Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 January 2015 to 31 January 2015

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

ANNEX I

List of the names, pharmaceutical form, strengths of the medicinal products, route of administration, applicant in the Member States

Member State EU/EEA	Applicant	(Invented) Name	Strength	Pharmaceutical form	Route of administration
Austria	Teva Pharma B.V. Computerweg 10 3542 DR Utrecht The Netherlands	Seasonique Filmtabletten	0,15/0,03 mg and 0,01 mg	film-coated tablet	oral use
Belgium	Teva Pharma B.V. Computerweg 10 3542 DR Utrecht The Netherlands	Seasonique 0,15 mg/0,03 mg filmomhulde tabletten en 0,01 mg filmomhulde tabletten	0,15/0,03 mg and 0,01 mg	film-coated tablet	oral use
France	Teva Pharma B.V. Computerweg 10 3542 DR Utrecht The Netherlands	Seasonique	0,15/0,03 mg and 0,01 mg	film-coated tablet	oral use
Germany	Teva Pharma B.V. Computerweg 10 3542 DR Utrecht The Netherlands	Seasonique	0,15/0,03 mg and 0,01 mg	film-coated tablet	oral use
Italy	Teva Pharma B.V. Computerweg 10 3542 DR Utrecht The Netherlands	Seasonique	0,15/0,03 mg and 0,01 mg	film-coated tablet	oral use
Poland	Teva Pharma B.V. Computerweg 10 3542 DR Utrecht The Netherlands	Seasonique	0,15/0,03 mg and 0,01 mg	film-coated tablet	oral use
Romania	Teva Pharma B.V. Computerweg 10 3542 DR Utrecht The Netherlands	SEASONIQUE 150 micrograme/30 micrograme şi 10 micrograme comprimate filmate	0,15/0,03 mg and 0,01 mg	film-coated tablet	oral use
Slovak Republic	Teva Pharma B.V. Computerweg 10 3542 DR Utrecht The Netherlands	Seasonique	0,15/0,03 mg and 0,01 mg	film-coated tablet	oral use
Slovenia	Teva Pharma B.V. Computerweg 10 3542 DR Utrecht The Netherlands	Seasonique 0,15 mg/0,03 mg in 0,01 mg filmsko obložene tablete	0,15/0,03 mg and 0,01 mg	film-coated tablet	oral use

ANNEX II

List of the names, pharmaceutical form, strength of the medicinal products, route of administration, Marketing Authorisation Holders in the Member States

