List of nationally authorised medicinal products · 46851 $ 46852 $ MTNR. 46850 Krka Sverige Ab Denmark Galantamin Krka SI/H/0118/001 $ SI/H/0118/002 $ SI/H/0118/003 MTNR. 10-7572

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© European Medicines Agency, 2016. Reproduction is authorised provided the source is acknowledged.

27 October 2016 EMA/735162/2016 Procedure Management and Committees Support

List of nationally authorised medicinal products

Active substance: galantamine

Procedure no.: PSUSA/00001512/201603

List of nationally authorised medicinal products EMA/735162/2016

Page 2/35

Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number

MAH of product in the member state

Member State where product is authorised

Acumor Xl NL/H/2030/002 $ NL/H/2030/003

PL 04569/1332 $ PL 04569/1333 $ PL 04569/1334

Generics [uk] Limited United Kingdom

Alenzo DK/H/1805/001 $ DK/H/1805/002

45707 $ 45708 Teva Denmark A/S Denmark

Alenzo DK/H/1805/003 45709 Teva Denmark A/S Denmark

Aneprosil 23791/13 Verisfield (Uk) Ltd Greece

Bergal Sr SI/H/0120/001 $ SI/H/0120/002 $ SI/H/0120/003

RVG 107504 $ RVG 107505 $ RVG 107506

Krka, D.D., Novo Mesto Netherlands

Consion Xl DE/H/3074/001 $ DE/H/3074/002 $ DE/H/3074/003

PL 17277/0254 $ PL 17277/0255 $ PL 17277/0256

Pharmathen S.A. United Kingdom

Elmino Xl PT/H/1289/001 $ PT/H/1289/002 $ PT/H/1289/003

PL 17780/0558 $ PL 17780/0559 $ PL 17780/0560

Winthrop Pharmaceuticals Uk Ltd

United Kingdom

Elmino Xl PT/H/1289/001/DC $ PT/H/1289/002/DC $ PT/H/1289/003/DC

PL 17780/0558 $ PL 17780/0559 $ PL 17780/0560

Winthrop Pharmaceuticals Uk Ltd

United Kingdom

Galabar Sr SI/H/0119/001 $ SI/H/0119/002 $ SI/H/0119/003

5363-I-433/12 $ 5363-I-434/12 $ 5363-I-435/12

Lek Pharmaceuticals D.D. Ljubljana

Slovenia

Galantamin 1 A Pharma

DE/H/3935/001 81097.00.00 1 A Pharma Gmbh Germany

Galantamin 1 A Pharma

SI/H/0119/001 $ SI/H/0119/002 $ SI/H/0119/003

81941.00.00 $ 81942.00.00 $ 81943.00.00

1 A Pharma Gmbh Germany

Galantamin Actavis DE/H/2135/001 $ DE/H/2135/002 $ DE/H/2135/003

1-31619 $ 1-31620 $ 1-31621

Actavis Group Ptc Ehf. Austria


44398 $ 44399 $ 44400 Actavis Group Ptc Ehf. Sweden


46944 $ 46945 $ 46946 Actavis Group Ptc Ehf. Denmark


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Galantamin Actavis DE/H/2135/002 $ DE/H/2135/003

75395.00.00 $ 75396.00.00

Actavis Group Ptc Ehf. Germany

Galantamin Al DE/H/2877/001 $ DE/H/2877/002 $ DE/H/2877/003

82179.00.00 $ 82180.00.00 $ 82181.00.00

Aliud Pharma Gmbh Germany

Galantamin Heumann DE/H/2134/01 $ DE/H/2134/02 $ DE/H/2134/03

75391.00.00 $ 75392.00.00 $ 75393.00.00

Heumann Pharma Gmbh & Co. Generica Kg

Germany

Galantamin Hexal DE/H/3934/001 81202.00.00 Hexal Ag Germany

Galantamin Hexal SI/H/0121/001 $ SI/H/0121/002 $ SI/H/0121/003

81948.00.00 $ 81949.00.00 $ 81950.00.00

Hexal Ag Germany

Galantamin Hormosan DE/H/2876/001 $ DE/H/2876/002 $ DE/H/2876/003

82176.00.00 $ 82177.00.00 $ 82178.00.00

Pharmathen S.A. Germany

Galantamin Krka SI/H/0118/001 $ SI/H/0118/002 $ SI/H/0118/003

1-30483 $ 1-30484 $ 1-30485

Krka, D.D., Novo Mesto Austria


28699 $ 28700 $ 28701 Krka Sverige Ab Finland


44310 $ 44311 $ 44312 Krka Sverige Ab Sweden


46851 $ 46852 $ MTNR. 46850

Krka Sverige Ab Denmark


MTNR. 10-7572 $ MTNR. 10-7573 $ MTNR. 10-7574

Krka Sverige Ab Norway

Galantamin Mylan NL/H/2030/001 $ NL/H/2030/002 $ NL/H/2030/003

06/0023/12-S $ 06/0024/12-S $ 06/0025/12-S

Generics [uk] Limited Slovakia

Galantamin Mylan NL/H/2030/001 $ NL/H/2030/002 $

06/803/11-C $ 06/804/11-C $ 06/805/11-C

Generics [uk] Limited Czech Republic


Page 4/35






NL/H/2030/003


28792 $ 28793 $ 28794 Mylan Ab Finland


44442 $ 44443 $ 44444 Mylan Ab Sweden


82089.00.00 $ 82090.00.00 $ 82091.00.00

Mylan Dura Gmbh Germany

Galantamin Neuraxpharm

DE/H/3127/001/DC $ DE/H/3127/002/DC $ DE/H/3127/003/DC

84385.00.00 $ 84386.00.00 $ 84387.00.00

Neuraxpharm Arzneimittel Gmbh

Germany

Galantamin Orion DE/H/3117/01/DC $ DE/H/3117/02/DC $ DE/H/3117/03/DC

48201 $ 48202 $ 48203 Orion Corporation Denmark

Galantamin Orion DE/H/3117/01/DC $ DE/H/3117/02/DC $ DE/H/3117/03/DC $ FI/H/0850/001 $ FI/H/0850/002

