On kožni poliv, raztopina za govedo | Ivermectin Closantel | 5 mg/ml 200 mg/ml | Pour-On solution | Cattle | Topical use |
| Slovakia | Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Northern Ireland | Closamectin 5 mg/ml + 200 mg/ml pour-on roztok pre hovädzí dobytok | Ivermectin Closantel | 5 mg/ml 200 mg/ml | Pour-On solution | Cattle | Topical use |
| United Kingdom | Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Northern Ireland | Closamectin 5 mg/ml + 200 mg/ml Pour-on Solution for Cattle | Ivermectin Closantel | 5 mg/ml 200 mg/ml | Pour-On solution | Cattle | Topical use |
| United Kingdom | Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Northern Ireland | Closiver 5 mg/ml + 200 mg/ml Pour-On Solution for Cattle | Ivermectin Closantel | 5 mg/ml 200 mg/ml | Pour-On solution | Cattle | Topical use |
| United Kingdom | Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Northern Ireland | Norofas Pour-On Solution for Cattle | Ivermectin Closantel | 5 mg/ml 200 mg/ml | Pour-On solution | Cattle | Topical use |

Member State (EU/EEA)

Marketing authorisation holder

Product name

INN

Strength

Pharmaceutical form

Animal species

Route of administration

Austria

Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Northern Ireland

Closamectin 5 mg/ml + 200 mg/ml Pour-On Lösung für Rinder

Ivermectin Closantel

5 mg/ml 200 mg/ml

Pour-On solution

Cattle

Topical use

Belgium

Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Northern Ireland

Closamectin 5 mg/ml + 200 mg/ml pour-on oplossing voor rundvee

Ivermectin Closantel

5 mg/ml 200 mg/ml

Pour-On solution

Cattle

Topical use

Czech Republic

Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Northern Ireland

Closamectin 5 mg/ml + 200 mg/ml roztok pro nalévání na hřbet — pour-on

Ivermectin Closantel

5 mg/ml 200 mg/ml

Pour-On solution

Cattle

Topical use

Denmark

Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Northern Ireland

Closamectin Pour-On

Ivermectin Closantel

5 mg/ml 200 mg/ml

Pour-On solution

Cattle

Topical use

France

Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Northern Ireland

CLOSAMECTIN POUR-ON SOLUTION POUR BOVINS

Ivermectin Closantel

5 mg/ml 200 mg/ml

Pour-On solution

Cattle

Topical use

Germany

Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Northern Ireland

Closamectin 5 mg/ml + 200 mg/ml Pour-On Lösung zum Übergießen für Rinder

Ivermectin Closantel

5 mg/ml 200 mg/ml

Pour-On solution

Cattle

Topical use

Greece

Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Northern Ireland

Closamectin 5 mg/ml + 200 mg/ml διάλυμα επίχυσης για Βοοειδή

Ivermectin Closantel

5 mg/ml 200 mg/ml

Pour-On solution

Cattle

Topical use

Ireland

Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Northern Ireland

Closamectin 5 mg/ml + 200 mg/ml Pour-On Solution for Cattle

Ivermectin Closantel

5 mg/ml 200 mg/ml

Pour-On solution

Cattle

Topical use

Ireland

Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Northern Ireland

Closivet Pour-On Solution for Cattle

Ivermectin Closantel

5 mg/ml 200 mg/ml

Pour-On solution

Cattle

Topical use

Italy

Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Northern Ireland

Closamectin 5 mg/ml + 200 mg/ml Soluzione Pour-On per bovini

Ivermectin Closantel

5 mg/ml 200 mg/ml

Pour-On solution

Cattle

Topical use

Italy

Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Northern Ireland

Vermax Pour-On 5 mg/ml + 200 mg/ml Soluzione Pour-On per bovini

Ivermectin Closantel

5 mg/ml 200 mg/ml

Pour-On solution

Cattle

Topical use

Poland

Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Northern Ireland

Closamectin Pour-On 5 mg/ml + 200 mg/ml, roztwór do polewania dla bydła

Ivermectin Closantel

5 mg/ml 200 mg/ml

Pour-On solution

Cattle

Topical use

Portugal

Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Northern Ireland

Closamectin FF 5 mg/ml + 200 mg/ml solução para unção contínua para bovinos

Ivermectin Closantel

5 mg/ml 200 mg/ml

Pour-On solution

Cattle

Topical use

Romania

Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Northern Ireland

Closamectin 5 mg/ml + 200 mg/ml Soluţie Pour-On pentru bovine

Ivermectin Closantel

5 mg/ml 200 mg/ml

Pour-On solution

Cattle

Topical use

Spain

Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Northern Ireland

CLOSAMECTIN 5 mg/ml + 200 mg/ml SOLUCION POUR-ON PARA BOVINO

Ivermectin Closantel

5 mg/ml 200 mg/ml

Pour-On solution

Cattle

Topical use

Spain

Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Northern Ireland

Closivet Solución Pour-On

Ivermectin Closantel

5 mg/ml 200 mg/ml

Pour-On solution

Cattle

Topical use

Sweden

Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Northern Ireland

Closamectin vet 5 mg/ml+200 mg/ml Pour-on lösning till nöt

Ivermectin Closantel

5 mg/ml 200 mg/ml

Pour-On solution

Cattle

Topical use

Slovenia

Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Northern Ireland

Closamectin 5 mg/ml + 200 mg/ml Pour-On kožni poliv, raztopina za govedo

Ivermectin Closantel

5 mg/ml 200 mg/ml

Pour-On solution

Cattle

Topical use

Slovakia

Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Northern Ireland

Closamectin 5 mg/ml + 200 mg/ml pour-on roztok pre hovädzí dobytok

Ivermectin Closantel

5 mg/ml 200 mg/ml

Pour-On solution

Cattle

Topical use

United Kingdom

Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Northern Ireland

Closamectin 5 mg/ml + 200 mg/ml Pour-on Solution for Cattle

Ivermectin Closantel

5 mg/ml 200 mg/ml

Pour-On solution

Cattle

Topical use

United Kingdom

Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Northern Ireland

Closiver 5 mg/ml + 200 mg/ml Pour-On Solution for Cattle

Ivermectin Closantel

5 mg/ml 200 mg/ml

Pour-On solution

Cattle

Topical use

United Kingdom

Norbrook Laboratories Ltd Station Works, Newry, BT35 6JP Northern Ireland

Norofas Pour-On Solution for Cattle

Ivermectin Closantel

5 mg/ml 200 mg/ml

Pour-On solution

Cattle

Topical use

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