Not the law itself: Notice

Address https://gelex.eu/eli/EU/notice/oj/C/2012/371/04@2012-11-30/en

Contents

1. Preamble
2. ANNEX
3. 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
4. ANNEX II LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTH OF THE MEDICINAL PRODUCT, ROUTE OF ADMINISTRATION, APPLICANT IN THE MEMBER STATES
5. 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
6. ANNEX IV Condition of the marketing authorisations

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

ANNEX

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 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 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 Epsicaprom 25 2500 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 Cyklokapron 100 mg/5 ml Solution for injection intravenous use BE - 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 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 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 Exacyl 100 mg/ml Solution for injection intravenous use DE - Germany 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 Tranexamsyre Pfizer 100 mg/ml Solution for injection intravenous use EL - Greece 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 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 CYKLOKAPRON 100 mg/ml solution for injection intravenous use FI - 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 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 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 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 Tranexamsyre Pfizer 100 mg/ml Solution for injection intravenous use IT - 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 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 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 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 Cyklokapron 100 mg/ml Solution for injection Intravenous use NL - Netherlands 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 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 Exacyl 100 mg/ml solution for infusion intravenous use PL - Poland 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 Cyklokapron 100 mg/ml Solution for injection intravenous use UK - 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 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.

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.

Versions

1. 2012-11-30