do-me/EUR-LEX huggingface dataset:
Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 September 2016 to 30 September 2016 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
Date: 2016-12-30
Institutions: European Commission
Subjects: drug surveillance, market approval, marketing standard, medicinal product








C_2016490EN.01002201.xml










30.12.2016   


EN


Official Journal of the European Union


C 490/22





Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 September 2016 to 30 September 2016
(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (1))
(2016/C 490/10)
—   Modification of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted










Date of the decision


Name of the medicinal product


Holder of the marketing authorization


Number of the entry in the Community Register


Date of notification




26.9.2016


Nuwiq


Octapharma AB
Lars Forssells gata 23, 112 75 Stockholm, Sverige


EU/1/14/936


28.10.2016




30.9.2016


ALPROLIX


Swedish Orphan Biovitrum AB (publ)
SE-112 76 Stockholm, Sverige


EU/1/16/1098


4.10.2016




Anyone wishing to consult the public assessment report on the medicinal products in question and the decisions relating thereto is invited to contact:





European Medicines Agency




30 Churchill Place




Canary Wharf




London E14 5EU




United Kingdom






(1)  OJ L 136, 30.4.2004, p. 1.
Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 June 2016 to 30 June 2016 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
Date: 2016-12-30
Institutions: European Commission
Subjects: drug surveillance, market approval, marketing standard, medicinal product, veterinary medicine








C_2016490EN.01001901.xml










30.12.2016   


EN


Official Journal of the European Union


C 490/19





Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 June 2016 to 30 June 2016
(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (1))
(2016/C 490/07)
—   Modification of a marketing authorisation (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted










Date of the decision


Name of the medicinal product


Holder of the marketing authorization


Number of the entry in the Community Register


Date of notification




21.6.2016


Nobivac Myxo-RHD


Intervet International B.V.
Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland


EU/2/11/132


23.6.2016




Anyone wishing to consult the public assessment report on the medicinal products in question and the decisions relating thereto is invited to contact:





European Medicines Agency




30 Churchill Place




Canary Wharf




London E14 5EU




United Kingdom






(1)  OJ L 136, 30.4.2004, p. 1.
Case C-687/16 P: Appeal brought on 30 December 2016 by Capella EOOD against the judgment delivered by the General Court (Eighth Chamber) on 12 May 2016 in Case T-750/14, Ivo-Kermartin GmbH v European Union Intellectual Property Office
Date: 2016-12-30
Institutions: Court of Justice
Subjects: EU trade mark, energy-generating product, medical device, registered trade mark, trade-mark law, vehicle parts








C_2017249EN.01001601.xml










31.7.2017   


EN


Official Journal of the European Union


C 249/16






Appeal brought on 30 December 2016 by Capella EOOD against the judgment delivered by the General Court (Eighth Chamber) on 12 May 2016 in Case T-750/14, Ivo-Kermartin GmbH v European Union Intellectual Property Office
(Case C-687/16 P)
(2017/C 249/23)
Language of the case: German

Parties


Appellant: Capella EOOD (represented by: C. Pfitzer, Rechtsanwalt)

Other party to the proceedings: European Union Intellectual Property Office
By order of 7 June 2017, the Court of Justice of the European Union (Tenth Chamber) dismissed the appeal and ordered the appellant to bear its own costs.
Case C-679/16: Request for a preliminary ruling from the Korkein hallinto-oikeus (Finland) lodged on 30 December 2016 — A
Date: 2016-12-30
Institutions: Court of Justice
Subjects: Finland, care of people with disabilities, disabled person, equal treatment, free movement of persons, freedom to provide services, health insurance, social security legislation








C_2017086EN.01001601.xml










20.3.2017   


EN


Official Journal of the European Union


C 86/16





Request for a preliminary ruling from the Korkein hallinto-oikeus (Finland) lodged on 30 December 2016 — A
(Case C-679/16)
(2017/C 086/20)
Language of the case: Finnish

Referring court

Korkein hallinto-oikeus

Parties to the main proceedings


Appellant: A

Other party: Espoon kaupungin sosiaali- ja terveyslautakunnan yksilöasioiden jaosto

Questions referred







1.


Is a benefit such as personal assistance in accordance with the Disability Services Law a sickness benefit within the meaning of Article 3(1) of Regulation No 883/2004? (1)











2.


If the answer to Question 1 is in the negative, are the rights of Union citizens to move and reside freely in the territory of another Member State, laid down in Articles 20 and 21 TFEU, restricted in a situation in which the grant abroad of a benefit such as personal assistance in accordance with the Disability Services Law is not separately provided for and the conditions for grant of the benefit are interpreted in such a way that personal assistance is not granted in another Member State in which the person completes a three-year course of higher education studies leading to a degree?






—


Is it relevant, in assessing the matter, that a benefit such as personal assistance may be granted in Finland in a municipality other than the person’s home municipality, for example when the person is studying in another municipality in Finland?