Member State EU/EEA	Marketing authorisation holder	(Invented) Name	Strength	Pharmaceutical form	Route of administration	Content (concentration)
Austria	Merck Sharp & Dohme Ges.m.b.H. Am Euro Platz 2 1120 Wien Austria	Nasonex aquosum — Nasenspray	50 μg/ actuation	Nasal spray, suspension	Nasal use	0,05 % w/w Mometasone furoate calculated on the anhydrous basis
Belgium	MSD Belgium BVBA/SPRL Clos du Lynx 5 B-1200 Bruxelles Belgium	Nasonex	50 μg/ actuation	Nasal spray, suspension	Nasal use	0,05 % w/w Mometasone furoate calculated on the anhydrous basis
Bulgaria	Merck Sharp and Dohme Bulgaria EOOD 55, Nikola Vaptzarov blvd. EXPO 2000, East Wing, Sectors B1 & B2 1407 Sofia Bulgaria	NASONEX	50 μg/ actuation	Nasal spray, suspension	Nasal use	0,05 % w/w Mometasone furoate calculated on the anhydrous basis
Croatia	Merck Sharp & Dohme d.o.o. Heinzelova 62a 10 000 Zagreb Croatia	Nasonex	50 μg/ actuation	Nasal spray, suspension	Nasal use	0,05 % w/w Mometasone furoate calculated on the anhydrous basis
Czech Republic	Merck Sharp & Dohme B.V. Waarderweg 39 2031 BN Haarlem The Netherlands	NASONEX	50 μg/ dose	Nasal spray, suspension	Nasal use	0,05 % w/w Mometasone furoate calculated on the anhydrous basis
Denmark	Merck Sharp & Dohme BV Waarderweg 39 Postbox 581 2003 PC Haarlem The Netherlands	Nasonex	50 μg/ actuation	Nasal spray, suspension	Nasal use	0,05 % w/w Mometasone furoate calculated on the anhydrous basis
Estonia	Merck Sharp & Dohme B.V. Waarderweg 39 2031 BN Haarlem The Netherlands	Nasonex	50 μg/ actuation	Nasal spray, suspension	Nasal use	0,05 % w/w Mometasone furoate calculated on the anhydrous basis
Finland	Merck Sharp & Dohme B.V. Box 581 2003 PC Haarlem The Netherlands	Nasonex	50 μg/ actuation	Nasal spray, suspension	Nasal use	0,05 % w/w Mometasone furoate calculated on the anhydrous basis
France	MSD France 34 avenue Léonard de Vinci 92400 Courbevoie France	Nasonex	50 μg/ actuation	Nasal spray, suspension	Nasal use	0,05 % w/w Mometasone furoate calculated on the anhydrous basis
Germany	MSD SHARP & DOHME GMBH Lindenplatz 1 85540 Haar Germany	Nasonex	50 μg/ actuation	Nasal spray, suspension	Nasal use	0,05 % w/w Mometasone furoate calculated on the anhydrous basis
Greece	Merck Sharp & Dohme S.A. Ag. Dimitriou 63 174 56 Alimos Greece	Nasonex	50 μg/ actuation	Nasal spray, suspension	Nasal use	0,05 % w/w Mometasone furoate calculated on the anhydrous basis
Hungary	MSD Pharma Hungary Kft. H-1095 Budapest Lechner Ödön fasor 8. Hungary	Nasonex	50 μg/ actuation	Nasal spray, suspension	Nasal use	0,05 % w/w Mometasone furoate calculated on the anhydrous basis
Iceland	Merck Sharp & Dohme B.V. Box 581 2003 PC Haarlem The Netherlands	Nasonex	50 μg/ actuation	Nasal spray, suspension	Nasal use	0,05 % w/w Mometasone furoate calculated on the anhydrous basis
Ireland	Merck Sharp & Dohme Ireland (Human Health) Limited Red Oak North South County Business Park Leopardstown Dublin 18 Ireland	Nasonex	50 μg/ actuation	Nasal Spray, Suspension	Nasal use	0,05 % w/w Mometasone furoate calculated on the anhydrous basis
Italy	MSD Italia S.r.l. Via Vitorchiano 151 00189 Roma Italy	Nasonex	50 μg/ actuation	Nasal Spray, Suspension	Nasal use	0,05 % w/w Mometasone furoate calculated on the anhydrous basis
Italy	Malesci Istituto Farmacobiologico S.p.A Via Lungo l’Ema 7 Bagno a Ripoli (FI) Italy	Rinelon	50 μg/ actuation	Nasal Spray, Suspension	Nasal use	0,05 % w/w Mometasone furoate calculated on the anhydrous basis
