Stephansplatz 8a 1010 Wien Inverkehrbringer Arzneimittel 482359 Alte Spora Apotheke Mag.pharm. Stephan Öhlzelt KG Wiener Straße 18 3100 St. Pölten Inverkehrbringer Arzneimittel 482321 A-med GmbH Gener [...] Arzneimittel 482918 Aposcience AG Dresdner Straße 87/A 21 1200 Wien Hersteller klinischer Prüfpräparate 483029 Apotheke Abtenau Mag. Planitzer e.U. Markt 253A 5441 Abtenau Inverkehrbringer Arzneimittel 484393 [...] ße 9 2401 Fischamend Inverkehrbringer Wirkstoffe 480601 Chiesi Pharmaceuticals GmbH Gonzagagasse 16/16 1010 Wien Hersteller Arzneimittel, Inverkehrbringer Arzneimittel, PV-System 482872 Competencia Handels

Referenced at:

• Freedom of information
• Pharmaceutical companies

Valid from: 22.04.2025 21/22 6.4 Notification of a new temporary reduction of stock If a temporary reduction of stock occurs again for the same package size of a medicinal product, after the previous reduction [...] size as part of the notification of the end of the reduction of a package size (see 6.2) or as part of the notification of a new reduction of a package size (see 6.4). Guidance notes for the notification of [...] Temporary reduction of stock resulting from the usual circumstances of a rolling warehouse system are not subject to reporting. A notification of the temporary reduction of stock is only possible after

Referenced at:

• FAQ online Service
• National stockpiling
• FAQ National stockpiling
• FAQ National stockpiling
• FAQ National stockpiling

s, the guideline proposes a tailored risk assessment. Phase II: Phase II is divided into two tiers: Tier A and Tier B. Tier A: This tier assesses whether a substance poses a risk to water bodies and soils [...] assessment in a Phase II ERA is necessary. Risk Assessment: A calculation of the Predicted Environmental Concentration (PEC) in surface water is performed. If the PEC value is ≥ 0.01 µg/L, a detailed assessment [...] medicinal product with its consent in the form of a "Letter of Access," or based on publicly available data that allow for a complete and independent assessment. A reference to ERA data from the dossier of the

Up-to-date information from the 27.03.-30.03.2024 meeting on new approvals, extensions of indication, newly published EPAR's and recently started procedures.

The fees valid on the date of application at BASG after 01.08.2021.

Referenced at:

• Fees

in a decentralised procedure (DCP) pursuant to § 18a AMG I.2.a DCP-RMS I.2.a.1 for a new active ingredient 55.969 EURO I.2.a.2 for a known active ingredient 41.416 EURO I.2.b DCP-CMS I.2.b.1 for a new [...] authorisation in a mutual recognition procedure (MRP) pursuant to § 18a Austrian Medicinal Product Act (AMG) I.1.a MRP- RMS - Update I.1.a.1 for a new active ingredient 43.992 EURO I.1.a.2 for a known active [...] for a known active ingredient 7.611 EURO I.3 Marketing authorisation in a national procedure I.3.a Marketing authorisation pursuant to § 9a AMG I.3.a.1 for a new active ingredient 11.978 EURO I.3.a.2 for

Referenced at:

• Fees

volume flow recording. 15. I am a veterinarian and would like to register a TÄ-HAPO. 16. I am a veterinarian and would like to be added to the list of veterinarians who run a pharmacy. Do I have to do something [...] 17. I am a veterinarian and would like to know how to get my TÄ-HAPO identification number. 18. I am a veterinarian and run a TÄ-HAPO. Which general recording obligations apply to me? 19. I am a veterinarian [...] 41. Does a notification also have to be submitted in the case of a RECLASSIFICATION of medicinal products with antimicrobial active substances in context of a therapeutic emergency? 42. Is a dispensing

Nebenwirkungen Alter in Jahren Anzahl Personen unbekannt 394 über 75 292 65-75 134 45-64 5.222 18-44 9.731 16-17 17 Geschlechterverteilung Abbildung 2. Geschlechterverteilung der Personen mit vermuteten Nebenwirkungen [...] konnte aufgrund des Obduktionsberichts ein Zusammenhang mit der Impfung ausgeschlossen werden. Bei 16 Personen fiel die Impfung in die Inkubationszeit einer COVID-19-Erkrankung im Rahmen derer die Bericht [...] (leichtes) Fieber, Abgeschlagenheit, grippeartige Beschwerden, Kopf-, Gelenks- und Gliederschmerzen u.a. sein. Grundsätzlich wird aber jede Meldung aufgenommen, ungeachtet dessen, ob es sich um eine Nebenwirkung

Referenced at:

• Reports COVID-19 Vaccination

C=AT Datum/Zeit-UTC 2011-05-12T11:26:19+02:00 Aussteller-Zertifikat CN=a-sign-corporate-light-02,OU=a-sign-corporate- light-02,O=A-Trust Ges. f. Sicherheitssysteme im elektr. Datenverkehr GmbH,C=AT Serien-Nr [...] GG, Wachter A, Kotz R, and Rainer H: Exposure of oncologic nurses to methotrexate in the treatment of osteosarcoma. Arch Environ Health 51: 310-314, 1996. [3] Jakab MG, Major J, and Tompa A: Follow-up [...] einen Erlass betreffend Schutzmaßnahmen beim Umgang mit Zytostatika verlautbart (BKA-GZ: 61.405/83- VI/A/14/90). Dieser Erlass ist durch die Entwicklung der Medizin und Medizintechnik in vielen Punkten überholt

Referenced at:

• Cytostatics Decree

future EUDAMED. It is not possible to submit a MIR for an accessory or a systems/procedure pack that is not a device in its own right, only a manufacturer of a device or its authorised representative if [...] Annex A level 2 code as "Choice 1". If it is not possible to assign an adequate Annex A level 2 code, select a suitable code of Annex A level 1 as "Choice 1". For some medical device problems, Annex A does [...] if incident date is unknown, please enter a date range when you think the incident occurred. - If this incident is a result of a literature report, please enter a date range similar to the range of the report

Referenced at:

• Medical devices vigilance