| 102999020 | 30.12.2025 17:56 | 12/26/2025 | Einstimmig | Bescheid | Zulassung nach § 10 (GENA) | Lenvatinib Accord 4 mg Hartkapseln | | 143038 | Lenvima 4 mg capsules hard, Eisai GmbH | MR/DC Neuzulassung/Registrierung human AT=CMS | | | Accord Healthcare B.V., Winthontlaan 200, 3526 KV Utrecht, Niederlande | | Arzneimittel zur einmaligen Abgabe auf aerztliche Verschreibung | | L01EX08 | |
| 102999020 | 30.12.2025 17:56 | 12/26/2025 | Einstimmig | Decision | Authorisation according to Art. 10 (GENA) | Lenvatinib Accord 4 mg Hartkapseln | | 143038 | Lenvima 4 mg capsules hard, Eisai GmbH | new application MR/DC - human AT=CMS | | | Accord Healthcare B.V., Winthontlaan 200, 3526 KV Utrecht, Kingdom of the Netherlands | | Medicinal product on medical prescription for non-renewable delivery | | L01EX08 | |
| 102999023 | 30.12.2025 17:55 | 12/26/2025 | Einstimmig | Decision | Authorisation according to Art. 10 (GENA) | Lenvatinib Accord 10 mg Hartkapseln | | 143039 | Lenvima 10 mg capsules hard, Eisai GmbH | new application MR/DC - human AT=CMS | | | Accord Healthcare B.V., Winthontlaan 200, 3526 KV Utrecht, Kingdom of the Netherlands | | Medicinal product on medical prescription for non-renewable delivery | | L01EX08 | |
| 102999023 | 30.12.2025 17:55 | 12/26/2025 | Einstimmig | Bescheid | Zulassung nach § 10 (GENA) | Lenvatinib Accord 10 mg Hartkapseln | | 143039 | Lenvima 10 mg capsules hard, Eisai GmbH | MR/DC Neuzulassung/Registrierung human AT=CMS | | | Accord Healthcare B.V., Winthontlaan 200, 3526 KV Utrecht, Niederlande | | Arzneimittel zur einmaligen Abgabe auf aerztliche Verschreibung | | L01EX08 | |
| 102035406 | 30.12.2025 13:48 | 12/26/2025 | Einstimmig | Decision | Conditional authorisation according to Art. 10 (GENA) | Ezetimib/Atorvastatin Althera 10 mg/10 mg Filmtabletten | | 143031 | ATOZET, N.V. Organon | new application MR/DC - human AT=CMS | | | Althera Laboratories Limited, D1 Swords Enterprise Park Feltrim Road -, K67 T868 Swords, Ireland | | Medicinal product on medical prescription for non-renewable delivery | | C10BA05 | |
| 102035406 | 30.12.2025 13:48 | 12/26/2025 | Einstimmig | Bescheid | Bedingte Zulassung nach § 10 (GENA) | Ezetimib/Atorvastatin Althera 10 mg/10 mg Filmtabletten | | 143031 | ATOZET, N.V. Organon | MR/DC Neuzulassung/Registrierung human AT=CMS | | | Althera Laboratories Limited, D1 Swords Enterprise Park Feltrim Road -, K67 T868 Swords, Irland | | Arzneimittel zur einmaligen Abgabe auf aerztliche Verschreibung | | C10BA05 | |
| 104341673 | 30.12.2025 10:52 | | | | | Ibuprofen Pfleger 400 mg Filmtabletten | | 135445 | | Variation human AT=CMS | C.I.z Safety, efficacy, pharmacovigilance changes | | Dr. Pfleger Arzneimittel GmbH, Dr.-Robert-Pfleger-Straße 12, 96052 Bamberg, Deutschland | | Arzneimittel zur Abgabe ohne aerztliche Verschreibung | | M01AE01 | |
| 104341673 | 30.12.2025 10:52 | | | | | Ibuprofen Pfleger 400 mg Filmtabletten | | 135445 | | variation - human AT=CMS | C.I.z Safety, efficacy, pharmacovigilance changes | | Dr. Pfleger Arzneimittel GmbH, Dr.-Robert-Pfleger-Straße 12, 96052 Bamberg, Federal Republic of Germany | | Medicinal product not subject to medical prescription | | M01AE01 | |
