# C_2013154EN.01001201.xml

| 31.5.2013 | EN | Official Journal of the European Union | C 154/12 |
| --- | --- | --- | --- |

31.5.2013

EN

Official Journal of the European Union

C 154/12

---

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 January to 31 January 2012

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

(Decisions taken pursuant to Article 34 of Directive 2001/83/EC

1

or Article 38 of Directive 2001/82/EC

2

)

2013/C 154/03

—   Issuing, maintenance or modification of a national marketing authorization

Issuing, maintenance or modification of a national marketing authorization

| Date of the decision | Name(s) of the medicinal product | Holder(s) of the marketing authorization | MemberStateconcerned | Date of notification |
| --- | --- | --- | --- | --- |
| 20.1.2012 | Terpenic derivatives | See Annex | See Annex | 24.1.2012 |

Date of the decision

Name(s) of the medicinal product

Holder(s) of the marketing authorization

MemberStateconcerned

Date of notification

20.1.2012

Terpenic derivatives

See Annex

See Annex

24.1.2012

---

(1)  OJ L 311, 28.11.2001, p. 67.

1

(2)  OJ L 311, 28.11.2001, p. 1.

2

---

ANNEX

LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTES OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES

| Member State
  EU/EEA | Marketing authorisation holder company name, address
  Invented Name | INN | Strength | Pharmaceutical | form | Route of administration |
| --- | --- | --- | --- | --- | --- | --- |
| Belgium | Medgenix benelux NV |
| Vliegveld 21 |
| BE-8500 Wevelgem |
| Belgium |

Member State

EU/EEA

Marketing authorisation holder company name, address

Invented Name

INN

Strength

Pharmaceutical

form

Route of administration

Belgium

Medgenix benelux NV

Vliegveld 21

BE-8500 Wevelgem

Belgium

Eucalyptine

camphora

inn: eucalyptol

inn: guaiacol

60 mg

50 mg

20 mg

suppository

rectal use

Belgium

| Medgenix benelux NV |
| --- |
| Vliegveld 21 |
| BE-8500 Wevelgem |
| Belgium |

Medgenix benelux NV

Vliegveld 21

BE-8500 Wevelgem

Belgium

Eucalyptine Pholcodine Child

camphora

inn: eucalyptol

inn: guaiacol

inn: pholcodine

inn: phenol

100 mg

80 mg

30 mg

5 mg

6 mg

suppository

rectal use

Belgium

| Medgenix benelux NV |
| --- |
| Vliegveld 21 |
| BE-8500 Wevelgem |
| Belgium |

Medgenix benelux NV

Vliegveld 21

BE-8500 Wevelgem

Belgium

Eucalyptine Lebrun

eucalyptol

inn: codéine phosphate

80 mg

5 mg

suppository

rectal use

Finland

| Oy Leiras FinlandAb, Paciuksenkatu 21 |
| --- |
| PL 1406, |
| 00101 Helsinki, |
| Finland |

Oy Leiras FinlandAb, Paciuksenkatu 21

PL 1406,

00101 Helsinki,

Finland

Hädensa

ichthammolum, mentholum

ichthammolum 4 mg, mentholum 50 mg

suppository

rectal use

France

| AMIDO |
| --- |
| 37 avenue Gabriel PériB.P. 232 |
| 92503 RUEIL MALMAISON CEDEX |
| France |

AMIDO

37 avenue Gabriel PériB.P. 232

92503 RUEIL MALMAISON CEDEX

France

CODATUX ENFANTS, suppositoire

cinéole

0,0500 g

suppository

rectal use

France

| AMIDO |
| --- |
| 37 avenue Gabriel PériB.P. 232 |
| 92503 RUEIL MALMAISON CEDEX |
| France |

AMIDO

37 avenue Gabriel PériB.P. 232

92503 RUEIL MALMAISON CEDEX

France

CODATUX NOURRISSONS, suppositoire

cinéole

25 mg

suppository

rectal use

France

| BOUCHARA RECORDATI |
| --- |
| 38 rue Marjolin - BP67 |
| 92302 Levallois-Perret Cedex |
| France |