—


Must relevance be attached, in assessing the matter with respect to EU law, to the rights derived from Article 19 of the United Nations Convention on the Rights of Disabled Persons?














3.


If the Court of Justice considers, in its answer to Question 2, that an interpretation of national law such as that in the present case constitutes a restriction of freedom of movement, is such a restriction none the less justifiable on compelling grounds of the public interest in connection with the obligation of the municipality to supervise the arranging of personal assistance, the municipality’s possibilities of choosing the most suitable way of arranging assistance, and the maintenance of the coherence and efficacy of the system of personal assistance in accordance with the Disability Services Law?






(1)  Regulation (EC) No 883/2004 of the European Parliament and of the Council of 29 April 2004 on the coordination of social security systems (OJ L 166, 30.4.2004, p. 1).
Euro exchange rates
Date: 2016-12-30
Institutions: European Commission
Subjects: euro, exchange rate








C_2016489EN.01000101.xml










30.12.2016   


EN


Official Journal of the European Union


C 489/1





Euro exchange rates (1)

29 December 2016
(2016/C 489/01)

1 euro =











 


Currency


Exchange rate




USD


US dollar


1,0453 




JPY


Japanese yen


122,04 




DKK


Danish krone


7,4338 




GBP


Pound sterling


0,85300 




SEK


Swedish krona


9,5585 




CHF


Swiss franc


1,0714 




ISK


Iceland króna


 




NOK


Norwegian krone


9,0758 




BGN


Bulgarian lev


1,9558 




CZK


Czech koruna


27,021 




HUF


Hungarian forint


310,09 




PLN


Polish zloty


4,4141 




RON


Romanian leu


4,5375 




TRY


Turkish lira


3,6926 




AUD


Australian dollar


1,4505 




CAD


Canadian dollar


1,4154 




HKD


Hong Kong dollar


8,1076 




NZD


New Zealand dollar


1,5040 




SGD


Singapore dollar


1,5156 




KRW


South Korean won


1 264,25 




ZAR


South African rand


14,2922 




CNY


Chinese yuan renminbi


7,2706 




HRK


Croatian kuna


7,5593 




IDR


Indonesian rupiah


14 072,35 




MYR


Malaysian ringgit


4,6876 




PHP


Philippine peso


51,912 




RUB


Russian rouble


63,2555 




THB


Thai baht


37,568 




BRL


Brazilian real


3,4123 




MXN


Mexican peso


21,6329 




INR


Indian rupee


71,0950 






(1)  Source: reference exchange rate published by the ECB.
Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 February 2016 to 29 February 2016 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
Date: 2016-12-30
Institutions: European Commission
Subjects: drug surveillance, market approval, marketing standard, medicinal product








C_2016490EN.01001301.xml










30.12.2016   


EN


Official Journal of the European Union


C 490/13





Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 February 2016 to 29 February 2016
(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (1))
(2016/C 490/03)
—   Issuing of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Rejected










Date of the decision


Name of the medicinal product


Holder of the marketing authorization


Number of the entry in the Community Register


Date of notification




11.2.2016


Solumarv


Marvel Lifesciences Limited
Congress House Lyon Road HA1 2EN Harrow United Kingdom


—


15.2.2016




—   Modification of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted










Date of the decision


Name of the medicinal product


Holder of the marketing authorization


Number of the entry in the Community Register


Date of notification




11.2.2016


Tybost


Gilead Sciences International Limited
Cambridge CB21 6GT, United Kingdom


EU/1/13/872


7.3.2016




26.2.2016


Clopidogrel Zentiva


Sanofi-Aventis groupe
54 rue La Boétie, F-75008 Paris, France


EU/1/08/465


1.3.2016




Anyone wishing to consult the public assessment report on the medicinal products in question and the decisions relating thereto is invited to contact:





European Medicines Agency




30 Churchill Place




Canary Wharf




London E14 5EU




United Kingdom






(1)  OJ L 136, 30.4.2004, p. 1.
Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 August 2016 to 31 August 2016 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
Date: 2016-12-30
Institutions: European Commission
Subjects: drug surveillance, market approval, marketing standard, medicinal product








C_2016490EN.01002101.xml










30.12.2016   


EN


Official Journal of the European Union


C 490/21





Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 August 2016 to 31 August 2016
(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (1))
(2016/C 490/09)
—   Modification of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted










Date of the decision


Name of the medicinal product


Holder of the marketing authorization


Number of the entry in the Community Register


Date of notification




22.8.2016


Adempas


Bayer Pharma AG
D-13342 Berlin, Deutschland


EU/1/13/907


24.8.2016




Anyone wishing to consult the public assessment report on the medicinal products in question and the decisions relating thereto is invited to contact:





European Medicines Agency




30 Churchill Place




Canary Wharf




London E14 5EU




United Kingdom






(1)  OJ L 136, 30.4.2004, p. 1.
Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 May 2016 to 31 May 2016 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
Date: 2016-12-30
Institutions: European Commission
Subjects: drug surveillance, market approval, marketing standard, medicinal product








