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 or Article 38 of Directive 2001/82/EC)
Date: 2016-04-29
Institutions: European Commission
Subjects: EU Member State, cattle, drug surveillance, market approval, marketing standard, medicinal product, veterinary drug








C_2016154EN.01000801.xml










29.4.2016   


EN


Official Journal of the European Union


C 154/8





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))
(2016/C 154/02)
—   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




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






(1)  OJ L 311, 28.11.2001, p. 67.

(2)  OJ L 311, 28.11.2001, p. 1.


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