Summary of Community decisions on marketing authorizations in respect of medicinal products from 15 May 2003 to 15 June 2003 (Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC)
Date: 2003-07-01
Institutions: European Commission
Subjects: EU Member State, market approval, medicinal product, preparation for market, product designation

C 153/6

EN

Official Journal of the European Union

1.7.2003

Summary of Community decisions on marketing authorizations in respect of medicinal products
from 15 May 2003 to 15 June 2003

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

(2003/C 153/03)

— 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

21.5.2003

Enalapril

See Annex I

See Annex I

26.5.2003

21.5.2003

Salmeterol/Fluti-
casone propionate

21.5.2003

Salmeterol/Fluti-
casone propionate

See Annex II

See Annex II

23.5.2003

See Annex III

See Annex III

23.5.2003

12.6.2003

Calcitonin

See Annex IV

See Annex IV

13.6.2003

— 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

12.6.2003

Felodipine

See Annex V

See Annex V

13.6.2003

— Repeal of Commission Decision C(2002) 3370 of 9 September 2002

Date of the decision

Name(s) of the
medicinal product

Date of notification

11.6.2003

Captopril

12.6.2003

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

1.7.2003

EN

Official Journal of the European Union

C 153/7

LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCT, ROUTE OF
ADMINISTRATION, MARKETING AUTHORISATION HOLDERS, PACKAGING AND PACKAGE SIZES IN
THE MEMBER STATES

ANNEX I

Member State

Marketing Authorisation
Holder

Invented
name/Name

Strength

Pharma-
ceutical Form

Route of
administration

Packaging

Package-size

AUSTRIA

Merck Sharp & Dohme
GmbH
Donau Citystraße 6
A-1220 Wien

5 mg

Tablets

Oral use

10 mg

Tablets

Oral use

20 mg

Tablets

Oral use

Renitec
5 mg
Tabletten

Renitec
10 mg
Tabletten

Renitec
20 mg
Tabletten

Kwizda
Effingergasse 21
A-1160 Wien

Mepril

5 mg

Tablets

Oral use

Mepril

10 mg

Tablets

Oral use

Mepril

20 mg

Tablets

Oral use

BELGIUM

Merck Sharp & Dohme BV
Chaussée de waterloo 1135
B-1180 Bruxelles

Renitec

2,5 mg

Tablets

Oral use

Renitec

5 mg

Tablets

Oral use

Renitec

10 mg

Tablets

Oral use

Renitec

20 mg

Tablets

Oral use

DENMARK

Merck Sharp & Dohme BV
Waarderweg 39
2031 BN Haarlem
Nederland

Renitec

2,5 mg

Tablets

Oral use

Renitec

5 mg

Tablets

Oral use

Renitec

10 mg

Tablets

Oral use

Renitec

20 mg

Tablets

Oral use

FINLAND

Merck Sharp & Dohme BV
Waarderweg 39
2031 BN Haarlem
Nederland

Renitec

2,5 mg

Tablets

Oral use

Renitec

5 mg

Tablets

Oral use

Blister
(Alu/Alu)

Blister
(Alu/Alu)

Blister
(Alu/Alu)

Blister
(Alu/Alu)

Blister
(Alu/Alu)

Blister
(Alu/Alu)

Blister
(Alu/Alu)

Blister
(Alu/Alu)

Blister
(Alu/Alu)

Blister
(Alu/Alu)

Blister
(Alu/Alu)

Blister
(Alu/Alu)

Blister
(Alu/Alu)

Blister
(Alu/Alu)

Blister
(Alu/Alu)

Blister
(Alu/Alu)

28 tablets

28 tablets

28, 98 tablets

28 tablets

28 tablets

28 tablets

14 tablets

14, 28 tablets and
28 × 1 (unit dose)

28, 56 tablets

28, 56, 98 tablets
and 28 × 1 (unit
dose)

49 tablets

28, 98 tablets

28, 98 tablets

28, 98 tablets

49 tablets

28, 98 tablets

Renitec

10 mg

Tablets

Oral use

Renitec

20 mg

Tablets

Oral use

Bottle (glass)

100 tablets

Blister
(Alu/Alu)

28, 98 tablets

Bottle (glass)

100 tablets

Blister
(Alu/Alu)

28, 98 tablets

Bottle (glass)

100 tablets

Oy Leiras Finland AB
Yliopistonkatu 34 A
PO Box 102
FIN-20101 Turku

Enaloc

Enaloc

Enaloc

5 mg

Tablets

Oral use

10 mg

Tablets

Oral use

20 mg

Tablets

Oral use

Bottle (glass)

Bottle (glass)

Bottle (glass)

30, 100 tablets

30, 100 tablets

30, 100 tablets

C 153/8

EN

Official Journal of the European Union

1.7.2003

Member State

Marketing Authorisation
Holder

Invented
name/Name

Strength

Pharma-
ceutical Form

Route of
administration

Packaging

Package-size

FRANCE

MSD-Chibret
3, avenue Hoche
F-75114 Paris Cedex 08

MSD-Chibret
3, avenue Hoche
F-75114 Paris Cedex 08

GERMANY

MSD Sharp & Dohme
GmbH
Lindenplatz 1
D-85540 Haar

Boehringer Ingelheim
Pharma KG
Binger Straße
D-55216 Ingelheim

GREECE

Vianex SA
Tatoiou str.
18th Km Athens-Lamia
National Road
GR-14671 N. Erithrea

Renitec cp
sécable

Renitec cp
sécable

Renitec cp
sécable

Enalapril
MSD
5 mg

Enalapril
MSD
20 mg

Enalapril
Chibret
5 mg

Enalapril
Chibret
20 mg

Xanef Cor
2,5 mg

Xanef
5 mg

Xanef
10 mg

Xanef
20 mg

Racen Cor
2,5 mg

Racen
5 mg

Racen
10 mg

Racen
20 mg

2,5 mg

Tablets

Oral use

5 mg

Tablets

Oral use

20 mg

Tablets

Oral use

5 mg

Tablets

Oral use

20 mg

Tablets

Oral use

5 mg

Tablets

Oral use

20 mg

Tablets

Oral use

2,5 mg

Tablets

Oral use

5 mg

Tablets

Oral use

10 mg

Tablets

Oral use

20 mg

Tablets

Oral use

2,5 mg

Tablets

Oral use

5 mg

Tablets

Oral use

10 mg

Tablets

Oral use

20 mg

Tablets

Oral use

Pres 2,5 mg 2,5 mg

Tablets

Oral use

Pres 5 mg

5 mg

Tablets

Oral use

Pres
10 mg

Pres
20 mg

10 mg

Tablets

Oral use

20 mg

Tablets

Oral use

Renitec

2,5 mg

Tablets

Oral use

Renitec

5 mg

Tablets

Oral use

Renitec

20 mg

Tablets

Oral use

Vitobel

2,5 mg

Tablets

Oral use

Vitobel

5 mg

Tablets

Oral use

Vitobel

20 mg

Tablets

Oral use

Blister
(Alu/Alu)

Blister
(Alu/Alu)

Blister
(Alu/Alu)

Blister
(Alu/Alu)

Blister
(Alu/Alu)

Blister
(Alu/Alu)

Blister
(Alu/Alu)

Blister
(Alu/Alu)

Blister
(Alu/Alu)

Blister
(Alu/Alu)

Blister
(Alu/Alu)

Blister
(Alu/Alu)

Blister
(Alu/Alu)

Blister
(Alu/Alu)

Blister
(Alu/Alu)

Blister
(Alu/Alu)

Blister
(Alu/Alu)

Blister
(Alu/Alu)

Blister
(Alu/Alu)

Blister
(Alu/Alu)

Blister
(Alu/Alu)

Blister
(Alu/Alu)

Blister
(Alu/Alu)

Blister
(Alu/Alu)

Blister
(Alu/Alu)

11 tablets

14, 28, 50 tablets

14, 28, 50 tablets

14, 28, 50 tablets

14, 28, 50 tablets

14, 28, 50 tablets

14, 28, 50 tablets

30, 50, 100, 300
tablets

30, 50, 100, 300
tablets

30, 50, 100, 300
tablets

30, 50, 100, 300
tablets

30, 50, 100, 300
tablets

30, 50, 100, 300
tablets

30, 50, 100, 300
tablets

30, 50, 100, 300
tablets

30, 50, 100, 300
tablets

30, 50, 100, 300
tablets

30, 50, 100, 300
tablets

30, 50, 100, 300
tablets

20, 30, 40 tablets

30 tablets

10 tablets

20, 30, 40 tablets

30 tablets

10 tablets

1.7.2003

EN

Official Journal of the European Union

C 153/9

Member State

Marketing Authorisation
Holder

Invented
name/Name

Strength

Pharma-
ceutical Form

Route of
administration

Packaging

Package-size

IRELAND

Merck Sharp & Dohme
Limited
Hertford Road
Hoddesdon
Herts
EN11 9BU
United Kingdom

2,5 mg

Tablets

Oral use

5 mg

Tablets

Oral use

10 mg

Tablets

Oral use

20 mg

Tablets

Oral use

40 mg

Tablets

Oral use

Innovace
tablets
2,5 mg

Innovace
tablets
5 mg

Innovace
tablets
10 mg

Innovace
tablets
20 mg

Innovace
tablets
40 mg

ITALY

Merck Sharp & Dohme
(Italia) SpA
Via G. Fabbroni, 6
I-00191 Roma

Istituto Gentili SpA
Via Mazzini, 112
I-56125 Pisa

Enapren

5 mg

Tablets

Oral use

Enapren

20 mg

Tablets

Oral use

Converten

5 mg

Tablets

Oral use

Converten

20 mg

Tablets

Oral use

Sigma-Tau Industrie
Farmaceutiche Riunite SpA
V.le Shakespeare, 47
I-00144 Roma

Naprilene

5 mg

Tablets

Oral use

Naprilene

20 mg

Tablets

Oral use

LUXEMBOURG Merck Sharp & Dohme BV

Renitec

2,5 mg

Tablets

Oral use

Chaussée de waterloo 1135
B-1180 Bruxelles

NETHERLANDS Merck Sharp & Dohme BV

PO Box 581
2003 PC Haarlem
Nederland

PORTUGAL

Merck Sharp & Dohme, Lda
Quinta da Fonte 19
Porto Salvo
P-2780-730 Paço de Arcos

Renitec

5 mg

Tablets

Oral use

Renitec

10 mg

Tablets

Oral use

Renitec

20 mg

Tablets

Oral use

Renitec
5 mg

Renitec
10 mg

Renitec
20 mg

Renitec
40 mg

5 mg

Tablets

Oral use

10 mg

Tablets

Oral use

20 mg

Tablets

Oral use

40 mg

Tablets

Oral use

Renitec 2,5

2,5 mg

Tablets

Oral use

Renitec 5

5 mg

Tablets

Oral use

Renitec 10

10 mg

Tablets

Oral use

Renitec

20 mg

Tablets

Oral use

Blister
(Alu/Alu)

Blister
(Alu/Alu)

Blister
(Alu/Alu)

Blister
(Alu/Alu)

Blister
(Alu/Alu)

Blister
(Alu/Alu)

Blister
(Alu/Alu)

Blister
(Alu/Alu)

Blister
(Alu/Alu)

Blister
(Alu/Alu)

Blister
(Alu/Alu)

Blister
(Alu/Alu)

Blister
(Alu/Alu)

Blister
(Alu/Alu)

Blister
(Alu/Alu)

Blister
(Alu/Alu)

Blister
(Alu/Alu)

Blister
(Alu/Alu)

Blister
(Alu/Alu)

Blister
(Alu/Alu)

Blister
(Alu/Alu)

Blister
(Alu/Alu)

Blister
(Alu/Alu)

2, 11, 28 tablets

2, 14, 28 tablets

28 tablets

28 tablets

28 tablets

28 tablets

14 tablets

28 tablets

14 tablets

28 tablets

14 tablets

14 tablets

14, 28 tablets and
28 × 1 (unit dose)

28, 56 tablets

28, 56, 98 tablets
and 28 × 1
(unit dose)

30, 50 tablets

30, 50 tablets

30, 50 tablets

30, 50 tablets

20, 60 tablets

20, 60 tablets

10, 60 tablets

30, 60 tablets

C 153/10

EN

Official Journal of the European Union

1.7.2003

Member State

Marketing Authorisation
Holder

Invented
name/Name

Strength

Pharma-
ceutical Form

Route of
administration

Packaging

Package-size

SPAIN

Merck Sharp & Dohme de
España SA
Josefa Valcarel, 38
E-28027 Madrid

Laboratorios Abelló SA
Josefa Valcarel, 38
E-28027 Madrid

5 mg

Tablets

Oral use

20 mg

Tablets

Oral use

5 mg

Tablets

Oral use

20 mg

Tablets

Oral use

Renitec
5 mg

Renitec
20 mg

Enalapril
Abelló
5 mg

Enalapril
Abelló
20 mg

Iquinosa
Alpedrete, 24
E-28045 Madrid

Presitan 5

5 mg

Tablets

Oral use

Presitan 20

20 mg

Tablets

Oral use

Sigma-Tau SA
Poligono Industrial Azque
Bolivia 15
Alcala de Henares
E-28806 Madrid

Uriach
Dega Bahi, 59
E-08026 Barcelona

Naprilene
5

Naprilene
20

Crinoren
5 mg

Crinoren
20 mg

5 mg

Tablets

Oral use

20 mg

Tablets

Oral use

5 mg

Tablets

Oral use

20 mg

Tablets

Oral use

SWEDEN

Merck Sharp & Dohme BV
Waarderweg 39
2031 BN Haarlem
Nederland

Renitec

2,5 mg

Tablets

Oral use

Renitec

5 mg

Tablets

Oral use

UNITED
KINGDOM

Merck Sharp & Dohme
Limited
Hertford Road
Hoddesdon
Herts EN11 9BU
United Kingdom

Renitec

10 mg

Tablets

Oral use

Renitec

20 mg

Tablets

Oral use

2,5 mg

Tablets

Oral use

5 mg

Tablets

Oral use

10 mg

Tablets

Oral use

20 mg

Tablets

Oral use

Innovace
tablets
2,5 mg

Innovace
tablets
5 mg

Innovace
tablets
10 mg

Innovave
tablets
20 mg

ICELAND

Merck Sharp & Dohme BV
Waarderweg 39
2031 BN Haarlem
Nederland

Renitec

2,5 mg

Tablets

Oral use

Renitec

5 mg

Tablets

Oral use

Renitec

10 mg

Tablets

Oral use

Renitec

20 mg

Tablets

Oral use

Blister
(Alu/Alu)

Blister
(Alu/Alu)

Blister
(Alu/Alu)

Blister
(Alu/Alu)

Blister
(Alu/Alu)

Blister
(Alu/Alu)

Blister
(Alu/Alu)

Blister
(Alu/Alu)

Blister
(Alu/Alu)

Blister
(Alu/Alu)

Blister
(Alu/Alu)

Blister
(Alu/Alu)

10, 60 tablets

28, 500 tablets

10, 60 tablets

28 tablets

10, 60 tablets

28 tablets

10, 60 tablets

28 tablets

10, 60 tablets

28 tablets

49 tablets

28, 49, 98 tablets

Bottle (glass)

100 tablets

Blister
(Alu/Alu)

28, 49, 98 tablets

Bottle (glass)

100 tablets

Blister
(Alu/Alu)

28, 49, 98 tablets

Bottle (glass)

100 tablets

Blister
(Alu/Alu)

Blister
(Alu/Alu)

Blister
(Alu/Alu)

Blister
(Alu/Alu)

Blister
(Alu/Alu)

Blister
(Alu/Alu)

Blister
(Alu/Alu)

Blister
(Alu/Alu)

2, 11, 28 tablets

2, 14, 28 tablets

28 tablets

28 tablets

49 tablets

28, 98 tablets

28, 98 tablets

28, 98 tablets

1.7.2003

EN

Official Journal of the European Union

C 153/11

Member State

Marketing Authorisation
Holder

Invented
name/Name

Strength

Pharma-
ceutical Form

Route of
administration

Packaging

Package-size

NORWAY

Merck Sharp & Dohme BV
Waarderweg 39
2031 BN Haarlem
Nederland

Renitec

2,5 mg

Tablets

Oral use

Renitec

5 mg

Tablets

Oral use

Renitec

10 mg

Tablets

Oral use

Renitec

20 mg

Tablets

Oral use

Renitec

2,5 mg
+
10 mg

Tablets

Oral use

Blister
(Alu/Alu)

Blister
(Alu/Alu)

Blister
(Alu/Alu)

Blister
(Alu/Alu)

Blister
(Alu/Alu)

11, 49 tablets

28, 49, 98 tablets

28, 49, 98 tablets

28, 49, 98 tablets

11 × (2,5 mg) +
14 × (10 mg)
Tablets

ANNEX II

LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE
OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS, PACKAGING AND PACKAGE SIZES IN
THE MEMBER STATES

SALMETEROL AND FLUTICASONE FIXED COMBINATION MEDICINAL PRODUCTS WITH MARKETING AUTHOR-
ISATION IN THE MEMBER STATES

Member State

Marketing Authorisation Holder Invented Name

Strength

Pharmaceutical
Form

Route of
administration

Packaging

Package size

AUSTRIA

GlaxoSmithKline
Pharma GmbH
Albert-Schweitzer-Gasse 6
A-1140 Wien

Seretide
Diskus forte

50/500

Inhalation
powder,
pre-dispensed

Inhalation

Blister. Double foil
28 or 60 dose

1×28, 1×60, 2×60,
3×60, 10×60 doses

GlaxoSmithKline
Pharma GmbH
Albert-Schweitzer-Gasse 6
A-1140 Wien

Seretide
Diskus
junior

50/100

Inhalation
powder,
pre-dispensed

Inhalation

Blister. Double foil
28 or 60 dose

1×28, 1×60, 2×60,
3×60, 10×60

GlaxoSmithKline
Pharma GmbH
Albert-Schweitzer-Gasse 6
A-1140 Wien

Seretide
Diskus
standard

50/250

Inhalation
powder,
pre-dispensed

Inhalation

Blister. Double foil
28 or 60 dose

1×28, 1×60, 2×60,
3×60, 10×60 doses

BELGIUM

GlaxoSmithKline SA/NV
Rue du Tilleul, 13
B-1332 Genval

Seretide
Diskus
50/100

50/100

Inhalation
powder,
pre-dispensed

Inhalation

Blister. Double foil
28 or 60 dose

1×28, 1×60, 2×60,
3×60, 10×60 doses

GlaxoSmithKline SA/NV
Rue du Tilleul, 13
B-1332 Genval

Seretide
Diskus
50/250

50/250

Inhalation
powder,
pre-dispensed

Inhalation

Blister. Double foil
28 or 60 dose

1×28, 1×60, 2×60,
3×60, 10×60 doses

GlaxoSmithKline SA/NV
Rue du Tilleul, 13
B-1332 Genval

Seretide
Diskus
50/500

50/500

Inhalation
powder,
pre-dispensed

Inhalation

Blister. Double foil
28 or 60 dose

1×28, 1×60, 2×60,
3×60, 10×60 doses

C 153/12

EN

Official Journal of the European Union

1.7.2003

Member State

Marketing Authorisation Holder Invented Name

Strength

Pharmaceutical
Form

Route of
administration

Packaging

Package size

DENMARK

GlaxoSmithKline
Pharma A/S
Nykær 68
DK-2605 Brøndby

GlaxoSmithKline
Pharma A/S
Nykær 68
DK-2605 Brøndby

GlaxoSmithKline
Pharma A/S
Nykær 68
DK-2605 Brøndby

Seretide
(Diskos)

50/100

Inhalation
powder,
pre-dispensed

Inhalation

Blister. Double foil
28 or 60 dose

1×28, 1×60, 2×60,
3×60, 10×60 doses

Seretide
(Diskos)

50/250

Inhalation
powder,
pre-dispensed

Inhalation

Blister. Double foil
28 or 60 dose

1×28, 1×60, 2×60,
3×60, 10×60 doses

Seretide
(Diskos)

