# C_2012371EN.01002601.xml

| 30.11.2012 | EN | Official Journal of the European Union | C 371/26 |
| --- | --- | --- | --- |

30.11.2012

EN

Official Journal of the European Union

C 371/26

---

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

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

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

1

or Article 38 of Directive 2001/82/EC

2

)

2012/C 371/04

—   Issuing, maintenance or modification of a national marketing authorization

Issuing, maintenance or modification of a national marketing authorization

| Date of the decision | Name(s) of the medicinal product | Holder(s) of the marketing authorization | Member State concerned | Date of notification |
| --- | --- | --- | --- | --- |
| 10.10.2012 | Aminocaproic acid containing medicinal products (antifibrynolitics) | See Annex I | See Annex I | 12.10.2012 |
| 8.10.2012 | Mometasone Furoate Sandoz and associated names | See Annex II | See Annex II | 9.10.2012 |
| 10.10.2012 | Tranexamic acid containing medicinal products (antifibrynolitics) | See Annex III | See Annex III | 12.10.2012 |
| 8.10.2012 | Baytril | See Annex IV | See Annex IV | 9.10.2012 |

Date of the decision

Name(s) of the medicinal product

Holder(s) of the marketing authorization

Member State concerned

Date of notification

10.10.2012

Aminocaproic acid containing medicinal products (antifibrynolitics)

See Annex I

See Annex I

12.10.2012

8.10.2012

Mometasone Furoate Sandoz and associated names

See Annex II

See Annex II

9.10.2012

10.10.2012

Tranexamic acid containing medicinal products (antifibrynolitics)

See Annex III

See Annex III

12.10.2012

8.10.2012

Baytril

See Annex IV

See Annex IV

9.10.2012

---

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

1

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

2

---

ANNEX I

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

Aminocaproic acid containing medicinal products with Marketing Authorisation in the European Union

| Member State
  (EU/EEA) | Marketing Authorisation Holder | Invented name | Strength | Pharmaceutical form | Route of administration |
| --- | --- | --- | --- | --- | --- |
| ES - Spain | ROTTAPHARM, S.L. |
| Avda. Diagonal 67-69 |
| 08019 Barcelona |
| España |

Member State

(EU/EEA)

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical form

Route of administration

ES - Spain

ROTTAPHARM, S.L.

Avda. Diagonal 67-69

08019 Barcelona

España

CAPROAMIN FIDES 4 g SOLUCIÓN INYECTABLE

4 g/10 ml

solution for injection

intravenous use

HU - Hungary

| PannonPharma Kft. |
| --- |
| Pannonpharma út 1. |
| 7720 Pécsvárad |
| Hungary |

PannonPharma Kft.

Pannonpharma út 1.

7720 Pécsvárad

Hungary

Acepramin

4 g/10 ml

solution for infusion

intravenous use

PT - Portugal

| Bial - Aristegui, |
| --- |
| Produtos Farmacêuticos, S.A. |
| À Av. da Siderurgia Nacional Apartado 100 |
| 4745-457 S. Mamede do Coronado |
| Portugal |

Bial - Aristegui,

Produtos Farmacêuticos, S.A.

À Av. da Siderurgia Nacional Apartado 100

4745-457 S. Mamede do Coronado

Portugal

Epsicaprom 25

2 500 mg/10 ml

Solution for infusion

intravenous use

---

ANNEX II

LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTH OF THE MEDICINAL PRODUCT, ROUTE OF ADMINISTRATION, APPLICANT IN THE MEMBER STATES

| Member State
  EU/EEA | Applicant | Name | Strength | Pharmaceutical form | Route of administration |
| --- | --- | --- | --- | --- | --- |
| Belgium | Sandoz B.V. |
| Veluwezoom 22 |
| 1327 AH Almere |
| P.O. box 10332 |
| 1301 AH Almere |
| The Netherlands |

Member State

EU/EEA

Applicant

Name

Strength

Pharmaceutical form

Route of administration

Belgium

Sandoz B.V.