29486 $ 29487 $ 29488 Orion Corporation Finland

Galantamin Orion FI/H/0850/001 $ FI/H/0850/002

45689 $ 45690 $ 45691 Orion Corporation Sweden

Galantamin Ratiopharm

DE/H/3116/001 1-31741 $ 1-31742 $ 1-31743 $ 1-31802

Ratiopharm Arzneimittel Vertriebs-Gmbh

Austria


DE/H/3116/001 $ DE/H/3116/002 $ DE/H/3116/003

84225.00.00 $ 84226.00.00 $ 84227.00.00

Ratiopharm Gmbh Germany


DE/H/3116/003 1-31804 Ratiopharm Arzneimittel Vertriebs-Gmbh

Austria

Galantamin Ratiopharm Gmbh

DE/H/3116/002 1-31803 Ratiopharm Arzneimittel Vertriebs-Gmbh

Austria

Galantamin Sandoz DE/H/2876/001 $ DE/H/2876/002 $ DE/H/2876/003

44401 $ 44402 $ 44403 Sandoz A/S Sweden


Page 5/35






Galantamin Sandoz SI/H/0119/001 $ SI/H/0119/002 $ SI/H/0119/003

1-30486 $ 1-30487 $ 1-30488

Sandoz Gmbh Austria

Galantamin Sandoz SI/H/0119/001 $ SI/H/0119/002 $ SI/H/0119/003

BE394642 $ BE394651 $ BE394667

Sandoz N.V. Belgium

Galantamin Stada DE/H/3072/001 $ DE/H/3072/002 $ DE/H/3072/003

29529 $ 29530 $ 29531 Stada Arzneimittel Ag Finland


45627 $ 45628 $ 45629 Stada Arzneimittel Ag Sweden


48195 $ 48196 $ 48197 Stada Arzneimittel Ag Denmark


83917.00.00 $ 83918.00.00 $ 83919.00.00

Stadapharm Gmbh Germany

Galantamin Teva DK/H/0991/001 $ DK/H/0991/002 $ DK/H/0991/003

39284 $ 39285 $ 39286 Teva Denmark A/S Denmark

Galantamina Actavis DE/H/2135/001 $ DE/H/2135/002 $ DE/H/2135/003

74626 $ 74627 $ 74628 Actavis Group Ptc Ehf. Spain

Galantamina Apotex DE/H/2876/001 $ DE/H/2876/002 $ DE/H/2876/003

74.366 $ 74.367 $ 74.368 Apotex Europe Bv Spain

Galantamina Aristo 5247234 $ 5247242 $ 5247259 $ 5247267 $ 5247275 $ 5247309 $ 5247317 $ 5247325 $ 5247333 $ 5247341 $ 5248026 $ 5248034

Aristo Pharma Iberia, S.L.

Portugal

Galantamina Azevedos 5085824 $ 5085832 $ 5085840 $ 5085857 $ 5085865 $ 5085873 $

Laboratórios Azevedos - Indústria Farmacêutica, S.A.

Portugal


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5085907 $ 5085915 $ 5085923 $ 5085931 $ 5085949 $ 5085956 $ 5085964 $ 5085972 $ 5086004 $ 5086012 $ 5086020 $ 5086038 $ 5086046 $ 5086053 $ 5086061

Galantamina Azevedos 5086079 $ 5086103 $ 5086111

Laboratórios Azevedos - Indústria Farmacêutica, S.A.

Portugal

Galantamina Ciclum DE/H/2877/001 $ DE/H/2877/002 $ DE/H/2877/003

5435748 $ 5435755 $ 5435763 $ DE/H/2877/001 $ DE/H/2877/002 $ DE/H/2877/003

Ciclum Farma Unipessoal, Lda

Portugal

Galantamina Cinfa DE/H/3074/001 $ DE/H/3074/002 $ DE/H/3074/003

77288 $ 77289 $ 77290 Laboratorios Cinfa, S.A. Spain

Galantamina Combix DE/H/3118/001 $ DE/H/3118/002 $ DE/H/3118/003

77131 $ 77132 $ 77133 Laboratorios Combix, S.L.U.

Spain

Galantamina Galema Sr

SI/H/0120/001 $ SI/H/0120/002 $ SI/H/0120/003 $ SI/H/0120/004

5380175 $ 5380209 $ 5380217 $ 5380225 $ 5380316 $ 5380324 $ 5380332 $ 5380340

Krka, D.D., Novo Mesto Portugal

Galantamina Generis 5086129 Generis Farmacêutica, S.A.

Portugal


Portugal


Portugal


Portugal


Portugal


Page 7/35







Portugal


Portugal


Portugal


Portugal


Portugal


Portugal


Portugal


Portugal


Portugal


Portugal


Portugal


Portugal


Portugal


Portugal


Portugal


Portugal


Portugal


Portugal


Page 8/35







Portugal

Galantamina Generis SI/H/0123/001 5380233 Generis Farmacêutica, S.A.

Portugal


Portugal


Portugal


Portugal


Portugal


Portugal

Galantamina Kern Pharma

SI/H/0123/001 74.351 Kern Pharma, S.L. Spain





Galantamina Krka 5338777 $ 5339650 $ 5339668 $ 5339676 $ 5339700 $ 5339718 $ 5339726 $ 5339734 $ 5339742 $ 5339759 $ 5339767 $ 5339775

Krka Farmacêutica, Unipessoal Lda.

Portugal

Galantamina Labesfal 5478177-5478201-5478219

Generis Farmacêutica, S.A.

Portugal

Galantamina Mylan NL/H/2030/001 $ NL/H/2030/002 $ NL/H/2030/003

5413968 $ 5413976 $ 5414008 $ 5414016 $ 5414024 $ 5414032 $ 5414040 $ 5414057 $ 5414065 $ 5414073 $ 5414107 $ 5414115 $ 5414123 $ 5414131 $ 5414149 $ 5414156 $

Mylan, Lda Portugal


Page 9/35






5414164 $ 5414172

Galantamina Mylan NL/H/2030/001 $ NL/H/2030/002 $ NL/H/2030/003

74686 $ 74687 $ 74688 Mylan Pharmaceuticals S.L.

Spain

Galantamina Normon 72514 Laboratorios Normon, S.A.

Spain

Galantamina Normon 78442 Laboratorios Normon, S.A.

Spain

Galantamina Normon 78443 $ 78444 Laboratorios Normon, S.A.

