| 105097473 | 30.01.2026 10:09 | | | | | Atenolan 50 mg - Filmtabletten | | 1-18999 | | nationale Variation human | C.3.a) Implementation of the agreed wording | | G.L. Pharma GmbH, Schloßplatz 1, 8502 Lannach, Österreich | | Arzneimittel zur wiederholten Abgabe gegen aerztliche Verschreibung | | C07AB03 | |
| 105097473 | 30.01.2026 10:09 | | | | | Atenolan 100 mg - Filmtabletten | | 1-19001 | | variation national - human | C.3.a) Implementation of the agreed wording | | G.L. Pharma GmbH, Schloßplatz 1, 8502 Lannach, Republic of Austria | | Medicinal product on medical prescription for renewable delivery | | C07AB03 | |
| 105097473 | 30.01.2026 10:09 | | | | | Atenolan 50 mg - Filmtabletten | | 1-18999 | | variation national - human | C.3.a) Implementation of the agreed wording | | G.L. Pharma GmbH, Schloßplatz 1, 8502 Lannach, Republic of Austria | | Medicinal product on medical prescription for renewable delivery | | C07AB03 | |
| 105097473 | 30.01.2026 10:09 | | | | | Atenolan 100 mg - Filmtabletten | | 1-19001 | | nationale Variation human | C.3.a) Implementation of the agreed wording | | G.L. Pharma GmbH, Schloßplatz 1, 8502 Lannach, Österreich | | Arzneimittel zur wiederholten Abgabe gegen aerztliche Verschreibung | | C07AB03 | |
| 104657893 | 30.01.2026 09:57 | | | | | Analeptol 50 mg/ml + 50 mg/ml Injektionslösung für Rinder, Pferde, Schweine, Hunde und Katzen | | 841644 | | variation - veterinary AT=CMS | G.I.18 One-off alignment of the product information with version 9.0 of the QRD templates i.e. major update of the QRD templates in accordance with Regulation (EU) 2019/6, for veterinary medicinal products placed on the market in accordance with Directive 2001/82/EC or Regulation (EC) No 726/2004 | G.I.19 Change(s) in the Summary of Product Characteristics, Labelling or Package Leaflet to implement the outcome of the MAH’s signal management process according to Article 81(2) of Regulation (EU) 2019/6 | | CP-Pharma Handelsgesellschaft mbH, Ostlandring 13, 31303 Burgdorf, Federal Republic of Germany | | Medicinal product on medical prescription for renewable delivery | | QR03DA51 | |
| 104657893 | 30.01.2026 09:57 | | | | | Analeptol 50 mg/ml + 50 mg/ml Injektionslösung für Rinder, Pferde, Schweine, Hunde und Katzen | | 841644 | | Variation veterinär AT=CMS | G.I.18 One-off alignment of the product information with version 9.0 of the QRD templates i.e. major update of the QRD templates in accordance with Regulation (EU) 2019/6, for veterinary medicinal products placed on the market in accordance with Directive 2001/82/EC or Regulation (EC) No 726/2004 | G.I.19 Change(s) in the Summary of Product Characteristics, Labelling or Package Leaflet to implement the outcome of the MAH’s signal management process according to Article 81(2) of Regulation (EU) 2019/6 | | CP-Pharma Handelsgesellschaft mbH, Ostlandring 13, 31303 Burgdorf, Deutschland | | Arzneimittel zur wiederholten Abgabe gegen aerztliche Verschreibung | | QR03DA51 | |
| 104830397 | 30.01.2026 09:00 | | | | | Hydal 50 mg/ml Injektions-/Infusionslösung | | 1-28308 | | variation - human AT=CMS | C.I.3.a Changes requested by PSUR/PASS/PDWS, no additional data | | Mundipharma Ges.m.b.H., Wiedner Gürtel 13 Turm 24, OG 15, A-1100 Vienna, Republic of Austria | | Medicinal products subject to special medical prescription, narcotics | | N02AA03 | |
| 104830397 | 30.01.2026 09:00 | | | | | Hydal 50 mg/ml Injektions-/Infusionslösung | | 1-28308 | | Variation human AT=CMS | C.I.3.a Changes requested by PSUR/PASS/PDWS, no additional data | | Mundipharma Ges.m.b.H., Wiedner Gürtel 13 Turm 24, OG 15, A-1100 Vienna, Österreich | | Arzneimittel zur Abgabe gegen besondere aerztliche Verschreibung, Suchtgifte | | N02AA03 | |