| 103214981 | 30.12.2025 08:54 | 12/26/2025 | Einstimmig | Decision | Authorisation according to Art. 10 (GENA) | Amlodipin ratiopharm GmbH 10 mg - Tabletten | | 143148 | Norvasc 10 mg tablets, Viatris Healthcare Limited | new application MR/DC - human AT=CMS | | | Teva B.V., Swensweg 5, 2031 GA Haarlem, Kingdom of the Netherlands | | Medicinal product on medical prescription for renewable delivery | | C08CA01 | |
| 103214981 | 30.12.2025 08:54 | 12/26/2025 | Einstimmig | Bescheid | Zulassung nach § 10 (GENA) | Amlodipin ratiopharm GmbH 10 mg - Tabletten | | 143148 | Norvasc 10 mg tablets, Viatris Healthcare Limited | MR/DC Neuzulassung/Registrierung human AT=CMS | | | Teva B.V., Swensweg 5, 2031 GA Haarlem, Niederlande | | Arzneimittel zur wiederholten Abgabe gegen aerztliche Verschreibung | | C08CA01 | |
| 102387511 | 30.12.2025 08:28 | 3/13/2025 | Einstimmig | Decision | Authorisation surrendered | Klean-Prep - Pulver | | 1-20823 | | withdrawal of the marketing authorisation by the MAH - human | | | Norgine GmbH, Im Westpark 14, 35435 Wettenberg, Federal Republic of Germany | | Medicinal product on medical prescription for renewable delivery | | A06AD65 | |
| 102387511 | 30.12.2025 08:28 | 3/13/2025 | Einstimmig | Bescheid | Aufhebung der Zulassung | Klean-Prep - Pulver | | 1-20823 | | Aufhebung der Zulassung human auf Antrag der Firma | | | Norgine GmbH, Im Westpark 14, 35435 Wettenberg, Deutschland | | Arzneimittel zur wiederholten Abgabe gegen aerztliche Verschreibung | | A06AD65 | |
| 104836737 | 30.12.2025 06:28 | | | | | Dophasin Vet 200 000 I.E./ml Injektionslösung für Rinder, Schafe, Ziegen und Schweine | | 842156 | | VET AT=CMS VNRA | C.10.a) Administrative information concerning the holder's representative | | Dopharma Research B.V., Zalmweg 24, 4941 VX Raamsdonksveer, Kingdom of the Netherlands | | Veterinary medicinal product subject to not renewable veterinary prescription | | QJ01FA90 | |
| 104836737 | 30.12.2025 06:28 | | | | | Dophasin Vet 200 000 I.E./ml Injektionslösung für Rinder, Schafe, Ziegen und Schweine | | 842156 | | VET AT=CMS VNRA | C.10.a) Administrative information concerning the holder's representative | | Dopharma Research B.V., Zalmweg 24, 4941 VX Raamsdonksveer, Niederlande | | Veterinärarzneimittel zur einmaligen Abgabe auf aerztliche Verschreibung | | QJ01FA90 | |
| 102035452 | 29.12.2025 16:31 | 12/26/2025 | Einstimmig | Bescheid | Bedingte Zulassung nach § 10 (GENA) | Ezetimib/Atorvastatin Althera 10 mg/40 mg Filmtabletten | | 143033 | ATOZET, N.V. Organon | MR/DC Neuzulassung/Registrierung human AT=CMS | | | Althera Laboratories Limited, D1 Swords Enterprise Park Feltrim Road -, K67 T868 Swords, Irland | | Arzneimittel zur einmaligen Abgabe auf aerztliche Verschreibung | | C10BA05 | |
| 102035452 | 29.12.2025 16:31 | 12/26/2025 | Einstimmig | Decision | Conditional authorisation according to Art. 10 (GENA) | Ezetimib/Atorvastatin Althera 10 mg/40 mg Filmtabletten | | 143033 | ATOZET, N.V. Organon | new application MR/DC - human AT=CMS | | | Althera Laboratories Limited, D1 Swords Enterprise Park Feltrim Road -, K67 T868 Swords, Ireland | | Medicinal product on medical prescription for non-renewable delivery | | C10BA05 | |
| 102035409 | 29.12.2025 16:23 | 12/26/2025 | Einstimmig | Bescheid | Bedingte Zulassung nach § 10 (GENA) | Ezetimib/Atorvastatin Althera 10 mg/20 mg Filmtabletten | | 143032 | ATOZET, N.V. Organon | MR/DC Neuzulassung/Registrierung human AT=CMS | | | Althera Laboratories Limited, D1 Swords Enterprise Park Feltrim Road -, K67 T868 Swords, Irland | | Arzneimittel zur einmaligen Abgabe auf aerztliche Verschreibung | | C10BA05 | |