BOUCHARA RECORDATI

38 rue Marjolin - BP67

92302 Levallois-Perret Cedex

France

EUCALYPTOSPIRINE ENFANTS, suppositoire

cinéole

0,1 g

suppository

rectal use

France

| BOUCHARA RECORDATI |
| --- |
| 38 rue Marjolin - BP67 |
| 92302 Levallois-Perret Cedex |
| France |

BOUCHARA RECORDATI

38 rue Marjolin - BP67

92302 Levallois-Perret Cedex

France

HEXAPNEUMINE ENFANTS, suppositoire

cinéole

0,07 g

suppository

rectal use

France

| BOUCHARA RECORDATI |
| --- |
| 38 rue Marjolin - BP67 |
| 92302 Levallois-Perret Cedex |
| France |

BOUCHARA RECORDATI

38 rue Marjolin - BP67

92302 Levallois-Perret Cedex

France

NEO-CODION ENFANTS, suppositoire

cinéole

0,05 g

suppository

rectal use

France

| BOUCHARA RECORDATI |
| --- |
| 38 rue Marjolin - BP67 |
| 92302 Levallois-Perret Cedex |
| France |

BOUCHARA RECORDATI

38 rue Marjolin - BP67

92302 Levallois-Perret Cedex

France

EUCALYPTOSPIRINE NOURRISSONS, suppositoire

cinéole

50 mg

suppository

rectal use

France

| BOUCHARA RECORDATI |
| --- |
| 38 rue Marjolin - BP67 |
| 92302 Levallois-Perret Cedex |
| France |

BOUCHARA RECORDATI

38 rue Marjolin - BP67

92302 Levallois-Perret Cedex

France

HEXAPNEUMINE NOURRISSONS, suppositoire

cinéole

35 mg

suppository

rectal use

France

| COOPERATION PHARMACEUTIQUE FRANCAISE |
| --- |
| Place Lucien Auvert |
| 77020 Melun Cedex |
| France |

COOPERATION PHARMACEUTIQUE FRANCAISE

Place Lucien Auvert

77020 Melun Cedex

France

PHOLCONES BISMUTH ENFANTS, suppositoire

cinéole

60 mg

suppository

rectal use

France

| COOPERATION PHARMACEUTIQUE FRANCAISE |
| --- |
| Place Lucien Auvert |
| 77020 Melun Cedex |
| France |

COOPERATION PHARMACEUTIQUE FRANCAISE

Place Lucien Auvert

77020 Melun Cedex

France

PHOLCONES ENFANTS, suppositoire

cinéole

0,05 g

suppository

rectal use

France

| LABORATOIRE DES REALISATIONS THERAPEUTIQUES ELERTE |
| --- |
| 181-183 rue André Karman |
| BP101 |
| 93303 Aubervilliers Cedex |
| France |

LABORATOIRE DES REALISATIONS THERAPEUTIQUES ELERTE

181-183 rue André Karman

BP101

93303 Aubervilliers Cedex

France

COQUELUSEDAL ENFANTS, suppositoire

niaouli

20 mg

suppository

rectal use

France

| LABORATOIRE HEPATOUM |
| --- |
| 1 rue de Plaisance |
| 94130 Nogent-sur-Marne |
| France |

LABORATOIRE HEPATOUM

1 rue de Plaisance

94130 Nogent-sur-Marne

France

EUCALYPTINE ENFANTS, suppositoire

cinéole

0,0750 g

suppository

rectal use

France

| LABORATOIRE HEPATOUM |
| --- |
| 1 rue de Plaisance |
| 94130 Nogent-sur-Marne |
| France |