50/500

Inhalation
powder,
pre-dispensed

Inhalation

Blister. Double foil
28 or 60 dose

1×28, 1×60, 2×60,
3×60, 10×60 doses

FINLAND

GlaxoSmithKline Oy
Kurjenkellontie 5
FIN-02271 Espoo

Seretide
Diskus

50/100

Inhalation
powder,
pre-dispensed

Inhalation

Blister. Double foil
28 or 60 dose

1×28, 1×60, 2×60,
3×60, 10×60 doses

GlaxoSmithKline Oy
Kurjenkellontie 5
FIN-02271 Espoo

Seretide
Diskus

50/250

Inhalation
powder,
pre-dispensed

Inhalation

Blister. Double foil
28 or 60 dose

1×28, 1×60, 2×60,
3×60, 10×60 doses

GlaxoSmithKline Oy
Kurjenkellontie 5
FIN-02271 Espoo

Seretide
Diskus

50/100

Inhalation
powder,
pre-dispensed

Inhalation

Blister. Double foil
28 or 60 dose

1×28, 1×60, 2×60,
3×60, 10×60 doses

FRANCE

Laboratoire
GlaxoSmithKline
100, route de Versailles
F-78163 Marly-le-Roi
Cedex

Laboratoire
GlaxoSmithKline
100, route de Versailles
F-78163 Marly-le-Roi
Cedex

Laboratoire
GlaxoSmithKline
100, route de Versailles
F-78163 Marly-le-Roi
Cedex

Seretide
Diskus

50/100

Inhalation
powder,
pre-dispensed

Inhalation

Blister. Double foil
28 or 60 dose

1×28, 1×60, 2×60,
3×60, 10×60 doses

Seretide
Diskus

50/250

Inhalation
powder,
pre-dispensed

Inhalation

Blister. Double foil
28 or 60 dose

1×28, 1×60, 2×60,
3×60, 10×60 doses

Seretide
Diskus

50/500

Inhalation
powder,
pre-dispensed

Inhalation

Blister. Double foil
28 or 60 dose

1×28, 1×60, 2×60,
3×60, 10×60 doses

GERMANY

Schwarz Pharma
Deutschland GmbH
Alfred-Nobel-Straße 10
D-40789 Monheim

Atmadisc
mite Diskus

50/100

Inhalation
powder,
pre-dispensed

Inhalation

Blister. Double foil
28 or 60 dose

1×28, 1×60, 2×60,
3×60, 10×60 doses

Schwarz Pharma
Deutschland GmbH
Alfred-Nobel-Straße 10
D-40789 Monheim

Atmadisc
Diskus

50/250

Inhalation
powder,
pre-dispensed

Inhalation

Blister. Double foil
28 or 60 dose

1×28, 1×60, 2×60,
3×60, 10×60 doses

1.7.2003

EN

Official Journal of the European Union

C 153/13

Member State

Marketing Authorisation Holder Invented Name

Strength

Pharmaceutical
Form

Route of
administration

Packaging

Package size

GERMANY
(cont’d)

Schwarz Pharma
Deutschland GmbH
Alfred-Nobel-Straße 10
D-40789 Monheim

Atmadisc
forte Diskus

50/500

Inhalation
powder,
pre-dispensed

Inhalation

Blister. Double foil
28 or 60 dose

1×28, 1×60, 2×60,
3×60, 10×60 doses

GREECE

Allen Pharmaceuticals SA
Filellinon 34
GR-152 32 Halandri
Athens

Seretide
diskus

50/100

Inhalation
powder,
pre-dispensed

Inhalation

Blister. Double foil
28 or 60 dose

1×28, 1×60, 2×60,
3×60, 10×60 doses

Allen Pharmaceuticals SA
Filellinon 34
GR-152 32 Halandri
Athens

Seretide
diskus

50/250

Inhalation
powder,
pre-dispensed

Inhalation

Blister. Double foil
28 or 60 dose

1×28, 1×60, 2×60,
3×60, 10×60 doses

Allen Pharmaceuticals SA
Filellinon 34
GR-152 32 Halandri
Athens

Seretide
diskus

50/500

Inhalation
powder,
pre-dispensed

Inhalation

Blister. Double foil
28 or 60 dose

1×28, 1×60, 2×60,
3×60, 10×60 doses

IRELAND

Allen & Hansburys
Limited
Stockley Park West
Uxbridge
Middlesex UB11 1BT
United Kingdom

Allen & Hansburys
Limited
Stockley Park West
Uxbridge
Middlesex UB11 1BT
United Kingdom

Allen & Hansburys
Limited
Stockley Park West
Uxbridge
Middlesex UB11 1BT
United Kingdom

Seretide
Diskus

50/100

Inhalation
powder,
pre-dispensed

Inhalation

Blister. Double foil
28 or 60 dose

1×28, 1×60, 2×60,
3×60, 10×60 doses

Seretide
Diskus

50/250

Inhalation
powder,
pre-dispensed

Inhalation

Blister. Double foil
28 or 60 dose

1×28, 1×60, 2×60,
3×60, 10×60 doses

Seretide
Diskus

50/500

Inhalation
powder,
pre-dispensed

Inhalation

Blister. Double foil
28 or 60 dose

1×28, 1×60, 2×60,
3×60, 10×60 doses

ITALY

GlaxoSmithKline SpA
Via A. Fleming, 2
I-37135 Verona

Seretide
Diskus

50/100

Inhalation
powder,
pre-dispensed

Inhalation

Blister. Double foil
28 or 60 dose

1×28, 1×60, 2×60,
3×60, 10×60 doses

GlaxoSmithKline SpA
Via A. Fleming, 2
I-37135 Verona

Seretide
Diskus

50/250

Inhalation
powder,
pre-dispensed

Inhalation

Blister. Double foil
28 or 60 dose

1×28, 1×60, 2×60,
3×60, 10×60 doses

GlaxoSmithKline SpA
Via A. Fleming, 2
I-37135 Verona

Seretide
Diskus

50/500

Inhalation
powder,
pre-dispensed

Inhalation

Blister. Double foil
28 or 60 dose

1×28, 1×60, 2×60,
3×60, 10×60 doses

C 153/14

EN

Official Journal of the European Union

1.7.2003

Member State

Marketing Authorisation Holder Invented Name

Strength

Pharmaceutical
Form

Route of
administration

Packaging

Package size

LUXEMBOURG

GlaxoSmithKline SA/NV
Rue du Tilleul 13
B-1332 Genval

Seretide
Diskus

50/100

Inhalation
powder,
pre-dispensed

Inhalation

Blister. Double foil
28 or 60 dose

1×28, 1×60, 2×60,
3×60, 10×60 doses

GlaxoSmithKline SA/NV
Rue du Tilleul 13
B-1332 Genval

Seretide
Diskus

50/250

Inhalation
powder,
pre-dispensed

Inhalation

Blister. Double foil
28 or 60 dose

1×28, 1×60, 2×60,
3×60, 10×60 doses

GlaxoSmithKline SA/NV
Rue du Tilleul 13
B-1332 Genval

Seretide
Diskus

50/500

Inhalation
powder,
pre-dispensed

Inhalation

Blister. Double foil
28 or 60 dose

1×28, 1×60, 2×60,
3×60, 10×60 doses

NETHERLANDS

GlaxoSmithKline BV
Huis Ter Heideweg 62
3705 Lz Zeist
Nederland

Seretide
50/100
Diskus

50/100

Inhalation
powder,
pre-dispensed

Inhalation

Blister. Double foil
28 or 60 dose

1×28, 1×60, 2×60,
3×60, 10×60 doses

GlaxoSmithKline BV
Huis Ter Heideweg 62
3705 Lz Zeist
Nederland

Seretide
50/250
Diskus

50/250

Inhalation
powder,
pre-dispensed

Inhalation

Blister. Double foil
28 or 60 dose

1×28, 1×60, 2×60,
3×60, 10×60 doses

GlaxoSmithKline BV
Huis Ter Heideweg 62
3705 Lz Zeist
Nederland

Seretide
50/500
Diskus

50/500

Inhalation
powder,
pre-dispensed

Inhalation

Blister. Double foil
28 or 60 dose

1×28, 1×60, 2×60,
3×60, 10×60 doses

PORTUGAL

SPAIN

Glaxo Wellcome
Farmacêutica, Lda
Rua Dr. António Loureiro
Borges, 3
Arquiparque, Miraflores
P-1495-131 Algés

Glaxo Wellcome
Farmacêutica, Lda
Rua Dr. António Loureiro
Borges, 3
Arquiparque, Miraflores
P-1495-131 Algés

Glaxo Wellcome
Farmacêutica, Lda
Rua Dr. António Loureiro
Borges, 3
Arquiparque, Miraflores
P-1495-131 Algés

Glaxo Wellcome SA
Parque Tecnologico de
Madrid
Calle Severo Ochoa, 2
E-28760 Tres Cantos
Madrid

Seretaide
Diskus

50/500

Inhalation
powder,
pre-dispensed

Inhalation

Blister. Double foil
28 or 60 dose

1×28, 1×60, 2×60,
3×60, 10×60 doses

Seretaide
Diskus

50/250

Inhalation
powder,
pre-dispensed

Inhalation

Blister. Double foil
28 or 60 dose

1×28, 1×60, 2×60,
3×60, 10×60 doses

Seretaide
Diskus

50/100

Inhalation
powder,
pre-dispensed

Inhalation

Blister. Double foil
28 or 60 dose

1×28, 1×60, 2×60,
3×60, 10×60 doses

Seretide
50/500
Accuhaler

50/500

Inhalation
powder,
pre-dispensed

Inhalation

Blister. Double foil
28 or 60 dose

1×28, 1×60, 2×60,
3×60, 10×60 doses

1.7.2003

EN

Official Journal of the European Union

C 153/15

Member State

Marketing Authorisation Holder Invented Name

Strength

Pharmaceutical
Form

Route of
administration

Packaging

Package size

SPAIN
(cont’d)

Glaxo Wellcome SA
Parque Tecnologico de
Madrid
Calle Severo Ochoa, 2
E-28760 Tres Cantos
Madrid

Glaxo Wellcome SA
Parque Tecnologico de
Madrid
Calle Severo Ochoa, 2
E-28760 Tres Cantos
Madrid

Seretide
50/250
Accuhaler

50/250

Inhalation
powder,
pre-dispensed

Inhalation

Blister. Double foil
28 or 60 dose

1×28, 1×60, 2×60,
3×60, 10×60 doses

Seretide
50/100
Accuhaler

50/100

Inhalation
powder,
pre-dispensed

Inhalation

Blister. Double foil
28 or 60 dose

1×28, 1×60, 2×60,
3×60, 10×60 doses

SWEDEN

GlaxoSmithKline AB
PO Box 263
S-431 23 Mölndal

Seretide
Diskus

50/100

GlaxoSmithKline AB
PO Box 263
S-431 23 Mölndal

Seretide
Diskus

50/250

GlaxoSmithKline AB
PO Box 263
S-431 23 Mölndal

Seretide
Diskus

50/500

Inhalation
powder,
pre-dispensed

Inhalation
powder,
pre-dispensed

Inhalation
powder,
pre-dispensed

Inhalation

Blister. Double foil
28 or 60 dose

1×28, 1×60, 2×60,
3×60, 10×60 doses

Inhalation

Blister. Double foil
28 or 60 dose

1×28, 1×60, 2×60,
3×60, 10×60 doses

Inhalation

Blister. Double foil
28 or 60 dose

1×28, 1×60, 2×60,
3×60, 10×60 doses

UNITED
KINGDOM

Glaxo Wellcome UK
Limited
Trading As
Allen & Hanburys
Stockley Park West
Uxbridge
Middlesex UB11 1BT
United Kingdom

Glaxo Wellcome UK
Limited
Trading As
Allen & Hanburys
Stockley Park West
Uxbridge
Middlesex UB11 1BT
United Kingdom

Glaxo Wellcome UK
Limited
Trading As
Allen & Hanburys
Stockley Park West
Uxbridge
Middlesex UB11 1BT
United Kingdom

Seretide
Accuhaler

50/100

Inhalation
powder,
pre-dispensed

Inhalation

Blister. Double foil
28 or 60 dose

28, 60, 120, 180
and 600 actuations

Seretide
Accuhaler

50/250

Inhalation
powder,
pre-dispensed

Inhalation

Blister. Double foil
28 or 60 dose

28, 60, 120, 180
and 600 actuations

Seretide
Accuhaler

50/500

Inhalation
powder,
pre-dispensed

Inhalation

Blister. Double foil
28 or 60 dose

28, 60, 120, 180
and 600 actuations

C 153/16

EN

Official Journal of the European Union

1.7.2003

ANNEX III

LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE
OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS, PACKAGING AND PACKAGE SIZES IN
THE MEMBER STATES

SALMETEROL AND FLUTICASONE FIXED COMBINATION MEDICINAL PRODUCTS WITH MARKETING AUTHOR-
ISATION IN THE MEMBER STATES

Member State

Marketing Authorisation
Holder

Invented Name

Strength

Pharmaceutical
Form

Route of
administration

Packaging

Package size

AUSTRIA

Allen Pharmazeutika
Gesellschaft mbH
Albert-Schweitzer-Gasse 6
A-1140 Wien

Viani Diskus
forte

50/500 Inhalation

Inhalation

powder, predis-
pensed

Blister, Double foil
28 or 60 dose

1×28, 1×60, 2×60,
3×60, 10×60 doses

Allen Pharmazeutika
Gesellschaft mbH
Albert-Schweitzer-Gasse 6
A-1140 Wien

Viani Diskus
junior

50/100 Inhalation

Inhalation

powder, predis-
pensed

Blister, Double foil
28 or 60 dose

1×28, 1×60, 2×60,
3×60, 10×60 doses

Allen Pharmazeutika
Gesellschaft mbH
Albert-Schweitzer-Gasse 6
A-1140 Wien

Viani Diskus
standard

50/250 Inhalation

Inhalation

powder, predis-
pensed

Blister, Double foil
28 or 60 dose

1×28, 1×60, 2×60,
3×60, 10×60 doses

BELGIUM

GlaxoSmithKline SA/NV
Rue du Tilleul, 13
B-1332 Genval

Viani Diskus
50/100

50/100 Inhalation

Inhalation

powder, predis-
pensed

Blister, Double foil
28 or 60 dose

1×28, 1×60, 2×60,
3×60, 10×60 doses

GlaxoSmithKline SA/NV
Rue du Tilleul, 13
B-1332 Genval

Viani Diskus
50/250

50/250 Inhalation

Inhalation

powder, predis-
pensed

Blister, Double foil
28 or 60 dose

1×28, 1×60, 2×60,
3×60, 10×60

GlaxoSmithKline SA/NV
Rue du Tilleul, 13
B-1332 Genval

Viani Diskus
50/500

50/500 Inhalation

Inhalation

powder, predis-
pensed

Blister, Double foil
28 or 60 dose

1×28, 1×60, 2×60,
3×60, 10×60 doses

FNNLAND

GlaxoSmithKline Oy
Kurjenkellontie 5
FIN-02271 Espoo

Viani Diskus 50/100 Inhalation

Inhalation

powder, predis-
pensed

Blister, Double foil
28 or 60 dose

1×28, 1×60, 2×60,
3×60, 10×60 doses

GlaxoSmithKline Oy
Kurjenkellontie 5
FIN-02271 Espoo

Viani Diskus 50/250 Inhalation

Inhalation

powder, predis-
pensed

Blister, Double foil
28 or 60 dose

1×28, 1×60, 2×60,
3×60, 10×60 doses

GlaxoSmithKline Oy
Kurjenkellontie 5
FIN-02271 Espoo

Viani Diskus 50/100 Inhalation

Inhalation

powder, predis-
pensed

Blister, Double foil
28 or 60 dose

1×28, 1×60, 2×60,
3×60, 10×60 doses

1.7.2003

EN

Official Journal of the European Union

C 153/17

Member State

Marketing Authorisation
Holder

Invented Name

Strength

Pharmaceutical
Form

Route of
administration

Packaging

Package size

FRANCE

Laboratoire
GlaxoSmithKline
100, route de Versailles
F-78163 Marly-le-Roi
Cedex

Viani Diskus 50/100 Inhalation

Inhalation

powder, predis-
pensed

Blister, Double foil
28 or 60 dose

1×28, 1×60, 2×60,
3×60, 10×60 doses

Laboratoire
GlaxoSmithKline
100, route de Versailles
F-78163 Marly-le-Roi
Cedex

Laboratoire
GlaxoSmithKline
100, route de Versailles
F-78163 Marly-le-Roi
Cedex

Viani Diskus 50/250 Inhalation

Inhalation

powder, predis-
pensed

Blister, Double foil
28 or 60 dose

1×28, 1×60, 2×60,
3×60, 10×60 doses

Viani Diskus 50/500 Inhalation

Inhalation

powder, predis-
pensed

Blister, Double foil
28 or 60 dose

1×28, 1×60, 2×60,
3×60, 10×60 doses

GERMANY

GlaxoSmithKline
GmbH & Co. KG
Leopoldstraße 175
D-80804 München

Atmadisc
mite Diskus

50/100 Inhalation

Inhalation

powder, predis-
pensed

Blister, Double foil
28 or 60 dose

1×28, 1×60, 2×60,
3×60, 10×60 doses

GlaxoSmithKline
GmbH & Co. KG
Leopoldstraße 175
D-80804 München

GlaxoSmithKline
GmbH & Co. KG
Leopoldstraße 175
D-80804 München

Atmadisc
Diskus

50/250 Inhalation

Inhalation

powder, predis-
pensed

Blister, Double foil
28 or 60 dose

1×28, 1×60, 2×60,
3×60, 10×60 doses

Atmadisc
forte Diskus

50/500 Inhalation

Inhalation

powder, predis-
pensed

Blister, Double foil
28 or 60 dose

1×28, 1×60, 2×60,
3×60, 10×60 doses

GREECE

Glaxo Wellcome AEBE
Leof. Kifisias 266
GR-152 32 Halandri
Athens

Viani diskus

50/100 Inhalation

Inhalation

powder, predis-
pensed

Blister, Double foil
28 or 60 dose

1×28, 1×60, 2×60,
3×60, 10×60 doses

Glaxo Wellcome AEBE
Leof. Kifisias 266
GR-152 32 Halandri
Athens

Glaxo Wellcome AEBE
Leof. Kifisias 266
GR-152 32 Halandri
Athens

Viani diskus

50/250 Inhalation

Inhalation

powder, predis-
pensed

Blister, Double foil
28 or 60 dose

1×28, 1×60, 2×60,
3×60, 10×60 doses

Viani diskus

50/500 Inhalation

Inhalation

powder, predis-
pensed

Blister, Double foil
28 or 60 dose

1×28, 1×60, 2×60,
3×60, 10×60 doses

C 153/18

EN

Official Journal of the European Union

1.7.2003

Member State

Marketing Authorisation
Holder

Invented Name

Strength

Pharmaceutical
Form

Route of
administration

Packaging

Package size

IRELAND

Allen & Hansburys
Limited
Stockley Park West
Uxbridge
Middlesex UB11 1BT
United Kingdom

Allen & Hansburys
Limited
Stockley Park West
Uxbridge
Middlesex UB11 1BT
United Kingdom

Allen & Hansburys
Limited
Stockley Park West
Uxbridge
Middlesex UB11 1BT
United Kingdom

