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 or Article 38 of Directive 2001/82/EC)
Date: 2015-02-27
Institutions: European Commission
Subjects: drug surveillance, market approval, marketing standard, medicinal product








C_2015071EN.01001101.xml










27.2.2015   


EN


Official Journal of the European Union


C 71/11





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))
(2015/C 071/03)
—   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




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






(1)  OJ L 311, 28.11.2001, p. 67.

(2)  OJ L 311, 28.11.2001, p. 1.


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