Spain

Galantamina Ratio 77074 $ 77075 $ 77076 Ratiopharm Espana Sa Spain

Galantamina Sandoz DE/H/3934/001 73357 Sandoz Farmacéutica, S.A.

Spain

Galantamina Sandoz SI/H/0119/001 $ SI/H/0119/002 $ SI/H/0119/003

5380142 $ 5380159 $ 5380167 $ 5380266 $ 5380274 $ 5380308

Sandoz Farmacêutica Lda.

Portugal

Galantamina Sandoz SI/H/0119/001 $ SI/H/0119/002 $ SI/H/0119/003

74332 $ 74333 $ 74334 Sandoz Farmacéutica, S.A.

Spain

Galantamina Stada DE/H/3072/001 $ DE/H/3072/002 $ DE/H/3072/003

77.147 $ 77.148 $ 77.151 Laboratorio Stada, S.L. Spain

Galantamina Teva DE/H/3116/001 $ DE/H/3116/002 $ DE/H/3116/003

5594049 $ 5594056 $ 5594429

Teva Pharma – Produtos Farmacêuticos Lda

Portugal

Galantamina Teva DK/H/0991/001 $ DK/H/0991/002 $ DK/H/0991/003

5087762 $ 5087770 $ 5087804 $ 5087812 $ 5087838

Teva Pharma – Produtos Farmacêuticos Lda

Portugal

Galantamina Tevagen DE/H/3116/001 77471 Teva Pharma S.L.U Spain

Galantamina Tevagen DE/H/3116/002 $ DE/H/3116/003

77472 $ 77473 Teva Pharma S.L.U Spain

Galantamina Tolife 5550231 $ 5550249 $ 5550322

Tolife - Produtos Farmacêuticos, S.A.

Portugal

Galantamina Tolife 5550246 $ 5550264 $ Tolife - Produtos Portugal


Page 10/35






5550306 $ 5550314 Farmacêuticos, S.A.

Galantamina Wynn 5437371 $ 5437405 $ 5437413 $ 5437421 $ 5437439 $ 5437447 $ 5437454 $ 5437462 $ 5437470 $ 5437504 $ 5437512 $ 5437520

Pharmathen S.A. Portugal

Galantamina Zentiva PT/H/1289/001 $ PT/H/1289/002 $ PT/H/1289/003

5565049 $ 5565056 $ 5565064 $ DE/H/3073/001/DC

Sanofi - Produtos Farmaceuticos Lda

Portugal

Galantamine Actavis DE/H/2135/001 $ DE/H/2135/002 $ DE/H/2135/003

28767 $ 28768 $ 28769 Actavis Group Ptc Ehf. Finland

Galantamine Actavis Group Ptc

DE/H/2135/001 75394.00.00 Actavis Group Ptc Ehf. Germany

Galantamine Apotex DE/H/2876/001 $ DE/H/2876/002 $ DE/H/2876/003

BE398097 $ BE398106 $ BE398115

Apotex Europe Bv Belgium

Galantamine Arrow 50667 Arrow Generiques France

Galantamine Biogaran 3400922010915 $ 3400922011165 $ 3400922011226 $ 3400927921698 $ 3400958172083 $ 3400958172144 $ 3400958691454

Biogaran France

Galantamine Generics NL/H/2030/001 $ NL/H/2030/002 $ NL/H/2030/003

2516/23-01-2013 $ 2517/23-01-2013 $ 2518/23-01-2013

Generics Pharma Hellas Ltd

Greece

Galantamine Krka SI/H/0118/001 $ SI/H/0118/002 $ SI/H/0118/003

42161/22-6-12 $ 42162/22-6-12 $ 42163/22-6-12

Krka, D.D., Novo Mesto Greece

Galantamine Krka SI/H/0123/001 $ SI/H/0123/002 $ SI/H/0123/003

Krka, D.D., Novo Mesto France


Page 11/35






Galantamine Krka SI/H/0123/002/DC (NL39890, CIS 6 467 935 0) 34009 418 710 7 8

Krka, D.D., Novo Mesto France

Galantamine Lp Arrow 50668 $ 50669 Arrow Generiques France

Galantamine Lp Cristers

34009 220 102 7 4 $ 34009 220 103 3 5 $ 34009 220 113 9 4 $ 34009 220 114 5 5 $ 34009 220 124 0 7 $ 34009 220 125 7 5 $ 34009 220 131 7 6 $ 34009 220 132 3 7 $ 34009 581 710 2 4 $ 34009 581 711 9 2 $ 34009 581 712 5 3 $ 34009 581 726 6 3 $ 34009 581 735 5 4 $ 34009 581 736 1 5 $ 34009 581 737 8 3

Cristers France

Galantamine Lp Eg DE/H/3072/001 NL40785 Eg Labo - Laboratoires Eurogenerics

France

Galantamine Lp Eg DE/H/3072/002 $ DE/H/3072/003

NL40786 $ NL40787 Eg Labo - Laboratoires Eurogenerics

France

Galantamine Lp Mylan NL/H/2030/001 $ NL/H/2030/002 $ NL/H/2030/003

NL 40077 $ NL 40078 $ NL 40079

Mylan S.A.S France

Galantamine Lp Teva Santé

DE/H/3116/002 NL40783 Teva Santé France

Galantamine Lp Zentiva Lab

34009 219 711 3 2 $ 34009 219 713 6 1 $ 34009 219 714 2 2 $ 34009 219 715 9 0 $ 34009 219 717 1 2 $ 34009 219 718 8 0 $ 34009 219 719 4 1 $ 34009 219 720 2 3 $ 34009 581 549 7 3 $

Sanofi-Aventis France France


Page 12/35






34009 581 550 5 5 $ 34009 581 551 1 6 $ 34009 581 552 8 4 $ 34009 581 553 4 5 $ 34009 581 554 0 6 $ 34009 581 555 7 4

Galantamine Lp Zydus 34009 220 105 6 4 $ 34009 220 106 2 5 $ 34009 220 115 1 6 $ 34009 220 116 8 4 $ 34009 220 134 6 6 $ 34009 220 135 2 7 $ 34009 220 136 9 5 $ 34009 220-137 5 6 $ 34009 581 713 1 4 $ 34009 581 714 8 2 $ 34009 581 715 4 3 $ 34009 581 727 2 4 $ 34009 581 728 9 2 $ 34009 581 729 5 3 $ 34009 581 739 0 5