Viani Diskus 50/100 Inhalation

Inhalation

powder, predis-
pensed

Blister, Double foil
28 or 60 dose

1×28, 1×60, 2×60,
3×60, 10×60 doses

Viani Diskus 50/250 Inhalation

Inhalation

powder, predis-
pensed

Blister, Double foil
28 or 60 dose

1×28, 1×60, 2×60,
3×60, 10×60 doses

Viani Diskus 50/500 Inhalation

Inhalation

powder, predis-
pensed

Blister, Double foil
28 or 60 dose

1×28, 1×60, 2×60,
3×60, 10×60 doses

ITALY

Glaxo Allen SpA
Via Alessandro Fleming, 2
I-37135 Verona

Aliflus
Diskus

50/100 Inhalation

Inhalation

powder, predis-
pensed

Blister, Double foil
28 or 60 dose

1×28, 1×60, 2×60,
3×60, 10×60 doses

Glaxo Allen SpA
Via Alessandro Fleming, 2
I-37135 Verona

Aliflus
Diskus

50/250 Inhalation

Inhalation

powder, predis-
pensed

Blister, Double foil
28 or 60 dose

1×28, 1×60, 2×60,
3×60, 10×60 doses

Glaxo Allen SpA
Via Alessandro Fleming, 2
I-37135 Verona

Aliflus
Diskus

50/500 Inhalation

Inhalation

powder, predis-
pensed

Blister, Double foil
28 or 60 dose

1×28, 1×60, 2×60,
3×60, 10×60 doses

LUXEMBOURG

GlaxoSmithKline SA/NV
Rue du Tilleul, 13
B-1332 Genval

Viani Diskus 50/100 Inhalation

Inhalation

powder, predis-
pensed

Blister, Double foil
28 or 60 dose

1×28, 1×60, 2×60,
3×60, 10×60 doses

GlaxoSmithKline SA/NV
Rue du Tilleul, 13
B-1332 Genval

Viani Diskus 50/250 Inhalation

Inhalation

powder, predis-
pensed

Blister, Double foil
28 or 60 dose

1×28, 1×60, 2×60,
3×60, 10×60 doses

GlaxoSmithKline SA/NV
Rue du Tilleul, 13
B-1332 Genval

Viani Diskus 50/500 Inhalation

Inhalation

powder, predis-
pensed

Blister, Double foil
28 or 60 dose

1×28, 1×60, 2×60,
3×60, 10×60 doses

1.7.2003

EN

Official Journal of the European Union

C 153/19

Member State

Marketing Authorisation
Holder

Invented Name

Strength

Pharmaceutical
Form

Route of
administration

Packaging

Package size

NETHERLANDS

GlaxoSmithKline BV
Huis Ter Heideweg 62
3705 Lz Zeist
Nederland

Viani 50/100
Diskus

50/100 Inhalation

Inhalation

powder, predis-
pensed

Blister, Double foil
28 or 60 dose

1×28, 1×60, 2×60,
3×60, 10×60 doses

GlaxoSmithKline BV
Huis Ter Heideweg 62
3705 Lz Zeist
Nederland

GlaxoSmithKline BV
Huis Ter Heideweg 62
3705 Lz Zeist
Nederland

Viani 50/250
Diskus

50/250 Inhalation

Inhalation

powder, predis-
pensed

Blister, Double foil
28 or 60 dose

1×28, 1×60, 2×60,
3×60, 10×60 doses

Viani 50/500
Diskus

50/500 Inhalation

Inhalation

powder, predis-
pensed

Blister, Double foil
28 or 60 dose

1×28, 1×60, 2×60,
3×60, 10×60 doses

PORTUGAL

Alodial Farmacêutica Lda
Estrada Marco do Grilo
Zemouto
P-2830 Coina

Veraspir
Diskus

50/500 Inhalation

Inhalation

powder, predis-
pensed

Blister, Double foil
28 or 60 dose

1×28, 1×60, 2×60,
3×60, 10×60 doses

Alodial Farmacêutica Lda
Estrada Marco do Grilo
Zemouto
P-2830 Coina

Veraspir
Diskus

50/250 Inhalation

Inhalation

powder, predis-
pensed

Blister, Double foil
28 or 60 dose

1×28, 1×60, 2×60,
3×60, 10×60 doses

Alodial Farmacêutica Lda
Estrada Marco do Grilo
Zemouto
P-2830 Coina

Veraspir
Diskus

50/100 Inhalation

Inhalation

powder, predis-
pensed

Blister, Double foil
28 or 60 dose

1×28, 1×60, 2×60,
3×60, 10×60 doses

SPAIN

Glaxo Wellcome SA
Parque Tecnologico de
Madrid
Calle Severo Ochoa, 2
E-28760 Tres Cantos
Madrid

Glaxo Wellcome SA
Parque Tecnologico de
Madrid
Calle Severo Ochoa, 2
E-28760 Tres Cantos
Madrid

Glaxo Wellcome SA
Parque Tecnologico de
Madrid
Calle Severo Ochoa, 2
E-28760 Tres Cantos
Madrid

Viani 50/500
Accuhaler

50/500 Inhalation

Inhalation

powder, predis-
pensed

Blister, Double foil
28 or 60 dose

1×28, 1×60, 2×60,
3×60, 10×60 doses

Viani 50/250
Accuhaler

50/250 Inhalation

Inhalation

powder, predis-
pensed

Blister, Double foil
28 or 60 dose

1×28, 1×60, 2×60,
3×60, 10×60 doses

Viani 50/100
Accuhaler

50/100 Inhalation

Inhalation

powder, predis-
pensed

Blister, Double foil
28 or 60 dose

1×28, 1×60, 2×60,
3×60, 10×60 doses

C 153/20

EN

Official Journal of the European Union

1.7.2003

Member State

Marketing Authorisation
Holder

Invented Name

Strength

Pharmaceutical
Form

Route of
administration

Packaging

Package size

SWEDEN

GlaxoSmithKline AB
PO Box 263
S-431 23 Mölndal

Viani Diskus 50/100 Inhalation

Inhalation

powder, predis-
pensed

Blister, Double foil
28 or 60 dose

1×28, 1×60, 2×60,
3×60, 10×60 doses

UNITED
KINGDOM

Viani Diskus 50/250 Inhalation

Inhalation

powder, predis-
pensed

Blister, Double foil
28 or 60 dose

1×28, 1×60, 2×60,
3×60, 10×60 doses

Viani Diskus 50/500 Inhalation

Inhalation

powder, predis-
pensed

Blister, Double foil
28 or 60 dose

1×28, 1×60, 2×60,
3×60, 10×60 doses

Viani
Accuhaler

50/100 Inhalation

Inhalation

powder, predis-
pensed

Blister, Double foil
28 or 60 dose

28, 60, 120, 180
and 600 actuations

Viani
Accuhaler

50/250 Inhalation

Inhalation

powder, predis-
pensed

Blister, Double foil
28 or 60 dose

28, 60, 120, 180
and 600 actuations

Viani
Accuhaler

50/500 Inhalation

Inhalation

powder, predis-
pensed

Blister, Double foil
28 or 60 dose

28, 60, 120, 180
and 600 actuations

GlaxoSmithKline AB
PO Box 263
S-431 23 Mölndal

GlaxoSmithKline AB
PO Box 263
S-431 23 Mölndal

Glaxo Wellcome UK
Limited
Trading As Allen
& Hanburys
Stockley Park West
Uxbridge
Middlesex, UB11 1BT
United Kingdom

Glaxo Wellcome UK
Limited
Trading As Allen
& Hanburys
Stockley Park West
Uxbridge
Middx, UB11 1BT
United Kingdom

Glaxo Wellcome UK
Limited
Trading As Allen
& Hanburys
Stockley Park West
Uxbridge
Middx, UB11 1BT
United Kingdom

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

ANNEX IV

.

.

1
7
2
0
0
3

Member State

Marketing authorisation
holder

Name

Strength

Pharmaceutical
form

Route of
administration

Packaging

Content

Package
size

ITALY

A. Menarini Industrie
Farmaceutiche Riunite Srl
Via Sette Santi, 3
I-50131 Firenze

A. Menarini Industrie
Farmaceutiche Riunite Srl
Via Sette Santi, 3
I-50131 Firenze

A. Menarini Industrie
Farmaceutiche Riunite Srl
Via Sette Santi, 3
I-50131 Firenze

Alfa Wassermann SpA
Contrada S. Emidio
I-65020 Alanno

Aventis Pharma SpA
Piazzale Turr, 5
I-20100 Milano

Laboratorio Chimico Garant Srl
Via Melchiorre Gioia, 47
I-20100 Milano

Dompe' Farmaceutica SpA
Via S. Martino, 12
I-20122 Milano

Dompe' Farmaceutica SpA
Via S. Martino, 12
I-20122 Milano

Osteotonina

50 IU/ml
100 IU/ml

Solution for
injection

Intramuscular use
Intravenous use
Subcutaneous use

Ampoule

1 ml

5

Osteotonina
Spray

200 IU/dose

Nasal spray,
solution

Nasal use

Vial

(12 doses)

1

Osteotonina

400 IU/2 ml

Solution for
injection

Intramuscular use
Intravenous use
Subcutaneous use

Vial

Multidose
2 ml

Tonocalcin

50 IU
100 IU

Solution for
injection

Rulicalcin

50 IU
100 IU

Solution for
injection

Intramuscular use
Intravenous use
Subcutaneous use

Intramuscular use
Intravenous use
Subcutaneous use

Ampoule

1 ml

Ampoule

1 ml

Salmocalcin

50 IU
100 IU

Solution for
injection

Intramuscular use
Intravenous use

Ampoule

1 ml

Prontocalcin

50 IU/0,5 ml

Solution for
injection

Intramuscular use
Intravenous use

Ampoule

0,5 ml

Prontocalcin

100 IU/ml

Solution for
injection

Intramuscular use
Intravenous use

Ampoule

1 ml

5

5

6

5

E
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Member State

Marketing authorisation
holder

Name

Strength

Pharmaceutical
form

Route of
administration

Packaging

Content

Package
size

ITALY
(cont’d)

Esseti Farmaceutici SpA
Via dei Mille, 40
I-80046 Napoli

Biocalcin

50 IU/ml
100 IU/ml

Solution for
injection

Intramuscular use
Intravenous use
Subcutaneous use

Ampoule

1 ml

5

5

5

F.I.R.M.A. SpA
Via di Scandicci, 37
I-50143 Firenze

F.I.R.M.A. SpA
Via di Scandicci, 37
I-50143 Firenze

F.I.R.M.A. SpA
Via di Scandicci, 37
I-50143 Firenze

Francia Farmaceutici Industria
Farmaco Biologica Srl
Via dei Pestagalli, 7
I-20138 Milano

Instituto Biochimico Nazionale
Savio Srl
Via E. Bazzano, 14
I-16019 Ronco Scrivia

LPB Instituto Farmaceutico SpA
Strada Statale 233
(Varesina) km 20,5
I-21040 Origgio

LPB Instituto Farmaceutico SpA
Strada Statale 233
(Varesina) km 20,5
I-21040 Origgio

Calciben Fiale 50 IU

Solution for
injection

Intramuscular use
Intravenous use
Subcutaneous use

Ampoule

1 ml

Calciben Fiale 100 IU

Solution for
injection

Intramuscular use
Intravenous use
Subcutaneous use

Ampoule

1 ml

Calciben
Spray

200 IU/dose

Nasal spray,
solution

Nasal use

Vial

(12 doses)

1

Miadenil

50 IU/ml
100 IU/ml

Solution for
injection

Intramuscular use
Intravenous use

Ampoule

1 ml

Porostenina

50 IU/ml
100 IU/ml

Solution for
injection

Intramuscular use
Subcutaneous use

Ampoule

1 ml

Miacalcic
50 Fiale

50 IU

Solution for
injection

Miacalcic 100
Fiale

100 IU

Solution for
injection

Intramuscular use
Intravenous use
Subcutaneous use

Intramuscular use
Intravenous use
Subcutaneous use

Ampoule

1 ml

Ampoule

1 ml

5

5

5

5

C

1
5
3
/
2
2

E
N

O

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f
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Member State

Marketing authorisation
holder

Name

Strength

Pharmaceutical
form

Route of
administration

Packaging

Content

Package
size

ITALY
(cont’d)

LPB Instituto Farmaceutico SpA
Strada Statale 233
(Varesina) km 20,5
I-21040 Origgio

Miacalcic
Spray

200 IU/dose

Nasal spray,
solution

Nasal use

Vial

(12 doses)

1

Calcitene

50 IU

Solution for
injection

Injectable use

Ampoule

1 ml

5

Molteni Farmaceutici
L. Molteni EC. Dei F.lli Alitti
Società di Esercizio SpA
Strada Statale 67
Tosco Romagnola
I-50018 Frazione Granatieri-
Scandicci

Molteni Farmaceutici
L. Molteni EC. Dei F.lli Alitti
Società di Esercizio SpA
Strada Statale 67
Tosco Romagnola
I-50018 Frazione Granatieri-
Scandicci

La.Fa.Re. Srl
Via Sacerdote Benedetto
Cozzolino, 77
I-80056 Ercolano Resina (NA)

La.Fa.Re. Srl
Via Sacerdote Benedetto
Cozzolino, 77
I-80056 Ercolano Resina (NA)

Calcitene

100 IU

Solution for
injection

Injectable use

Ampoule

1 ml

Salmofar

50 IU

Solution for
injection

Intramuscular use
Subcutaneous use

Ampoule

1 ml

Salmofar

100 IU

Solution for
injection

Intramuscular use
Subcutaneous use

Ampoule

1 ml

Laboratorio Italiano
Biochimico Farmaceutico

Calco

50 IU

Solution for
injection

Intramuscular use
Intravenous use
Subcutaneous use

Ampoule

1 ml

Lisapharma SpA
Via Licinio 11-15
I-22036 Erba

Laboratorio Italiano
Biochimico Farmaceutico

Calco

100 IU

Solution for
injection

Intramuscular use
Intravenous use
Subcutaneous use

Ampoule

1 ml

Lisapharma SpA
Via Licinio 11-15
I-22036 Erba

5

5

5

.

.

1
7
2
0
0
3

E
N

O

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Member State

Marketing authorisation
holder

Name

Strength

Pharmaceutical
form

Route of
administration

Packaging

Content

Package
size

ITALY
(cont’d)

Magis Farmaceuticini SpA
Via Cacciamali, 34, 36, 38A
I-25128 Brescia

Catonin

100 IU/ml

Solution for
injection

Intramuscular use
Intravenous use
Subcutaneous use

1 ml

5

Novartis Farma SpA
Strada Statale 23, km 20,5
I-21040 Origgio (VA)

Calcitonina
Sandoz Fiale

50 IU

Solution for
injection

Novartis Farma SpA
Strada Statale 23, km 20,5
I-21040 Origgio (VA)

Calcitonina
Sandoz Fiale

100 IU

Solution for
injection

Intramuscular use
Intravenous use
Subcutaneous use

Intramuscular use
Intravenous use
Subcutaneous use

Ampoule + Syringe

1 ml

Ampoule 1 ml + 5
Syringes

Ampoule + Syringe

1 ml

Ampoule 1 ml + 5
Syringes

Novartis Farma SpA
Strada Statale 23, km 20,5
I-21040 Origgio (VA)

Calcitonina
Sandoz Spray

200 IU/dose

Nasal spray,
solution

Nasal use

Vial

(12 doses)

1 vial

Nuovo Consorzio Sanitario
Nazionale Srl
Via Svetonio, 6
I-00136 Roma

Nuovo Consorzio Sanitario
Nazionale Srl
Via Svetonio, 6
I-00136 Roma

Osteovis

50 IU/ml

Solution for
injection

Intramuscular use
Intravenous use
Subcutaneous use

Ampoule

1 ml

Osteovis

100 IU/ml

Solution for
injection

Intramuscular use
Intravenous use
Subcutaneous use

Ampoule

1 ml

Pierre Fabre Italia SpA
Via G.G. Winckelmann, 1
I-20146 Milano

Ellecalcin

50 IU/ml

Solution for
injection

Intramuscular use
Intravenous use
Subcutaneous use

Ampoule

1 ml

Procter & Gamble Holding SpA
Cesare Pavese, 385
I-00144 Roma
[Rep: Mrs Silvia Etock,
Tel. (39-06) 50 09 00 58,
Fax (39-06) 50 09 00 92]

Carbicalcin

0,25 mg

Powder for solution
solution for
injection

Subcutaneous use

Ampoule

1 ml

5

5

5

5

C

1
5
3
/
2
4

E
N

O

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f
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Member State

Marketing authorisation
holder

Name

Strength

Pharmaceutical
form

Route of
administration

Packaging

Content

Package
size

ITALY
(cont’d)

Procter & Gamble Holding SpA
Cesare Pavese, 385
I-00144 Roma
[Rep: Mrs Silvia Etock,
Tel. (39-06) 50 09 00 58,
Fax (39-06) 50 09 00 92]

Procter & Gamble Holding SpA
Cesare Pavese, 385
I-00144 Roma
[Rep: Mrs Silvia Etock,
Tel. (39-06) 50 09 00 58,
Fax (39-06) 50 09 00 92]

Calcitonina
50 Armour

50 IU/0,5 ml

Solution for
injection

Intramuscular use
Intravenous use
Subcutaneous use

Prefilled syringe

0,5 ml

6

Calcitonina
100 Armour

100 IU/ml

Solution for
injection

Intramuscular use
Intravenous use
Subcutaneous use

Prefilled syringe

1 ml

5

Pulizer Italiana Srl
Via Tiburtina, 1004
I-00156 Roma

Rottapharm Srl
Via Valosa di Sopra, 9
I-20052 Monza

Rottapharm Srl
Via Valosa di Sopra, 9
I-20052 Monza

Rottapharm Srl
Via Valosa di Sopra, 9
I-20052 Monza

Salus Researches SpA
Via Aurelia, 58
I-00165 Roma

Salus Researches SpA
Via Aurelia, 58
I-00165 Roma

Calciosint

50 IU/ml
100 IU/ml

Solution for
injection

Intramuscular use
Intravenous use
Subcutaneous use

Ampoule

1 ml

Sical 50

50 IU/ml

Solution for
injection

Intramuscular use
Intravenous use
Subcutaneous use

Ampoule

1 ml

Sical 100

100 IU/ml

Solution for
injection

Intramuscular use
Intravenous use
Subcutaneous use

Ampoule

1 ml

Sical 200

200 IU/neb

Nasal spray,
solution

Nasal use

Ipocalcin Fiale 50 IU/ml

Solution for
injection

Intramuscular use
Intravenous use
Subcutaneous use

Ampoule

1 ml

Ipocalcin Fiale 100 IU/ml

Solution for
injection

Intramuscular use
Intravenous use
Subcutaneous use

Ampoule

1 ml

5

5

5

5

5

.

.

1
7
2
0
0
3

E
N

O

f
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J
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5

Member State

Marketing authorisation
holder

Name

Strength

Pharmaceutical
form

Route of
administration

Packaging

Content

Package
size

ITALY
(cont’d)

San Carlo Farmaceutici SpA
Torre Maggiore
I-00040 Santa Palomba
Pomezia

Calcioton

50 IU/ml

Solution for
injection

Intramuscular use
Intravenous use

Ampoule

1 ml

Calcioton

100 IU/ml

Solution for
injection

Intramuscular use
Intravenous use

Ampoule

1 ml

5

5

San Carlo Farmaceutici SpA
Torre Maggiore
I-00040 Santa Palomba
Pomezia

Sigma-Tau Industrie
Farmaceutiche RI.E.nite SpA
Shakespeare, 47
I-00144 Roma

Sigma-Tau Industrie
Farmaceutiche RI.E.nite SpA
Shakespeare, 47
I-00144 Roma

Eptacalcin

50 IU/0,5 ml

Solution for
injection

Intramuscular use
Intravenous use

Ampoule

0,5 ml

6 × 0,5 ml + 6
syringes

Eptacalcin

100 IU/ml

Solution for
injection

Intramuscular use
Intravenous use

Ampoule

1 ml

5 × 1 ml + 5
syringes

GlaxoSmithKline
Via Zambeletti
I-20021 Baranzate di Bollate
(Milano)

Turbocalcin

Solution for
injection

Intramuscular use
Intravenous use

Ampoule

1 ml

So.Se.Pharm Srl
Società Di Servizio per
L'industria Farmaceutica Ed Aff
Via dei Castelli Romani, 22
I-00040 Pomezia (Roma)

So.Se.Pharm Srl
Società Di Servizio per
L'industria Farmaceutica Ed Aff
Via dei Castelli Romani, 22
I-00040 Pomezia (Roma)

Tosi Farmaceutici SAS
Corso della Vittoria, 12/B
I-28100 Novara

Steocin

50 IU

Powder for solution
for injection

Intramuscular use
Subcutaneous use

Ampoule +
Ampoule solvent

1 ml + 2 ml 6 × 1 ml + 6

ampoules solvent

Steocin

100 IU

Powder for solution
for injection

Intramuscular use
Subcutaneous use

Ampoule + ampoule
solvent

1 ml + 2 ml 5 × 1 ml + 5

ampoules solvent

Osteocalcin

50 IU/ml

Solution for
injection

Intramuscular use
Intravenous use

Ampoule

1 ml

5

C

1
5
3
/
2
6

E
N

O

f
f
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J
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Member State

Marketing authorisation
holder

Name

Strength

Pharmaceutical
form

Route of
administration

Packaging

Content

Package
size

ITALY
(cont’d)

Tosi Farmaceutici SAS
Corso della Vittoria, 12/B
I-28100 Novara

Osteocalcin

100 IU/ml

Solution for
injection

Intramuscular use
Intravenous use

Ampoule

1 ml

5

FAGEN
S.S. 233 (Varesina), km. 20,5
Origgio Varese

Calcitonina
Fagen

200 IU

Nasal spray,
solution

Nasal use

Vial

(14 doses)

1 vial

GERMANY

ct-Arzneimittel GmbH
Lengeder Straße 42a
D-13407 Berlin

ct-Arzneimittel GmbH
Lengeder Straße 42a
D-13407 Berlin

Calcitonin
von ct
Nasenspray

Calcitonin
von ct
Nasenspray

100 IU/dose

Nasal spray,
solution

Nasal use

Spray container

100 IU/dose

Nasal spray,
solution

Nasal use

Spray container

1,39 ml
(14 doses)

2,78 ml
(28 doses)

1

1

ct-Arzneimittel GmbH
Lengeder Straße 42a
D-13407 Berlin

Calcitonin 50
von ct
Amp.