LABORATOIRE HEPATOUM

1 rue de Plaisance

94130 Nogent-sur-Marne

France

EUCALYPTINE LE BRUN NOURRISSONS, suppositoire

cinéole

50 mg

suppository

rectal use

France

| LABORATOIRES GENEVRIER SA |
| --- |
| 280 rue de Goa |
| Les trois Moulins - Parc de Sophia Antipolis |
| 06600 Antibes |
| France |

LABORATOIRES GENEVRIER SA

280 rue de Goa

Les trois Moulins - Parc de Sophia Antipolis

06600 Antibes

France

CODOTUSSYL ENFANTS, suppositoire

cinéole

0,050 g

suppository

rectal use

France

| LABORATOIRES JOLLY JATEL |
| --- |
| 28 avenue Carnot |
| 78951 Saint-Germain en Laye Cedex |
| France |

LABORATOIRES JOLLY JATEL

28 avenue Carnot

78951 Saint-Germain en Laye Cedex

France

SULFORGAN ENFANTS, suppositoire

cinéole

0,050 g

suppository

rectal use

France

| LABORATOIRES MAYOLY SPINDLER |
| --- |
| 6, Avenue de l'Europe |
| BP51 |
| 78401 Chatou Cedex |
| France |

LABORATOIRES MAYOLY SPINDLER

6, Avenue de l'Europe

BP51

78401 Chatou Cedex

France

BRONCHORECTINE AU CITRAL ENFANTS, suppositoire

terpinol, pin, serpolet

0,02 gmg terpinol

0,02 g pin

0,01 g serpolet

suppository

rectal use

France

| LABORATOIRES MAYOLY SPINDLER |
| --- |
| 6, Avenue de l'Europe |
| BP51 |
| 78401 Chatou Cedex |
| France |

LABORATOIRES MAYOLY SPINDLER

6, Avenue de l'Europe

BP51

78401 Chatou Cedex

France

BRONCHORECTINE AU CITRAL NOURRISSONS, suppositoire

terpinol, pin, serpolet

10 mg terpinol

10 mg pin

5 mg serpolet

suppository

rectal use

France

| Laboratoires ROSA PHYTOPHARMA |
| --- |
| 68, rue Jean-Jacques Rousseau |
| 75001 Paris |
| France |

Laboratoires ROSA PHYTOPHARMA

68, rue Jean-Jacques Rousseau

75001 Paris

France

TERPONE ENFANTS, suppositoire

niaouli, huile essentielle d'eucalyptus, terpine, huile essentielle d'aiguilles de pin de siberie

8,33 mg pin

8,33 mg niaouli

suppository

rectal use

France

| Laboratoires ROSA PHYTOPHARMA |
| --- |
| 68, rue Jean-Jacques Rousseau |
| 75001 Paris |
| France |

Laboratoires ROSA PHYTOPHARMA

68, rue Jean-Jacques Rousseau

75001 Paris

France

TERPONE NOURRISSONS, suppositoire

niaouli, huile essentielle d'eucalyptus, terpine, huile essentielle d'aiguilles de pin de siberie

5 mg, pin

5 mg niaouli

suppository

rectal use

France

| MERCK MEDICATION FAMILIALE SAS |
| --- |
| 37 rue Saint-Romain |
| 69379 Lyon Cedex 08 |
| France |

MERCK MEDICATION FAMILIALE SAS

37 rue Saint-Romain

69379 Lyon Cedex 08

France

BI-QUI-NOL ENFANTS, suppositoire

camphre racémique, cinéole

30 mg cineole

15 mg camphre

suppository

rectal use

France

| MERCK MEDICATION FAMILIALE SAS |
| --- |
| 37 rue Saint-Romain |
| 69379 Lyon Cedex 08 |
| France |

MERCK MEDICATION FAMILIALE SAS

37 rue Saint-Romain

69379 Lyon Cedex 08

France

CAMPHOCALYPTOL SIMPLE ENFANTS 0,07 g, suppositoire

cinéole

0,07 g

suppository

rectal use

France

| MERCK MEDICATION FAMILIALE SAS |
| --- |
| 37 rue Saint-Romain |
| 69379 Lyon Cedex 08 |
| France |

