101390866 | 31.01.2023 16:57 | | | | | Cartexan 400 mg Hartkapseln | | 135946 | | Variation human AT=CMS | A.5.a Name/Address of manufacturer, finished product, batch release | | Laboratorio Reig Jofre S.A., Gran Capita 10, 08970 Sant Joan Despi/Barcelona, Spanien | | Arzneimittel zur wiederholten Abgabe gegen aerztliche Verschreibung | | M01AX25 | |
100396581 | 31.01.2023 16:43 | | | | | Esketamin Sintetica 5 mg/ml Injektions-/Infusionslösung | | 140107 | | Variation human AT=CMS | B.II.b.1.a Finished Product, manufacturing site | B.II.b.1.f Finished Product, manufacturing site | B.II.b.2.a Finished Product, manufacture, change batch release details or quality control | B.II.b.2.c.1 Finished Product, manufacture, change batch release details or importer | B.II.b.4.z Finished Product, manufacture, batch size | B.II.e.1.b.2 Finished Product, Container Closure System, type of container | B.II.e.5.c Finished Product, Container Closure System, pack size | | Sintetica GmbH, Albersloher Weg 11, 48155 Münster, Deutschland | | Arzneimittel zur einmaligen Abgabe auf aerztliche Verschreibung | | N01AX14 | |
100639690 | 31.01.2023 16:21 | | | | | Esketamin Sintetica 25 mg/ml Injektions-/Infusionslösung | | 140108 | | Variation human AT=CMS | B.II.b.1.a Finished Product, manufacturing site | B.II.b.1.f Finished Product, manufacturing site | B.II.b.2.a Finished Product, manufacture, change batch release details or quality control | B.II.b.2.c.1 Finished Product, manufacture, change batch release details or importer | B.II.b.4.z Finished Product, manufacture, batch size | B.II.b.5.b Finished Product, manufacture, in process testing | B.II.e.1.b.2 Finished Product, Container Closure System, type of container | B.II.e.5.a.1 Finished Product, Container Closure System, pack size | B.II.e.5.c Finished Product, Container Closure System, pack size | | Sintetica GmbH, Albersloher Weg 11, 48155 Münster, Deutschland | | Arzneimittel zur einmaligen Abgabe auf aerztliche Verschreibung | | N01AX14 | |
101282966 | 31.01.2023 16:11 | | | | | Ezetimib/Atorvastatin ratiopharm 10 mg/80 mg Filmtabletten | | 140754 | | Variation human AT=CMS | C.I.6.a therapeutic indication, new/modification of an approved one | | Teva B.V., Swensweg 5, 2031 GA Haarlem, Niederlande | | Arzneimittel zur einmaligen Abgabe auf aerztliche Verschreibung | | C10BA05 | |
101282966 | 31.01.2023 16:11 | | | | | Ezetimib/Atorvastatin ratiopharm 10 mg/10 mg Filmtabletten | | 140751 | | Variation human AT=CMS | C.I.6.a therapeutic indication, new/modification of an approved one | | Teva B.V., Swensweg 5, 2031 GA Haarlem, Niederlande | | Arzneimittel zur einmaligen Abgabe auf aerztliche Verschreibung | | C10BA05 | |
101282966 | 31.01.2023 16:11 | | | | | Ezetimib/Atorvastatin ratiopharm 10 mg/40 mg Filmtabletten | | 140753 | | Variation human AT=CMS | C.I.6.a therapeutic indication, new/modification of an approved one | | Teva B.V., Swensweg 5, 2031 GA Haarlem, Niederlande | | Arzneimittel zur einmaligen Abgabe auf aerztliche Verschreibung | | C10BA05 | |
101282966 | 31.01.2023 16:11 | | | | | Ezetimib/Atorvastatin ratiopharm 10 mg/20 mg Filmtabletten | | 140752 | | Variation human AT=CMS | C.I.6.a therapeutic indication, new/modification of an approved one | | Teva B.V., Swensweg 5, 2031 GA Haarlem, Niederlande | | Arzneimittel zur einmaligen Abgabe auf aerztliche Verschreibung | | C10BA05 | |
101651506 | 31.01.2023 15:57 | | | | | Salofalk 500 mg magensaftresistente Tabletten | | 1-19004 | | nationale Variation human | C.I.3.a Changes requested by PSUR/PASS/PDWS, no additional data | | Dr. Falk Pharma GmbH, Leinenweberstraße 5, 79108 Freiburg, Deutschland | | Arzneimittel zur wiederholten Abgabe gegen aerztliche Verschreibung | | A07EC02 | |