50 IU/ml

Solution for
injection

Subcutaneous use

Ampoule

5, 10, 20, 50

ct-Arzneimittel GmbH
Lengeder Straße 42a
D-13407 Berlin

Ratiopharm GmbH
Graf-Arco-Straße 3
D-89079 Ulm

Ratiopharm GmbH
Graf-Arco-Straße 3
D-89079 Ulm

Calcitonin
100 von ct
Amp.

Calcitonin-
Ratiopharm
Nasenspray

Calcitonin-
Ratiopharm
Nasenspray

100 IU/ml

Solution for
injection

Subcutaneous use

Ampoule

5, 10, 20, 50

100 IU/dose

Nasal spray,
solution

Nasal use

Spray container

100 IU/dose

Nasal spray,
solution

Nasal use

Spray container

1,39 ml
(14 doses)

2,78 ml
(28 doses)

1

1

Ratiopharm GmbH
Graf-Arco-Straße 3
D-89079 Ulm

Caltonin
Ratiopharma
Nasenspray

100 IU/dose

Nasal spray,
solution

Nasal use

Vial

.

.

1
7
2
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3

E
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Member State

Marketing authorisation
holder

Name

Strength

Pharmaceutical
form

Route of
administration

Packaging

Content

Package
size

GERMANY
(cont’d)

Ratiopharm GmbH
Graf-Arco-Straße 3
D-89079 Ulm

Caltonin
Nasenspray

100 IU/dose

Nasal spray,
solution

Nasal use

Vial

Ratiopharm GmbH
Graf-Arco-Straße 3
D-89079 Ulm

Ratiopharm GmbH
Graf-Arco-Straße 3
D-89079 Ulm

Ratiopharm GmbH
Graf-Arco-Straße 3
D-89079 Ulm

Ratiopharm GmbH
Graf-Arco-Straße 3
D-89079 Ulm

Calcitonin-
Ratiopharm
50

Calcitonin-
Ratiopharm
100

Lachscal-
citonin-
Ratiopharm
50

Lachscal-
citonin-
Ratiopharm
100

50 IU/ml

Solution for
injection

Injectable use

Ampoule

1 ml

5, 10, 20, 50

100 IU/ml

Solution for
injection

Injectable use

Ampoule

1 ml

5, 10, 20, 50

50 IU/ml

Solution for
injection

Injectable use

Ampoule

1 ml

100 IU/ml

Solution for
injection

Injectable use

Ampoule

1 ml

Jenapharm GmbH & Co. KG
Otto-Schott-Straße 15
D-07745 Jena

Ostostabil
50 I.E.

50 IU/ml

Solution for
injection

Jenapharm GmbH & Co. KG
Otto-Schott-Straße 15
D-07745 Jena

Ostostabil
100 I.E.

100 IU/ml

Solution for
injection

Intramuscular use
Intravenous use
Subcutaneous use

Intramuscular use
Intravenous use
Subcutaneous use

Prefilled syringe/
Ampoule

1 ml
ampoule

Prefilled syringe/
Ampoule

1 ml
ampoule

Pre-filled syringe: 5,
25
Ampoules 5, 10,
20 × 1 ml

Pre-filled syringe: 5,
25
Ampoules 5, 10,
20 × 1 ml

Rotexmedica GmbH
Arzneimittelwerk
Bunsenstraße 4
D-22946 Trittau

Rotexmedica GmbH
Arzneimittelwerk
Bunsenstraße 4
D-22946 Trittau

Calcitonin
50 I.E. —
Rotexmedica

50 IU/ml

Solution for
injection

Intramuscular use
Intravenous use
Subcutaneous use

Ampoule

1 ml

5, 10, 20, 50

Calcitonin
100 I.E. —
Rotexmedica

100 IU/ml

Solution for
injection

Intramuscular use
Intravenous use
Subcutaneous use

Ampoule

1 ml

5, 10, 20, 50

C

1
5
3
/
2
8

E
N

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Member State

Marketing authorisation
holder

Name

Strength

Pharmaceutical
form

Route of
administration

Packaging

Content

GERMANY
(cont’d)

Hexal AG
Industriestraße 25
D-83607 Holzkirchen

Osteoposan
50

50 IU/ml

Solution for
injection

Injectable use

Ampoule

1 ml

Package
size

5, 10, 20, 50
(5 × 10)

5, 10, 20, 50
(5 × 10)

Hexal AG
Industriestraße 25
D-83607 Holzkirchen

Hexal AG
Industriestraße 25
D-83607 Holzkirchen

Hexal AG
Industriestr. 25
D-83607 Holzkirchen

TAD Pharma GmbH
Heinz-Lohman-Straße 5
D-27472 Cuxhaven

TAD Pharma GmbH
Heinz-Lohman-Straße 5
D-27472 Cuxhaven

Osteoposan
100

100 IU/ml

Solution for
injection

Injectable use

Ampoule

1 ml

Calcibio 50

50 IU

Calcibio 100

100 IU

Solution for
injection

Solution for
injection

Intravenous infusion
Intramuscular injection
Subcutaneous injection

Ampoule

1 ml

5, 10, 20, 50
(5 × 10)

Osteos 50

50 IU

Solution for
injection

Subcutaneous use
Intramuscular use

Ampoule

1 ml

5, 10, 25

Osteos 100

100 IU

Solution for
injection

Subcutaneous use
Intramuscular use

Ampoule

1 ml

5, 10, 25

Wieb Pharm Vertriebs GmbH
Johann-Sebastian-Bach-Straße 45
D-59457 Werl

Calcitonin
Wieb 50 I.E.

50 IU

Solution for
injection

Intramuscular use
Intravenous use
Subcutaneous use

Ampoule

1 ml
(50 IU/ml)

5, 20, 50 (5 × 10)

Wieb Pharm Vertriebs GmbH
Johann-Sebastian-Bach-Straße 45
D-59457 Werl

Calcitonin
Wieb 100 I.E.

100 IU

Solution for
injection

Intramuscular use
Intravenous use
Subcutaneous use

Ampoule

1 ml
(100 IU/ml)

5, 20, 50 (5 × 10)

ExterI.E.s Helathcare GmbH
Robert-Kock-Straße 2
D-51674 Wiehl

Calcitonin
Exterius 5
50 I.E.

50 IU/ml

Solution for
injection

Injectable use

Pre-filled syringe

1 ml

5, 25

ExterI.E.s Helathcare GmbH
Robert-Kock-Straße 2
D-51674 Wiehl

Calcitonin
Exterius
100 I.E.

100 IU/ml

Solution for
injection

Injectable use

Pre-filled syringe

1 ml

5, 25

.

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1
7
2
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E
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O

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J
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e

E
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o
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1
5
3
/
2
9

Member State

Marketing authorisation
holder

Name

Strength

Pharmaceutical
form

Route of
administration

Packaging

Content

Package
size

GERMANY
(cont’d)

ExterI.E.s Helathcare GmbH
Robert-Kock-Straße 2
D-51674 Wiehl

Calcitonin
Opfermann
50 I.E.

50 IU/ml

Solution for
injection

Injectable use

Ampoule

1 ml

5, 20, 50, 100

ExterI.E.s Helathcare GmbH
Robert-Kock-Straße 2
D-51674 Wiehl

Calcitonin
Opfermann
100 I.E.

100 IU/ml

Solution for
injection

Injectable use

Ampoule

1 ml

5, 20, 50, 100

Azupharma GmbH & Co
Dieselstraße 5
D-70839 Gerlingen

Azupharma GmbH & Co
Dieselstraße 5
D-70839 Gerlingen

Azupharma GmbH & Co
Dieselstraße 5
D-70839 Gerlingen

Azupharma GmbH & Co
Dieselstraße 5
D-70839 Gerlingen

Azucalcitonin
50 I.E.

50 IU/ml

Solution for
injection

Injectable use

Ampoule

5, 20, 50

Azucalcitonin
100 I.E.

100 IU/ml

Solution for
injection

Injectable use

Ampoule

5, 20, 50

Azucalcit
50 I.E.

50 IU/ml

Solution for
injection

Azucalcit
100 I.E.

100 IU/ml

Solution for
injection

Intramuscular use
Intravenous use
Subcutaneous use

Intramuscular use
Intravenous use
Subcutaneous use

Ampoule

1 ml

5, 20, 50

Ampoule

5, 20, 50

Azupharma GmbH & Co
Dieselstraße 5
D-70839 Gerlingen

Calcitonin
AZU
Nasenspray

100 IU/dose

Nasal spray,
solution

Nasal use

Spray container

2 ml

1, 3 vials

Stadapharm GmbH
Stadastraße 2—18
D-61118 Bad Vilbel

Stadapharm GmbH
Stadastraße 2—18
D-61118 Bad Vilbel

Calcitonin
stada 50 I.E.

50 IU/ml

Solution for
injection

Calcitonin
Stada 100 I.E.

100 IU

Solution for
injection

Intramuscular use
Intravenous use
Subcutaneous use

Intramuscular use
Intravenous use
Subcutaneous use

Ampoule

1 ml

5, 10, 20, 50

Ampoule

1 ml

5, 10, 20, 50

C

1
5
3
/
3
0

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
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p
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a
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U
n
o
n

i

.

.

1
7
2
0
0
3

Member State

Marketing authorisation
holder

Name

Strength

Pharmaceutical
form

Route of
administration

Packaging

Content

Package
size

GERMANY
(cont’d)

MIBE GmbH
Arzneimittel
Luise-Ullrich-Straße 6
D-82031 München-Grünwald

Calcitex 50

50 IU

Solution for
injection

Injectable use

Vial + solvent
ampoule

MIBE GmbH
Arzneimittel
Luise-Ullrich-Straße 6
D-82031 München-Grünwald

Calcitex 100

100 IU

Solution for
injection

Injectable use

Vial + solvent
ampoule

3, 5, 10, 20, 50, 60

Novartis Pharma GmbH
Roonstraße 25
D-90429 Nürnberg

Cibacalcin
0,25 mg

0,25 mg

Powder and solvent
for
for
solution
injection

Intramuscular use
Intravenous use
Subcutaneous use

Vial + solvent
ampoule

(50 IU/ml
after recon-
stitution)

5, 50, 60
vials + ampoules

Novartis Pharma GmbH
Roonstraße 25
D-90429 Nürnberg

Cibacalcin
0,5 mg

0,5 mg

Powder and solvent
for
for
solution
injection

Intramuscular use
Intravenous use
Subcutaneous use

Vial + solvent
ampoule

(100 IU/ml
after recon-
stitution)

5, 50
vials + ampoules

Novartis Pharma GmbH
Roonstraße 25
D-90429 Nürnberg

Human-
Calcitonin-
Novartis

0,5 mg

Powder and solvent
for
for
solution
injection

Injectable use

Vial + solvent
ampoule

5, 50

Novartis Pharma GmbH
Roonstraße 25
D-90429 Nürnberg

Novartis Pharma GmbH
Roonstraße 25
D-90429 Nürnberg

Miacalcic
200 I.E.
Nasenspray

Ostulex
200 I.E.
Nasenspray

200 IU/neb

Nasal spray,
solution

Nasal use

Vial

(14 doses)

1

200 IU/neb

Nasal spray,
solution

Nasal use

Vial

(14 doses)

1

Novartis Pharma GmbH
Roonstraße 25
D-90429 Nürnberg

Karil 50 I.E.
Injektions-
lösung

50 IU

Solution for
injection

Intramuscular use
Intravenous use
Subcutaneous use

Ampoule

0,5 ml

5, 50, 100

Novartis Pharma GmbH
Roonstraße 25
D-90429 Nürnberg

Karil 50 I.E.
Injektions-
lösung

50 IU

Solution for
injection

Intramuscular use
Intravenous use
Subcutaneous use

Prefilled syringe

0,5 ml

5, 10, 20

.

.

1
7
2
0
0
3

E
N

O

f
f
i
c
i
a
l

J
o
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n
a
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E
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3
1

Member State

Marketing authorisation
holder

Name

Strength

Pharmaceutical
form

Route of
administration

Packaging

Content

Package
size

GERMANY
(cont’d)

Novartis Pharma GmbH
Roonstraße 25
D-90429 Nürnberg

Karil 100 I.E.
Injektions-
lösung

100 IU

Solution for
injection

Intramuscular use
Intravenous use
Subcutaneous use

Ampoule

5, 10, 50, 100

Novartis Pharma GmbH
Roonstraße 25
D-90429 Nürnberg

Karil 100 I.E.
Injektions-
lösung

100 IU

Solution for
injection

Injectable use

Prefilled syringe

1 ml

5, 10, 100

Novartis Pharma GmbH
Roonstraße 25
D-90429 Nürnberg

Novartis Pharma GmbH
Roonstraße 25
D-90429 Nürnberg

Aventis Rhone-Poulenc-Rorer
GmbH
Nattermannallee 1
D-50829 Köln

Karil 100 I.E.
Nasenspray

100 IU

Nasal spray,
solution

Nasal use

Spray container

2 ml

1

Karil 200 I.E.
Nasenspray

200 IU

Nasal spray,
solution

Nasal use

Vial

(14 doses)

1

Calsynar 100

100 IU

Solution for
injection

Intramuscular use
Intravenous use
Subcutaneous use

Prefilled syringe

5 × 1 ml,
2 × 5 à 1 ml,
5 × 5 à 1 ml

GREECE

Proel SA Koronis EG
Dilou 9
GR-12134 Peristeri

Nylex

100 IU/ml

Solution for
injection

Intramuscular use
Intravenous use
Subcutaneous use

Ampoule

1 ml

5

Proel SA Koronis EG
Dilou 9
GR-12134 Peristeri

Proel SA Koronis EG
Dilou 9
GR-12134 Peristeri

Nylex

100 IU/ml

Nylex

100 IU/ml

Nasal spray,
solution

Nasal spray,
solution

Nasal use

Vial

2 ml

(14 doses)

Nasal use

Vial

4 ml

(28 doses)

Pharmacia & Upjohn Hellas AE
Mar. Antypa 62-66
GR-14121 N. Irakleio, Attiki

Ostosalm

50 IU/ml

Solution for
injection

Intramuscular use
Intravenous use
Subcutaneous use

Ampoule

1 ml

5

C

1
5
3
/
3
2

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

.

.

1
7
2
0
0
3

Member State

Marketing authorisation
holder

Name

Strength

Pharmaceutical
form

Route of
administration

Packaging

Content

Package
size

GREECE
(cont’d)

Pharmacia & Upjohn Hellas AE
Mar. Antypa 62-66
GR-14121 N. Irakleio, Attiki

Ostosalm

100 IU/ml

Solution for
injection

Intramuscular use
Intravenous use
Subcutaneous use
Intr.For.Inf.

Ampoule

1 ml

5

Pharmacia & Upjohn Hellas AE
Mar. Antypa 62-66
GR-14121 N. Irakleio, Attiki

Ostosalm

50 IU/dose

Nasal spray,
solution

Nasal use

Vial

2 ml

(14 doses)

Pharmacia & Upjohn Hellas AE
Mar. Antypa 62-66
GR-14121 N. Irakleio, Attiki

Ostosalm

100 IU/dose

Nasal spray,
solution

Nasal use

Vial

1 ml

(7 doses)

Pharmacia & Upjohn Hellas AE
Mar. Antypa 62-66
GR-14121 N. Irakleio, Attiki

Ostosalm

100 IU/dose

Nasal spray,
solution

Nasal use

Vial

2 ml

(14 doses)

Iasis Chemipharma AE
Ag. Kon/nou 40
GR-15124 Marousi

Iasis Chemipharma AE
Ag. Kon/nou 40
GR-15124 Marousi

Iasis Chemipharma AE
Ag. Kon/nou 40
GR-15124 Marousi

Iasis Chemipharma AE
Ag. Kon/nou 40
GR-15124 Marousi

Calco

100 IU/ml

Solution for
injection

Intramuscular use
Subcutaneous use

Ampoule

1 ml

5

Calco

100 IU/ml

Calco

100 IU/ml

Calco

100 IU/ml

Nasal spray,
solution

Nasal spray,
solution

Nasal spray,
solution

Nasal use

Vial

0,9 ml

(7 doses)

Nasal use

Vial

1,8 ml

(14 doses)

Nasal use

Vial

3,6 ml

(28 doses)

Aventis Pharma AEBE
2, Aftokratoros Nikolaou str.
GR-17971 Athens

Calsynar

100 IU/ml

Solution for
injection

Intramuscular use
Subcutaneous use

Ampoule

1 ml

5

.

.

1
7
2
0
0
3

E
N

O

f
f
i
c
i
a
l

J
o
u
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n
a
l

o
f

t
h
e

E
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a
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3
3

Member State

Marketing authorisation
holder

Name

Strength

Pharmaceutical
form

Route of
administration

Packaging

Content

Package
size

GREECE
(cont’d)

Aventis Pharma AEBE
2, Aftokratoros Nikolaou str.
GR-17971 Athens

Calsynar

100 IU/ml

Solution for
injection

Intramuscular use
Subcutaneous use

Prefilled syringes

1 ml

5

Aventis Pharma AEBE
2, Aftokratoros Nikolaou str.
GR-17971 Athens

Calsynar

100 IU/dose

Nasal spray,
solution

Nasal use

Vial

0,5 ml

(7 doses)

Aventis Pharma AEBE
2, Aftokratoros Nikolaou str.
GR-17971 Athens

Calsynar

100 IU/dose

Nasal spray,
solution

Nasal use

Vial

Monodose

(7, 14, 28 doses)

Aventis Pharma AEBE
2, Aftokratoros Nikolaou str.
GR-17971 Athens

Calsynar

200 IU/dose

Nasal spray,
solution

Nasal use

Vial

1,4 ml

(14 doses)

Pharmanel Pharmaceutical SA
Marathonos 106
GR-15344 Gerakas

Tosicalcin

100 IU/ml

Solution for
injection

Intramuscular use
Intravenous use
Subcutaneous use
Intr.For.Inf.

Ampoule

1 ml

5

Pharmanel Pharmaceutical SA
Marathonos 106
GR-15344 Gerakas

Tosicalcin

100 IU/dose

Nasal spray,
solution

Nasal use

Pharmanel Pharmaceutical SA
Marathonos 106
GR-15344 Gerakas

Tosicalcin

100 IU/dose

Nasal spray,
solution

Nasal use

Pharmanel Pharmaceutical SA
Marathonos 106
GR-15344 Gerakas

Tosicalcin

200 IU/dose

Nasal spray,
solution

Nasal use

Vial

Vial

Vial

2 ml
(15 doses)

2 ml

4 ml
(28 doses)

4 ml

2 ml
(14 doses)

2 ml

Alvia SA
18 km Athens-Marathonos Ave.
GR-15344 Pallini

Calciplus
solution for
injection

100 IU/ampoule

Solution for
injection

Ampoule

5

C

1
5
3
/
3
4

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

.

.

1
7
2
0
0
3

Member State

Marketing authorisation
holder

Name

Strength

Pharmaceutical
form

Route of
administration

Packaging

Content

Package
size

GREECE
(cont’d)

Alvia SA
18 km Athens-Marathonos Ave.
GR-15344 Pallini

Calciplus
nasal spray
100 IU/dose

100 IU/puff

Nasal spray

Nasal use

Pulverisations

14, 28

.