MERCK MEDICATION FAMILIALE SAS

37 rue Saint-Romain

69379 Lyon Cedex 08

France

CAMPHOCALYPTOL SIMPLE NOURRISSONS 0,06 g, suppositoire

cinéole

0,06 g

suppository

rectal use

France

| PHOCEAL |
| --- |
| Avenue de Provence |
| BP7 |
| 13718 Allauch |
| France |

PHOCEAL

Avenue de Provence

BP7

13718 Allauch

France

EUCALYBROL BISMUTH ENFANTS, suppositoire

cinéole

0,030 g

suppository

rectal use

France

| S.E.R.P (Société d'Etudes et de Recherches Pharmaceutiques) |
| --- |
| 5, rue du Gabian |
| Immeuble ‘Le triton’ |
| 98000 Monaco |
| France |

S.E.R.P (Société d'Etudes et de Recherches Pharmaceutiques)

5, rue du Gabian

Immeuble ‘Le triton’

98000 Monaco

France

BRONCHODERMINE ENFANTS, suppositoire

cinéole, huile essentielle de pin

0,0200 g cineole

0,025 g pin

suppository

rectal use

France

| S.E.R.P (Société d'Etudes et de Recherches Pharmaceutiques) |
| --- |
| 5, rue du Gabian |
| Immeuble ‘Le triton’ |
| 98000 Monaco |
| France |

S.E.R.P (Société d'Etudes et de Recherches Pharmaceutiques)

5, rue du Gabian

Immeuble ‘Le triton’

98000 Monaco

France

BRONCHODERMINE NOURRISSONS, suppositoire

cinéole, huile essentielle de pin

0,01 g cineole

0,0125 g pin

suppository

rectal use

France

| SANOFI AVENTIS France |
| --- |
| 1-13 boulevard Romain Rolland |
| 75014 Paris |
| France |

SANOFI AVENTIS France

1-13 boulevard Romain Rolland

75014 Paris

France

TROPHIRES COMPOSE ENFANTS, suppositoire

huile essentielle d'eucalyptus

0,075 g

suppository

rectal use

France

| SANOFI AVENTIS France |
| --- |
| 1-13 boulevard Romain Rolland |
| 75014 Paris |
| France |

SANOFI AVENTIS France

1-13 boulevard Romain Rolland

75014 Paris

France

TROPHIRES ENFANTS, suppositoire

huile essentielle d'eucalyptus

0,075 g

suppository

rectal use

France

| SANOFI AVENTIS France |
| --- |
| 1-13 boulevard Romain Rolland |
| 75014 Paris |
| France |

SANOFI AVENTIS France

1-13 boulevard Romain Rolland

75014 Paris

France

FEBRECTOL ENFANTS, suppositoire

pin

0,030 g

suppository

rectal use

France

| SANOFI AVENTIS France |
| --- |
| 1-13 boulevard Romain Rolland |
| 75014 Paris |
| France |

SANOFI AVENTIS France

1-13 boulevard Romain Rolland

75014 Paris

France

TROPHIRES COMPOSE NOURRISSONS, suppositoire

huile essentielle d'eucalyptus

0,044 g

suppository

rectal use

France

| SANOFI AVENTIS France |
| --- |
| 1-13 boulevard Romain Rolland |
| 75014 Paris |
| France |

SANOFI AVENTIS France

1-13 boulevard Romain Rolland

75014 Paris

France

TROPHIRES NOURRISSONS, suppositoire

huile essentielle d'eucalyptus

0,044 g

suppository

rectal use

France

| SANOFI AVENTIS France |
| --- |
| 1-13 boulevard Romain Rolland |
| 75014 Paris |
| France |

SANOFI AVENTIS France

1-13 boulevard Romain Rolland

75014 Paris

France

FEBRECTOL NOURRISSONS, suppositoire

pin

0,020 g

suppository

rectal use

France

| URGO SOINS & SANTÉ |
| --- |
| 42, rue de Longvic |
| BP157 |
| 21304 Chenove Cedex |
| France |