101190221 | 31.01.2023 15:46 | | | | | Levetiracetam +pharma 1000 mg Filmtabletten | | 1-30902 | | Variation human AT=RMS | C.I.2.a SmPC PIL LAB, generic/hybrid/biosimilar, referred to the reference product, no additional data | | +pharma arzneimittel gmbh, Hafnerstrasse 211, 8054 Graz, Österreich | | Arzneimittel zur einmaligen Abgabe auf aerztliche Verschreibung | | N03AX14 | |
101190221 | 31.01.2023 15:46 | | | | | Levetiracetam +pharma 500 mg Filmtabletten | | 1-30900 | | Variation human AT=RMS | C.I.2.a SmPC PIL LAB, generic/hybrid/biosimilar, referred to the reference product, no additional data | | +pharma arzneimittel gmbh, Hafnerstrasse 211, 8054 Graz, Österreich | | Arzneimittel zur einmaligen Abgabe auf aerztliche Verschreibung | | N03AX14 | |
101651544 | 31.01.2023 15:40 | | | | | Salofalk 500 mg Zäpfchen | | 1-19005 | | nationale Variation human | C.I.3.a Changes requested by PSUR/PASS/PDWS, no additional data | | Dr. Falk Pharma GmbH, Leinenweberstraße 5, 79108 Freiburg, Deutschland | | Arzneimittel zur wiederholten Abgabe gegen aerztliche Verschreibung | | A07EC02 | |
101651572 | 31.01.2023 15:39 | | | | | Salofalk 4 g - Klysmen | | 1-19003 | | nationale Variation human | C.I.3.a Changes requested by PSUR/PASS/PDWS, no additional data | | Dr. Falk Pharma GmbH, Leinenweberstraße 5, 79108 Freiburg, Deutschland | | Arzneimittel zur wiederholten Abgabe gegen aerztliche Verschreibung | | A07EC02 | |
101225594 | 31.01.2023 15:08 | | | | | Crusia 10.000 I.E. (100 mg)/1 ml Injektionslösung in einer Fertigspritze | | 237641 | | Variation human AT=CMS | C.I.2.b SmPC PIL LAB, generic/hybrid/biosimilar, referred to the reference product, new additional data | | Laboratorios Farmaceuticos Rovi SA, C/. Julian Camarillo 35, 28037 Madrid, Spanien | | Arzneimittel zur wiederholten Abgabe gegen aerztliche Verschreibung | | B01AB05 | |
101225594 | 31.01.2023 15:08 | | | | | Crusia 6.000 I.E. (60 mg)/0,6 ml Injektionslösung in einer Fertigspritze | | 237643 | | Variation human AT=CMS | C.I.2.b SmPC PIL LAB, generic/hybrid/biosimilar, referred to the reference product, new additional data | | Laboratorios Farmaceuticos Rovi SA, C/. Julian Camarillo 35, 28037 Madrid, Spanien | | Arzneimittel zur wiederholten Abgabe gegen aerztliche Verschreibung | | B01AB05 | |
101225594 | 31.01.2023 15:08 | | | | | Crusia 2.000 I.E. (20 mg)/0,2 ml Injektionslösung in einer Fertigspritze | | 237645 | | Variation human AT=CMS | C.I.2.b SmPC PIL LAB, generic/hybrid/biosimilar, referred to the reference product, new additional data | | Laboratorios Farmaceuticos Rovi SA, C/. Julian Camarillo 35, 28037 Madrid, Spanien | | Arzneimittel zur wiederholten Abgabe gegen aerztliche Verschreibung | | B01AB05 | |
101225594 | 31.01.2023 15:08 | | | | | Crusia 8.000 I.E. (80 mg)/0,8 ml Injektionslösung in einer Fertigspritze | | 237642 | | Variation human AT=CMS | C.I.2.b SmPC PIL LAB, generic/hybrid/biosimilar, referred to the reference product, new additional data | | Laboratorios Farmaceuticos Rovi SA, C/. Julian Camarillo 35, 28037 Madrid, Spanien | | Arzneimittel zur wiederholten Abgabe gegen aerztliche Verschreibung | | B01AB05 | |
101225594 | 31.01.2023 15:08 | | | | | Crusia 4.000 I.E. (40 mg)/0,4 ml Injektionslösung in einer Fertigspritze | | 237644 | | Variation human AT=CMS | C.I.2.b SmPC PIL LAB, generic/hybrid/biosimilar, referred to the reference product, new additional data | | Laboratorios Farmaceuticos Rovi SA, C/. Julian Camarillo 35, 28037 Madrid, Spanien | | Arzneimittel zur wiederholten Abgabe gegen aerztliche Verschreibung | | B01AB05 | |