Zydus France France

Galantamine Pharmathen

DE/H/2134/001 $ DE/H/2134/002 $ DE/H/2134/003

90020/20-12-2012 $ 90021/20-12-2012 $ 90022/20-12-2012

Pharmathen Hellas S.A. Greece

Galantamine Portfarma DE/H/2134/001-003/DC IS/1/11/062/01-03 Portfarma Ehf Iceland

Galantamine Raiopharm

DE/H/3116/002 29479 Teva Pharma B.V. Finland

Galantamine Ratiopharm

DE/H/3116/001 $ DE/H/3116/003

29478 $ 29563 Teva Pharma B.V. Finland

Galantamine Retard Cf DE/H/3072/001 $ DE/H/3072/002 $ DE/H/3072/003

RVG 109148 $ RVG 109149 $ RVG 109150

Centrafarm B.V. Netherlands

Galantamine Retard Mylan

NL/H/2030/001 $ NL/H/2030/002

2012090041 $ 2012090042 $ 2012090043

Mylan Bvba/Sprl Luxembourg


NL/H/2030/001 $ NL/H/2030/002 $

BE404695 $ BE404704 $ BE404713 $ BE404722 $

Mylan Bvba/Sprl Belgium


Page 13/35






NL/H/2030/003 BE404731 $ BE404747 $ BE404756 $ BE404765 $ BE404774 $ BE404783 $ BE404792 $ BE404801


NL/H/2030/001 $ NL/H/2030/002 $ NL/H/2030/003

RVG 107647 $ RVG 107649 $ RVG 107650

Mylan B.V. Netherlands

Galantamine Sandoz SI/H/0119/001 $ SI/H/0119/002 $ SI/H/0119/003

34009 418 641 5 5 $ 34009 418 642 1 6 $ 34009 418 643 8 4 $ 34009 418 644 4 5 $ 34009 418 645 0 6 $ 34009 418 646 7 4 $ 34009 418 647 3 5 $ 34009 418 649 6 4 $ 34009 418 655 6 5 $ 34009 418 656 2 6 $ 34009 418 658 5 5 $ 34009 418 659 1 6 $ 34009 418 661 6 6 $ 34009 418 662 2 7 $ 34009 418 663 9 5 $ 34009 418 664 5 6 $ 34009 418 665 1 7 $ 34009 418 666 8 5 $ 34009 418 667 4 6 $ 34009 418 668 0 7 $ 34009 418 669 7 5 $ 34009 418 670 5 7 $ 34009 418 671 1 8 $ 34009 418 672 8 6 $ 34009 580 132 5 6 $ 34009 580 133 1 7 $ 34009 580 134 8 5 $ 34009 580 135 4 6 $ 34009 580 136 0 7 $

Sandoz France


Page 14/35






34009 580 137 7 5 $ 34009 580 138 3 6 $ 34009 580 140 8 6 $ 34009 580 141 4 7 $ 34009 580 142 0 8 $ 34009 580 143 7 6 $ 34009 580 144 3 7 $ 34009 580 146 6 6 $ 34009 580 147 2 7 $ 34009 580 148 9 5 $ 34009 580 149 5 6 $ 34009 580 150 3 8 $ 34009 580 152 6 7 $ 34009 580 153 2 8 $ 34009 580 154 9 6 $ 34009 580 155 5 7 $ 34009 580 156 1 8 $ 34009 580 157 8 6 $ 34009 580 158 4 7 $ 34009 580 159 0 8 $ 34009 580 160 9 7 $ 34009 580 161 5 8 $ 34009 580 162 1 9 $ 34009 580 163 8 7 $ 34009 580 164 4 8

Galantamine Sandoz SI/H/0119/001 $ SI/H/0119/002 $ SI/H/0119/003

RVG 107501 $ RVG 107502 $ RVG 107503

Sandoz B.V. Netherlands

Galantamine Teva Santé


Galantamine Teva Santé Lp


Galantamine Teva Uk DK/H/0991/001 $ DK/H/0991/003

PL 00289/1444 $ PL 00289/1445 $ PL 00289/1446

Teva Uk Limited United Kingdom

Galantamină Zentiva PT/H/1289/001 $ 5554/2013/02 $ Zentiva, K.S. Romania


Page 15/35






PT/H/1289/001/DC $ PT/H/1289/002 $ PT/H/1289/003

5554/2013/03 $ 5554/2013/04 $ 5554/2013/05 $ 5554/2013/06 $ 5554/2013/07 $ 5554/2013/08 $ 5555/2013/02 $ 5555/2013/03 $ 5555/2013/04 $ 5555/2013/05 $ 5555/2013/06 $ 5555/2013/07 $ 5555/2013/08 $ 5556/2013/02 $ 5556/2013/03 $ 5556/2013/04 $ 5556/2013/05 $ 5556/2013/06 $ 5556/2013/07 $ 5556/2013/08

Galantamină Zentiva PT/H/1289/001 $ PT/H/1289/002 $ PT/H/1289/003

5554/2013/01 $ 5555/2013/01 $ 5556/2013/01

Zentiva, K.S. Romania

Galantex Retard DE/H/2876/001-3/DC RVG 107578 $ RVG 107579 $ RVG 107580

Pharmathen S.A. Netherlands

Galantex Xl DE/H/2876/001-3/DC PL 17277/0199 $ PL 17277/0200 $ PL 17277/0201

Pharmathen S.A. United Kingdom

Galanthen DE/H/2875/001-3/DC 82173.00.00 $ 82174.00.00 $ 82175.00.00


Galanyl 37670/12/25-02-2013 Viofar Ltd Greece

Galema Sr SI/H/0120/001 $ SI/H/0120/002 $ SI/H/0120/003 $ SI/H/0120/004

H/11/00668/001 $ H/11/00668/002 $ H/11/00668/003 $ H/11/00668/004 $

Krka, D.D., Novo Mesto Slovenia


Page 16/35






H/11/00668/005 $ H/11/00668/006 $ H/11/00668/007 $ H/11/00668/008 $ H/11/00668/009 $ H/11/00668/010 $ H/11/00668/011 $ H/11/00668/012 $ H/11/00668/013 $ H/11/00668/014 $ H/11/00668/015 $ H/11/00668/016 $ H/11/00668/017 $ H/11/00668/018 $ H/11/00668/019 $ H/11/00668/020 $ H/11/00668/021 $ H/11/00668/022 $ H/11/00668/023 $ H/11/00668/024 $ H/11/00668/025 $ H/11/00668/026 $ H/11/00668/027 $ H/11/00668/028 $ H/11/00668/029 $ H/11/00668/030 $ H/11/00668/031 $ H/11/00668/032 $ H/11/00668/033 $ H/11/00668/034 $ H/11/00668/035 $ H/11/00668/036 $ H/11/00668/037 $ H/11/00668/038 $ H/11/00668/039 $ H/11/00668/040 $


