Human medicines

IKERVIS 1 mg/ml Augentropfen, Emulsion New

Recall | Medicines | 08/04/2020
Recall due to colourless, instead of milky white emulsion
IKERVIS 1 mg/ml Augentropfen, Emulsion Read more

GinoRing Vaginalring

Recall | Medicines | 12/03/2020
Recall due to increased reports of ring breakage
GinoRing Vaginalring Read more

Coldistan Augentropfen

Recall | Medicines | 03/03/2020
Recall due to particles affecting batches 8234, 8235 und 8236
Coldistan Augentropfen Read more

Tetmodis 25 mg Tabletten

Recall | Medicines | 26/02/2020
Recall due to reduced active ingredient content
Tetmodis 25 mg Tabletten Read more

Picato

Recall | Medicines | 04/02/2020
Recall due to suspension of the marketing authorization
Picato Read more

PSUR-submissions for homeopathic human medicinal products

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.
PSUR-submissions for homeopathic human medicinal products Read more

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.
Colistinsulfat Read more

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.
Nutriflex Omega Emulsion zur Infusion Read more
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