Veluwezoom 22

1327 AH Almere

P.O. box 10332

1301 AH Almere

The Netherlands

Mometasone Sandoz 50 mcg/dosis neusspray, suspensie

50 microgram/dose

nasal spray, suspension

nasal use

Czech Republic

| Sandoz B.V. |
| --- |
| Veluwezoom 22 |
| 1327 AH Almere |
| P.O. box 10332 |
| 1301 AH Almere |
| The Netherlands |

Sandoz B.V.

Veluwezoom 22

1327 AH Almere

P.O. box 10332

1301 AH Almere

The Netherlands

Mommox 0,05 mg/dávku

50 microgram/dose

nasal spray, suspension

nasal use

Denmark

| Sandoz B.V. |
| --- |
| Veluwezoom 22 |
| 1327 AH Almere |
| P.O. box 10332 |
| 1301 AH Almere |
| The Netherlands |

Sandoz B.V.

Veluwezoom 22

1327 AH Almere

P.O. box 10332

1301 AH Almere

The Netherlands

Mometasone Sandoz

50 microgram/dose

nasal spray, suspension

nasal use

Estonia

| Sandoz B.V. |
| --- |
| Veluwezoom 22 |
| 1327 AH Almere |
| P.O. box 10332 |
| 1301 AH Almere |
| The Netherlands |

Sandoz B.V.

Veluwezoom 22

1327 AH Almere

P.O. box 10332

1301 AH Almere

The Netherlands

Nasometin

50 microgram/dose

nasal spray, suspension

nasal use

Finland

| Sandoz B.V. |
| --- |
| Veluwezoom 22 |
| 1327 AH Almere |
| P.O. box 10332 |
| 1301 AH Almere |
| The Netherlands |

Sandoz B.V.

Veluwezoom 22

1327 AH Almere

P.O. box 10332

1301 AH Almere

The Netherlands

Mometasone furoate Sandoz

50 microgram/dose

nasal spray, suspension

nasal use

France

| Sandoz B.V. |
| --- |
| Veluwezoom 22 |
| 1327 AH Almere |
| P.O. box 10332 |
| 1301 AH Almere |
| The Netherlands |

Sandoz B.V.

Veluwezoom 22

1327 AH Almere

P.O. box 10332

1301 AH Almere

The Netherlands

MOMETASONE Sandoz 50 microgrammes/dose, suspension pour pulvérisation nasale

50 microgram/dose

nasal spray, suspension

nasal use

Germany

| Sandoz B.V. |
| --- |
| Veluwezoom 22 |
| 1327 AH Almere |
| P.O. box 10332 |
| 1301 AH Almere |
| The Netherlands |

Sandoz B.V.

Veluwezoom 22

1327 AH Almere

P.O. box 10332

1301 AH Almere

The Netherlands

Mometasonfuroat Sandoz 50 Mikrogramm/Sprühstoß Nasenspray, Suspension

50 microgram/dose

nasal spray, suspension

nasal use

Greece

| Sandoz B.V. |
| --- |
| Veluwezoom 22 |
| 1327 AH Almere |
| P.O. box 10332 |
| 1301 AH Almere |
| The Netherlands |

Sandoz B.V.

Veluwezoom 22

1327 AH Almere

P.O. box 10332

1301 AH Almere

The Netherlands

Mometasone Furoate/Sandoz

50 microgram/dose

nasal spray, suspension

nasal use

Hungary

| Sandoz B.V. |
| --- |
| Veluwezoom 22 |
| 1327 AH Almere |
| P.O. box 10332 |
| 1301 AH Almere |
| The Netherlands |

Sandoz B.V.

Veluwezoom 22

1327 AH Almere

P.O. box 10332

1301 AH Almere

The Netherlands

Mometason Sandoz 50 mikrogramm/adag oldatos orrspray

50 microgram/dose

nasal spray, suspension

nasal use

Italy

| Sandoz B.V. |
| --- |
| Veluwezoom 22 |
| 1327 AH Almere |
| P.O. box 10332 |
| 1301 AH Almere |
| The Netherlands |

Sandoz B.V.