Page 17/35






H/11/00668/041 $ H/11/00668/042 $ H/11/00668/043 $ H/11/00668/044 $ H/11/00668/045 $ H/11/00668/046 $ H/11/00668/047 $ H/11/00668/048 $ H/11/00668/049 $ H/11/00668/050 $ H/11/00668/051 $ H/11/00668/052 $ H/11/00668/053 $ H/11/00668/054 $ H/11/00668/055 $ H/11/00668/056

Galnora SI/H/0120/001 $ SI/H/0120/002 $ SI/H/0120/003

74329 $ 74330 $ 74331 Krka, D.D., Novo Mesto Spain

Galnora SI/H/0120/004 $ SI/H/0122/001 $ SI/H/0122/002 $ SI/H/0122/003

81947.00.00 $ 81952.00.00 $ 81953.00.00 $ 81954.00.00

Tad Pharma Gmbh Germany

Galnora SI/H/0123/001 $ SI/H/0123/002 $ SI/H/0123/003

039889011 $ 039889023 $ 039889035 $ 039889047 $ 039889050 $ 039889062 $ 039889074 $ 039889086 $ 039889098 $ 039889112 $ 039889124 $ 039889136 $ 039889148 $ 039889151 $ 039889163 $ 039889175 $ 039889187 $ 039889199 $ 039889201 $ 039889213 $ 039889225 $ 039889237 $ 039889249 $ 039889252 $ 039889264 $ 039889276 $

Krka, D.D., Novo Mesto Italy


Page 18/35






039889288 $ 039889290 $ 039889302 $ 039889314 $ 039889326 $ 039889338 $ 039889340 $ 039889353 $ 039889365 $ 039889377 $ 039889403 $ 039889415 $ 039889427 $ 039889439 $ 039889441 $ 039889454 $ 039889466 $ 039889478 $ 039889480 $ 039889492 $ 039889504 $ 039889516 $ 039889528 $ 039889530 $ 039889542 $ 039889555 $ 039889567 $ 039889579

Galsya SI/H/0118/001 $ SI/H/0118/002 $ SI/H/0118/003

8710/2016/01 $ 8710/2016/02 $ 8710/2016/03 $ 8710/2016/04 $ 8710/2016/05 $ 8710/2016/06 $ 8710/2016/07 $ 8710/2016/08 $ 8710/2016/09 $ 8710/2016/10 $ 8710/2016/11 $ 8710/2016/12 $ 8710/2016/13 $ 8710/2016/14 $ 8710/2016/15 $ 8710/2016/16 $ 8710/2016/17 $ 8710/2016/18 $ 8711/2016/01 $ 8711/2016/02 $ 8711/2016/03 $ 8711/2016/04 $

Krka, D.D., Novo Mesto Romania


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8711/2016/05 $ 8711/2016/06 $ 8711/2016/07 $ 8711/2016/08 $ 8711/2016/09 $ 8711/2016/10 $ 8711/2016/11 $ 8711/2016/12 $ 8711/2016/13 $ 8711/2016/14 $ 8711/2016/15 $ 8711/2016/16 $ 8711/2016/17 $ 8711/2016/18 $ 8712/2016/01 $ 8712/2016/02 $ 8712/2016/03 $ 8712/2016/04 $ 8712/2016/05 $ 8712/2016/06 $ 8712/2016/07 $ 8712/2016/08 $ 8712/2016/09 $ 8712/2016/10 $ 8712/2016/11 $ 8712/2016/12 $ 8712/2016/13 $ 8712/2016/14 $ 8712/2016/15 $ 8712/2016/16 $ 8712/2016/17 $ 8712/2016/18


LT/1/11/2541/001 $ LT/1/11/2541/002 $ LT/1/11/2541/003 $ LT/1/11/2541/004 $

Krka, D.D., Novo Mesto Lithuania


Page 20/35






LT/1/11/2541/005 $ LT/1/11/2541/006 $ LT/1/11/2541/007 $ LT/1/11/2541/008 $ LT/1/11/2541/009 $ LT/1/11/2541/010 $ LT/1/11/2541/011 $ LT/1/11/2541/012 $ LT/1/11/2541/013 $ LT/1/11/2541/014 $ LT/1/11/2541/015 $ LT/1/11/2541/016 $ LT/1/11/2541/017 $ LT/1/11/2541/018 $ LT/1/11/2541/019 $ LT/1/11/2541/020 $ LT/1/11/2541/021 $ LT/1/11/2541/022 $ LT/1/11/2541/023 $ LT/1/11/2541/024 $ LT/1/11/2541/025 $ LT/1/11/2541/026 $ LT/1/11/2541/027


OGYI-T-21837/01 $ OGYI-T-21837/02 $ OGYI-T-21837/03 $ OGYI-T-21837/04 $ OGYI-T-21837/05 $ OGYI-T-21837/06 $ OGYI-T-21837/07 $ OGYI-T-21837/08 $ OGYI-T-21837/09 $ OGYI-T-21837/10 $ OGYI-T-21837/11 $ OGYI-T-21837/12

Krka, D.D., Novo Mesto Hungary

Galsya Sr SI/H/0118/001 $ 06/0239/11-S $ Krka, D.D., Novo Mesto Slovakia


Page 21/35






SI/H/0118/002 $ SI/H/0118/003

06/0240/11-S $ 06/0241/11-S

Galsya Sr SI/H/0118/001 $ SI/H/0118/002 $ SI/H/0118/003

11-0195 $ 11-0196 $ 11-0197

Krka, D.D., Novo Mesto Latvia


18515 $ 18516 $ 18517 Krka, D.D., Novo Mesto Poland


746211 $ 746311 $ 746411 Krka, D.D., Novo Mesto Estonia


H/11/00669/001 $ H/11/00669/002 $ H/11/00669/003 $ H/11/00669/004 $ H/11/00669/005 $ H/11/00669/006 $ H/11/00669/007 $ H/11/00669/008 $ H/11/00669/009 $ H/11/00669/010 $ H/11/00669/011 $ H/11/00669/012 $ H/11/00669/013 $ H/11/00669/014 $ H/11/00669/015 $ H/11/00669/016 $ H/11/00669/017 $ H/11/00669/018 $ H/11/00669/019 $ H/11/00669/020 $ H/11/00669/021 $ H/11/00669/022 $ H/11/00669/023 $ H/11/00669/024 $ H/11/00669/025 $



