# C_2007018EN.01000401.xml

| 26.1.2007 | EN | Official Journal of the European Union | C 18/4 |
| --- | --- | --- | --- |

26.1.2007

EN

Official Journal of the European Union

C 18/4

---

Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 December 2006 to 31 December 2006

(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

2

(2007/C 18/03)

—   Issuing, maintenance or modification of a national marketing authorisation

| Date of the decision | Name(s) of the medicinal product | Holder(s) of the marketing authorization | Member State concerned | Date of notification |
| --- | --- | --- | --- | --- |
| 13.12.2006 | Glucomed | See Annex I | See Annex I | 14.12.2006 |
| 13.12.2006 | Agopton | See Annex II | See Annex II | 14.12.2006 |

Date of the decision

Name(s) of the medicinal product

Holder(s) of the marketing authorization

Member State concerned

Date of notification

13.12.2006

Glucomed

See Annex I

See Annex I

14.12.2006

13.12.2006

Agopton

See Annex II

See Annex II

14.12.2006

—   Suspension of a national marketing authorization

| Date of the decision | Name(s) of the medicinal product | Holder(s) of the marketing authorization | Member State concerned | Date of notification |
| --- | --- | --- | --- | --- |
| 19.12.2006 | Cetirizine Nordic Drugs | See Annex III | See Annex III | 21.12.2006 |
| 19.12.2006 | Cetirizine Dermapharm | See Annex IV | See Annex IV | 21.12.2006 |
| 19.12.2006 | Cetirizine Apex | See Annex V | See Annex V | 21.12.2006 |

Date of the decision

Name(s) of the medicinal product

Holder(s) of the marketing authorization

Member State concerned

Date of notification

19.12.2006

Cetirizine Nordic Drugs

See Annex III

See Annex III

21.12.2006

19.12.2006

Cetirizine Dermapharm

See Annex IV

See Annex IV

21.12.2006

19.12.2006

Cetirizine Apex

See Annex V

See Annex V

21.12.2006

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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, STRENGTH OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANT, MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES

| Member State | Marketing Authorisation Holder | Applicant | Invented name | Strength | Pharmaceutical Form | Route of administration |
| --- | --- | --- | --- | --- | --- | --- |
| Austria | — | Navamedic ASA |
| Vollsveien 13 C |
| N-1327 Lysaker |