Veluwezoom 22

1327 AH Almere

P.O. box 10332

1301 AH Almere

The Netherlands

MOMETASONE FUROATO SANDOZ 50 microgrammi/erogazione, spray nasale

50 microgram/dose

nasal spray, suspension

nasal use

Luxembourg

| Sandoz B.V. |
| --- |
| Veluwezoom 22 |
| 1327 AH Almere |
| P.O. box 10332 |
| 1301 AH Almere |
| The Netherlands |

Sandoz B.V.

Veluwezoom 22

1327 AH Almere

P.O. box 10332

1301 AH Almere

The Netherlands

Mometason Sandoz 50 mcg/dose spray nasale

50 microgram/dose

nasal spray, suspension

nasal use

Netherlands

| Sandoz B.V. |
| --- |
| Veluwezoom 22 |
| 1327 AH Almere |
| P.O. box 10332 |
| 1301 AH Almere |
| The Netherlands |

Sandoz B.V.

Veluwezoom 22

1327 AH Almere

P.O. box 10332

1301 AH Almere

The Netherlands

Mometasonfuroaat Sandoz 50 microgram/dosis, neusspray, suspensie

50 microgram/dose

nasal spray, suspension

nasal use

Norway

| Sandoz B.V. |
| --- |
| Veluwezoom 22 |
| 1327 AH Almere |
| P.O. box 10332 |
| 1301 AH Almere |
| The Netherlands |

Sandoz B.V.

Veluwezoom 22

1327 AH Almere

P.O. box 10332

1301 AH Almere

The Netherlands

Mometasone Sandoz

50 microgram/dose

nasal spray, suspension

nasal use

Poland

| Sandoz B.V. |
| --- |
| Veluwezoom 22 |
| 1327 AH Almere |
| P.O. box 10332 |
| 1301 AH Almere |
| The Netherlands |

Sandoz B.V.

Veluwezoom 22

1327 AH Almere

P.O. box 10332

1301 AH Almere

The Netherlands

Nasometin

50 microgram/dose

nasal spray, suspension

nasal use

Portugal

| Sandoz B.V. |
| --- |
| Veluwezoom 22 |
| 1327 AH Almere |
| P.O. box 10332 |
| 1301 AH Almere |
| The Netherlands |

Sandoz B.V.

Veluwezoom 22

1327 AH Almere

P.O. box 10332

1301 AH Almere

The Netherlands

Mometasona Sandoz

50 microgram/dose

nasal spray, suspension

nasal use

Romania

| Sandoz B.V. |
| --- |
| Veluwezoom 22 |
| 1327 AH Almere |
| P.O. box 10332 |
| 1301 AH Almere |
| The Netherlands |

Sandoz B.V.

Veluwezoom 22

1327 AH Almere

P.O. box 10332

1301 AH Almere

The Netherlands

Mometazonă furoat Sandoz 50 micrograme/doza, spray nazal, suspensie

50 microgram/dose

nasal spray, suspension

nasal use

Slovak Republic

| Sandoz B.V. |
| --- |
| Veluwezoom 22 |
| 1327 AH Almere |
| P.O. box 10332 |
| 1301 AH Almere |
| The Netherlands |

Sandoz B.V.

Veluwezoom 22

1327 AH Almere

P.O. box 10332

1301 AH Almere

The Netherlands

Mometasone Sandoz 50 mikrogramov

50 microgram/dose

nasal spray, suspension

nasal use

Slovenia

| Sandoz B.V. |
| --- |
| Veluwezoom 22 |
| 1327 AH Almere |
| P.O. box 10332 |
| 1301 AH Almere |
| The Netherlands |

Sandoz B.V.

Veluwezoom 22

1327 AH Almere

P.O. box 10332

1301 AH Almere

The Netherlands

FUMOMO 50 mikrogramov/vpih pršilo za nos, suspenzija

50 microgram/dose

nasal spray, suspension

nasal use

Spain

| Sandoz B.V. |
| --- |
| Veluwezoom 22 |
| 1327 AH Almere |
| P.O. box 10332 |
| 1301 AH Almere |
| The Netherlands |

Sandoz B.V.