101225294 | 31.01.2023 15:08 | | | | | Enoxaparin Becat 4.000 IE (40 mg)/0,4 ml Injektionslösung in einer Fertigspritze | | 237669 | | Variation human AT=CMS | C.I.2.a SmPC PIL LAB, generic/hybrid/biosimilar, referred to the reference product, no additional data | C.I.2.b SmPC PIL LAB, generic/hybrid/biosimilar, referred to the reference product, new additional data | | Laboratorios Farmaceuticos Rovi SA, C/. Julian Camarillo 35, 28037 Madrid, Spanien | | Arzneimittel zur wiederholten Abgabe gegen aerztliche Verschreibung | | B01AB05 | |
101225294 | 31.01.2023 15:08 | | | | | Enoxaparin Becat 8.000 IE (80 mg)/0,8 ml Injektionslösung in einer Fertigspritze | | 237667 | | Variation human AT=CMS | C.I.2.a SmPC PIL LAB, generic/hybrid/biosimilar, referred to the reference product, no additional data | C.I.2.b SmPC PIL LAB, generic/hybrid/biosimilar, referred to the reference product, new additional data | | Laboratorios Farmaceuticos Rovi SA, C/. Julian Camarillo 35, 28037 Madrid, Spanien | | Arzneimittel zur wiederholten Abgabe gegen aerztliche Verschreibung | | B01AB05 | |
101225294 | 31.01.2023 15:08 | | | | | Enoxaparin Becat 6.000 IE (60 mg)/0,6 ml Injektionslösung in einer Fertigspritze | | 237668 | | Variation human AT=CMS | C.I.2.a SmPC PIL LAB, generic/hybrid/biosimilar, referred to the reference product, no additional data | C.I.2.b SmPC PIL LAB, generic/hybrid/biosimilar, referred to the reference product, new additional data | | Laboratorios Farmaceuticos Rovi SA, C/. Julian Camarillo 35, 28037 Madrid, Spanien | | Arzneimittel zur wiederholten Abgabe gegen aerztliche Verschreibung | | B01AB05 | |
101225294 | 31.01.2023 15:08 | | | | | Enoxaparin Becat 10.000 IE (100 mg)/1 ml Injektionslösung in einer Fertigspritze | | 237666 | | Variation human AT=CMS | C.I.2.a SmPC PIL LAB, generic/hybrid/biosimilar, referred to the reference product, no additional data | C.I.2.b SmPC PIL LAB, generic/hybrid/biosimilar, referred to the reference product, new additional data | | Laboratorios Farmaceuticos Rovi SA, C/. Julian Camarillo 35, 28037 Madrid, Spanien | | Arzneimittel zur wiederholten Abgabe gegen aerztliche Verschreibung | | B01AB05 | |
101225294 | 31.01.2023 15:08 | | | | | Enoxaparin Becat 2.000 IE (20 mg)/0,2 ml Injektionslösung in einer Fertigspritze | | 237670 | | Variation human AT=CMS | C.I.2.a SmPC PIL LAB, generic/hybrid/biosimilar, referred to the reference product, no additional data | C.I.2.b SmPC PIL LAB, generic/hybrid/biosimilar, referred to the reference product, new additional data | | Laboratorios Farmaceuticos Rovi SA, C/. Julian Camarillo 35, 28037 Madrid, Spanien | | Arzneimittel zur wiederholten Abgabe gegen aerztliche Verschreibung | | B01AB05 | |
14285907 | 31.01.2023 14:38 | | | | | Daylina 0,02 mg/3 mg Filmtabletten | | 1-31841 | | Variation human AT=RMS | C.I.z Safety, efficacy, pharmacovigilance changes | | Gedeon Richter Plc., Gyömroi út 19-21, 1103 Budapest, Ungarn | | Arzneimittel zur wiederholten Abgabe gegen aerztliche Verschreibung | | G03AA12 | |
101371696 | 31.01.2023 13:50 | | | | | Ibufix 400 mg/10 mg Filmtabletten | | 138378 | | Variation human AT=RMS | C.I.3.z Changes requested by PSUR/PASS/PDWS | | Stada Arzneimittel GmbH, Muthgasse 36/2, 1190 Wien, Österreich | | Arzneimittel zur wiederholten Abgabe gegen aerztliche Verschreibung | | M01AE51 | |
101205787 | 31.01.2023 13:10 | | | | | Floxal 3 mg/g Augensalbe | | 1-23679 | | nationale Variation human | C.I.z Safety, efficacy, pharmacovigilance changes | | Dr. Gerhard Mann Chem.-Pharm. Fabrik GmbH, Brunsbütteler Damm 165/173, 13581 Berlin, Deutschland | Dr. Gerhard Mann Chem.-Pharm. Fabrik GmbH, Brunsbütteler Damm 165-173, 13581 Berlin, Deutschland | Arzneimittel zur einmaligen Abgabe auf aerztliche Verschreibung | | S01AE01 | |