Member State

Marketing Authorisation Holder

Applicant

Invented name

Strength

Pharmaceutical Form

Route of administration

Austria

—

Navamedic ASA

Vollsveien 13 C

N-1327 Lysaker

Flexove

625 mg

Tablet

Oral use

Belgium

—

| Navamedic ASA |
| --- |
| Vollsveien 13 C |
| N-1327 Lysaker |

Navamedic ASA

Vollsveien 13 C

N-1327 Lysaker

Flexove

625 mg

Tablet

Oral use

Cyprus

—

| Navamedic ASA |
| --- |
| Vollsveien 13 C |
| N-1327 Lysaker |

Navamedic ASA

Vollsveien 13 C

N-1327 Lysaker

Glucomed

625 mg

Tablet

Oral use

Czech Republic

—

| Navamedic ASA |
| --- |
| Vollsveien 13 C |
| N-1327 Lysaker |

Navamedic ASA

Vollsveien 13 C

N-1327 Lysaker

Flexove

625 mg

Tablet

Oral use

Denmark

—

| Navamedic ASA |
| --- |
| Vollsveien 13 C |
| N-1327 Lysaker |

Navamedic ASA

Vollsveien 13 C

N-1327 Lysaker

Glucomed

625 mg

Tablet

Oral use

Estonia

—

| Navamedic ASA |
| --- |
| Vollsveien 13 C |
| N-1327 Lysaker |

Navamedic ASA

Vollsveien 13 C

N-1327 Lysaker

Glucomed

625 mg

Tablet

Oral use

Finland

—

| Navamedic ASA |
| --- |
| Vollsveien 13 C |
| N-1327 Lysaker |

Navamedic ASA

Vollsveien 13 C

N-1327 Lysaker

Glucomed

625 mg

Tablet

Oral use

France

—

| Navamedic ASA |
| --- |
| Vollsveien 13 C |
| N-1327 Lysaker |

Navamedic ASA

Vollsveien 13 C

N-1327 Lysaker

Glucomed

625 mg

Tablet

Oral use

Germany

—

| Navamedic ASA |
| --- |
| Vollsveien 13 C |
| N-1327 Lysaker |

Navamedic ASA

Vollsveien 13 C

N-1327 Lysaker

Glucomed

625 mg

Tablet

Oral use

Greece

—

| Navamedic ASA |
| --- |
| Vollsveien 13 C |
| N-1327 Lysaker |

Navamedic ASA

Vollsveien 13 C

N-1327 Lysaker

Glucomed

625 mg

Tablet

Oral use

Hungary

—

| Navamedic ASA |
| --- |
| Vollsveien 13 C |
| N-1327 Lysaker |

Navamedic ASA

Vollsveien 13 C

N-1327 Lysaker

Flexove

625 mg

Tablet

Oral use

Ireland

—

| Navamedic ASA |
| --- |
| Vollsveien 13 C |
| N-1327 Lysaker |

Navamedic ASA

Vollsveien 13 C

N-1327 Lysaker

Flexove

625 mg

Tablet

Oral use

Italy

—

| Navamedic ASA |
| --- |
| Vollsveien 13 C |
| N-1327 Lysaker |

Navamedic ASA

Vollsveien 13 C

N-1327 Lysaker

Glucomed

625 mg

Tablet

Oral use

Latvia

—

| Navamedic ASA |
| --- |
| Vollsveien 13 C |
| N-1327 Lysaker |

Navamedic ASA

Vollsveien 13 C

N-1327 Lysaker

Glucomed

625 mg

Tablet

Oral use

Lithuania

—

| Navamedic ASA |
| --- |
| Vollsveien 13 C |
| N-1327 Lysaker |

Navamedic ASA

Vollsveien 13 C

N-1327 Lysaker

Glucomed

625 mg

Tablet

Oral use

Luxemburg

—

| Navamedic ASA |
| --- |
| Vollsveien 13 C |
| N-1327 Lysaker |

Navamedic ASA

Vollsveien 13 C

N-1327 Lysaker

Glucomed

625 mg

Tablet

Oral use

The Netherlands

—

| Navamedic ASA |
| --- |
| Vollsveien 13 C |
| N-1327 Lysaker |

Navamedic ASA

Vollsveien 13 C

N-1327 Lysaker

Glucomed

625 mg

Tablet

Oral use

Poland

—

| Navamedic ASA |
| --- |
| Vollsveien 13 C |
| N-1327 Lysaker |

Navamedic ASA

Vollsveien 13 C

N-1327 Lysaker

Glucomed

625 mg

Tablet

Oral use

Portugal

—

| Navamedic ASA |
| --- |
| Vollsveien 13 C |
| N-1327 Lysaker |

Navamedic ASA

Vollsveien 13 C

N-1327 Lysaker

Glucomed

625 mg

Tablet

Oral use

Slovakia