C_2016490EN.01001601.xml










30.12.2016   


EN


Official Journal of the European Union


C 490/16





Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 May 2016 to 31 May 2016
(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (1))
(2016/C 490/06)
—   Issuing of a marketing authorisation (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted













Date of the decision


Name of the medicinal product


INN (International Non-Proprietary Name)


Holder of the marketing authorisation


Number of the entry in the Community Register


Pharmaceutical form


ATC code (Anatomical Therapeutic Chemical Code)


Date of notification




26.5.2016


Flixabi


infliximab


Samsung Bioepis UK Limited
3000 Hillswood Drive, Chertsey, Surrey KT16 0RS, United Kingdom


EU/1/16/1106


Powder for concentrate for solution for infusion


L04AB02


31.5.2016




—   Modification of a marketing authorisation (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted










Date of the decision


Name of the medicinal product


Holder of the marketing authorisation


Number of the entry in the Community Register


Date of notification




26.5.2016


Erivedge


Roche Registration Limited
6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom


EU/1/13/848


31.5.2016




26.5.2016


Fampyra


Biogen Idec Limited
Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom


EU/1/11/699


31.5.2016




26.5.2016


Zeffix


Glaxo Group Ltd
980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom


EU/1/99/114


31.5.2016




27.5.2016


Clopidogrel TAD


TAD Pharma GmbH
Heinz-Lohmann-Straße 5, D-27472 Cuxhaven, Deutschland


EU/1/09/555


29.5.2016




Anyone wishing to consult the public assessment report on the medicinal products in question and the decisions relating thereto is invited to contact:





European Medicines Agency




30 Churchill Place




Canary Wharf




London E14 5EU




United Kingdom






(1)  OJ L 136, 30.4.2004, p. 1.
Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 March 2016 to 31 March 2016 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
Date: 2016-12-30
Institutions: European Commission
Subjects: drug surveillance, market approval, marketing standard, medicinal product, veterinary drug








C_2016490EN.01001401.xml










30.12.2016   


EN


Official Journal of the European Union


C 490/14





Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 March 2016 to 31 March 2016
(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (1))
(2016/C 490/04)
—   Modification of a marketing authorization (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted










Date of the decision


Name of the medicinal product


Holder of the marketing authorization


Number of the entry in the Community Register


Date of notification




15.3.2016


Purevax RCP FeLV


Merial
29 avenue Tony Garnier, F-69007 Lyon, France


EU/2/04/048


17.3.2016




22.3.2016


Zuprevo


Intervet International B.V.
Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland


EU/2/11/124


25.3.2016




Anyone wishing to consult the public assessment report on the medicinal products in question and the decisions relating thereto is invited to contact:





European Medicines Agency




30 Churchill Place




Canary Wharf




London E14 5EU




United Kingdom






(1)  OJ L 136, 30.4.2004, p. 1.
Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 April 2016 to 30 April 2016 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
Date: 2016-12-30
Institutions: European Commission
Subjects: drug surveillance, market approval, marketing standard, medicinal product








C_2016490EN.01001501.xml










30.12.2016   


EN


Official Journal of the European Union


C 490/15





Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 April 2016 to 30 April 2016
(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (1))
(2016/C 490/05)
—   Modification of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted










Date of the decision


Name of the medicinal product


Holder of the marketing authorization


Number of the entry in the Community Register


Date of notification




4.4.2016


JEVTANA


Sanofi-Aventis groupe
54 rue La Boétie, F-75008 Paris, France


EU/1/11/676


6.4.2016




Anyone wishing to consult the public assessment report on the medicinal products in question and the decisions relating thereto is invited to contact:





European Medicines Agency




30 Churchill Place




Canary Wharf




London E14 5EU




United Kingdom






(1)  OJ L 136, 30.4.2004, p. 1.
Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 July 2016 to 31 July 2016 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
Date: 2016-12-30
Institutions: European Commission
Subjects: drug surveillance, market approval, marketing standard, medicinal product








C_2016490EN.01002001.xml










30.12.2016   


EN


Official Journal of the European Union


C 490/20





Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 July 2016 to 31 July 2016
(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (1))
(2016/C 490/08)
—   Modification of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted










Date of the decision


Name of the medicinal product


Holder of the marketing authorization


Number of the entry in the Community Register


Date of notification




29.7.2016


Fluenz Tetra


MedImmune, LLC
Lagelandseweg 78, NL-6545 CG Nijmegen, Nederland


EU/1/13/887


2.8.2016




29.7.2016


Nimenrix


Pfizer Limited
Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom


EU/1/12/767


3.8.2016




29.7.2016


Zontivity


Merck Sharp & Dohme Limited
Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom


EU/1/14/976


2.8.2016




Anyone wishing to consult the public assessment report on the medicinal products in question and the decisions relating thereto is invited to contact:





European Medicines Agency




30 Churchill Place




Canary Wharf




London E14 5EU




United Kingdom






(1)  OJ L 136, 30.4.2004, p. 1.