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H/11/00669/026 $ H/11/00669/027 $ H/11/00669/028 $ H/11/00669/029 $ H/11/00669/030 $ H/11/00669/031 $ H/11/00669/032 $ H/11/00669/033 $ H/11/00669/034 $ H/11/00669/035 $ H/11/00669/036 $ H/11/00669/037 $ H/11/00669/038 $ H/11/00669/039 $ H/11/00669/040 $ H/11/00669/041 $ H/11/00669/042 $ H/11/00669/043 $ H/11/00669/044 $ H/11/00669/045 $ H/11/00669/046 $ H/11/00669/047 $ H/11/00669/048 $ H/11/00669/049 $ H/11/00669/050 $ H/11/00669/051 $ H/11/00669/052 $ H/11/00669/053 $ H/11/00669/054


PA1347/015/001 $ PA1347/015/002 $ PA1347/015/003

Krka, D.D., Novo Mesto Ireland

Galsya Xl SI/H/0123/001 $ SI/H/0123/002 $ SI/H/0123/003

PL 01656/0129 $ PL 01656/0130 $ PL 01656/0131

Krka, D.D., Novo Mesto United Kingdom

Gamyl NL/H/2030/001 $ 5363-I-1143/12 $ 5363-I- Generics [uk] Limited Slovenia


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NL/H/2030/002 $ NL/H/2030/003

1144/12 $ 5363-I-1145/12

Gatalin Xl DE/H/2134/001 $ DE/H/2134/002 $ DE/H/2134/003

PL 35533/0015 $ PL 35533/0016 $ PL 35533/0017

Aspire Pharma Limited United Kingdom

Gazylan DE-H-3116-001-003-DC LT/1/13/3232/001 - LT/1/13/3232/015

Teva B.V; Swensweg 5, Haarlem, 2031ga, Netherlands

Lithuania

Gazylan DE/H/3116/001 $ DE/H/3116/002 $ DE/H/3116/003

H/13/00676/001 $ H/13/00676/016 $ H/13/00676/031

Teva Pharma B.V. Slovenia

Gazylan DE/H/3116/002 $ DE/H/3116/003

LT/1/13/3232/016 $ LT/1/13/3232/017 $ LT/1/13/3232/019 $ LT/1/13/3232/021 $ LT/1/13/3232/026 $ LT/1/13/3232/030 $ LT/1/13/3232/032 $ LT/1/13/3232/034 $ LT/1/13/3232/036 $ LT/1/13/3232/041 $ LT/1/13/3232/045

Teva B.V Lithuania

Gazylan DE/H/3116/002 $ DE/H/3116/003

LT/1/13/3232/018 $ LT/1/13/3232/020 $ LT/1/13/3232/022 $ LT/1/13/3232/023 $ LT/1/13/3232/024 $ LT/1/13/3232/027 $ LT/1/13/3232/028 $ LT/1/13/3232/031 $ LT/1/13/3232/033 $ LT/1/13/3232/035 $ LT/1/13/3232/037 $ LT/1/13/3232/038 $ LT/1/13/3232/039 $ LT/1/13/3232/042 $

Teva B.V Lithuania


Page 24/35






LT/1/13/3232/043

Gazylan DE/H/3116/002 $ DE/H/3116/003

LT/1/13/3232/025 $ LT/1/13/3232/029 $ LT/1/13/3232/040 $ LT/1/13/3232/044

Teva B.V; Swensweg 5, Haarlem, 2031ga, Netherlands

Lithuania

Gazylan Xl DE/H/3116/001 $ DE/H/3116/002 $ DE/H/3116/003

PL 00289/1890 $ PL 00289/1891 $ PL 00289/1892

Teva Uk Limited United Kingdom

Girlamen DE/H/3118/001-02-03/DC

84231.00.00 $ 84232.00.00 $ 84233.00.00


Lotprosin Xl DE/H/2135/001 $ DE/H/2135/002 $ DE/H/2135/003

PL 30306/0315 $ PL 30306/0316 $ PL 30306/0317

Actavis Group Ptc Ehf. United Kingdom

Luventa Xl PL 42924/0001 Fontus Health United Kingdom



Margal SI/H/0120/001 $ SI/H/0120/002 $ SI/H/0120/003

1-30489 $ 1-30490 $ 1-30491

Krka, D.D., Novo Mesto Austria

Masparen DE/H/3074/001 $ DE/H/3074/002 $ DE/H/3074/003

83923.00.00 $ 83924.00.00 $ 83925.00.00


Masparen DE/H/3074/001-02-03/DC $ DE/H/3074/003

BE435662 $ BE435671 $ BE435687

Pharmathen S.A. Belgium

Masparen Retard DE/H/3074/001 $ DE/H/3074/002 $ DE/H/3074/003

109100 $ 109101 $ 109102 Pharmathen S.A. Netherlands

Memo 78730/10/3-5-2011 Farmellas Enterprises Ltd

Greece

Memoton-Life 78734/10/3-5-2011 Farmellas Enterprises Ltd

Greece

Micol 32234/12/31-01-2013 Raldex Enterprises Ltd Greece


Page 25/35






Natagal Sr SI/H/0122/001 $ SI/H/0122/002 $ SI/H/0122/003

H/11/01086/001 $ H/11/01086/002 $ H/11/01086/003 $ H/11/01086/004 $ H/11/01086/005 $ H/11/01086/006 $ H/11/01086/007 $ H/11/01086/008 $ H/11/01086/009 $ H/11/01086/010 $ H/11/01086/011 $ H/11/01086/012 $ H/11/01086/013 $ H/11/01086/014 $ H/11/01086/015 $ H/11/01086/016 $ H/11/01086/017 $ H/11/01086/018 $ H/11/01086/019 $ H/11/01086/020 $ H/11/01086/021 $ H/11/01086/022 $ H/11/01086/023 $ H/11/01086/024 $ H/11/01086/025 $ H/11/01086/026 $ H/11/01086/027 $ H/11/01086/028 $ H/11/01086/029 $ H/11/01086/030 $ H/11/01086/031 $ H/11/01086/032 $ H/11/01086/033 $ H/11/01086/034 $ H/11/01086/035 $ H/11/01086/036 $