—

| Navamedic ASA |
| --- |
| Vollsveien 13 C |
| N-1327 Lysaker |

Navamedic ASA

Vollsveien 13 C

N-1327 Lysaker

Glucomed

625 mg

Tablet

Oral use

Spain

—

| Navamedic ASA |
| --- |
| Vollsveien 13 C |
| N-1327 Lysaker |

Navamedic ASA

Vollsveien 13 C

N-1327 Lysaker

Glucomed

625 mg

Tablet

Oral use

Sweden

—

| Navamedic ASA |
| --- |
| Vollsveien 13 C |
| N-1327 Lysaker |

Navamedic ASA

Vollsveien 13 C

N-1327 Lysaker

Glucomed

625 mg

Tablet

Oral use

United Kingdom

—

| Navamedic ASA |
| --- |
| Vollsveien 13 C |
| N-1327 Lysaker |

Navamedic ASA

Vollsveien 13 C

N-1327 Lysaker

Glucomed

625 mg

Tablet

Oral use

Iceland

—

| Navamedic ASA |
| --- |
| Vollsveien 13 C |
| N-1327 Lysaker |

Navamedic ASA

Vollsveien 13 C

N-1327 Lysaker

Glucomed

625 mg

Tablet

Oral use

Norway

—

| Navamedic ASA |
| --- |
| Vollsveien 13 C |
| N-1327 Lysaker |

Navamedic ASA

Vollsveien 13 C

N-1327 Lysaker

Flexove

625 mg

Tablet

Oral use

---

ANNEX II

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

| Member State | Marketing Authorisation Holder | Product name | Strength | Pharmaceutical form | Route of administration |
| --- | --- | --- | --- | --- | --- |
| Austria | Takeda Pharma Ges.m.b.H. |
| Seidengasse 33-35 |
| A-1070 Vienna |

Member State

Marketing Authorisation Holder

Product name

Strength

Pharmaceutical form

Route of administration

Austria

Takeda Pharma Ges.m.b.H.

Seidengasse 33-35

A-1070 Vienna

AGOPTON

15 mg

Capsule

Oral use

AGOPTON

30 mg

Capsule

Oral use

AGOPTON Rapid

15 mg

Oro-dispersible tablet

Oral use

AGOPTON Rapid

30 mg

Oro-dispersible tablet

Oral use

Belgium

| Sanofi-Synthelabo SA NV |
| --- |
| Dobbelenberg |
| 5, Avenue de la Metrologie |
| B-1130 Brussels |

Sanofi-Synthelabo SA NV

Dobbelenberg

5, Avenue de la Metrologie

B-1130 Brussels

DAKAR

15mg

Capsule

Oral use

DAKAR

30 mg

Capsule

Oral use

NIBITOR

30 mg

Capsule

Oral use

Denmark

| Wyeth ab |
| --- |
| Box 1822 |
| S-171 24 Solna |

Wyeth ab

Box 1822

S-171 24 Solna

LANZO

15 mg

Capsule

Oral use

LANZO

30 mg

Capsule

Oral use

Finland

| Wyeth AB |
| --- |
| Box 1822 |
| S-171 24 Solna |

Wyeth AB

Box 1822

S-171 24 Solna

LANZO

30 mg

Capsule

Oral use

LANZO

15 mg

Oro-dispersible tablet

Oral use

LANZO

30 mg

Oro-dispersible tablet

Oral use

France

| Laboratoires Takeda SA |
| --- |
| 15, quai de Dion Bouton |
| F-92816 Puteaux Cedex |

Laboratoires Takeda SA

15, quai de Dion Bouton

F-92816 Puteaux Cedex

OGAST

15 mg

Capsule

Oral use

OGAST

30 mg

Capsule

Oral use

| Sanofi-Aventis |
| --- |
| 46 quai de la Râpée |
| F-75601 Paris Cedex 12 |

Sanofi-Aventis

46 quai de la Râpée

F-75601 Paris Cedex 12

LANZOR

15 mg

Capsule

Oral use

LANZOR

30 mg

Capsule

Oral use

Germany

| Takeda Pharma GmbH |
| --- |
| Viktoriaallee 3-5 |
| D-52066 Aachen |

Takeda Pharma GmbH

Viktoriaallee 3-5

D-52066 Aachen

AGOPTON

15 mg

Capsule

Oral use

AGOPTON

30 mg

Capsule

Oral use

LANZOR

15 mg

Capsule

Oral use

LANZOR

30 mg

Capsule

Oral use

Greece

| Vianex S.A. |
| --- |
| Tatoiou Street |
| EL-146 71 Nea Erythrea, Athens |

Vianex S.A.