| 102035409 | 29.12.2025 16:23 | 12/26/2025 | Einstimmig | Decision | Conditional authorisation according to Art. 10 (GENA) | Ezetimib/Atorvastatin Althera 10 mg/20 mg Filmtabletten | | 143032 | ATOZET, N.V. Organon | new application MR/DC - human AT=CMS | | | Althera Laboratories Limited, D1 Swords Enterprise Park Feltrim Road -, K67 T868 Swords, Ireland | | Medicinal product on medical prescription for non-renewable delivery | | C10BA05 | |
| 102035473 | 29.12.2025 15:54 | 12/26/2025 | Einstimmig | Decision | Conditional authorisation according to Art. 10 (GENA) | Ezetimib/Atorvastatin Althera 10 mg/80 mg Filmtabletten | | 143034 | ATOZET, N.V. Organon | new application MR/DC - human AT=CMS | | | Althera Laboratories Limited, D1 Swords Enterprise Park Feltrim Road -, K67 T868 Swords, Ireland | | Medicinal product on medical prescription for non-renewable delivery | | C10BA05 | |
| 102035473 | 29.12.2025 15:54 | 12/26/2025 | Einstimmig | Bescheid | Bedingte Zulassung nach § 10 (GENA) | Ezetimib/Atorvastatin Althera 10 mg/80 mg Filmtabletten | | 143034 | ATOZET, N.V. Organon | MR/DC Neuzulassung/Registrierung human AT=CMS | | | Althera Laboratories Limited, D1 Swords Enterprise Park Feltrim Road -, K67 T868 Swords, Irland | | Arzneimittel zur einmaligen Abgabe auf aerztliche Verschreibung | | C10BA05 | |
| 104903746 | 29.12.2025 15:46 | | | | | Desmopressin Gebro 0,1 mg/ml Nasenspray | | 1-22854 | | MRP/RUP human AT=RMS | | | Gebro Pharma GmbH, Bahnhofbichl 13, 6391 Fieberbrunn, Österreich | | Arzneimittel zur wiederholten Abgabe gegen aerztliche Verschreibung | | H01BA02 | |
| 104903746 | 29.12.2025 15:46 | | | | | Desmopressin Gebro 0,1 mg/ml Nasenspray | | 1-22854 | | MRP/RUP - human AT=RMS | | | Gebro Pharma GmbH, Bahnhofbichl 13, 6391 Fieberbrunn, Republic of Austria | | Medicinal product on medical prescription for renewable delivery | | H01BA02 | |
| 103099700 | 29.12.2025 15:35 | 12/26/2025 | Einstimmig | Decision | Authorisation according to Art. 10 (GENA) | Allopurinol !$tada 300 mg Tabletten | | 143143 | Zyloric 100 mg Tablets, Aspen Pharma Trading Limited | new application MR/DC - human AT=CMS | | | STADA Arzneimittel Gesellschaft m.b.H., Muthgasse 36/2, 1190 Wien, Republic of Austria | | Medicinal product on medical prescription for renewable delivery | | M04AA01 | |
| 103099700 | 29.12.2025 15:35 | 12/26/2025 | Einstimmig | Bescheid | Zulassung nach § 10 (GENA) | Allopurinol !$tada 300 mg Tabletten | | 143143 | Zyloric 100 mg Tablets, Aspen Pharma Trading Limited | MR/DC Neuzulassung/Registrierung human AT=CMS | | | STADA Arzneimittel Gesellschaft m.b.H., Muthgasse 36/2, 1190 Wien, Österreich | | Arzneimittel zur wiederholten Abgabe gegen aerztliche Verschreibung | | M04AA01 | |
| 103099669 | 29.12.2025 15:34 | 12/26/2025 | Einstimmig | Decision | Authorisation according to Art. 10 (GENA) | Allopurinol !$tada 200 mg Tabletten | | 143142 | Zyloric 100 mg Tablets, Aspen Pharma Trading Limited | new application MR/DC - human AT=CMS | | | STADA Arzneimittel Gesellschaft m.b.H., Muthgasse 36/2, 1190 Wien, Republic of Austria | | Medicinal product on medical prescription for renewable delivery | | M04AA01 | |
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