| 104830397 | 30.01.2026 09:00 | | | | | Hydal 10 mg/ml Injektions-/Infusionslösung | | 1-28306 | | variation - human AT=CMS | C.I.3.a Changes requested by PSUR/PASS/PDWS, no additional data | | Mundipharma Ges.m.b.H., Wiedner Gürtel 13 Turm 24, OG 15, A-1100 Vienna, Republic of Austria | | Medicinal products subject to special medical prescription, narcotics | | N02AA03 | |
| 104830397 | 30.01.2026 09:00 | | | | | Hydal 10 mg/ml Injektions-/Infusionslösung | | 1-28306 | | Variation human AT=CMS | C.I.3.a Changes requested by PSUR/PASS/PDWS, no additional data | | Mundipharma Ges.m.b.H., Wiedner Gürtel 13 Turm 24, OG 15, A-1100 Vienna, Österreich | | Arzneimittel zur Abgabe gegen besondere aerztliche Verschreibung, Suchtgifte | | N02AA03 | |
| 104830397 | 30.01.2026 09:00 | | | | | Hydal 2 mg/ml Injektions-/Infusionslösung | | 1-28305 | | variation - human AT=CMS | C.I.3.a Changes requested by PSUR/PASS/PDWS, no additional data | | Mundipharma Ges.m.b.H., Wiedner Gürtel 13 Turm 24, OG 15, A-1100 Vienna, Republic of Austria | | Medicinal products subject to special medical prescription, narcotics | | N02AA03 | |
| 104830397 | 30.01.2026 09:00 | | | | | Hydal 20 mg/ml Injektions-/Infusionslösung | | 1-28307 | | variation - human AT=CMS | C.I.3.a Changes requested by PSUR/PASS/PDWS, no additional data | | Mundipharma Ges.m.b.H., Wiedner Gürtel 13 Turm 24, OG 15, A-1100 Vienna, Republic of Austria | | Medicinal products subject to special medical prescription, narcotics | | N02AA03 | |
| 104830397 | 30.01.2026 09:00 | | | | | Hydal 20 mg/ml Injektions-/Infusionslösung | | 1-28307 | | Variation human AT=CMS | C.I.3.a Changes requested by PSUR/PASS/PDWS, no additional data | | Mundipharma Ges.m.b.H., Wiedner Gürtel 13 Turm 24, OG 15, A-1100 Vienna, Österreich | | Arzneimittel zur Abgabe gegen besondere aerztliche Verschreibung, Suchtgifte | | N02AA03 | |
| 104830397 | 30.01.2026 09:00 | | | | | Hydal 2 mg/ml Injektions-/Infusionslösung | | 1-28305 | | Variation human AT=CMS | C.I.3.a Changes requested by PSUR/PASS/PDWS, no additional data | | Mundipharma Ges.m.b.H., Wiedner Gürtel 13 Turm 24, OG 15, A-1100 Vienna, Österreich | | Arzneimittel zur Abgabe gegen besondere aerztliche Verschreibung, Suchtgifte | | N02AA03 | |
| 105060768 | 30.01.2026 08:19 | | | | | Fosicomb - Tabletten | | 1-21946 | | nationale Variation human | A.5.a Name/Address of manufacturer, finished product, batch release | | Bausch Health Ireland Limited, 3013 Lake Drive Citywest Business Campus -, D24 PPT3 Dublin 24, Irland | | Arzneimittel zur wiederholten Abgabe gegen aerztliche Verschreibung | | C09BA09 | |
| 105060768 | 30.01.2026 08:19 | | | | | Fosicomb - Tabletten | | 1-21946 | | variation national - human | A.5.a Name/Address of manufacturer, finished product, batch release | | Bausch Health Ireland Limited, 3013 Lake Drive Citywest Business Campus -, D24 PPT3 Dublin 24, Ireland | | Medicinal product on medical prescription for renewable delivery | | C09BA09 | |
| 104321118 | 29.01.2026 16:15 | | | | | Co-Lisinostad 20 mg/25 mg - Tabletten | | 1-29035 | | nationale Variation human | A.5.a Name/Address of manufacturer, finished product, batch release | B.II.b.1.a Finished Product, manufacturing site | B.II.b.1.b Finished Product, manufacturing site | B.II.b.1.e Finished Product, manufacturing site | B.II.b.2.c.2 Finished Product, manufacture, change batch release details or importer | B.II.b.3.a Finished Product, manufacture, manufacturing process | B.II.e.1.b.1 Finished Product, Container Closure System, type of container | | STADA Arzneimittel Gesellschaft m.b.H., Muthgasse 36/2, 1190 Wien, Österreich | | Arzneimittel zur wiederholten Abgabe gegen aerztliche Verschreibung | | C09BA03 | |