Tatoiou Street

EL-146 71 Nea Erythrea, Athens

LAPRAZOL

15 mg

Capsule

Oral use

LAPRAZOL

30 mg

Capsule

Oral use

LAPRAZOL FasTab

15 mg

Oro-dispersible tablet

Oral use

LAPRAZOL FasTab

30 mg

Oro-dispersible tablet

Oral use

Hungary

| Gedeon Richter |
| --- |
| Gyomrói út 19-21 |
| H-1103 Budapest |

Gedeon Richter

Gyomrói út 19-21

H-1103 Budapest

LANSONE

30 mg

Capsule

Oral use

Ireland

| John Wyeth & Brother Limited |
| --- |
| Trading as Wyeth Pharmaceuticals |
| Huntercombe Lane South |
| Taplow, Maidenhead |
| Berkshire SL6 0PH |
| United Kingdom |

John Wyeth & Brother Limited

Trading as Wyeth Pharmaceuticals

Huntercombe Lane South

Taplow, Maidenhead

Berkshire SL6 0PH

United Kingdom

ZOTON

15 mg

Capsule

Oral use

ZOTON

30 mg

Capsule

Oral use

ZOTON FasTab

15 mg

Oro-dispersible tablet

Oral use

ZOTON FasTab

30 mg

Oro-dispersible tablet

Oral use

| Cyanamid of Great Briain Ltd. |
| --- |
| Fareham Road |
| GOSPORT Hampshire PO13 0AS |
| United Kingdom |

Cyanamid of Great Briain Ltd.

Fareham Road

GOSPORT Hampshire PO13 0AS

United Kingdom

ZOTON

30mg

Gastro-resistant granules for oral suspension

Oral use

Italy

| Takeda Italia Farmaceutici S.p.A. |
| --- |
| Via Elio Vittorini 129 |
| I-00144 Roma |

Takeda Italia Farmaceutici S.p.A.

Via Elio Vittorini 129

I-00144 Roma

LANSOX

15 mg

Capsule

Oral use

LANSOX

30 mg

Capsule

Oral use

LANGAST

15 mg

Capsule

Oral use

LANGAST

30 mg

Capsule

Oral use

LANSOX

15 mg

Oro-dispersible tablet

Oral use

LANSOX

30 mg

Oro-dispersible tablet

Oral use

| Sigma-Tau S.p.A. |
| --- |
| Via Pontina km. 30,400 |
| I-00040 Pomezia, Roma |

Sigma-Tau S.p.A.

Via Pontina km. 30,400

I-00040 Pomezia, Roma

LIMPIDEX

15 mg

Capsule

Oral use

LIMPIDEX

30 mg

Capsule

Oral use

LIMPIDEX

15 mg

Oro-dispersible tablet

Oral use

LIMPIDEX

30 mg

Oro-dispersible tablet

Oral use

| Wyeth Lederle S.p.A. |
| --- |
| Via Nettunense, 90 |
| I-04011 Aprilia (LT) |

Wyeth Lederle S.p.A.

Via Nettunense, 90

I-04011 Aprilia (LT)

ZOTON

15 mg

Capsule

Oral use

ZOTON

30 mg

Capsule

Oral use

ZOTON

15 mg

Oro-dispersible tablet

Oral use

ZOTON

30 mg

Oro-dispersible tablet

Oral use

Luxembourg

| Sanofi-Synthelabo SA NV |
| --- |
| Dobbelenberg, 5, Avenue de la Metrologie |
| B-1130 Brussels |

Sanofi-Synthelabo SA NV

Dobbelenberg, 5, Avenue de la Metrologie

B-1130 Brussels

DAKAR

15 mg

Capsule

Oral use

DAKAR

30 mg

Capsule

Oral use

Netherlands

| Sanofi-Synthelabo B.V./Aventis Pharma B.V. |
| --- |
| Kampenringweg 45 D-E (toren D en E) |
| 2803 PE Gouda |
| Nederland |

Sanofi-Synthelabo B.V./Aventis Pharma B.V.

Kampenringweg 45 D-E (toren D en E)

2803 PE Gouda

Nederland

PREZAL

15 mg

Capsule

Oral use

PREZAL

30 mg

Capsule

Oral use

Portugal

| Seber Portuguesa Farmacêutica, SA |
| --- |
| Rua Norberto de Oliveira, 1 a 5 |
| P-2620-111 Póvoa de Santo Adrião |

Seber Portuguesa Farmacêutica, SA

Rua Norberto de Oliveira, 1 a 5

P-2620-111 Póvoa de Santo Adrião

OGASTO

15 mg

Capsule

Oral use

OGASTO

30 mg

Capsule

Oral use

OGASTO

15 mg

Oro-dispersible tablet

Oral use

OGASTO

30 mg

Oro-dispersible tablet

Oral use

Spain

| Almirall Prodesfarma, S.A. |
| --- |
| General Mitre, 151 |
| E-08022 Barcelona |

Almirall Prodesfarma, S.A.

