# C_2015071EN.01001101.xml

| 27.2.2015 | EN | Official Journal of the European Union | C 71/11 |
| --- | --- | --- | --- |

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))

1

2

(2015/C 071/03)

—   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 |
| --- | --- | --- | --- | --- | --- |
| 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 |

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

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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 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 |

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

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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 |

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

---