Veluwezoom 22

1327 AH Almere

P.O. box 10332

1301 AH Almere

The Netherlands

Mometasona Sandoz 50 mcg/dosis suspensión para nebulización nasal

50 microgram/dose

nasal spray, suspension

nasal use

Sweden

| Sandoz B.V. |
| --- |
| Veluwezoom 22 |
| 1327 AH Almere |
| P.O. box 10332 |
| 1301 AH Almere |
| The Netherlands |

Sandoz B.V.

Veluwezoom 22

1327 AH Almere

P.O. box 10332

1301 AH Almere

The Netherlands

Mometasone Sandoz

50 microgram/dose

nasal spray, suspension

nasal use

United Kingdom

| Sandoz B.V. |
| --- |
| Veluwezoom 22 |
| 1327 AH Almere |
| P.O. box 10332 |
| 1301 AH Almere |
| The Netherlands |

Sandoz B.V.

Veluwezoom 22

1327 AH Almere

P.O. box 10332

1301 AH Almere

The Netherlands

Mometasone Furoate 50 micrograms/dose, nasal spray, suspension

50 microgram/dose

nasal spray, suspension

nasal use

---

ANNEX III

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

Tranexamic acid containing medicinal products with Marketing Authorisation in the European Union

| Member State
  (EU/EEA) | Marketing Authorisation Holder | Invented name | Strength | Pharmaceutical form | Route of administration |
| --- | --- | --- | --- | --- | --- |
| AT - Austria | Pfizer Corporation Austria GmbH |
| Floridsdorfer Hauptstraße 1 |
| A-1210 Wien |
| Austria |

Member State

(EU/EEA)

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical form

Route of administration

AT - Austria

Pfizer Corporation Austria GmbH

Floridsdorfer Hauptstraße 1

A-1210 Wien

Austria

Cyklokapron - Ampullen

0,5 g/5 ml

Solution for injection

intravenous use

BE - Belgium

| PFIZER S.A.N.V. |
| --- |
| Bld de la Plaine 17 |
| 1050 Brussels |
| Belgium |

PFIZER S.A.N.V.

Bld de la Plaine 17

1050 Brussels

Belgium

Cyklokapron

100 mg/5 ml

Solution for injection

intravenous use

BE - Belgium

| Eumedica S.A. |
| --- |
| Winston Churchilllaan 67 |
| 1180 Brussels |
| Belgium |

Eumedica S.A.

Winston Churchilllaan 67

1180 Brussels

Belgium

Exacyl 500

500 mg/5 ml

Solution for injection

intravenous use

CY - Cyprus

| MEDOCHEMIE LTD, 1-10 CONSTANTINOUPOLEOS STREET, P.O.BOX 51409, |
| --- |
| 3505 LEMESOS, CYPRUS |

MEDOCHEMIE LTD, 1-10 CONSTANTINOUPOLEOS STREET, P.O.BOX 51409,

3505 LEMESOS, CYPRUS

AZEPTIL INJECTION 500 MG/5 ML

500 MG/5 ML

INJECTION

intravenous use

CY - Cyprus

| MEDOCHEMIE LTD, 1-10 CONSTANTINOUPOLEOS STREET, P.O.BOX 51409, |
| --- |
| 505 LEMESOS, CYPRUS |

MEDOCHEMIE LTD, 1-10 CONSTANTINOUPOLEOS STREET, P.O.BOX 51409,

505 LEMESOS, CYPRUS

AZEPTIL INJECTION 250 MG/5 ML

250 MG/5 ML

INJECTION

intravenous use

CZ - Czech Republic

| Sanofi-Aventis, s.r.o., Evropská 846/176a, |
| --- |
| 160 00 Praha 6, Czech Republic |

Sanofi-Aventis, s.r.o., Evropská 846/176a,

160 00 Praha 6, Czech Republic

Exacyl

100 mg/ml

Solution for injection

intravenous use

DE - Germany

| Pharmacia GmbH |
| --- |
| Linkstr. 10 |
| D-10785 Berlin |

Pharmacia GmbH

Linkstr. 10

D-10785 Berlin

Cyklokapron-Injektionslösung

500 mg/5 ml

Solution for injection

intravenous use

DK - Denmark

| Pfizer ApS, |
| --- |
| Lautrupvang 8, |
| DK-2750 Ballerup, Denmark |

Pfizer ApS,

Lautrupvang 8,

DK-2750 Ballerup, Denmark

Tranexamsyre ‘Pfizer’

