Printed 23/05/2012

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Authorisation and supervision

News about supervision and inspection

24 April 2012

The EDQM has withdrawn the Certificate of Suitability for the active substance Acetylsalicylic acid

EDQM, the European Directorate for the Quality of Medicines and Healthcare, has withdrawn the following Certificate of Suitability (CEP): R0-CEP 2006-195-Rev 00 / Acetylsalicylic acid.
24 April 2012

The EDQM has suspended the Certificate of Suitability for the active substance Stanozolol Micronised

EDQM, the European Directorate for the Quality of Medicines and Healthcare, has suspended the following Certificate of Suitability (CEP): R1-CEP 2002-222-Rev 01 / Stanozolol Micronised.
24 April 2012

The EDQM has withdrawn the Certificate of Suitability for the active substance Oxaliplatin
18 April 2012

The EDQM has withdrawn Certificates of Suitability for the active substance Diclofenac Sodium
17 April 2012

The EDQM has withdrawn or suspended Certificates of Suitability from Aarti Drugs Limited
17 April 2012

The EDQM has withdrawn Certificates of Suitability from CSPC Innovation Pharmaceutical Co., Ltd.
11 April 2012

The EDQM has suspended the Certificate of Suitability for the active substance Trimetazidine dihydrochloride
28 March 2012

The EDQM has suspended the Certificates of Suitability for the active substances Pilocarpine nitrate and Pilocarpine hydrochloride
22 March 2012

Danish package leaflet database checked for statutory uploads
29 February 2012

Compliance check of package leaflets and product labelling (winter 2012)
23 February 2012

The EDQM has suspended the Certificates of Suitability for the active substances theophylline, theophylline-ethylenediamine anhydrous and caffeine
07 February 2012

The EDQM has suspended the Certificate of Suitability for the active substance trimetazidine dihydrochloride
07 February 2012

The EDQM has suspended the Certificate of Suitability for the active substance erythromycin
02 January 2012

The EDQM has suspended the Certificate of Suitability for a number of active substances
21 December 2011

Recall of Vistide® deliveries causes no supply issues
12 December 2011

No supply problems caused by recall of batches of Luminity® and Ecalta®
23 November 2011

The use of Caelyx® should be limited due to quality issue
23 November 2011

No supply problems caused by recall of batches of Busilvex®, Velcade® and Vidaza®
21 November 2011

Withdrawal of a medicine due to possible counterfeiting
09 November 2011

Requirement for raised dots led to recalls after spot checks

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