| 104321118 | 29.01.2026 16:15 | | | | | Co-Lisinostad 20 mg/25 mg - Tabletten | | 1-29035 | | variation national - human | A.5.a Name/Address of manufacturer, finished product, batch release | B.II.b.1.a Finished Product, manufacturing site | B.II.b.1.b Finished Product, manufacturing site | B.II.b.1.e Finished Product, manufacturing site | B.II.b.2.c.2 Finished Product, manufacture, change batch release details or importer | B.II.b.3.a Finished Product, manufacture, manufacturing process | B.II.e.1.b.1 Finished Product, Container Closure System, type of container | | STADA Arzneimittel Gesellschaft m.b.H., Muthgasse 36/2, 1190 Wien, Republic of Austria | | Medicinal product on medical prescription for renewable delivery | | C09BA03 | |
| 104367119 | 29.01.2026 15:47 | 1/7/2026 | Einstimmig | Decision | Registration (HOMREG) | Equisetum arvense Remedia Globuli | | 643161 | | new application national - human | | | Remedia Homöopathie Mag. Pharm. Robert Müntz Ges.m.b.H., Hauptstraße 4, 7000 Eisenstadt, Republic of Austria | | Medicinal product not subject to medical prescription | | | |
| 104367119 | 29.01.2026 15:47 | 1/7/2026 | Einstimmig | Bescheid | Registrierung (HOMREG) | Equisetum arvense Remedia Globuli | | 643161 | | nationale Neuzulassung/Registrierung human | | | Remedia Homöopathie Mag. Pharm. Robert Müntz Ges.m.b.H., Hauptstraße 4, 7000 Eisenstadt, Österreich | | Arzneimittel zur Abgabe ohne aerztliche Verschreibung | | | |
| 104460984 | 29.01.2026 15:45 | 1/7/2026 | Einstimmig | Bescheid | Registrierung (HOMREG) | Dioscorea villosa Remedia Globuli | | 643160 | | nationale Neuzulassung/Registrierung human | | | Remedia Homöopathie Mag. Pharm. Robert Müntz Ges.m.b.H., Hauptstraße 4, 7000 Eisenstadt, Österreich | | Arzneimittel zur Abgabe ohne aerztliche Verschreibung | | | |
| 104460984 | 29.01.2026 15:45 | 1/7/2026 | Einstimmig | Decision | Registration (HOMREG) | Dioscorea villosa Remedia Globuli | | 643160 | | new application national - human | | | Remedia Homöopathie Mag. Pharm. Robert Müntz Ges.m.b.H., Hauptstraße 4, 7000 Eisenstadt, Republic of Austria | | Medicinal product not subject to medical prescription | | | |
| 104367141 | 29.01.2026 15:43 | 1/7/2026 | Einstimmig | Decision | Registration (HOMREG) | Artemisia vulgaris Remedia Globuli | | 643157 | | new application national - human | | | Remedia Homöopathie Mag. Pharm. Robert Müntz Ges.m.b.H., Hauptstraße 4, 7000 Eisenstadt, Republic of Austria | | Medicinal product not subject to medical prescription | | | |
| 104367141 | 29.01.2026 15:43 | 1/7/2026 | Einstimmig | Bescheid | Registrierung (HOMREG) | Artemisia vulgaris Remedia Globuli | | 643157 | | nationale Neuzulassung/Registrierung human | | | Remedia Homöopathie Mag. Pharm. Robert Müntz Ges.m.b.H., Hauptstraße 4, 7000 Eisenstadt, Österreich | | Arzneimittel zur Abgabe ohne aerztliche Verschreibung | | | |
| 105044522 | 29.01.2026 13:21 | | | | | Atenolol "Stada" 50 mg Tabletten | | 1-20766 | | variation national - human | C.I.3.a Changes requested by PSUR/PASS/PDWS, no additional data | | STADA Arzneimittel Gesellschaft m.b.H., Muthgasse 36/2, 1190 Wien, Republic of Austria | | Medicinal product on medical prescription for renewable delivery | | C07AB03 | |
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