General Mitre, 151

E-08022 Barcelona

OPIREN

15 mg

Capsule

Oral use

OPIREN

30 mg

Capsule

Oral use

BAMALITE

15 mg

Capsule

Oral use

BAMALITE

30 mg

Capsule

Oral use

OPIREN Flas

15 mg

Oro-dispersible tablet

Oral use

OPIREN Flas

30 mg

Oro-dispersible tablet

Oral use

BAMALITE Flas

15 mg

Oro-dispersible tablet

Oral use

BAMALITE Flas

30 mg

Oro-dispersible tablet

Oral use

Sweden

| Wyeth AB |
| --- |
| Box 1822 |
| S-171 24 Solna |

Wyeth AB

Box 1822

S-171 24 Solna

LANZO

15 mg

Capsule

Oral use

LANZO

30 mg

Capsule

Oral use

LANZO

15 mg

Oro-dispersible tablet

Oral use

LANZO

30 mg

Oro-dispersible tablet

Oral use

United Kingdom

| John Wyeth & Brother Limited |
| --- |
| Trading as Wyeth Pharmaceuticals |
| Huntercombe Lane South |
| Taplow, Maidenhead |
| Berkshire SL6 0PH |
| United Kingdom |

John Wyeth & Brother Limited

Trading as Wyeth Pharmaceuticals

Huntercombe Lane South

Taplow, Maidenhead

Berkshire SL6 0PH

United Kingdom

ZOTON

15 mg

Capsule

Oral use

ZOTON

30 mg

Capsule

Oral use

ZOTON

30 mg

Gastro-resistant granules for oral suspension

Oral use

ZOTON FasTab

15 mg

Oro-dispersible Tablet

Oral use

ZOTON FasTab

30 mg

Oro-dispersible Tablet

Oral use

Iceland

| Wyeth AB |
| --- |
| Box 1822 |
| S-171 24 Solna |

Wyeth AB

Box 1822

S-171 24 Solna

LANZO

15 mg

Capsule

Oral use

LANZO

30 mg

Capsule

Oral use

ZOTON

15 mg

Capsule

Oral use

ZOTON

30 mg

Capsule

Oral use

LANZO

15 mg

Oro-dispersible tablet

Oral use

LANZO

30 mg

Oro-dispersible tablet

Oral use

Norway

| Wyeth AB |
| --- |
| Box 1822 |
| S-171 24 Solna |

Wyeth AB

Box 1822

S-171 24 Solna

LANZO

15 mg

Capsule

Oral use

LANZO

30 mg

Capsule

Oral use

LANZO

15 mg

Oro-dispersible tablet

Oral use

LANZO

30 mg

Oro-dispersible tablet

Oral use

---

ANNEX III

LIST OF THE INVENTED NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES

CETIRIZINE DIHYDROCHLORIDE NORDIC DRUGS 10 mg AND ASSOCIATED NAMES

| Member State | Marketing Authorisation Holder | Product Name | Strength | Pharmaceutical Form | Route of administration |
| --- | --- | --- | --- | --- | --- |
| Denmark | Nordic Drugs AB |
| Geijersgatan 4 C |
| S-200 61 Limhamn |

Member State

Marketing Authorisation Holder

Product Name

Strength

Pharmaceutical Form

Route of administration

Denmark

Nordic Drugs AB

Geijersgatan 4 C

S-200 61 Limhamn

Gardex

10 mg

Film coated tablet

Oral

Finland

| Nordic Drugs AB |
| --- |
| Geijersgatan 2A |
| Box 30035 |
| S-200 61 Limhamn |

