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AMK Meldungen

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Die Meldungen der Arzneimittelkommission sind Fachinformationen, die nur bestimmten Berufsgruppen zur Verfügung gestellt werden können. Apotheker finden die notwendigen Zugangsdaten in jeder Druckausgabe der PZ online in der Rubrik AMK-Nachrichten.

  Meldungen der Arzneimittelkommission

AM-Rückruf Klasse 1

13.08.2018

Rapid Alert Notification of a Quality Defect

Rapid Alert Notification of a Quality Defect
RAN-I-Meldung – Thiopental Rotexmedica

Product Recall Class of Defect:
I

Falsification/Fraud (specify)*:
--

Product:
Thiopental Rotexmedica

Marketing Authorisation Number:*
For use in humans

Brand/Trade Name:
Thiopental Rotexmedica 1000 mg Pulver zur Herstellung einer Injektionslösung
Thiopental Rotexmedica 500mg Pulver zur Herstellung einer Injektionslösung

INN or Generic Name:
Thiopental

Dosage Form:
powder for injection

Strength:
1000mg or 500 mg

Batch number (and bulk, if different):
n/a

Expiry Date:
n/a

Pack size and Presentation:
10

Date Manufactured:*
--

Marketing Authorisation Holder: *
Rotexmedica GmbH Arzneimittelwerk, Bunsenstraße 4, D-22946 Trittau

Manufacturer:
1. Sterile API:
Lamugnani Farmaceutici S.p.A.
Via Gramsci 4, I-20014 Nerviano
2. Finished Product + Release
Panpharma S.A.
10 Rue de Chenot,
F-56380 Beignon
Contact Person: -
Telephone: -

Concerned MAH
Rotexmedica GmbH Arzneimittelwerk,
Bunsenstraße 4,
D-22946 Trittau
Contact Person:
Dr. Karnatz
Telephone: +49 (0)4154 862 200

Recall Number Assigned (if available):
--

Details of Defect:
Due to the non-GMP-compliance statement of AIFA for the sterile API manufacturer Lampug-nani Pharmaceutici of July 17th 2018 (Eudra-GMP Database Report No.: IT/NCR/API//1/2018) there is a risk of unsterility of the product.

Information on distribution including exports (type of customer, e. g. hospitals):*
Wholesalers and hospitals

Action taken by Issuing Authority:
The Agency and BfArM have evaluated the situation with regard to the treatment of patients with special needs and decided not to perform any recall but to restrain further distribution only to hospitals for patients with special needs (esp. intracranial pressure and pediatric anesthe-sia).

Proposed Action:
Information of physicians with a separate leaflet as hand-out and distribution only directly to hospitals.

From (Issuing Authority):
Landesamt für soziale Dienste Schleswig-Holstein
Abteilung Gesundheits- und Verbraucherschutz
Dezernat 31 Arzneimittelüberwachung
Adolf-Westphal-Straße 4
24143 Kiel

Contact Person:
Dr. Beate Reutter
Telephone:
+49 (0)431 988 5549
beate.reutter@lasd.landsh.de

Signed:
Dr. Beate Reutter

Date:
13.08.2018


Update nach Mitteilung vom Hessischen Ministerium für Soziales und Integration vom 14.08.2018:
Betroffen ist auch das Präparat Thiopental Inresa.

 

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09.08.2018

Rapid Alert Notification of a Quality Recall

Rapid Alert Notification of a Quality Recall
RAN-I-Meldung – Robinul® zur Injektion 0,2 mg/ml

Product Recall Class of Defect:
I

Falsification/Fraud (specify):
no

Product:
Robinul® zur Injektion 0,2 mg/mL,
solution for injection

Marketing Authorisation Number:
6739722.00.00
For use in humans

Brand/Trade Name:
Robinul® zur Injektion 0,2 mg/ml

INN or Generic Name:
Glycopyrronium Bromide

Dosage Form:
Solution for injection

Strength:
0,2 mg/mL

Batch number (and bulk, if different):
a) D1K11
b) D1K14
c) D1L01
d) D1K13 (Austria- MAH Chiesi
    Phamaceuticals GmbH)

Expiry Date:
a) 08.2019
b) 10.2019
c) 01.2020
d) 10.2019

Pack size and Presentation:
a) 5x1 ml, solution for injection
b) 2x5x1 ml, solution for injection
c) 2x5x1 ml, solution for injection
d) 5x1 ml, solution for injection

Date Manufactured:
a) 08.12.2016
b) 01.02.2017
c) 24.03.2017
d) 16.01.2017

Marketing Authorisation Holder:
RIEMSER Pharma GmbH, An der Wiek 7, 17493 Greifswald-Insel Riems, Germany

Manufacturer:
Kern Pharma, S.L.
Venus, 72
8228 Terrassa (Spain)

Prestige Promotion
Lindigstraße 6
63801 Kleinostheim
(secondary packaging only)

Recalling Firm (if different):
RIEMSER Pharma GmbH, Germany
Contact Person:
Mrs Dr. Sabine Hertwig
Telephone: +49 30 338 427 625

Recall Number Assigned (if available):
AMKI 32/18, LAGuS 226/2018

Details of Defect/Reason for Recall:
cracks in the ampoule glass and leaking product; As a possible cause inadequate glass quality of an ampoule batch was identified.
Product produced with other batches of ampoules are available for the market after additional integrity checks.

Information on distribution including exports (type of customer, e. g. hospitals):
distribution to pharmacies and wholesalers in Germany, export to Austria (MAH Chiesi Phamaceuticals GmbH)

Action taken by Issuing Authority:
Recall of defective product-batches on wholesale-distribution- & pharmacy level by German MA-holder (see 16.), surveillance of the recall

Proposed Action:
- Follow-up at manufacturer/batch-release site (Kern Pharma, Spain) by the competent authority in Spain and the MAH

From (Issuing Authority):
Landesamt für Gesundheit und Soziales
Mecklenburg-Vorpommern
Arzneimittelüberwachungs- und -prüfstelle
Wismarsche Straße 298
19055 Schwerin
GERMANY

Contact Person:
Mr. Dr. Andreas Schieweck
Telephone:
+49 385 588 59 390

Signed:
Andreas Schieweck

Date:
08/Aug/2018

Time:
11:00 AM

 

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