URGO SOINS & SANTÉ

42, rue de Longvic

BP157

21304 Chenove Cedex

France

calmosedyl

cinéole

0,07 g

suppository

rectal use

France

| ZAMBON FRANCE |
| --- |
| 13 rue René Jacques |
| 92138 Issy-les-Moulineaux Cedex |
| France |

ZAMBON FRANCE

13 rue René Jacques

92138 Issy-les-Moulineaux Cedex

France

BIOCALYPTOL A LA PHOLCODINE ENFANTS, suppositoire

cinéole

0,100 g

suppository

rectal use

France

| ZAMBON FRANCE |
| --- |
| 13 rue René Jacques |
| 92138 Issy-les-Moulineaux Cedex |
| France |

ZAMBON FRANCE

13 rue René Jacques

92138 Issy-les-Moulineaux Cedex

France

OZOTHINE ENFANTS 30 mg, suppositoire

terebenthine (huile essentielle de)

0,03 g

suppository

rectal use

France

| ZAMBON FRANCE |
| --- |
| 13 rue René Jacques |
| 92138 Issy-les-Moulineaux Cedex |
| France |

ZAMBON FRANCE

13 rue René Jacques

92138 Issy-les-Moulineaux Cedex

France

OZOTHINE A LA DIPROPHYLLINE ENFANTS, suppositoire

terebenthine (huile essentielle de)

0,03 g

suppository

rectal use

Italy

| Geymonat Spa |
| --- |
| Via S. Anna, 2 |
| 03012 Anagni (FR), |
| Italy |

Geymonat Spa

Via S. Anna, 2

03012 Anagni (FR),

Italy

Ozopulmin

Oxidation product of turpentine/pine essential oil

80 mg

(turpentine)

100 mg

(pine)

suppository

rectal use

Italy

| Geymonat Spa |
| --- |
| Via S. Anna, 2 |
| 03012 Anagni (FR), |
| Italy |

Geymonat Spa

Via S. Anna, 2

03012 Anagni (FR),

Italy

Ozopulmin

Oxidation product of turpentine/pine essential oil

40 mg

(turpentine)

50 mg

(pine)

suppository

rectal use

Italy

| Teofarma Srl |
| --- |
| Via F.lli Cervi, 8 |
| 27010 Pavia, |
| Italy |

Teofarma Srl

Via F.lli Cervi, 8

27010 Pavia,

Italy

Lipobalsamo

Eucalyptol/guaiacol

40 mg (eucalyptol)

2 mg

(guaiacol)

suppository

rectal use

Luxembourg

| Medgenix benelux NV |
| --- |
| Vliegveld 21 |
| BE-8500 Wevelgem |
| Belgium |

Medgenix benelux NV

Vliegveld 21

BE-8500 Wevelgem

Belgium

Eucalyptine-Pholcodine Enfants

camphre

eucalyptol

gaiacol

phenol

pholcodine

100 mg

80 mg

30 mg

6 mg

5 mg

suppository

rectal use

Luxembourg

| Sanofi-Aventis Belgium |
| --- |
| 1C, Culliganlaan |
| B-1831 Diegem |
| Belgium |

Sanofi-Aventis Belgium

1C, Culliganlaan

B-1831 Diegem

Belgium

Trophires Compose ENFANTS

eucalyptus huile essentielle

thiophene carboxylate

paracetamo

75 mg

130 mg

300 mg

suppository

rectal use

Luxembourg

| Sanofi-Aventis Belgium |
| --- |
| 1C, Culliganlaan |
| B-1831 Diegem |
| Belgium |

Sanofi-Aventis Belgium

1C, Culliganlaan

B-1831 Diegem

Belgium

Trophires Enfants

eucalyptus huile essentielle

thiophene carboxylate

paracetamo

75 mg

190 mg

suppository

rectal use

Luxembourg

| Sanofi-Aventis Belgium |
| --- |
| 1C, Culliganlaan |
| B-1831 Diegem |
| Belgium |