Page 26/35






H/11/01086/037 $ H/11/01086/038 $ H/11/01086/039 $ H/11/01086/040 $ H/11/01086/041 $ H/11/01086/042 $ H/11/01086/043 $ H/11/01086/044 $ H/11/01086/045 $ H/11/01086/046 $ H/11/01086/047 $ H/11/01086/048 $ H/11/01086/049 $ H/11/01086/050 $ H/11/01086/051 $ H/11/01086/052 $ H/11/01086/053 $ H/11/01086/054

Nivalin 06-0144 $ 06-0145 $ 11-0104

Briz Ltd Latvia

Nivalin 06-0146 Briz Ltd Latvia

Nivalin 06-0147 Briz Ltd Latvia

Nivalin LT/1/10/2216/001 $ LT/1/10/2216/002 $ LT/1/10/2216/003 $ LT/1/10/2216/004 $ LT/1/10/2216/005

Sopharma Ad Lithuania

Nivalin R/1418 Sopharma Warszawa Sp. Z O.O.

Poland

Nivalin R/1419 Sopharma Warszawa Sp. Z O.O.

Poland

Reminyl 018/00101 Janssen-Cilag International Nv

Malta


Malta


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Malta


Malta

Reminyl 19540 $ 19541 $ 19542 Janssen-Cilag International Nv

Cyprus

Reminyl 19543 Janssen-Cilag International Nv

Cyprus

Reminyl 4535/2004/01 Janssen Pharmaceutica Nv

Romania

Reminyl H/06/01336/001 $ H/06/01336/003 $ H/06701336/002

Johnson & Johnson Prodaja Medicinskih In Farmacevtskih Izdelkov, D.O.O.

Slovenia

Reminyl SE/H/0210/001 0162/10080820 Janssen-Cilag Nv Luxembourg


Reminyl SE/H/0210/001 034752016/M Janssen-Cilag Spa Italy


Reminyl SE/H/0210/001 1-23751 Janssen-Cilag Pharma Gmbh

Austria

Reminyl SE/H/0210/001 29837 Janssen-Cilag Pharmaceutical S.A.C.I.

Greece

Reminyl SE/H/0210/001 RVG 29073 Janssen-Cilag Bv Netherlands

Reminyl SE/H/0210/001 $ SE/H/0210/002 $ SE/H/0210/003

00-2143 $ 00-2144 $ 00-2145

Janssen-Cilag A/S Norway


15561 $ 15562 $ 15563 Janssen-Cilag Ab Sweden


15673 $ 15674 $ 15675 Janssen-Cilag Oy Finland

Reminyl SE/H/0210/001 $ SE/H/0210/002 $

31527 $ 31528 $ 31529 Janssen-Cilag A/S Denmark


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SE/H/0210/003


34009 355 366 2 4 $ 34009 355 367 9 2 $ 34009 355 368 5 3 $ 34009 357 017 5 6 $ 34009 563 157 3 4 $ 3400935536914 $ 34009562 844 7 4 $ 34009562 845 3 5

Janssen-Cilag France


3417581 $ 3417680 $ 3417789 $ 3417888 $ 3417987 $ 3418084 $ 3524584 $ 3529385

Janssen-Cilag Farmacêutica, Lda.

Portugal


BE217034 $ BE217043 $ BE217235

Janssen-Cilag Nv Belgium


IS/1/00/007/01 $ IS/1/00/007/02 $ IS/1/00/007/03

Janssen-Cilag Ab Iceland


PA 535/6/2 $ PA 535/6/3 $ PA 535/6/4 $ PA535/6/3

Shire Pharmaceuticals Limited

Ireland


PL 08557/0039 $ PL 08557/0040 $ PL 08557/0041


United Kingdom


Reminyl SE/H/0210/002 0162/10080821 $ 0162/10080824

Janssen-Cilag Nv Luxembourg

Reminyl SE/H/0210/002 034752028/M $ 034752093/M

Janssen-Cilag Spa Italy



Austria


Greece


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Reminyl SE/H/0210/003 034752042/M $ 034752055/M $ 034752067/M



Austria


Greece


Reminyl SE/H/0210/004 00-2146 Janssen-Cilag A/S Norway





Austria

Reminyl SE/H/0210/004 15565 Janssen-Cilag Ab Sweden

Reminyl SE/H/0210/004 15676 Janssen-Cilag Oy Finland

Reminyl SE/H/0210/004 2810-31526-00 Janssen-Cilag A/S Denmark


Greece

Reminyl SE/H/0210/004 31526 Janssen-Cilag A/S Denmark

Reminyl SE/H/0210/004 34009 355 372 2 5 Janssen-Cilag France

Reminyl SE/H/0210/004 3418183 Janssen-Cilag Farmacêutica, Lda.

Portugal

Reminyl SE/H/0210/004 49531.00.01 Janssen-Cilag Gmbh Germany

Reminyl SE/H/0210/004 63.388 Janssen-Cilag S.A. Spain

Reminyl SE/H/0210/004 BE217052 Janssen-Cilag Nv Belgium


Page 30/35






Reminyl SE/H/0210/004 IS/1/00/007/04 Janssen-Cilag Ab Iceland

Reminyl SE/H/0210/004 PA 535/6/1 Shire Pharmaceuticals Limited

Ireland

Reminyl SE/H/0210/004 PL 08557/0042 Shire Pharmaceuticals Limited

United Kingdom




Reminyl SE/H/0210/005 04-2774 Janssen-Cilag A/S Norway


Austria


Greece





19632 $ 19633 $ 19634 Janssen-Cilag Oy Finland


34 009 3675951 0 $ 34 009 3675968 8 $ 34 009 494 1171 9 $ 34 009 4941188 7 $ 34 009 5661864 4 $ 34 009 5661870 5 $ 34 009 5661887 3 $ 34 009 5663679 2 $ 34 009 5663685 3 $ 34 009 5663691 4 $ 34009 367 592 2 0 $ 34009 367 593 9 8 $ 34009 566 185 8 3