.

1
7
2
0
0
3

Alvia SA
18 km Athens-Marathonos Ave.
GR-15344 Pallini

Calciplus
nasal spray,
200 IU/dose

200 IU/puff

Nasal spray

Nasal use

Pulverisations

14

Genepharm SA
18th Klm Marathonos Ave.
GR-15344 Pallini

Genecalcin

100 IU/dose

Nasal spray,
solution

Nasal use

Vial

2 ml

(14 doses)

Genepharm SA
18th Klm Marathonos Ave.
GR-15344 Pallini

Genecalcin

100 IU/dose

Nasal spray,
solution

Nasal use

Vial

4 ml

1 × 4 ml
(28 doses),
2 × 4 ml
(56 doses)

Alfa Wassermann
Ditributor: Demo Abee
21st Klm Athina-Lamias Ave.
GR-14565 Athens

Alfa Wassermann
Ditributor: Demo Abee
21st Klm Athina-Lamias Ave.
GR-14565 Athens

Alfa Wassermann
Ditributor: Demo Abee
21st Klm Athina-Lamias Ave.
GR-14565 Athens

Alfa Wassermann
Ditributor: Demo Abee
21st Klm Athina-Lamias Ave.
GR-14565 Athens

Tonocalcin

100 IU/dose

Nasal spray,
solution

Nasal use

Vial

1,1 ml

(7 doses)

Tonocalcin

100 IU/dose

Nasal spray,
solution

Nasal use

Vial

2,1 ml

(14 doses)

Tonocalcin

100 IU/dose

Nasal spray,
solution

Nasal use

Vial

3,5 ml

(28 doses)

Tonocalcin

100 IU/ml

Solution for
injection

Injectable use

Ampoule

1 ml

5

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

C

1
5
3
/
3
5

Member State

Marketing authorisation
holder

Name

Strength

Pharmaceutical
form

Route of
administration

Packaging

Content

Package
size

GREECE
(cont’d)

Farmedia SA
2b, Algaiou Pelagous Str.
GR-15341 Ag. Paraskevi Athens

Ostifix

100 IU/ml

Solution for
injection

Parenteral use

Ampoule

1 ml

5

Farmedia SA
2b, Algaiou Pelagous Str.
GR-15341 Ag. Paraskevi Athens

Ostifix

50 IU/dose

Nasal spray,
solution

Nasal use

Vial

2 ml

(14 doses)

Farmedia SA
2b, Algaiou Pelagous Str.
GR-15341 Ag. Paraskevi Athens

Ostifix

100 IU/dose

Nasal spray,
solution

Nasal use

Anfarm Hellas SA
Acharnon 442
GR-11143 Athina

Biomedica-Chemica SA
25 G. Lyra Str.
GR-14564 Kiphisia

Biomedica-Chemica SA
25 G. Lyra Str.
GR-14564 Kiphisia

Biomedica-Chemica SA
25 G. Lyra Str.
GR-14564 Kiphisia

Biomedica-Chemica SA
25 G. Lyra Str.
GR-14564 Kiphisia

Biomedica-Chemica SA
25 G. Lyra Str.
GR-14564 Kiphisia

Miadenil

100 IU/ml

Solution for
injection

Ampoule

1 ml

5

Osticalcin

50 IU/dose

Nasal spray,
solution

Nasal use

Vial

2 ml

Osticalcin

100 IU/ml

Solution for
injection

Intramuscular use
Intravenous use
Subcutaneous use

Ampoule

1 ml

5

Norcalcin

100 IU/dose

Nasal spray,
solution

Nasal use

Vial

2 ml

(15 doses)

Norcalcin

100 IU/dose

Nasal spray,
solution

Nasal use

Vial

4 ml

(28 doses)

Norcalcin

50 IU/ml

Solution for
injection

C

1
5
3
/
3
6

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

.

.

1
7
2
0
0
3

Member State

Marketing authorisation
holder

Name

Strength

Pharmaceutical
form

Route of
administration

Packaging

Content

Package
size

GREECE
(cont’d)

Biomedica-Chemica SA
25 G. Lyra Str.
GR-14564 Kiphisia

Norcalcin

100 IU/ml

Solution for
injection

Ampoule

1 ml

V. Niadas & Sons SA
Agias Marinas Str.
GR-19002 Peania — Attica

Neostesin

100 IU/ml

Solution for
injection

Intramuscular use
Intravenous use
Subcutaneous use

Ampoule

1 ml

V. Niadas & Sons SA
Agias Marinas Str.
GR-19002 Peania — Attica

Neostesin

50 IU/ml

Solution for
injection

Intramuscular use
Intravenous use
Subcutaneous use

Ampoule

1 ml

5

5

5

V. Niadas & Sons SA
Agias Marinas Str.
GR-19002 Peania — Attica

Neostesin

50 IU/dose

Nasal spray,
solution

Nasal use

Vial

2 ml

(14 doses)

V. Niadas & Sons SA
Agias Marinas Str.
GR-19002 Peania — Attica

Neostesin

100 IU/dose

Nasal spray,
solution

Nasal use

Kleva EPE
Parnithos Ave. 189
GR-13671 Acharnai

Kleva EPE
Parnithos Ave. 189
GR-13671 Acharnai

Kleva EPE
Parnithos Ave. 189
GR-13671 Acharnai

Kleva EPE
Parnithos Ave. 189
GR-13671 Acharnai

Alciton

50 IU/ml

Solution for
injection

Intramuscular use
Intravenous use
Subcutaneous use

Ampoule

1 ml

Alciton

100 IU/ml

Solution for
injection

Intramuscular use
Intravenous use
Subcutaneous use

Ampoule

1 ml

5

5

Alciton

100 IU/dose

Nasal spray,
solution

Nasal use

Vial

0,9 ml

(7 doses)

Alciton

100 IU/dose

Nasal spray,
solution

Nasal use

Vial

1 × 14 doses
× 10 IU/dose

.

.

1
7
2
0
0
3

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

C

1
5
3
/
3
7

Member State

Marketing authorisation
holder

Name

Strength

Pharmaceutical
form

Route of
administration

Packaging

Content

Package
size

GREECE
(cont’d)

Kleva EPE
Parnithos Ave. 189
GR-13671 Acharnai

Alciton

100 IU/dose

Rafacalcin

50 IU/dose

Rafacalcin

100 IU/dose

Rafacalcin

100 IU/dose

Nasal spray,
solution

Nasal spray,
solution

Nasal spray,
solution

Nasal spray,
solution

Nasal use

Vial

1 × 28 doses 1
100 IU/dose

Nasal use

Vial

2 ml

(14 doses)

Nasal use

Vial

2 ml

(14 doses)

Nasal use

Vial

4 ml

(28 doses)

Rafacalcin

50 IU/ml

Solution for
injection

Intramuscular use
Intravenous use
Subcutaneous use

Ampoule

1 ml

Rafacalcin

100 IU/ml

Solution for
injection

Intramuscular use
Intravenous use
Subcutaneous use

Ampoule

1 ml

Tendolon

50 IU/ml

Solution for
injection

Intramuscular use
Intravenous use
Subcutaneous use

Ampoule

1 ml

Tendolon

100 IU/ml

Solution for
injection

Intramuscular use
Intravenous use
Subcutaneous use

Ampoule

1 ml

5

5

5

5

Tendolon

100 IU/dose

Nasal spray,
solution

Intramuscular use
Intravenous use
Subcutaneous use

Vial

2 ml

(14 doses)

Rafarm AEBE
Korinthou 12
GR-15451 N. Psychiko

Rafarm AEBE
Korinthou 12
GR-15451 N. Psychiko

Rafarm AEBE
Korinthou 12
GR-15451 N. Psychiko

Rafarm AEBE
Korinthou 12
GR-15451 N. Psychiko

Rafarm AEBE
Korinthou 12
GR-15451 N. Psychiko

Elpen S.A. Pharmaceutical
Industry
21st Klm Marathonos Ave.
GR-19009 Pikermi

Elpen SA Pharmaceutical
Industry
21st Klm Marathonos Ave.
GR-19009 Pikermi

Elpen SA Pharmaceutical
Industry
21st Klm Marathonos Ave.
GR-19009 Pikermi

C

1
5
3
/
3
8

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

.

.

1
7
2
0
0
3

Member State

Marketing authorisation
holder

Name

Strength

Pharmaceutical
form

Route of
administration

Packaging

Content

Package
size

GREECE
(cont’d)

Elpen SA Pharmaceutical
Industry
21st Klm Marathonos Ave.
GR-19009 Pikermi

Tendolon

100 IU/dose

Nasal spray,
solution

Intramuscular use
Intravenous use
Subcutaneous use

Vial

4 ml

(28 doses)

.

.

1
7
2
0
0
3

FARAN SA
Production & Marketing
of Medicines
Achaias & Trizinias
GR-14564 Kifissia

FARAN SA
Production & Marketing
of Medicines
Achaias & Trizinias
GR-14564 Kifissia

FARAN SA
Production & Marketing
of Medicines
Achaias & Trizinias
GR-14564 Kifissia

Boehringer Ingelheim
Hellas SA
Ellinikou 2
GR-16777 Elliniko

Boehringer Ingelheim
Hellas SA
Ellinikou 2
GR-16777 Elliniko

Boehringer Ingelheim
Hellas SA
Ellinikou 2
GR-16777 Elliniko

Vocate Ltd
Gounari 150
GR-16674 Ano Glyfada

Vocate Ltd
Gounari 150
GR-16674 Ano Glyfada

Latonina

100 IU/ml

Solution for
injection

Intramuscular use
Intravenous use
Subcutaneous use

Prefilled syringes

1 ml

5

Latonina

100 IU/dose

Nasal spray,
solution

Vial

2 ml

Latonina

100 IU/dose

Nasal spray,
solution

Vial

3,5 ml

(28 doses)

Crocalcin

100 IU/ml

Solution for
injection

Intramuscular use
Intravenous use
Subcutaneous use

Ampoule

1 ml

5

Crocalcin

100 IU/dose

Nasal spray,
solution

Nasal use

Vial

2 ml

(15 doses)

Crocalcin

100 IU/dose

Nasal spray,
solution

Nasal use

Vial

4 ml

(28 doses)

Iricalcin

100 IU/dose

Nasal spray,
solution

Nasal use

Iricalcin

100 IU/dose

Nasal spray,
solution

Nasal use

Vial

Vial

1,3 ml

(14 doses)

3,3 ml

(28 doses)

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
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p
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a
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U
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1
5
3
/
3
9

Member State

Marketing authorisation
holder

Name

Strength

Pharmaceutical
form

Route of
administration

Packaging

Content

Package
size

GREECE
(cont’d)

Vocate Ltd
Gounari 150
GR-16674 Ano Glyfada

Iricalcin

100 IU/ml

Salmoten

100 IU/ml

Salmoten

100 IU/ml

Salmoten

100 IU/dose

Solution for
injection

Solution for
injection

Solution for
injection

Nasal spray,
solution

Ampoule

1 ml

5

Vial

Vial

2 ml

(14 doses)

4 ml

(28 doses)

Nasal use

Ampoule

1 ml

5

Salmofar

100 IU/ml

Solution for
injection

Intramuscular use
Intravenous use
Subcutaneous use

Cibacalcin

0,5 mg

Powder for solution
for injection

Miacalcic

100 IU/ml

Solution for
injection

Intramuscular use
Intravenous use
Subcutaneous use

Ampoule

1 ml

Miacalcic

100 IU/dose

Nasal spray,
solution

Nasal use

Vial

2 ml

5

1

Miacalcic

200 IU/dose

Nasal spray,
solution

Nasal use

Vial

(14 doses)

ADIPHARM Ltd
54 Marni street
GR-10437 Athens

ADIPHARM Ltd
54 Marni street
GR-10437 Athens

ADIPHARM Ltd
54 Marni street
GR-10437 Athens

ADIPHARM Ltd
54 Marni street
GR-10437 Athens

Novartis (Hellas) SACI
12 km of National Road no 1
GR-14451 Metamorphosi
Attikis, Athens

Novartis (Hellas) SACI
12 km of National Road no 1
GR-14451 Metamorphosi
Attikis, Athens

Novartis (Hellas) SACI
12 km of National Road no 1
GR-14451 Metamorphosi
Attikis, Athens

Novartis (Hellas) SACI
12 km of National Road no 1
GR-14451 Metamorphosi
Attikis, Athens

C

1
5
3
/
4
0

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

.

.

1
7
2
0
0
3

Member State

Marketing authorisation
holder

Name

Strength

Pharmaceutical
form

Route of
administration

Packaging

Content

Package
size

IRELAND

Novartis Pharmaceuticals
UK Ltd
t/a Sandoz Pharmaceuticals
Frimley Business Park
Frimley
Camberley
Surrey
United Kingdom

Novartis Pharmaceuticals
UK Ltd
t/a Sandoz Pharmaceuticals
Frimley Business Park
Frimley
Camberley
Surrey
United Kingdom

Novartis Pharmaceuticals
UK Ltd
t/a Sandoz Pharmaceuticals
Frimley Business Park
Frimley
Camberley
Surrey
United Kingdom

Novartis Pharmaceuticals
UK Ltd
t/a Sandoz Pharmaceuticals
Frimley Business Park
Frimley
Camberley
Surrey
United Kingdom

Novartis Pharmaceuticals
UK Ltd
t/a Sandoz Pharmaceuticals
Frimley Business Park
Frimley
Camberley
Surrey
United Kingdom

Miacalcic

50 IU/ml

Solution for
injection

Intramuscular use
Intravenous use
Subcutaneous use

Ampoule

1 ml

5

Miacalcic

100 IU/ml

Solution for
injection

Intramuscular use
Intravenous use
Subcutaneous use

Ampoule

1 ml

5

Miacalcic

400 IU/2 ml

Solution for
injection

Intramuscular use
Intravenous use
Subcutaneous use

Multidose
Vial

2 ml

1

Miacalcic

100 IU

Nasal spray,
solution

Nasal use

Vial

(14 doses)

1

Miacalcic

200 IU

Nasal spray,
solution

Nasal use

Vial

(14 doses)

1

.

.

1
7
2
0
0
3

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

C

1
5
3
/
4
1

Member State

Marketing authorisation
holder

Name

Strength

Pharmaceutical
form

Route of
administration

Packaging

Content

Package
size

IRELAND
(cont’d)

NETHERLANDS

Novartis Pharmaceuticals
UK Ltd
t/a Sandoz Pharmaceuticals
Frimley Business Park
Frimley
Camberley
Surrey
United Kingdom

Novartis Pharmaceuticals
UK Ltd
t/a Sandoz Pharmaceuticals
Frimley Business Park
Frimley
Camberley
Surrey
United Kingdom

Rhone-Poulenc Rorer
50 Kings Hill Avenue
West Malling
Kent ME19 4AH
United Kingdom

Rhone-Poulenc Rorer
50 Kings Hill Avenue
West Malling
Kent ME19 4AH
United Kingdom

Novartis Pharma BV
Raapopseweg 1
6824 DP Arnhem
PO-Box 241
6800 LZ Arnheim
Nederland

Ostulex

200 IU

Nasal spray,
solution

Nasal use

Vial

(14 doses)

1

Miakaril

200 IU

Nasal spray,
solution

Nasal use

Vial

(14 doses)

1

Calsynar

100 IU

Solution for
injection

Nasal use

Vial

(14 doses)

1

Calsynar

200 IU

Solution for
injection

Nasal use

Vial

(14 doses)

1

Calcitonine-
Sandoz

100 IU/ml

Solution for
injection

Intravenous use

Ampoule

5

PORTUGAL

Novartis Farma
Produtos Farmacêuticos SA
Rua do Centro Empresarial,
Edifício 8, Quinta da Beloura
P-2710-444 Sintra

Cibacalcina

0,25 mg/ml

Powder and solvent
for
for
solution
injection

Intramuscular use
Subcutaneous use

Ampoule

1 ml

5

C

1
5
3
/
4
2

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

.

.

1
7
2
0
0
3

Member State

Marketing authorisation
holder

Name

Strength

Pharmaceutical
form

Route of
administration

Packaging

Content

Package
size

.

.

1
7
2
0
0
3

PORTUGAL
(cont’d)

Novartis Farma
Produtos Farmacêuticos SA
Rua do Centro Empresarial,
Edifício 8, Quinta da Beloura
P-2710-444 Sintra

Novartis Farma
Produtos Farmacêuticos SA
Rua do Centro Empresarial,
Edifício 8, Quinta da Beloura
P-2710-444 Sintra

Novartis Farma
Produtos Farmacêuticos SA
Rua do Centro Empresarial,
Edifício 8, Quinta da Beloura
P-2710-444 Sintra

Novartis Farma
Produtos Farmacêuticos SA
Rua do Centro Empresarial,
Edifício 8, Quinta da Beloura
P-2710-444 Sintra

Aventis Pharma Lda
PRT Estrada Nacional 249,
km 15
PO Box 39
P-2726-922 Mem Martins

Aventis Pharma Lda
PRT Estrada Nacional 249,
km 15
PO Box 39
P-2726-922 Mem Martins

Aventis Pharma Lda
PRT Estrada Nacional 249,
km 15
PO Box 39
P-2726-922 Mem Martins

Cibacalcina

0,5 mg/2 ml

Powder and solvent
for
for
solution
injection

Intramuscular use
Subcutaneous use

Ampoule

2 ml

Miacalcic

50 IU/ml
100 IU/ml

Solution for
injection

Intramuscular use
Subcutaneous use
Intravenous use

Ampoule

1 ml

Miacalcic

100 IU/ml

Solution for
injection

Intramuscular use
Subcutaneous use
Intravenous use

Ampoule

1 ml

5

5

5

Miacalcic 200
Spray Nasal

200 IU/dose

Nasal spray,
solution

Nasal use

Spray container

1 unit

1 × 14 doses,
1 × 28 doses

Calsyn

100 IU/2 ml

Solution for
injection

Intravenous use

Vial

2 ml

Calsyn

400 IU/2 ml

Solution for
injection

Intravenous use

Vial

2 ml

6

1

Calsyn

50 IU/0,5 ml

Solution for
injection

Intravenous use

Pre-filled syringe

0,5 ml

2,5

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
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o
p
e
a
n
U
n
o
n

i

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1
5
3
/
4
3

Member State

Marketing authorisation
holder

Name

Strength

Pharmaceutical
form

Route of
administration

Packaging

Content

Package
size

PORTUGAL
(cont’d)

Aventis Pharma Lda
PRT Estrada Nacional 249,
km 15
PO Box 39
P-2726-922 Mem Martins

Calsyn
Monospray

100 IU/dose

Nasal spray,
solution

Nasal use

Vial

Calsyn

100 IU/dose

Nasal spray,
solution

Nasal use

Vial

1

1

1 × 14 doses,
1 × 28 doses

1 × 7 doses

Aventis Pharma Lda
PRT Estrada Nacional 249,
km 15
PO Box 39
P-2726-922 Mem Martins

Laboratórios Delta Lda
Rua Direita n.o 148
Massamá
P-2745-751 Queluz

Laboratórios Delta Lda
Rua Direita n.o 148
Massamá
P-2745-751 Queluz

Laboratórios Delta Lda
Rua Direita n.o 148
Massamá
P-2745-751 Queluz

Laboratórios Delta Lda
Rua Direita n.o 148
Massamá
P-2745-751 Queluz

BYK Portugal — Produtos
Quimicos e Farmacêuticos, Lda
Quinta da Fonte-Edíficio
Gil Eanes
P-2780-730 Paço D'Arcos

Bionocalcin

50 IU/ml

Solution for
injection

Intramuscular use
Subcutaneous use
Intravenous use

Ampoule

1 ml

Bionocalcin
100

100 IU/ml

Solution for
injection

Intramuscular use
Subcutaneous use
Intravenous use

Ampoule

1 ml

5

5

Bionocalcin

50 IU/dose

Nebuliser, solution

Nasal use

Spray container

1 unit

1 × 14 doses

Bionocalcin
100

100 IU/dose

Nasal spray,
solution

Nasal use

Spray container

1 unit, 2
units

1 × 14 doses,
1 × 28 doses

Calcimon

50 IU/ml

Solution for
injection

Intramuscular use
Subcutaneous use
Intravenous use

Ampoule

1 ml

5

C

1
5
3
/
4
4

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

.