Nordic Drugs AB

Geijersgatan 2A

Box 30035

S-200 61 Limhamn

Gardex 10 mg tabletti, kalvopäällysteinen

10 mg

Film coated tablet

Oral

Netherlands

| Nordic Drugs AB |
| --- |
| Box 30035 |
| S-200 61 Limhamn |

Nordic Drugs AB

Box 30035

S-200 61 Limhamn

Cetirizine dihydrochloride Nordic Drugs 10 mg

10 mg

Film coated tablet

Oral

Norway

| Nordic Drugs AB, |
| --- |
| Box 30035 |
| S-200 61 Limhamn |

Nordic Drugs AB,

Box 30035

S-200 61 Limhamn

Acura

10 mg

Film coated tablet

Oral

Sweden

| Nordic Drugs AB |
| --- |
| Box 300 35 |
| S-200 61 Limhamn |

Nordic Drugs AB

Box 300 35

S-200 61 Limhamn

Acura

10 mg

Film coated tablet

Oral

---

ANNEX IV

LIST OF THE INVENTED NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES

CETIRIZINE DIHYDROCHLORIDE DERMAPHARM 10 mg AND ASSOCIATED NAMES

| Member State | Marketing Authorisation Holder | Product Name | Strength | Pharmaceutical Form | Route of administration |
| --- | --- | --- | --- | --- | --- |
| Austria | Dermapharm GmbH |
| Türkenstr. 25/12 |
| A-1090 Wien |

Member State

Marketing Authorisation Holder

Product Name

Strength

Pharmaceutical Form

Route of administration

Austria

Dermapharm GmbH

Türkenstr. 25/12

A-1090 Wien

Cetiderm 10 mg Filmtabletten

10 mg

Film coated tablet

Oral

Belgium

| Dermapharm AG |
| --- |
| Luise-Ullrich-Str. 6 |
| D-82031 Grünwald |

Dermapharm AG

Luise-Ullrich-Str. 6

D-82031 Grünwald

Cetirizine dihydrochloride Dermapharm 10 mg filmomhulde tabletten

10 mg

Film coated tablet

Oral

Germany

| Dermapharm AG |
| --- |
| Luise-Ullrich-Str. 6 |
| D-82031 Grünwald |

Dermapharm AG

Luise-Ullrich-Str. 6

D-82031 Grünwald

Cetiderm 10 mg Filmtabletten

10 mg

Film coated tablet

Oral

Netherlands

| Dermapharm AG |
| --- |
| Luise-Ullrich-Str. 6 |
| D-82031 Grünwald |

Dermapharm AG

Luise-Ullrich-Str. 6

D-82031 Grünwald

Cetirizine dihydrochloride Dermapharm 10 mg tabletten

10 mg

Film coated tablet

Oral

---

ANNEX V

LIST OF THE INVENTED NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES

CETIRIZINE DIHYDROCHLORIDE APEX 10 mg AND ASSOCIATED NAMES

| Member State | Marketing Authorisation Holder | Product Name | Strength | Pharmaceutical Form | Route of administration |
| --- | --- | --- | --- | --- | --- |
| Belgium | Docpharma N.V. |
| Ambachtenlaan 13 H |
| B-3001 Heverlee |

Member State

Marketing Authorisation Holder

Product Name

Strength

Pharmaceutical Form

Route of administration

Belgium

Docpharma N.V.

Ambachtenlaan 13 H

B-3001 Heverlee

Doccetiri

10 mg

Film coated tablet

Oral

Luxembourg

| Docpharma N.V. |
| --- |
| Ambachtenlaan 13 H |
| B-3001 Heverlee |

Docpharma N.V.

Ambachtenlaan 13 H

B-3001 Heverlee

Doccetiri-10

10 mg

Film coated tablet

Oral

Netherlands

| Apex Pharmaceuticals Ltd. |
| --- |
| 2nd Floor, Devlin House |
| 36 Saint George Street |
| Mayfair |
| W1S 2FW London |
| United Kingdom |

Apex Pharmaceuticals Ltd.

2nd Floor, Devlin House

36 Saint George Street

Mayfair

W1S 2FW London

United Kingdom

Cetirizine dihydrochloride-APEX 10 mg

10 mg

Film coated tablet

Oral

---