29.01.2024
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FAQ Variation submissions
Frequently asked questions about online variation submissions are answered here.
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02.01.2024
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Flat fees for database search
Hosting of the ABDA database at BfArM was discontinued on January 1st, 2024.
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11.01.2024
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Frequently asked questions
FAQ
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14.05.2024
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Further Information
Further Information
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07.06.2024
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German Act to Combat and Improve the Supply of Medicines
The Arzneimittel-Lieferengpassbekämpfungs- und Versorgungsverbesserungsgesetz (ALBVVG) was published on 26 July 2023 in the Federal Law Gazette (Bundesgesetzblatt).
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18.01.2024
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GHPP PharmTrain2 fellowship workshop: together towards clinical expertise
GHPP PharmTrain2 fellowship workshop: together towards clinical expertise
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18.01.2024
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GHPP PharmTrain2 workshop - joint guideline development for West Africa and beyond
GHPP PharmTrain2 workshop - joint guideline development for West Africa and beyond
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25.03.2024
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Guidelines
Guidelines
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25.03.2024
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Harmonisation
Harmonisation
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27.03.2024
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Hotels around BfArM
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03.06.2024
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ICD-11
ICD-11 2018 version is released on 18 June 2018 and was adopted by the WHA72 in May 2019.
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03.07.2024
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Index of European Pharmacopoeia 11.6
Index of European Pharmacopoeia 11.6
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02.05.2024
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Information Iris Webinar - May 2024
Information Iris Webinar - May 2024
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19.04.2024
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Information Letter on Aptivus 250 mg soft capsules: Missing or barely readable capsule imprint
Active substance: tipranavir
The company Boehringer Ingelheim Pharma GmbH & Co. KG informs that batch 308715 of the medicinal product Aptivus 250 mg soft capsules (120 capsules per bottle) may contain capsules with only a faint imprint “TPV 250” or without this imprint at all.
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23.05.2024
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Information letter on Carmubris powder and solvent for solution for infusion: incorrect labeling
Active substance: carmustine
The company TILLOMED PHARMA GmbH informs about an incorrect labeling of three batches of the medicinal product Carmubris powder and solvent for solution for infusion
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01.03.2024
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Information Letter on Spiolto Respimat: Possibly defective dose indicator
Active substance: tiotropium bromide/olodaterol hydrochloride
The company Boehringer Ingelheim Pharma GmbH & Co. KG informs about possibly defective dose indicators in two batches of the medicinal product Spiolto Respimat 2.5 micrograms/2.5 micrograms.
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14.02.2024
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Information ONS dictionary ICD-11
Information ONS dictionary ICD-11
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14.02.2024
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Iris and ICD-11
Iris and ICD-11
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19.01.2024
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Iris User Group Meeting – Dates have changed
As a result of necessary changes in the planning of meeting rooms the dates of the next Iris user group meeting have changed.
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06.06.2024
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Iris User Manual V5.8.3
Iris User Manual V5.8.3
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