Sanofi-Aventis Belgium

1C, Culliganlaan

B-1831 Diegem

Belgium

Trophires Bebes

eucalyptus huile essentielle

tenuate de sodium

44 mg

95 mg

suppository

rectal use

Luxembourg

| Sanofi-Aventis Belgium |
| --- |
| 1C, Culliganlaan |
| B-1831 Diegem |
| Belgium |

Sanofi-Aventis Belgium

1C, Culliganlaan

B-1831 Diegem

Belgium

Trophires Compose Nourrissons

paracetamol

essence d'eucalyptus

tenoate de sodium

150 mg

44 mg

65 mg

suppository

rectal use

Portugal

Meda Pharma - Produtos farmacêuticos, S.A. Rua do Centro Cultural, 13 1749-066 Lisboa Portugal

Transpulmina (Infantil)

Camphor + Eucalyptol + Menthol

13 mg + 31 mg + 4 mg

suppository

rectal use

Spain

| DIVISER AQUILEA S.L. Pont Reixat, 5 08960 Sant Just Desvern (Barcelona) |
| --- |
| Spain |

DIVISER AQUILEA S.L. Pont Reixat, 5 08960 Sant Just Desvern (Barcelona)

Spain

RECTAGMIGDOL INFANTIL

Bismuth camphocarbonate

150 mg

suppository

rectal use

Spain

| ESCANED |
| --- |
| C/Tomás Bretón, 46 |
| 28045 Madrid, |
| Spain |

ESCANED

C/Tomás Bretón, 46

28045 Madrid,

Spain

BROTA RECTAL SUPOSITORIOS

Cineole + Camphor + Gomenol (Niaouli oil)

100 mg cineole + 50 mg camphor + 90 mg gomenol

suppository

rectal use

Spain

| FERRER INTERNACIONAL, S.A. Gran Via Carlos III, 94 Barcelona, |
| --- |
| Spain |

FERRER INTERNACIONAL, S.A. Gran Via Carlos III, 94 Barcelona,

Spain

PILKA SUPOSITORIOS

Liquid extract of Thymus vulgaris

70 mg of liquid extract of Thymus vulgaris + 16 mg cineole

suppository

rectal use

Spain

| FERRER INTERNACIONAL, S.A. Gran Via Carlos III, 94 Barcelona, |
| --- |
| Spain |

FERRER INTERNACIONAL, S.A. Gran Via Carlos III, 94 Barcelona,

Spain

PILKA SUPOSITORIOS

Liquid extract of Thymus vulgaris

140 mg of liquid extract of Thymus vulgaris + 32 mg cineole

suppository

rectal use

Spain

| LABORATORIOS VIÑAS, S.A. Provenza, 386 Barcelona, |
| --- |
| Spain |

LABORATORIOS VIÑAS, S.A. Provenza, 386 Barcelona,

Spain

DIMINEX ANTITUSIGENO SUPOSITORIOS

Cineole

50 mg

suppository

rectal use

Spain

| LABORATORIOS VIÑAS, S.A. Provenza, 386 Barcelona, |
| --- |
| Spain |

LABORATORIOS VIÑAS, S.A. Provenza, 386 Barcelona,

Spain

DIMINEX ANTITUSIGENO SUPOSITORIOS

Cineole

50 mg

suppository

rectal use

Spain

| TEDEC MEIJI FARMA S.A. Ctra. M-300, Km. 30,500 28802 Alcalá de Henares (Madrid) |
| --- |
| Spain |

TEDEC MEIJI FARMA S.A. Ctra. M-300, Km. 30,500 28802 Alcalá de Henares (Madrid)

Spain

SOBREPIN SUPOSITORIOS INFANTIL

Sobrerol

100 mg

suppository

rectal use

---