.

1
7
2
0
0
3

Member State

Marketing authorisation
holder

Name

Strength

Pharmaceutical
form

Route of
administration

Packaging

Content

Package
size

.

.

1
7
2
0
0
3

PORTUGAL
(cont’d)

BYK Portugal — Produtos
Quimicos e Farmacêuticos, Lda
Quinta da Fonte-Edíficio
Gil Eanes
P-2780-730 Paço D'Arcos

BYK Portugal — Produtos
Quimicos e Farmacêuticos, Lda
Quinta da Fonte-Edíficio
Gil Eanes
P-2780-730 Paço D'Arcos

Pharmacia Corporation
Laboratórios, Lda
Avenida do forte, 3-Edifício
Suécia II
PO Box 206
P-2795-505 Carnaxide

Pharmacia Corporation
Laboratórios, Lda
Avenida do forte, 3-Edifício
Suécia II
PO Box 206
P-2795-505 Carnaxide

Euro Labor
Laboratórios de Síntese
Quimica e Especialidades
Farmaceuticas, SA
Rua Alfredo Silva, n.o 16
PO Box 60270
P-2720-028 Amadora

Euro Labor
Laboratórios de Síntese
Quimica e Especialidades
Farmaceuticas, SA
Rua Alfredo Silva, n.o 16
PO Box 60270
P-2720-028 Amadora

PH & T, SpA
Via Ariosto, 34
I-20145 Milano

Calcimon

100 IU/ml

Solution for
injection

Intramuscular use
Subcutaneous use
Intravenous use

Ampoule

1 ml

5

Calcimon

50 IU/dose

Nebuliser, solution

Nasal use

Spray container

2 ml

1 × 14 doses

Salcat

100 IU/dose

Nasal spray,
solution

Nasal use

Vial

1 unit

1 × 21 units,
1 × 28 units

Salcat

200 IU/dose

Nasal spray,
solution

Nasal use

Vial

1 unit

1 × 7 doses,
1 × 14 doses

Ostinate 100

100 IU

Nasal spray,
solution

Nasal use

Vial

1 unit

1 × 7 doses,
1 × 14 doses,
1 × 28 doses

Ostinate 200

200 IU/dose

Nasal spray,
solution

Nasal use

Vial

1 unit

1 × 14 doses,
1 × 28 doses

Neostesin

50 IU/dose

Nasal spray,
solution

Nasal use

Vial

1 ml

1

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

C

1
5
3
/
4
5

Member State

Marketing authorisation
holder

Name

Strength

Pharmaceutical
form

Route of
administration

Packaging

Content

Package
size

PORTUGAL
(cont’d)

PH & T, SpA
Via Ariosto, 34
I-20145 Milano

Neostesin

50 IU/dose

Nasal spray,
solution

Nasal use

Vial

2 ml

1

Sociedade de Produtos
Farmacêuticos Wander Lda
Rua do Centro Empresarial,
Edifício 8
Quinta da Beloura
P-2710-444 Sintra

Laboratório Normal
Produtos Farmacêuticos, SA
Rua do Centro Empresarial,
Edifício 8
Quinta da Beloura
P-2710-444 Sintra

Probios Produtos Químicos e
Farmacêuticos Lda
Rua João Chagas 53-A,
2.o-Escritório 201
P-1495-072 Algés

Probios Produtos Químicos e
Farmacêuticos Lda
Rua João Chagas 53-A,
2.o-Escritório 201
P-1495-072 Algés

Calcitonina
Wander 200

200 IU/dose

Nebuliser, solution

Nasal use

Spray container

1 unit

1 × 14 doses

Osseocalcina
200

200 IU/dose

Nasal spray,
solution

Nasal use

Spray container

1 unit

1 × 14 doses,
1 × 28 doses

Calogen

100 IU/ml

Solution for
injection

Intramuscular use
Subcutaneous use
Intravenous use

Ampoule

1 ml

6

Calogen

100 IU/dose

Nasal spray,
solution

Nasal use

Spray container

1 unit

1 × 14 doses,
1 × 28 doses

Zambon-Produtos
Farmacêuticos, Lda
Rua Comandandante Enrique
Maya n.o 1
P-1500-370 Lisboa

Tonocaltin
100

100 IU/dose

Nebuliser solution

Nasal use

Vial

1 unit

1 × 7 doses,
1 × 14 doses

Sanofi-Syntelabo-Produtos
Farmacêuticos SA
Praça Duque de Saldanha
n.o 1-4.o
P-1050-094 Lisboa

Calco

50 IU/ml
100 IU/ml

Solution for
injection

Subcutaneous use
Intramuscular use

Ampoule

1 ml

5

C

1
5
3
/
4
6

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

.

.

1
7
2
0
0
3

Member State

Marketing authorisation
holder

Name

Strength

Pharmaceutical
form

Route of
administration

Packaging

Content

Package
size

PORTUGAL
(cont’d)

Sanofi-Syntelabo-Produtos
Farmacêuticos SA
Praça Duque de Saldanha
n.o 1-4.o
P-1050-094 Lisboa

Rotta Farmacêutica,
Unipessoal Lda
R. Direita da Massamá, 150
P-2745-751 Sintra

Calco

50 IU/dose
100 IU/dose

Nasal spray,
solution

Nasal use

Vial

0,9 ml

1

Bionocálcio
100

100 IU/dose

Nasal spray,
solution

Nasal use

Spray container

1 unit
(2 ml)

1

SPAIN

Almirall — Prodesfarma SA
General Mitre, 151
E-08022 Barcelona

Calcitonina
Almirall
injectable

100 IU/ml

Injection

Subcutaneous use
Intramuscular use

Ampoule

1 ml

10

Almirall — Prodesfarma SA
General Mitre, 151
E-08022 Barcelona

Almirall — Prodesfarma SA
General Mitre, 151
E-08022 Barcelona

Almirall — Prodesfarma SA
General Mitre, 151
E-08022 Barcelona

Calcitonina
Almirall
200 UI
multidose
spray nasal

Calcitonina
Almirall
200 UI
multidose
spray nasal

Calcitonina
Almirall
200 UI
multidose
spray nasal

200 IU/dose

Nasal spray,
solution

Nasal use

Vial

Monodose spray
28 vials

200 IU/
Vial

Nasal spray,
solution

Nasal use

Vial

(14 doses)

Monodose spray
1

200 IU/
Vial

Nasal spray,
solution

Nasal use

Vial

(28 doses)

Monodose spray
2

Almirall — Prodesfarma SA
General Mitre, 151
E-08022 Barcelona

Calogen
spray nasal
100 aerosol

100 IU/neb

Nasal spray,
solution

Nasal use

Vial

(28 doses)

1 multidose
vial

Almirall — Prodesfarma SA
General Mitre, 151
E-08022 Barcelona

Calogen
injectable

100 IU/ml

Injection

Subcutaneous use
Intramuscular use

Ampoule

1 ml

10

.

.

1
7
2
0
0
3

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

C

1
5
3
/
4
7

Member State

Marketing authorisation
holder

Name

Strength

Pharmaceutical
form

Route of
administration

Packaging

Content

Package
size

SPAIN
(cont’d)

ICN-Iberica
c/Casanova, 27-31
E-08757 Corbera de Llobregat
(Barcelona)

Calcitonina
Hubber 100
UI injectable

100 IU/ml

Solution for
injection

Subcutaneous use
Intramuscular use

Ampoule

1 ml

10

ICN-Iberica
c/Casanova, 27-31
E-08757 Corbera de Llobregat
(Barcelona)

Calcitonina
200
Hubber
solucion
UI
para
pulver-
azacion nasal
multidosis

200 IU/neb

Nasal spray,
solution

Nasal use

Vial

14 doses

ICN-Iberica
c/Casanova, 27-31
E-08757 Corbera de Llobregat
(Barcelona)

Calcitonina
Hubber Nasal
200 UI
monodosis

200 IU/neb

Nasal spray,
solution

Nasal use

Vial

14 doses

ICN-Iberica
c/Casanova, 27-31
E-08757 Corbera de Llobregat
(Barcelona)

Calcitonina
Hubber Nasal
200 UI
monodosis

200 IU/neb

Nasal spray,
solution

Nasal use

Vial

28 doses

Aventis Pharma SA
Martinez Villergas 52
E-28027 Madrid

Aventis Pharma SA
Martinez Villergas 52
E-28027 Madrid

Calsynar 100

100 IU/
Vial

Calsynar 50

50 IU/
Vial

Vial

Vial

Subcutaneous use
Intramuscular use

Vial

1 vial + 1 ampoule
solvent, 10 vials +
10 ampoule solvent

Subcutaneous use
Intramuscular use

Vial

2 ml

10 vials 2 ml + 10
ampoule solvent

Aventis Pharma SA
Martinez Villergas 52
E-28027 Madrid

Calsynar
intranasal 200
UI monodosis

200 IU

Nasal spray,
solution

Nasal use

Vial

(28 doses)

Aventis Pharma SA
Martinez Villergas 52
E-28027 Madrid

Calsynar
Intranasal

200 IU/neb

Nasal spray,
solution

Nasal use

Vial

1 vial
multidoses

1 vial 14 neb

C

1
5
3
/
4
8

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

.

.

1
7
2
0
0
3

Member State

Marketing authorisation
holder

Name

Strength

Pharmaceutical
form

Route of
administration

Packaging

Content

Package
size

SPAIN
(cont’d)

Aventis Pharma SA
Martinez Villergas 52
E-28027 Madrid

Calsynar
Intranasal

200 IU/dose

Nasal spray,
solution

Nasal use

(28 doses)

.

.

1
7
2
0
0
3

Novartis Pharmaceutica SA
Gran Vía de les Corts
Catalanes, 764
E-08013 Barcelona

Novartis Pharmaceutica SA
Gran Vía de les Corts
Catalanes, 764
E-08013 Barcelona

Novartis Pharmaceutica SA
Gran Vía de les Corts
Catalanes, 764
E-08013 Barcelona

Altana Pharma SA
Francisca Delgado 11
Parque Empressarial Arroyo de
la Veja
E-28108 Alconbendas
(Madrid)

Altana Pharma SA
Francisca Delgado 11
Parque Empressarial Arroyo de
la Veja
E-28108 Alconbendas
(Madrid)

Altana Pharma SA
Francisca Delgado 11
Parque Empressarial Arroyo de
la Veja
E-28108 Alconbendas
(Madrid)

Miacalcic 100 100 IU/ml

Injection

Patenteral use

Ampoule

1 ml

1, 10

Miacalcic 200
Spray nasal

200 IU/neb

Nasal spray,
solution

Nasal use

Vial

Miacalcic 200
Spray nasal

200 IU/neb

Nasal spray,
solution

Nasal use

Vial

1

2

1 vial 2 ml
(14
doses/vial)

2 vials
(2 ml/vial)
(14
doses/vial)

Kalsimin 100
UI

100 IU/ml

Solution for
injection

Injectable use

Ampoule

1 ml

10

Kalsimin 50
UI

50 IU/ml

Solution for
injection

Injectable use

Ampoule

1 ml

10

Kalsimin
Nasal

50 IU/neb

Nasal spray,
solution

Nasal use

Vial

(14 doses)

1

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

C

1
5
3
/
4
9

Member State

Marketing authorisation
holder

Name

Strength

Pharmaceutical
form

Route of
administration

Packaging

Content

Package
size

SPAIN
(cont’d)

Faes SA
Máximo Aguirre, 14
Lejana Vizcaya

Oseototal
100 IU

100 IU/ml

Injection

Subcutaneous use
Intramuscular use

Ampoule

1 ml

1, 10

Faes SA
Máximo Aguirre, 14
Lejana Vizcaya

Oseototal 200
Spray nasal
Aerosol

200 IU/neb

Nasal spray,
solution

Nasal use

Ospor Spray
nasal

200 IU/neb

Nasal spray,
solution

Nasal use

Laboratorio Padro SA
Gran Vía de les Corts
Catalanes, 764
E-08013 Barcelona

Laboratorio Padro SA
Gran Vía de les Corts
Catalanes, 764
E-08013 Barcelona

Ospor Spray
nasal

200 IU/neb

Nasal spray,
solution

Nasal use

Vial

Vial

Vial

2 ml
(14 doses)

1, 2

2

2

2 ml
(14
doses/vial)

4 ml
(14
doses/vial)

Laboratorios CENTRUM SA
Sagitario 14
E-03006 Alicante

Osteobion
200 Solución
para
pulver-
ización nasal

200 IU/neb

Nasal spray,
solution

Nasal use

Vial

(14 doses)

1 vial

Rottapharm
Carretera de Barcelona, 2
E-46132 Almacera
(Valencia)

Rottapharm
Carretera de Barcelona, 2
E-46132 Almacera
(Valencia)

Rottapharm
Carretera de Barcelona, 2
E-46132 Almacera
(Valencia)

Zambon
c/Haresme s/n Pol. Urvasa
Sta Perpetua de Mogoda
Barcelona

Sical 50 UI
injectables

50 IU/ml

Solution for
injection

Injectable use

Ampoule

1 ml

10

Sical 100 UI
injectables

100 IU/ml

Solution for
injection

Injectable use

Ampoule

Sical nasal

50 IU/neb

Nasal spray,
solution

Nasal use

Vial

2 ml

2

Tonocaltin
100 IU Spray
nasal

100 IU/ml

Solution for
injection

Injectable use

Ampoule

1,10

C

1
5
3
/
5
0

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

.

.

1
7
2
0
0
3

Member State

Marketing authorisation
holder

Name

Strength

Pharmaceutical
form

Route of
administration

Packaging

Content

Package
size

SPAIN
(cont’d)

Zambon
c/Haresme s/n Pol. Urvasa
Sta Perpetua de Mogoda
Barcelona

Tonocaltin
200 UI
Solución para
pulverización
nasal

200 IU/dose

Nasal spray,
solution

Nasal use

Vial

2,1 ml
(14 pul)

14 pulverisations

Zambon
c/Haresme s/n Pol. Urvasa
Sta Perpetua de Mogoda
Barcelona

Alcalá Farma, SL
Ctra. M-300, km 29,920
Alcalá de Henares
(Madrid)

Alcalá Farma, SL
Ctra. M-300, km 29,920
Alcalá de Henares
(Madrid)

Ferrer Internacional, SA
Grand Via Carlos III, 94
E-08028 Barcelona

Ferrer Internacional, SA
Grand Via Carlos III, 94
E-08028 Barcelona

Tonocaltin 50
UI ampoule

50 IU/ml

Solution for
injection

Injectable use

Ampoule

1 ml

10

Carbicalcin
Spray Nasal

40 IU/neb

Nasal spray,
solution

Nasal use

Vial

(24 doses)

1

Carbicalcin
inyectable

40 IU/ml

Solution for
injection

Intramuscular use

Ampoule

1 ml

10

Diatin
injectable

40 IU/ml

Solution for
injection

Injectable use

Ampoule

1 ml

10

Diatin spray
nasal

40 IU/neb

Nasal spray,
solution

Nasal use

Vial

(24 doses)

1

Cepa Schwarz Pharma SL
Puerta de la Castellana 141
Ed. Cuzco IV Planta 15
E-28046 Madrid

Elcatonina
CEPA
inyectable

40 IU/ml

Solution for
injection

Injectable use

Ampoule

1 ml

10

Cepa Schwarz Pharma SL
Puerta de la Castellana 141
Ed. Cuzco IV Planta 15
E-28046 Madrid

Elcatonina
CEPA Spray
nasal

40 IU/neb

Nasal spray

Nasal use

Vial

1

(24 doses)

.

.

1
7
2
0
0
3

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

C

1
5
3
/
5
1

Member State

Marketing authorisation
holder

Name

Strength

Pharmaceutical
form

Route of
administration

Packaging

Content

Package
size

SPAIN
(cont’d)

SWEDEN

UNITED
KINGDOM

I.F.C
Industrial Farmaceutica
Cantabria, SA
C/ Arequipa, 1
E-28043 Madrid

I.F.C
Industrial Farmaceutica
Cantabria, SA
C/ Arequipa, 1
E-28043 Madrid

I.F.C
Industrial Farmaceutica
Cantabria, SA
C/ Arequipa, 1
E-28043 Madrid

Novartis Läkemedel
Novartis Sverige AB
Box 1150
S-18311 Täby

Novartis pharmaceuticals
UK ltd
Trading as:
Sandoz pharmaceuticals
Frimley business park
Frimley
Camberley
Surrey GU16 7SR
United Kingdom

Novartis pharmaceuticals
UK ltd
Trading as:
Sandoz pharmaceuticals
Frimley business park
Frimley
Camberley
Surrey GU16 7SR
United Kingdom

Elcatonina
CEPA
injectable

40 IU/ml

Solution for
injection

Injectable use

Ampoule

1 ml

10

Elcatonina
CEPA Spray
nasal

40 IU/neb

Nasal spray,
solution

Nasal use

Vial

(24 doses)

1

Elcatonina UR
40 UI aerosol

40 IU/neb

Nasal spray,
solution

Nasal use

Vial

(24 doses)

1

Miacalcic

100 IU/ml

Solution for
injection

Intramuscular use
Intravenous use
Subcutaneous use

1 ml

5

Miacalcic

50 IU/ml

Solution for
injection

Intramuscular use
Intravenous use
Subcutaneous use

Ampoule

Miacalcic

100 IU/ml

Solution for
injection

Intramuscular use
Intravenous use
Subcutaneous use

Ampoule

C

1
5
3
/
5
2

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

.

.

1
7
2
0
0
3

Member State

Marketing authorisation
holder

Name

Strength

Pharmaceutical
form

Route of
administration

Packaging

Content

Package
size

UNITED
KINGDOM
(cont’d)

Novartis pharmaceuticals
UK ltd
Trading as:
Sandoz pharmaceuticals
Frimley business park
Frimley
Camberley
Surrey GU16 7SR
United Kingdom

Novartis pharmaceuticals
UK ltd
Trading as:
Sandoz pharmaceuticals
Frimley business park
Frimley
Camberley
Surrey GU16 7SR
United Kingdom

May & Baker Ltd
50 Kings Hill Avenue
West Malling
Kent ME19 4AH
United Kingdom

May & Baker Ltd
50 Kings Hill Avenue
West Malling
Kent ME19 4AH
United Kingdom

Miacalcic

200 IU/ml

Nasal spray,
solution

Nasal use

Vial

(14 doses)

1

Miacalcic

400 IU/2 ml

Solution for
injection

Injectable use

Vial

2 ml

1

Calsynar

100 IU/ml

Injection

Subcutaneous use
Intramuscular use

Ampoule

1, 4, 5

Calsynar

200 IU/ml

Injection

Subcutaneous use
Intramuscular use

Ampoule

1, 4, 5

AUSTRIA

Novartis Pharma GmbH
Brunner Straße 59
A-1235 Wien

Novartis Pharma GmbH
Brunner Straße 59
A-1235 Wien

100 IU/ml

Injection

50 IU/ml

Injection

calcitonin
‘Novartis’
100 I.E.-
Ampullen

calcitonin
‘Novartis’
50 I.E.-
Ampullen

Intramuscular use
Intravenous use
Subcutaneous use

Intramuscular use
Intravenous use
Subcutaneous use

Ampoule

1 ml

Ampoule

1 ml

5

5

.

.