Latvia	Merck Sharp & Dohme B.V. Waarderweg 39 2031 BN Haarlem The Netherlands	Nasonex 50 mikrogrami/devā deguna aerosols, suspensija	50 μg/ dose	Nasal spray, suspension	Nasal use	0,05 % w/w Mometasone furoate calculated on the anhydrous basis
Lithuania	Merck Sharp & Dohme B.V. Waarderweg 39 2031 BN Haarlem The Netherlands	Nasonex	50 μg/ dose	Nasal spray, suspension	Nasal use	0,05 % w/w Mometasone furoate (monohydrate) calculated on the anhydrous basis
Luxembourg	MSD Belgium BVBA/SPRL Clos du Lynx 5 B-1200 Bruxelles Belgium	Nasonex	50 μg/ actuation	Nasal spray, suspension	Nasal use	0,05 % w/w Mometasone furoate calculated on the anhydrous basis
Malta	Merck Sharp & Dohme Ltd. Hertford Road Hoddesdon Hertfordshire EN11 9BU United Kingdom	Nasonex	50 μg/ actuation	Nasal spray, suspension	Nasal use	0,05 % w/w Mometasone furoate calculated on the anhydrous basis
Netherlands	Merck Sharp & Dohme B.V. Waarderweg 39 2031 BN Haarlem The Netherlands	Nasonex	50 μg/ actuation	Nasal spray, suspension	Nasal use	0,05 % w/w Mometasone furoate calculated on the anhydrous basis
Norway	Merck Sharp & Dohme B.V. Waarderweg 39 2031 BN Haarlem The Netherlands	Nasonex	50 μg/ actuation	Nasal spray, suspension	Nasal use	0,05 % w/w Mometasone furoate calculated on the anhydrous basis
Poland	MSD Polska Sp. z o.o. ul. Chłodna 51 00-867 Warszawa Poland	Nasonex	50 μg/ dose	Nasal spray, suspension	Nasal use	0,05 % w/w Mometasone furoate calculated on the anhydrous basis
Portugal	Merck Sharp & Dohme, Lda. Quinta da Fonte, 19 Edifício Vasco da Gama 2770-192 Paço de Arcos Portugal	Nasomet	50 μg/ dose	Nasal spray, suspension	Nasal use	0,05 % w/w Mometasone furoate calculated on the anhydrous basis
Romania	MERCK SHARP & DOHME ROMANIA S.R.L. Bucharest Business Park Şos. Bucureşti-Ploieşti Nr. 1A, Clădirea C1, Etaj 3, Sector 1, Bucureşti Romania	NASONEX	50 μg/ dose	Nasal spray, suspension	Nasal use	0,05 % w/w Mometasone furoate calculated on the anhydrous basis
Slovak Republic	Merck Sharp & Dohme B.V. Waarderweg 39 2031 BN Haarlem P.O. Box 581 2003 PC Haarlem The Netherlands	NASONEX	50 μg/ actuation	Nasal spray, suspension	Nasal use	0,05 % w/w Mometasone furoate calculated on the anhydrous basis
Slovenia	Merck Sharp & Dohme, inovativna zdravila d.o.o. Šmartinska cesta 140 1000 Ljubljana Slovenia	NASONEX	50 μg/ actuation	Nasal spray, suspension	Nasal use	0,05 % w/w Mometasone furoate calculated on the anhydrous basis
Spain	Merck Sharp & Dohme de España, S.A. C/Josefa Valcárcel, 38 28027 Madrid Spain	NASONEX 50 microgramos suspension para pulverización nasal	50 μg/ actuation	Nasal Spray, Suspension	Nasal use	0,05 % w/w Mometasone furoate calculated on the anhydrous basis
Spain	Desarrollos Farmacéuticos y Cosméticos, S.A. C/Josefa Valcárcel, 38 28027 Madrid Spain	Mometasona MSD 50 microgramos suspensión para pulverización nasal	50 μg/ actuation	Nasal Spray, Suspension	Nasal use	0,05 % w/w Mometasone furoate calculated on the anhydrous basis
Sweden	Merck Sharp & Dohme B.V. Box 581 2003 PC Haarlem The Netherlands	Nasonex	50 μg/ dose	Nasal spray, suspension	Nasal use	0,05 % w/w Mometasone furoate calculated on the anhydrous basis
United Kingdom	Merck Sharp & Dohme Ltd Hertford Road Hoddesdon Hertfordshire EN11 9BU United Kingdom	Nasonex	50 μg/ actuation	Nasal Spray, Suspension	Nasal use	0,05 % w/w Mometasone furoate calculated on the anhydrous basis

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
12.1.2015	Seasonique	See Annex I	See Annex I	See Annex I	13.1.2015
19.1.2015	Nasonex	See Annex II	See Annex II	See Annex II	20.1.2015
12.1.2015	Dexrazonane	Dexrazoxane	Not applicable	Not applicable	13.1.2015