Human medicines

Picato

Recall | Medicines | 04/02/2020
Recall due to suspension of the marketing authorization
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PSUR-submissions for homeopathic human medicinal products New

Medicines | 16/12/2019
Marketing authorisation holders of homeopathic human medicinal products are informed that from 01.01.2020 [i.e. from the Data Lock Point: 30.09.2019] no further PSUR submissions are necessary, unless they are ordered by the BASG on a case-by-case basis.
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Colistinsulfat

Recall | Medicines | 06/12/2019
The manufacturer informed its customers on 04 December, 2019, that the stated value of the active pharmaceutical ingredient content was too high.
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Chloramphenicol micronised

Recall | Medicines | 06/12/2019
The manufacturer informed its customers on 03 December, 2019, that the listed batches of active pharmaceutical ingredients are recalled as a precautionary measure due to the withdrawal of the manufacturer's certificate of the Indian original manufacturer "Mehta API Pvt. Ltd.".
Chloramphenicol micronised Read more

Ulsal Brausetabletten, Filmtabletten, Ampullen

Recall | Medicines | 20/11/2019
Die Zulassungsinhaberin hat die belieferten Kundinnen und Kunden mit Schreiben vom 20.11.2019 informiert, dass aufgrund von eingeleiteten Untersuchungen auf europäischer Ebene eine Verunreinigung des Wirkstoffes Ranitidin mit N-Nitrosodimethylamin (NDMA) bei oben angeführten Zulassungen von Ulsal nicht ausgeschlossen werden kann.
Ulsal Brausetabletten, Filmtabletten, Ampullen Read more

Nutriflex Omega Emulsion zur Infusion

Recall | Medicines | 29/10/2019
The marketing authorisation holder informed its customers on October 29, 2019 that some of the three-chamber bags show deviations in pH value, colouring and emulsion quality.
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Ulsal lösliche Tabletten

Recall | Medicines | 24/10/2019
The marketing authorisation holder informed its customers on October 24, 2019 that a review of ranitidine medicines after tests showed that below mentioned batches may contain an impurity called N-nitrosodimethylamine (NDMA).
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Ranitidin STADA

Recall | Medicines | 24/10/2019
The marketing authorisation holder informed its customers on October 24, 2019 that a review of ranitidine medicines after tests showed an impurity called N-nitrosodimethylamine (NDMA).
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Avonex

Recall | Medicines | 23/10/2019
The marketing authorisation holder informed its customers on October 22, 2019 that following out-of-specification results during manufacturing below mentioned batches are recalled as a precautionary measure.
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Ranitidin Accord

Recall | Medicines | 26/09/2019
The marketing authorisation holder informed its customers on September 26, 2019 that a review of ranitidine medicines after tests showed an impurity called N-nitrosodimethylamine (NDMA).
Ranitidin Accord Read more
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