100 mg/ml

Solution for injection

intravenous use

EL - Greece

| A. NIKOLAKOPOULOS A.E. |
| --- |
| GALATSIOU AVENUE 115, Athens 11146 |

A. NIKOLAKOPOULOS A.E.

GALATSIOU AVENUE 115, Athens 11146

TRANSAMIN

500 MG/5 ML

Solution for Injection or infusion

intravenous use

ES - Spain

| ROTTAPHARM S.L. |
| --- |
| Avda. Diagonal 67-69 |
| 08019 Barcelona |
| España |

ROTTAPHARM S.L.

Avda. Diagonal 67-69

08019 Barcelona

España

AMCHAFIBRIN

500 mg SOLUCIÓN INYECTABLE

500 mg/5 ml

solution for injection

intravenous use

ET - Estonia

| Pfizer Enterprises SARL Round-Point du Kirchberg |
| --- |
| 51, Avenue J.F. Kennedy |
| L-1855 Luxembourg |

Pfizer Enterprises SARL Round-Point du Kirchberg

51, Avenue J.F. Kennedy

L-1855 Luxembourg

CYKLOKAPRON

100 mg/ml

solution for injection

intravenous use

FI - Finland

| Oy Leiras Finland Ab |
| --- |
| Paciuksenkatu 21 |
| PL 1406 |
| 00101 Helsinki |
| Finland |

Oy Leiras Finland Ab

Paciuksenkatu 21

PL 1406

00101 Helsinki

Finland

CAPRILON

100 mg/ml

Solution for injection

intravenous use

FR - France

| Sanofi Aventis France |
| --- |
| 1-13, bd Romain Rolland |
| 75014 Paris |
| France |

Sanofi Aventis France

1-13, bd Romain Rolland

75014 Paris

France

Exacyl 0,5 g/5 ml I.V., solution injectable

0,5 g/5 ml

solution for injection

intravenous use

HU - Hungary

| sanofi-aventis Zrt. |
| --- |
| Tó u. 1-5. |
| 1045 Budapest, Hungary |

sanofi-aventis Zrt.

Tó u. 1-5.

1045 Budapest, Hungary

Exacyl

0,5 g/5 ml

solution for injection

intravenous use

IE - Ireland

| Pharmacia Ireland Ltd, |
| --- |
| 9 Riverwalk, National Digital Park, |
| Citywest Business Campus, |
| Dublin 24 |
| Ireland |

Pharmacia Ireland Ltd,

9 Riverwalk, National Digital Park,

Citywest Business Campus,

Dublin 24

Ireland

Cyklokapron 500 mg/5 ml solution for injection or infusion

100 mg/ml

Solution for injection

intravenous use

IS - Iceland

| Pfizer ApS, Lautrupvang 8, DK-2750 Ballerup, |
| --- |
| Denmark |

Pfizer ApS, Lautrupvang 8, DK-2750 Ballerup,

Denmark

Tranexamsyre ‘Pfizer’

100 mg/ml

Solution for injection

intravenous use

IT - Italy

| Rottapharm S.p.A. |
| --- |
| Via Valosa di Sopra, 9 |
| 20052 Monza - Italy |

Rottapharm S.p.A.

Via Valosa di Sopra, 9

20052 Monza - Italy

UGUROL

500 mg/5 ml

solution for injection

intravenous use

IT - Italy

| Istituto Farmacobiologico Malesci S.p.A. |
| --- |
| Via Lungo l'Ema 7 |
| 50015 Bagno a Ripoli (Firenze) |
| Italy |

Istituto Farmacobiologico Malesci S.p.A.

Via Lungo l'Ema 7

50015 Bagno a Ripoli (Firenze)

Italy

TRANEX

500 mg/5 ml

solution for injection

intravenous use

IT - Italy

| Bioindutria Laboratorio Italiano Medicinali spa |
| --- |
| Via De Ambrosiis, 2 |
| 15067 Novi Ligure Alessandria |
| Italy |

Bioindutria Laboratorio Italiano Medicinali spa

Via De Ambrosiis, 2

15067 Novi Ligure Alessandria

Italy

ACIDO TRANEXAMICO BIOINDUTRIA L.I.M.