Janssen-Cilag France

Reminyl SE/H/0210/005 $ SE/H/0210/006 $

36814 $ 36815 $ 36816 Janssen-Cilag A/S Denmark


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SE/H/0210/007


66.650 $ 66.651 $ 66.652 Janssen-Cilag S.A. Spain

Reminyl SE/H/0210/005 $ SE/H/0210/006 $ SE/H/0210/007 $ SE/H/0210/008

19348 $ 19349 $ 19350 $ 19351

Janssen-Cilag Ab Sweden


5269386 $ 5269485 $ 5269584 $ 5269683 $ 5269782 $ 5269881 $ 5269980 $ 5270087 $ 5270186 $ 5270285 $ 5270384 $ 5270483

Janssen-Cilag Farmacêutica, Lda.

Portugal


BE269421 $ BE269437 $ BE269446 $ BE269455 $ BE269464 $ BE269473 $ BE269482

Janssen-Cilag Nv Belgium


034752105 $ 034752129 $ 034752143 $ 034752156 $ 034752168 $ 034752182 $ 034752194 $ 034752206 $ 034752218/M





Austria


Greece



Reminyl SE/H/0210/006 $ SE/H/0210/007

IS/1/04/045/02 $ IS/1/04/045/03

Janssen-Cilag Ab Iceland


Page 32/35







04-2775 $ 04-2776 $ 04-2777

Janssen-Cilag A/S Norway




Austria


Greece






Austria




Greece

Reminyl SE/H/0210/008 BE 269437 $ BE269437 Janssen-Cilag Nv Belgium



Reminyl Xl SE/H/0210/005 $ SE/H/0210/006 $ SE/H/0210/007

PA 535/6/5 $ PA 535/6/6 $ PA 535/6/7


Ireland

Reminyl Xl SE/H/0210/005 $ SE/H/0210/006 $ SE/H/0210/007

PL 08557/0052 $ PL 08557/0053 $ PL 08557/0054


United Kingdom

Spegal Sr SI/H/0121/001 $ SI/H/0121/002 $ SI/H/0121/003 $

5363-I-429/12 $ 5363-I-430/12 $ 5363-I-431/12 $ 5363-I-432/12

Lek Pharmaceuticals D.D. Ljubljana

Slovenia


Page 33/35






SI/H/0121/004

Vertusal Sr SI/H/0123/001 $ SI/H/0123/002 $ SI/H/0123/003

H/11/01633/001 $ H/11/01633/002 $ H/11/01633/003 $ H/11/01633/004 $ H/11/01633/005 $ H/11/01633/006 $ H/11/01633/007 $ H/11/01633/008 $ H/11/01633/009 $ H/11/01633/010 $ H/11/01633/011 $ H/11/01633/012 $ H/11/01633/013 $ H/11/01633/014 $ H/11/01633/015 $ H/11/01633/016 $ H/11/01633/017 $ H/11/01633/018 $ H/11/01633/019 $ H/11/01633/020 $ H/11/01633/021 $ H/11/01633/022 $ H/11/01633/023 $ H/11/01633/024 $ H/11/01633/025 $ H/11/01633/026 $ H/11/01633/027 $ H/11/01633/028 $ H/11/01633/029 $ H/11/01633/030 $ H/11/01633/031 $ H/11/01633/032 $ H/11/01633/033 $ H/11/01633/034 $ H/11/01633/035 $



Page 34/35






H/11/01633/036 $ H/11/01633/037 $ H/11/01633/038 $ H/11/01633/039 $ H/11/01633/040 $ H/11/01633/041 $ H/11/01633/042 $ H/11/01633/043 $ H/11/01633/044 $ H/11/01633/045 $ H/11/01633/046 $ H/11/01633/047 $ H/11/01633/048 $ H/11/01633/049 $ H/11/01633/050 $ H/11/01633/051 $ H/11/01633/052 $ H/11/01633/053 $ H/11/01633/054

Zentan 21115 $ 21116 $ 21117 Delorbis Pharmaceuticals Ltd

Cyprus

Zoroflog 39015/15/13-01-2016 Provident Pharmaceuticals Ltd

Greece

галсия Sr SI/H/0118/001 $ SI/H/0118/002 $ SI/H/0118/003

20110303 $ 20110304 $ 20110305

Krka, D.D., Novo Mesto Bulgaria

нивалин 20020950 $ 20020951 Sopharma Ad Bulgaria

нивалин 9700572 Sopharma Ad Bulgaria

нивалин 9700573 $ 9700574 Sopharma Ad Bulgaria

нивалин 9700575 Sopharma Ad Bulgaria

тевалин DE/H/3116/001 $ DE/H/3116/002

20130393 $ 20130394 Teva Pharmaceuticals Bulgaria Eood

Bulgaria

тевалин DE/H/3116/003 20130395 Teva Pharmaceuticals Bulgaria Eood

Bulgaria


Page 35/35






Loxifren Prolonged release capsules

DE/H/2134/001-003/DC P.T. Hadjigeorgiou co ltd

Cyprus

Galantamin easypharm DE/H/2876/001-003/DC Easypharm Austria

Girlamen DE/H/3118/001-003/DC Pharmaten S.A France

Galantamina Bluelife 5649009-5648977-5649017-5648969

Axone, Lda. Portugal

Galantamina Actavis DE/H/2135/001 5396445-5396452-5396460

Actavis Group Ptc Ehf. Portugal

Galantamine Actavis Retard

DE/H/2135/001 RVG 107575-RVG 107576-RVG 107577

Actavis Group Ptc Ehf. Netherlands

Galantamin Heumann 8 mg Galantamin Heumann 16mg Galantamin Heumann 24mg

DE/2134/001-003/DC 93161.00.00 93162.00.00 93163.00.00

Heumann Pharma GmbH & Co. Generica KG

Germany

Documents

List of nationally authorised medicinal products · 46851 $ 46852 $ MTNR. 46850 Krka Sverige Ab Denmark Galantamin Krka SI/H/0118/001 $ SI/H/0118/002 $ SI/H/0118/003 MTNR. 10-7572