1
7
2
0
0
3

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

C

1
5
3
/
5
3

Member State

Marketing authorisation
holder

Name

Strength

Pharmaceutical
form

Route of
administration

Packaging

Content

Package
size

AUSTRIA
(cont’d)

Novartis Pharma GmbH
Brunner Straße 59
A-1235 Wien

Novartis Pharma GmbH
Brunner Straße 59
A-1235 Wien

Novartis Pharma GmbH
Brunner Straße 59
A-1235 Wien

Novartis Pharma GmbH
Brunner Straße 59
A-1235 Wien

Novartis Pharma GmbH
Brunner Straße 59
A-1235 Wien

Novartis Pharma GmbH
Brunner Straße 59
A-1235 Wien

Novartis Pharma GmbH
Brunner Straße 59
A-1235 Wien

Novartis Pharma GmbH
Brunner Straße 59
A-1235 Wien

calcitonin
‘Novartis’
100 I.E.-
Nasalspray

calcitonin
‘Novartis’
50 I.E.-
Nasalspray

Calcitonins
‘Novartis’
200 I.E.-
Nasalspray

calcitonin
‘Novartis’
100 I.E.-
Spritzam-
pullen

cibacalcin
0,5 mg-Dop-
pelkammer-
spritzam-
pullen

cibacalcin
0,5 mg-
Trocken-
substanz mit
Lösungsmittel

Miacalcic
50 I.E.-
Ampullen

Miacalcic
100 I.E.-
Nasalspray

100 IU/dose

Nasal spray,
solution

Nasal use

Spray container

(16 doses)

1, 3

50 IU/dose

Nasal spray,
solution

Nasal use

Spray container

(14 doses)

1, 3

200 IU/dose

Nasal spray,
solution

Nasal use

Spray container

(14 doses)

1

100 IU/ml

Solution for
injection

Intramuscular use
Intravenous use
Subcutaneous use

Ampoule

1 ml

5, 20, 25, 5 × 5

0,5 mg/ml

Solution for
injection

Injectable use

Syringe

1, 5, 5 × 5

0,5 mg

Powder

Injectable use

Vial

5 vials + 5 solvent
5 × 5 vials + 5
solvent

50 IU/ml

Solution for
injection

Injectable use

Ampoule

1 ml

5

100 IU/dose

Nasal spray,
× solution

Nasal use

Vial

(14 doses)

1, 3

C

1
5
3
/
5
4

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

.

.

1
7
2
0
0
3

Member State

Marketing authorisation
holder

Name

Strength

Pharmaceutical
form

Route of
administration

Packaging

Content

Package
size

AUSTRIA
(cont’d)

Novartis Pharma GmbH
Brunner Straße 59
A-1235 Wien

Miacalcic
50 I.E.-
Nasalspray

50 IU/dose

Nasal spray,
solution

Nasal use

Vial

(14 doses)

1, 3

Novartis Pharma GmbH
Brunner Straße 59
A-1235 Wien

Miacalcic
200 I.E.-
Nasalspray

200 IU/ml

Nasal spray,
solution

Nasal use

Vial

(14 doses)

1

F. Joh. Kwizda GesmbH
Dr.-Karl-Lueger-Ring 6
A-1010 Wien

Calco
100 mg
Ampullen

100 mg/ml

Injection

Subcutaneous use
Intramuscular use

Ampoule

1 ml

Calco 50 mg
Ampullen

50 mg/ml

Injection

Subcutaneous use
Intramuscular use

Ampoule

1 ml

5

5

F. Joh. Kwizda GesmbH
Dr.-Karl-Lueger-Ring 6
A-1010 Wien

UCB Pharma GesmbH
Brünnerstraße 73/5
A-1210 Wien

UCB Pharma GesmbH
Brünnerstraße 73/5
A-1210 Wien

Ucecal
50 I.E.-
Injections-
lösung

Ucecal
100 I.E.-
Injections-
lösung

50 IU/ml

Solution for
injection

Intramuscular use
Intravenous use
Subcutaneous use

Ampoule

1 ml

1, 5, 5 × 5

100 IU/ml

Solution for
injection

Intramuscular use
Intravenous use
Subcutaneous use

Ampoule

1 ml

1, 5, 5 × 5

UCB Pharma GesmbH
Brünnerstraße 73/5
A-1210 Wien

Ucecal
100 I.E.-
Nasalspray

100 IU/ml

Solution for
injection

Nasal use

Vial

0,1 ml

2,1 ml, 3,5 ml

.

.

1
7
2
0
0
3

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

C

1
5
3
/
5
5

Member State

Marketing authorisation
holder

Name

Strength

Pharmaceutical
form

Route of
administration

Packaging

Content

Package
size

AUSTRIA
(cont’d)

UCB Pharma GesmbH
Brünnerstraße 73/5
A-1210 Wien

Ucecal
200 I.E.-
Nasalspray

200 IU/ml

Solution for
injection

Nasal use

Vial

0,1 ml

2,1 ml, 3,5 ml

PHARMACIA & Upjohn
Pharma-Handels GesmbH
Oberlaaerstraße 247-251
A-1100 Wien

casalm
100 I.E./
ml-Spritzam-
pullen

100 IU/ml

Solution for
injection

Intramuscular use
Intravenous use
Subcutaneous use

Prefilled syringe

1 ml

5, 5 × 5

PHARMACIA & Upjohn
Pharma-Handels GesmbH
Oberlaaerstraße 247-251
A-1100 Wien

casalm
50 I.E./ml-
Spritzam-
pullen

50 IU/ml

Solution for
injection

Injectable use

Prefilled syringe

1 ml

5, 5 × 5

Nycomed Österreich
St.-Peter-Straße 25
A-4020 Linz

ELCIMEN
Ampullen

40 IU/ml

Solution for
injection

1 ml

5, 25

BELGIUM

Aventis Pharma SA
Boulevard de la Plaine 9
B-1150 Brussels

Calsynar
Intranasal

100 IU/dose

Nasal spray,
solution

Nasal use

Vial monodose

0,1 ml

14 vials
28 vials

Aventis Pharma SA
Boulevard de la Plaine 9
B-1150 Brussels

Calsynar
Intranasal

100 IU/dose

Nasal spray,
solution

Nasal use

Vial

(14 doses)

1

Aventis Pharma SA
Boulevard de la Plaine 9
B-1150 Brussels

Calsynar

50 IU/0,5 ml

Solution for
injection

Intramuscular use
Intravenous use
Subcutaneous use

Ampoule-syringe

0,5 ml

5, 15, 30

Aventis Pharma SA
Boulevard de la Plaine 9
B-1150 Brussels

Calsynar

100 IU/1 ml

Solution for
injection

Intramuscular use
Intravenous use
Subcutaneous use

Ampoule-syringe

1 ml

5, 15, 30

C

1
5
3
/
5
6

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

.

.

1
7
2
0
0
3

Member State

Marketing authorisation
holder

Name

Strength

Pharmaceutical
form

Route of
administration

Packaging

Content

Package
size

BELGIUM
(cont’d)

Aventis Pharma SA
Boulevard de la Plaine 9
B-1150 Brussels

Calsynar

400 IU/2 ml

Solution for
injection

Intramuscular use
Intravenous use
Subcutaneous use

Vial

2 ml

1 vial multidose

Sanico NV
Industrieterrein 4
B-2300 Turnhout

Novartis Pharma NV
Medialaan 40 bus 1
B-1800 Vilvoorde

Novartis Pharma NV
Medialaan 40 bus 1
B-1800 Vilvoorde

Novartis Pharma NV
Medialaan 40 bus 1
B-1800 Vilvoorde

Novartis Pharma NV
Medialaan 40 bus 1
B-1800 Vilvoorde

Novartis Pharma NV
Medialaan 40 bus 1
B-1800 Vilvoorde

Novartis Pharma NV
Medialaan 40 bus 1
B-1800 Vilvoorde

Calcivera

100 IU/0,1 ml

Nasal spray,
solution

Nasal use

Monodose
0,1 ml

7 doses

Miacalcic
Nasal

100 IU/dose

Nasal spray,
solution

Nasal use

Vial

(14 doses)

1, 4

Miacalcic
Nasal

200 IU/dose

Nasal spray,
solution

Nasal use

Vial

(14 doses)

1

Ostulex

200 IU/dose

Nasal spray,
solution

Nasal use

Vial

(14 doses)

1

Miacalcic

50 IU/ml

Solution for
injection

Injectable use

Prefilled syringe

0,5 ml

5, 15, 30 × 0,5 ml

Miacalcic

50 IU/ml

Solution for
injection

Injectable use

Ampoule

1 ml

5

Miacalcic

100 IU/ml

Solution for
injection

Injectable use

Prefilled syringe

1 ml

5, 15, 30 × 1 ml

.

.

1
7
2
0
0
3

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

C

1
5
3
/
5
7

Member State

Marketing authorisation
holder

Name

Strength

Pharmaceutical
form

Route of
administration

Packaging

Content

Package
size

BELGIUM
(cont’d)

Christiaens Pharma SC
Chaussée de Gand 615
B-1080 Brussels

Steocalcin

50 IU/ml

Solution for
injection

Injectable use

Ampoule

1 ml

Christiaens Pharma SC
Chaussée de Gand 615
B-1080 Brussels

Christiaens Pharma SC
Chaussée de Gand 615
B-1080 Brussels

Steocalcin

50 IU/ml

Solution for
injection

Injectable use

Prefilled syringes

1 ml

Steocalcin

100 IU/ml

Solution for
injection

Injectable use

Ampoule

1 ml

5

5

5

Christiaens Pharma SC
Chaussée de Gand 615
B-1080 Brussels

Steocalcin

100 IU/ml

Solution for
injection

Injectable use

Prefilled syringes

1 ml

5, 15, 30 × 1 ml

Christiaens Pharma SC
Chaussée de Gand 615
B-1080 Brussels

Steocalcin
Nasal

100 IU/dose

Nasal spray,
solution

Nasal use

Vial

1

(14 doses)

GlaxoSmithKline SA
Boulevard du Souverain 191
B-1160 Brussels

Carbicalcin

40 UI/0,1 ml

Nasal spray,
solution

Nasal use

Vial

1,2 ml
(12 doses)

GlaxoSmithKline SA
Boulevard du Souverain 191
B-1160 Brussels

Carbicalcin

40 UI/1 ml

Solution for
injection

Intramuscular use

Ampoule

1 ml

GlaxoSmithKline SA
Boulevard du Souverain 191
B-1160 Brussels

Turbocalcin

40 UI/0,1 ml

Nasal spray,
solution

Nasal use

Vial

1,2 ml
(12 doses)

1

5

1

C

1
5
3
/
5
8

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

.

.

1
7
2
0
0
3

Member State

Marketing authorisation
holder

Name

Strength

Pharmaceutical
form

Route of
administration

Packaging

Content

Package
size

BELGIUM
(cont’d)

GlaxoSmithKline SA
Boulevard du Souverain 191
B-1160 Brussels

Turbocalcin

40 UI/1 ml

Solution for
injection

Intramuscular use

Ampoule

1 ml

DENMARK

Novartis Healthcare AS
Lyngbyvej 172
DK- 2100 Køpenhavn

Miacalcic

100 IU/ml

Solution for
injection

Injectable use

Ampoule

1 ml

5

5

Novartis Healthcare AS
Lyngbyvej 172
DK-2100 Køpenhavn

Novartis Healthcare AS
Lyngbyvej 172
DK-2100 Køpenhavn

Aventis Pharma A/S
Slotsmarken 13
DK-2970 Hørsholm

Miacalcic
Nasal

100 IU/dose

Nasal spray,
solution

Nasal use

Vial

(14 doses)

1

Miacalcic
Nasal

200 IU/dose

Nasal spray,
solution

Nasal use

Vial

(14 doses)

1

Calsynar

200 IU/ml

Solution for
injection

Parenteral use

FINLAND

Novartis Finnland Oy
Metsanneidonkuja 10
FI-02130 Espoo

Miacalcic

100 IU/ml

Solution for
injection

Injectable use

Ampoule

1 ml

5

FRANCE

Novartis Finnland Oy
Metsanneidonkuja 10
FI-02130 Espoo

Specia
15, rue de la Vanne
F-92545 Montrouge Cedex

Laboratoire AVENTIS
46, quoi de la Rapée
F-75601 Paris Cedex 12

Miacalcic
Nasal

100 IU/dose

Nasal spray,
solution

Nasal use

Vial

(14 doses)

1

Calsyn

50 IU

Powder for solution
for injection

1 vial 50 IU + 1
ampoule 2 ml
solvent
1 vial 50 IU

.

.

1
7
2
0
0
3

E
N

O

f
f
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a
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J
o
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n
a
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o
f

t
h
e

E
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o
p
e
a
n
U
n
o
n

i

C

1
5
3
/
5
9

Member State

Marketing authorisation
holder

Name

Strength

Pharmaceutical
form

Route of
administration

Packaging

Content

Package
size

FRANCE
(cont’d)

Specia
15, rue de la Vanne
F-92545 Montrouge Cedex

Laboratoire AVENTIS
46, quoi de la Rapée
F-75601 Paris Cedex 12

Specia
15, rue de la Vanne
F-92545 Montrouge Cedex

Laboratoire AVENTIS
46, quoi de la Rapée
F-75601 Paris Cedex 12

Specia
15, rue de la Vanne
F-92545 Montrouge Cedex

Laboratoire AVENTIS
46, quoi de la Rapée
F-75601 Paris Cedex 12

Novartis Pharma SA
2-4, rue Lionel Terray
BP 308
F-92506 Reuil Malmaison
Cedex

Novartis Pharma SA
2-4, rue Lionel Terray
BP 308
F-92506 Reuil Malmaison
Cedex

Novartis Pharma SA
2-4, rue Lionel Terray
BP 308
F-92506 Reuil Malmaison
Cedex

Novartis Pharma SA
2-4, rue Lionel Terray
BP 308
F-92506 Reuil Malmaison
Cedex

Calsyn

100 IU

Powder for solution
for injection

1 vial 100 IU +
1 ampoule
solvent
1 vial 100 IU

Calsyn

50 IU/0,5 ml

Solution for
injection

Intramuscular use
Intravenous use
Subcutaneous use

Ampoule

0,5 ml

1

Calsyn

100 IU/1 ml

Solution for
injection

Intramuscular use
Intravenous use
Subcutaneous use

Ampoule

1 ml

1

Miacalcic
50 UI/1 ml

50 IU/1 ml

Solution for
injection

Miacalcic
80 UI/0,8 ml

80 IU/0,8 ml

Solution for
injection

Intramuscular use
Intravenous use
Subcutaneous use

Intramuscular use
Intravenous use
Subcutaneous use

Ampoule

1 ml

5

Ampoule

0,8 ml

6

Cibacalcine

0,25 mg

Powder and solvent
for
for
solution
injection

Intramuscular use
Intravenous use
Subcutaneous use

Powder ampoule
solvent
ampoule

(0,25 mg) +
1 mg

Cibacalcine

0,50 mg

Powder and solvent
for Solution for
injection

Intramuscular use
Intravenous use
Subcutaneous use

Powder ampoule,
solvent
ampoule

(0,5 mg) +
1 mg

(1 ampoule of
powder + 1
ampoule of
solvent) × 5

(1 ampoule of
powder + 1
ampoule of
solvent) × 5

C

1
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3
/
6
0

E
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O

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f
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J
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a
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U
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i

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1
7
2
0
0
3

Member State

Marketing authorisation
holder

Name

Strength

Pharmaceutical
form

Route of
administration

Packaging

Content

Package
size

FRANCE
(cont’d)

GNR Pharma
49, avenue Georges Pompidou
F-92593 Levallois Perret
Cedex

Calcitonine
GNR 50 UI/
1 ml

50 IU/ml

Solution for
injection

Injectable use

Ampoule

1 ml

5

GNR Pharma
49, avenue Georges Pompidou
F-92593 Levallois Perret
Cedex

Calcitonine
GNR 80 UI/
0,8 ml

80 IU/0,8 ml

Solution for
injection

Injectable use

Ampoule

0,8 ml

6

Cephalon France
20, rue Charles Martigny
F-94700 Maisons-Alfort

Cephalon France
20, rue Charles Martigny
F-94700 Maisons-Alfort

Zambon Frankreich
13, rue Rene Jacques
F-92138 Issy les Moulineaux
Cedex

Zambon Frankreich
13, rue Rene Jacques
F-92138 Issy les Moulineaux
Cedex

Laboratoires Pharmy II —
Strategy senter
26, rue des Gaudines
F-78100 Saint German en Laye

Laboratoires Pharmy II —
Strategy senter
26, rue des Gaudines
F-78100 Saint German en Laye

Calcitonine
L.lafon

50 IU/ml

Solution for
injection

Injectable use

Ampoule

1 ml

Calcitonine
L.lafon

100 IU/ml

Solution for
injection

Injectable use

Ampoule

1 ml

Cadens Gé

50 IU/ml

Solution for
injection

Intramuscular use
Intravenous use
Subcutaneous use

Ampoule

1 ml

5

5

5

Cadens Gé

80 IU/0,8 ml

Solution for
injection

Intramuscular use
Intravenous use
Subcutaneous use

Ampoule

0,8 ml

6

Calcitonine
Pharmy II

50 IU/ml

Solution for
injection

Calcitonine
Pharmy II

100 IU/ml

Solution for
injection

Intramuscular use
Intravenous use
Subcutaneous use

Intramuscular use
Intravenous use
Subcutaneous use

Ampoule

1 ml

Ampoule

1 ml

5

5

.

.

1
7
2
0
0
3

E
N

O

f
f
i
c
i
a
l

J
o
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n
a
l

o
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t
h
e

E
u
r
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p
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a
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U
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o
n

i

C

1
5
3
/
6
1

Member State

Marketing authorisation
holder

Name

Strength

Pharmaceutical
form

Route of
administration

Packaging

Content

Package
size

FRANCE
(cont’d)

Pharmaceutique Noroit
7, rue Jean-Baptiste Clément
F-94250 Gentilly

Staporos
50 UI/1 ml

50 IU/ml

Solution for
injection

Ampoule

1 ml

5

Pharmaceutique Noroit
7, rue Jean-Baptiste Clément
F-94250 Gentilly

Staporos
100 UI/1 ml

100 IU/ml

Solution for
injection

Ampoule

1 ml

5, 6

Pharmaceutique Noroit
7, rue Jean-Baptiste Clément
F-94250 Gentilly

Staporos
50 UI/1 ml

50 IU/ml

Pharmaceutique Noroit
7, rue Jean-Baptiste Clément
F-94250 Gentilly

Staporos
100 UI/1 ml

100 IU/ml

Pre-filled syringe

1 ml

Pre-filled syringe

1 ml

5

6

LUXEMBOURG

Aventis Pharma SA-NV
Boulevard de la Plaine 9
B-1050 Bruxelles

Calsynar
Intranasal

100 IU/0,1 ml

Nasal spray,
solution

Nasal use

Vial

0,1 ml

14

C

1
5
3
/
6
2

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

Aventis Pharma SA-NV
Boulevard de la Plaine 9
B-1050 Bruxelles

Calsynar

50 IU/0,5 ml

Solution for
injection

Intramuscular use
Intravenous use
Subcutaneous use

Ampoule

0,5 ml

5, 15, 30

Aventis Pharma SA-NV
Boulevard de la Plaine 9
B-1050 Bruxelles

Calsynar

100 IU/0,5 ml

Solution for
injection

Intramuscular use
Intravenous use
Subcutaneous use

Ampoule

0,5 ml

5, 15, 30

Aventis Pharma SA-NV
Boulevard de la Plaine 9
B-1050 Bruxelles

Calsynar

200 IU/2 ml

Solution for
injection

Intramuscular use
Intravenous use
Subcutaneous use

Vial

2 ml

1

.

.

1
7
2
0
0
3

Member State

Marketing authorisation
holder

Name

Strength

Pharmaceutical
form

Route of
administration

Packaging

Content

Package
size

LUXEMBOURG
(cont’d)

Novartis Pharma GmbH
Roonstraße 25
D-90429 Nürnberg

Cibacalcin

0,25 mg

Powder for
injection

Injectable use

Vial + solvent
ampoule

0,25 mg

5, 20, 50, 60
vial + ampoule

Novartis Pharma GmbH
Roonstraße 25
D-90429 Nürnberg

Cibacalcin

0,5 mg

Powder for
injection

Injectable use

Vial + solvent
ampoule

0,50 mg

5, 20, 50, 60
vial + ampoule

Novartis Pharma GmbH
Roonstraße 25
D-90429 Nürnberg

Karil

50 IU/0,5 ml

Solution for
injection

Prefilled syringe

0,5 ml

50, 100

Novartis Pharma GmbH
Roonstraße 25
D-90429 Nürnberg

Karil

100 IU/ml

Solution for
injection

Injectable use

Prefilled syringe

1 ml

50, 100

Novartis Pharma GmbH
Roonstraße 25
D-90429 Nürnberg

Karil

50 IU/0,5 ml

Solution for
injection

Injectable use

Ampoule

0,5 ml

5, 50, 100

Novartis Pharma GmbH
Roonstraße 25
D-90429 Nürnberg

Karil

100 IU/ml

Solution for
injection

Injectable use

Ampoule

1 ml

5, 50, 100

Novartis Pharma GmbH
Roonstraße 25
D-90429 Nürnberg

Novartis Pharma GmbH
Roonstraße 25
D-90429 Nürnberg

Karil

200 IU/dose

Nasal spray,
solution

Nasal use

Vial

2 ml

Miacalcic

200 IU/dose

Nasal spray,
solution

Nasal use

Vial

2 ml

1

1

.