500 mg/5 ml

solution for injection

intravenous use

LU - Luxembourg

| Eumedica SA |
| --- |
| 67, Avenue Winston Churchill |
| B-1180 Bruxelles |

Eumedica SA

67, Avenue Winston Churchill

B-1180 Bruxelles

EXACYL

500 mg/5 ml

solution for injection

intravenous use

LU - Luxembourg

| PFIZER S.A.N.V. |
| --- |
| Bld de la Plaine 17 |
| 1050 Brussels |
| Belgium |

PFIZER S.A.N.V.

Bld de la Plaine 17

1050 Brussels

Belgium

Cyklokapron

100 mg/ml

Solution for injection

Intravenous use

NL - Netherlands

| Pfizer B.V. |
| --- |
| Rivium Westlaan 142 |
| 2909 LD, Capelle a/d Ijssel |

Pfizer B.V.

Rivium Westlaan 142

2909 LD, Capelle a/d Ijssel

Cyklokapron, oplossing voor injectie 100 mg/ml

100 mg/ml

solution for injection

intravenous use

NO - Norway

| Pfizer AS |
| --- |
| Postboks 3 |
| 1324 Lysaker Norway |

Pfizer AS

Postboks 3

1324 Lysaker Norway

CYKLOKAPRON

100 mg/ml

injection for solution

intravenous use

PL - Poland

| Warszawskie Zakłady Farmaceutyczne POLFA S.A. |
| --- |
| 22/24 karolkowa st. |
| 01-207 Warsaw, Poland |

Warszawskie Zakłady Farmaceutyczne POLFA S.A.

22/24 karolkowa st.

01-207 Warsaw, Poland

Exacyl

100 mg/ml

solution for infusion

intravenous use

PL - Poland

| Sanofi-Aventis France |
| --- |
| Boulevard Romain Rolland 1-13, |
| F-75014 Paris, France |

Sanofi-Aventis France

Boulevard Romain Rolland 1-13,

F-75014 Paris, France

Exacyl

100 mg/ml

solution for infusion

intravenous use

SE - Sweden

| Pfizer AB |
| --- |
| 191 90 Sollentuna |
| Sweden |

Pfizer AB

191 90 Sollentuna

Sweden

Cyklokapron

100 mg/ml

Solution for injection

intravenous use

UK - United Kingdom

| Pharmacia Limited |
| --- |
| Walton Oaks, Dorking Road, Tadworth |
| Surrey KT20 7NS |
| United Kingdom |

Pharmacia Limited

Walton Oaks, Dorking Road, Tadworth

Surrey KT20 7NS

United Kingdom

CYKLOKAPRON INJECTION 500 MG/ML

500 mg/ml

Solution for Injection

intravenous use

---

ANNEX IV

Condition of the marketing authorisations

The National Competent Authorities shall ensure that the following condition is fulfilled by the marketing authorisation holders:

| — | The marketing authorisation holders should substantiate the dosing regimen in rabbits taking into account the current MIC distribution for the target pathogens, the variability in pharmacokinetics resulting from administration of enrofloxacin via the drinking water to groups of rabbits under field conditions and with the goal to ensure sustainable effective treatment. |
| --- | --- |

—

The marketing authorisation holders should substantiate the dosing regimen in rabbits taking into account the current MIC distribution for the target pathogens, the variability in pharmacokinetics resulting from administration of enrofloxacin via the drinking water to groups of rabbits under field conditions and with the goal to ensure sustainable effective treatment.

| — | Residue depletion studies should be provided for any proposed new dosage regimen. A shorter or lower dose regimen than the current 10 mg/kg for 5 days needs to be substantiated by new clinical data. |
| --- | --- |

—

Residue depletion studies should be provided for any proposed new dosage regimen. A shorter or lower dose regimen than the current 10 mg/kg for 5 days needs to be substantiated by new clinical data.

The results of those studies should be provided to the relevant Authorities for assessment not later than 18 months after the Commission Decision on this referral procedure.

---