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The list of medicines recommended to remain on the market is available here. The Agency also recommended that medicines not yet authorised but which are being evaluated on the basis of bioequivalence studies from these sites should not be authorised until bioequivalence is demonstrated using alternative data.

Micro Therapeutic Research Labs is a contract research organisation CRO which conducts the analytical and clinical parts of bioequivalence studies, some of which are used to support marketing authorisation applications of medicines in the EU.

The review of medicines studied by Micro Therapeutic Research Labs was started after inspections to check compliance with good clinical practice GCP by Austrian and Dutch authorities in February The inspections identified several concerns at the company's sites regarding misrepresentation of study data and deficiencies in documentation and data handling.

However, there is no evidence of harm or lack of effectiveness of medicines authorised and being evaluated in the EU on the basis of studies at the sites.

Some of the medicines which have been recommended for suspension may be of critical importance e. Therefore national authorities can temporarily postpone the suspension in the interest of patients.

Member States should also decide whether recalls of the affected medicines are needed in their territories. The CHMP 's recommendation concerning these medicines will now be sent to the European Commission for a legally binding decision valid throughout the EU.

The review covered one medicine authorised centrally through EMA Tadalafil Mylan , as well as medicines authorised by national procedures in EU Member States including decentralised or mutual recognition procedures , whose marketing authorisation applications included data from studies conducted by Micro Therapeutic Research Labs at two sites in India:.

The review also included ongoing marketing authorisation applications for medicines which use study data from these sites. The review was carried out by the Committee for Medicinal Products for Human Use CHMP , responsible for all questions concerning medicines for human use, which has adopted its opinion.

EMA Press office Tel. Skip to main content. Human regulatory Overview Research and development Marketing authorisation Post-authorisation Herbal products.

Veterinary regulatory Overview Research and development Marketing authorisation Post-authorisation. Medicines where suitable alternative data are available can remain on market The European Medicines Agency EMA has recommended suspending a number of nationally approved medicines for which bioequivalence studies were conducted by Micro Therapeutic Research Labs at two sites in India.

Information for patients and healthcare professionals A number of medicines for use in the EU were approved based on studies carried out at two Micro Therapeutic Research Labs sites in India.

The studies are unreliable because of problems in the way data and documents were managed at the sites. As a result, several medicines approved in the EU have been suspended.

There is currently no evidence of unexpected harm or lack of effectiveness with any medicine approved on the basis of studies conducted at Micro Therapeutic Research Labs.

The band participated in an omnibus in , but did not officially form until the next year. In , the band traveled to Europe and released an album there.

In , Kisaki Project resumed activities, performing live and releasing music once again. In , Kisaki Project officially disbanded at the same time as Phantasmagoria "sealed" activities.

This lineup released two demo CDs, a single that came with a DVD, and a mini-album containing all of this era's material. From Wikipedia, the free encyclopedia.

For the village in Tanzania, see Kisaki, Tanzania. This biography of a living person needs additional citations for verification. Please help by adding reliable sources.

Contentious material about living persons that is unsourced or poorly sourced must be removed immediately , especially if potentially libelous or harmful.

Dark rock alternative rock pop rock progressive rock. Musician record producer composer. Bass keyboards. La:Sadie's Phantasmagoria Anti Feminism. Insert between pages Shattered Tranquility.

Retrieved 8 June Authority control MusicBrainz : fdf4ab2ea-5f3ee9c0ca Categories : Japanese bass guitarists Visual kei musicians Japanese record producers births Living people Musicians from Wakayama Prefecture 21st-century bass guitarists.

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