.

1
7
2
0
0
3

E
N

O

f
f
i
c
i
a
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J
o
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n
a
l

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E
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U
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/
6
3

Member State

Marketing authorisation
holder

Name

Strength

Pharmaceutical
form

Route of
administration

Packaging

Content

Package
size

LUXEMBOURG
(cont’d)

Novartis Pharma GmbH
Roonstraße 25
D-90429 Nürnberg

Ostulex

200 IU/dose

Nasal spray,
solution

Nasal use

NORWAY

ICELAND

GlaxoSmithKline SA
Boulevard du Souverain 191
B-1160 Brussels

GlaxoSmithKline SA
Boulevard du Souverain 191
B-1160 Brussels

GlaxoSmithKline SA
Boulevard du Souverain 191
B-1160 Brussels

Novartis
Postbox 237 Økern
NO-0510 Oslo

Novartis
Postbox 237 Økern
NO-0510 Oslo

Thorarsen Lyf
Lynghals 13
IS-110 Reykjavik
Island

Thorarsen Lyf
Lynghals 13
IS-110 Reykjavik
Island

Thorarsen Lyf
Lynghals 13
IS-110 Reykjavik
Island

Vial

Vial

Vial

(14 doses)

1

1 ml

2 ml

1

1

5

Carbicalcin

40 UI/1 ml

Nasal spray,
solution

Nasal use

Carbicalcin

40 UI/2 ml

Nasal spray,
solution

Nasal use

Carbicalcin

40 UI/1 ml

Solution for
injection

Intramuscular

Ampoule

1 ml

Miacalcic
Nasal

200 IU/dose

Nasal spray,
solution

Nasal use

Vial

(14 doses)

1 vial

Miacalcic inj.
100 IU/ml

100 IU/ml

Solution for
injection

Injectable use

Ampoule

1 ml

Miacalcic

100 IU/ml

Solution for
injection

Injectable use

Ampoule

1 ml

5

5

Miacalcic

100 IU/ml

Nasal spray,
solution

Nasal use

Miacalcic

200 IU/ml

Nasal spray,
solution

Nasal use

Vial

Vial

(14 doses)

1

(14 doses)

1

C

1
5
3
/
6
4

E
N

O

f
f
i
c
i
a
l

J
o
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n
a
l

o
f

t
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LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF
ADMINISTRATION, MARKETING AUTHORISATION HOLDERS, APPLICANTS, PACKAGING AND PACKAGE
SIZES IN THE MEMBER STATES

ANNEX V

Member State

Marketing Authorisation Holder

Applicant

Name

Strength

Pharmaceutical Form Route of administration

Packaging

Package size

AUSTRIA

Arcana Arzneimittel GmbH
Zimbagasse 5
A-1147 Wien

Felodipine Arcana

2,5 mg

Prolonged Release
Tablet

Oral use

Blister
(PVC/PE/PVDC/Alu)

10, 14, 20, 28, 30,
50, 56, 60, 98, 100

Arcana Arzneimittel GmbH
Zimbagasse 5
A-1147 Wien

ratiopharm Arzneimittel
Vertriebs-GmbH
Albert-Schweitzer-Gasse 3
A-1140 Wien

ratiopharm Arzneimittel
Vertriebs-GmbH
Albert-Schweitzer-Gasse 3
A-1140 Wien

ratiopharm Arzneimittel
Vertriebs-GmbH
Albert-Schweitzer-Gasse 3
A-1140 Wien

STADA Arzneimittel GesmbH
Heiligenstädter Straße 52/2/8
A-1190 Wien

STADA Arzneimittel GesmbH
Heiligenstädter Straße 52/2/8
A-1190 Wien

STADA Arzneimittel GesmbH
Heiligenstädter Straße 52/2/8
A-1190 Wien

Felodipine Arcana

5 mg

Prolonged Release
Tablet

Oral use

Blister
(PVC/PE/PVDC/Alu)

10, 14, 20, 28, 30,
50, 56, 60, 98, 100

Felodipin ‘ratiopharm’

2,5 mg

Prolonged Release
Tablet

Oral use

Blister
(PVC/PE/PVDC/Alu)

20, 30, 28, 50, 98,
100 and 250

Felodipin ‘ratiopharm’

5 mg

Prolonged Release
Tablet

Oral use

Blister
(PVC/PE/PVDC/Alu)

20, 30, 28, 50, 98,
100 and 250

Felodipin ‘ratiopharm’

10 mg

Prolonged Release
Tablet

Oral use

Blister
(PVC/PE/PVDC/Alu)

20, 30, 28, 50, 98,
100 and 250

Felodistad

Felodistad

Felodistad

2,5 mg

Prolonged Release
Tablets

Oral use

Blister
(PVC/PE/PVDC/Alu)

5 mg

Prolonged Release
Tablets

Oral use

Blister
(PVC/PE/PVDC/Alu)

10 mg

Prolonged Release
Tablets

Oral use

Blister
(PVC/PE/PVDC/Alu)

10, 14, 20, 28, 30,
50, 56, 60, 90, 98,
100, 250, 500, 1 000

10, 14, 20, 28, 30,
50, 56, 60, 90, 98,
100, 250, 500, 1 000

10, 14, 20, 28, 30,
50, 56, 60, 90, 98,
100, 250, 500, 1 000

.

.

1
7
2
0
0
3

E
N

O

f
f
i
c
i
a
l

J
o
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n
a
l

o
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t
h
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E
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5
3
/
6
5

Member State

Marketing Authorisation Holder

Applicant

Name

Strength

Pharmaceutical Form Route of administration

Packaging

Package size

BELGIUM

DENMARK

Merck NV/SA
Brusselsesteenweg 288
B-3090 Overijse

Merck NV/SA
Brusselsesteenweg 288
B-3090 Overijse

ratiopharm Belgien SA
141, rue St.-Lambert
B-1200 Brussels

ratiopharm Belgien SA
141, rue St.-Lambert
B-1200 Brussels

SA Eurogenerics NV
Heizel Esplanade Heysel b 22
B-1020 Brussel

SA Eurogenerics NV
Heizel Esplanade Heysel b 22
B-1020 Brussel

Alpharma AS
Harbitzalléen 3
Post Box 158
Skoyen
NO-0212 Oslo

Alpharma AS
Harbitzalléen 3
Post Box 158
Skoyen
NO-0212 Oslo

Merck-Felodipine

5 mg

Prolonged Release
Tablet

Oral use

Blister
(PVC/PE/PVDC/Alu)

10, 14, 20, 28, 30,
50, 56, 60, 98, 100

Merck-Felodipine

10 mg

Prolonged Release
Tablet

Oral use

Blister
(PVC/PE/PVDC/Alu)

10, 14, 20, 28, 30,
50, 56, 60, 98, 100

Felodipine-ratiopharm

5 mg

Prolonged Release
Tablet

Oral use

Blister
(PVC/PE/PVDC/Alu)

Felodipine-ratiopharm

10 mg

Prolonged Release
Tablet

Oral use

Blister
(PVC/PE/PVDC/Alu)

Felodipine EG Retard

5 mg

Prolonged Release
Tablets

Oral use

Blister
(PVC/PE/PVDC/Alu)

Felodipine EG Retard

10 mg

Prolonged Release
Tablets

Oral use

Blister
(PVC/PE/PVDC/Alu)

Felodipin Alpharma

2,5 mg

Prolonged Release
Tablet

Oral use

Blister
(PVC/PE/PVDC/Alu)

20, 28, 30, 30×1, 50,
50×1, 98, 100,
100×1, 250

20, 28, 30, 30×1, 50,
50×1, 98, 100,
100×1, 250

10, 14, 20, 28, 30,
50, 56, 60, 90, 98,
100, 250, 500, 1 000

10, 14, 20, 28, 30,
50, 56, 60, 90, 98,
100, 250, 500, 1 000

10, 14, 20, 28, 30,
50, 56, 60, 90, 98,
100, 250, 500, 1 000

Felodipin Alpharma

5 mg

Prolonged Release
Tablet

Oral use

Blister
(PVC/PE/PVDC/Alu)

10, 14, 20, 28, 30,
50, 56, 60, 90, 98,
100, 250, 500, 1 000

C

1
5
3
/
6
6

E
N

O

f
f
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J
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n
a
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f

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E
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U
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i

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2
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Member State

Marketing Authorisation Holder

Applicant

Name

Strength

Pharmaceutical Form Route of administration

Packaging

Package size

DENMARK
(cont’d)

Alpharma AS
Harbitzalléen 3
Post Box 158
Skoyen
NO-0212 Oslo

Biochemie GmbH
Biochemiestraße 10
A-6250 Kundl

Biochemie GmbH
Biochemiestraße 10
A-6250 Kundl

Biochemie GmbH
Biochemiestraße 10
A-6250 Kundl

NM Pharma A/S
Overgaden neden Vandet 7
Dänemark

NM Pharma A/S
Overgaden neden Vandet 7
Dänemark

NM Pharma A/S
Overgaden neden Vandet 7
Dänemark

PharmaCoDane ApS
Marielundvej 46 A
DK-2730 Herlev

PharmaCoDane ApS
Marielundvej 46 A
DK-2730 Herlev

Felodipin Alpharma

10 mg

Prolonged Release
Tablet

Oral use

Blister
(PVC/PE/PVDC/Alu)

14, 10, 20, 28, 30,
50, 56, 60, 90, 98,
100, 250, 500, 1 000

Felodipin Biochemie

2,5 mg

Prolonged Release
Tablets

Oral use

Blister
(PVC/PE/PVDC/Alu)

20, 100, 100×1

Felodipin Biochemie

5 mg

Prolonged Release
Tablets

Oral use

Blister
(PVC/PE/PVDC/Alu)

20, 100, 100×1

Felodipin Biochemie

10 mg

Prolonged Release
Tablets

Oral use

Blister
(PVC/PE/PVDC/Alu)

20, 100, 100×1

Felodipin NM Pharma

2,5 mg

Prolonged Release
Tablet

Oral use

Blister
(PVC/PE/PVDC/Alu)

10, 14, 20, 28, 30,
50, 56, 60, 98, 100

Felodipin NM Pharma

5 mg

Prolonged Release
Tablet

Oral use

Blister
(PVC/PE/PVDC/Alu)

10, 14, 20, 28, 30,
50, 56, 60, 98, 100

Felodipin NM Pharma

10 mg

Prolonged Release
Tablet

Oral use

Blister
(PVC/PE/PVDC/Alu)

10, 14, 20, 28, 30,
50, 56, 60, 98, 100

Felodin

Felodin

2,5 mg

Prolonged Release
Tablets

Oral use

Blister
(PVC/PE/PVDC/Alu)

5 mg

Prolonged Release
Tablets

Oral use

Blister
(PVC/PE/PVDC/Alu)

10, 14, 20, 28, 30,
50, 56, 60, 90, 98,
100, 250, 500, 1 000

10, 14, 20, 28, 30,
50, 56, 60, 90, 98,
100, 250, 500, 1 000

.

.

1
7
2
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3

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Member State

Marketing Authorisation Holder

Applicant

Name

Strength

Pharmaceutical Form Route of administration

Packaging

Package size

DENMARK
(cont’d)

PharmaCoDane ApS
Marielundvej 46 A
DK-2730 Herlev

Felodin

10 mg

Prolonged Release
Tablets

Oral use

Blister
(PVC/PE/PVDC/Alu)

10, 14, 20, 28, 30,
50, 56, 60, 90, 98,
100, 250, 500, 1 000

ratiopharm GmbH
Graf-Arco-Straße 3
D-89079 Ulm

ratiopharm GmbH
Graf-Arco-Straße 3
D-89079 Ulm

ratiopharm GmbH
Graf-Arco-Straße 3
D-89079 Ulm

Felodipin ratiopharm

2,5 mg

Prolonged Release
Tablet

Oral use

Blister
(PVC/PE/PVDC/Alu)

28, 30, 50, 98, 100,
250

Felodipin ratiopharm

5 mg

Prolonged Release
Tablet

Oral use

Blister
(PVC/PE/PVDC/Alu)

28, 30, 50, 98, 100,
250

Felodipin ratiopharm

10 mg

Prolonged Release
Tablet

Oral use

Blister
(PVC/PE/PVDC/Alu)

28, 30, 50, 98, 100,
250

GERMANY

Alpharma-ISIS
GmbH & Co. KG
Elisabeth-Selbert-Straße 1
D-40764 Langenfeld

FELO-PUREN

2,5 mg

Prolonged Release
Tablet

Oral use

Blister
(PVC/PE/PVDC/Alu)

20, 50 and 100

C

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Alpharma-ISIS
GmbH & Co. KG
Elisabeth-Selbert-Straße 1
D-40764 Langenfeld

Alpharma-ISIS
GmbH & Co. KG
Elisabeth-Selbert-Straße 1
D-40764 Langenfeld

Azupharma GmbH & Co.
Dieselstraße 5
D-70839 Gerlingen

FELO-PUREN

10 mg

Prolonged Release
Tablet

Oral use

Blister
(PVC/PE/PVDC/Alu)

20, 50 and100
samples: 10

FELO-PUREN

5 mg

Prolonged Release
Tablet

Oral use

Blister
(PVC/PE/PVDC/Alu)

20, 50 and 100
samples: 10

Felodipin AZU

2,5 mg

Prolonged Release
Tablets

Oral use

Blister
(PVC/PE/PVDC/Alu)

20, 50 and 100

.

.

1
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Marketing Authorisation Holder

Applicant

Name

Strength

Pharmaceutical Form Route of administration

Packaging

Package size

GERMANY
(cont’d)

Azupharma GmbH & Co.
Dieselstraße 5
D-70839 Gerlingen

Felodipin AZU

5 mg

Prolonged Release
Tablets

Oral use

Blister
(PVC/PE/PVDC/Alu)

20, 50 and 100
samples: 10

.

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1
7
2
0
0
3

Azupharma GmbH & Co.
Dieselstraße 5
D-70839 Gerlingen

Merck dura GmbH
Frankfurter Straße 133
D-64293 Darmstadt

Merck dura GmbH
Frankfurter Straße 133
D-64293 Darmstadt

Merck dura GmbH
Frankfurter Straße 133
D-64293 Darmstadt

ratiopharm GmbH
Graf-Arco-Straße 3
D-89079 Ulm

ratiopharm GmbH
Graf-Arco-Straße 3
D-89079 Ulm

ratiopharm GmbH
Graf-Arco-Straße 3
D-89079 Ulm

Stadapharm GmbH
Stadastraße 2—18
D-61118 Bad Vilbel

Felodipin AZU

10 mg

Prolonged Release
Tablets

Oral use

Blisterg
(PVC/PE/PVDC/Alu)

20, 50 and 100
samples: 10

Felodipin dura

2,5 mg

Prolonged Release
Tablet

Oral use

Blister
(PVC/PE/PVDC/Alu)

20, 50, 100

Felodipin dura

5 mg

Prolonged Release
Tablet

Oral use

Blister
(PVC/PE/PVDC/Alu)

20, 50, 100
samples: 10

Felodipin dura

10 mg

Prolonged Release
Tablet

Oral use

Blister
(PVC/PE/PVDC/Alu)

20, 50, 100
samples: 10

Felodipin-ratiopharm

2,5 mg

Prolonged Release
Tablet

Oral use

Blister
(PVC/PE/PVDC/Alu)

20, 50, 100
samples: 10

Felodipin-ratiopharm

5 mg

Prolonged Release
Tablet

Oral use

Blister
(PVC/PE/PVDC/Alu)

20, 50, 100
samples: 20

Felodipin-ratiopharm

10 mg

Prolonged Release
Tablet

Oral use

Blister
(PVC/PE/PVDC/Alu)

20, 50, 100
samples: 20

Felodipin STADA

2,5 mg

Prolonged Release
Tablets

Oral use

Blister
(PVC/PE/PVDC/Alu)

20, 50, 100
samples: 20

E
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Marketing Authorisation Holder

Applicant

Name

Strength

Pharmaceutical Form Route of administration

Packaging

Package size

GERMANY
(cont’d)

LUXEMBOURG

Stadapharm GmbH
Stadastraße 2—18
D-61118 Bad Vilbel

Stadapharm GmbH
Stadastraße 2—18
D-61118 Bad Vilbel

ratiopharm GmbH
Graf-Arco-Straße 3
D-89079 Ulm

ratiopharm GmbH
Graf-Arco-Straße 3
D-89079 Ulm

Felodipin STADA

5 mg

Prolonged Release
Tablets

Oral use

Blister
(PVC/PE/PVDC/Alu)

20, 50, 100
samples: 20

Felodipin STADA

10 mg

Prolonged Release
Tablets

Oral use

Blister
(PVC/PE/PVDC/Alu)

20, 50, 100
samples: 20

Felodipin-ratiopharm

5 mg

Prolonged Release
Tablet

Oral use

Blister
(PVC/PE/PVDC/Alu)

20, 50, 100

Felodipin ratiopharm

10 mg

Prolonged Release
Tablet

Oral use

Blister
(PVC/PE/PVDC/Alu)

20, 50, 100

PORTUGAL

Alpharma ApS
Rua Virgílio Correia n.o 11A
P-1600-219 Lisboa

Felodipina Alpharma

10 mg

Prolonged Release
Tablet

Oral use

Blister
(PVC/PE/PVDC/Alu)

SPAIN

SWEDEN

Alpharma ApS
Rua Virgílio Correia n.o 11A
P-1600-219 Lisboa

Laboratorios Géminis SA
Gran Via de los Corts
Catalanes 764
E-08013-Barcelona

Biochemie GmbH
Biochemiestraße 10
A-6250 Kundl

Biochemie GmbH
Biochemiestraße 10
A-6250 Kundl

Biochemie GmbH
Biochemiestraße 10
A-6250 Kundl

10, 14, 20, 28, 30,
50, 56, 60, 90, 98,
100, 250, 500, 1 000

14, 10, 20, 28, 30,
50, 56, 60, 90, 98,
100, 250, 500, 1 000

Felodipina Alpharma

5 mg

Prolonged Release
Tablet

Oral use

Blister
(PVC/PE/PVDC/Alu)

Felodipino Géminis

5 mg

Prolonged Release
Tablets

Oral use

Blister
(PVC/PE/PVDC/Alu)

20

Felodipin Biochemie

2,5 mg

Prolonged Release
Tablets

Oral use

Blister
(PVC/PE/PVDC/Alu)

20, 100, 100×1

Felodipin Biochemie

5 mg

Prolonged Release
Tablets

Oral use

Blister
(PVC/PE/PVDC/Alu)

20, 100, 100×1

Felodipin Biochemie

10 mg

Prolonged Release
Tablets

Oral use

Blister
(PVC/PE/PVDC/Alu)

20, 100, 100×1

C

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Marketing Authorisation Holder

Applicant

Name

Strength

Pharmaceutical Form Route of administration

Packaging

Package size

UNITED
KINGDOM

Generics UK Ltd
Station Close
Potters Bar
Hertfordshire EN6 1TL
United Kingdom

Generics UK Ltd
Station Close
Potters Bar
Hertfordshire EN6 1TL
United Kingdom

Generics UK Ltd
Station Close
Potters Bar
Hertfordshire EN6 1TL
United Kingdom

Felogen XL

2,5 mg

Prolonged Release
Tablet

Oral use

Blister
(PVC/PE/PVDC/Alu)

10, 14, 20, 28, 30,
50, 56, 60, 98, 100

Felogen XL

5 mg

Prolonged Release
Tablet

Oral use

Blister
(PVC/PE/PVDC/Alu)

10, 14, 20, 28, 30,
50, 56, 60, 98, 100

Felogen XL

10 mg

Prolonged Release
Tablet

Oral use

Blister
(PVC/PE/PVDC/Alu)

10, 14, 20, 28, 30,
50, 56, 60, 98, 100

.

.

1
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2
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