sábado, 25 de abril de 2009

European Medicines Agency - Human Medicines - Referrals - Article 30 - 'SPC harmonisation' referrals

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European Medicines Agency - Human Medicines - Referrals - Article 30 - 'SPC harmonisation' referrals

Human Medicines - Referrals
List of Referrals - Article 30 - 'harmonisation' referrals

Article 30 of Directive 2001/83/EC as amended states that ‘ if two or more applications …have been made for marketing authorisation for a particular medicinal product, and if Member States have adopted divergent decisions …, a Member State, the Commission or the applicant or the marketing authorisation holder may refer the matter to the CHMP’. The same article also makes provision for the coordination group (CMD) to propose a list on a yearly basis of products to be harmonised. See here for the current work list produced by the CMD(h).

Prior to 2001, this type of referral was known as an article 11 referral (referring to article 11 of Council Directive 75/319/EEC as amended).

At the end of the referral, the CHMP opinion will contain a recommendation for a harmonised set of prescribing information documents (SPC, labelling and package leaflet).

Medicinal products
Date of publication
Approved name
INN/common name (s)

24/04/09 Tritace ramipril
14/04/2009 Tritazide ramipril and hydrochlorothiazide
12/03/2009 Diovan valsartan
19/12/2008 Efexor depot venlafaxine
18/12/2009 Efexor venlafaxine
12/11/2008 Risperdal risperidone
23/10/2008 Ciprofloxacin Bayer ciproflaxin
22/10/2008 Risperdal Consta risperidone
16/10/2008 Zyrtec certirizine
13/10/2008 Remeron mirtazapine
06/10/2008 Gemzar gemcitabine
25/09/2008 Cozaar Comp losartan + hydrochlorothiazide
25/09/2008 Cozaar losartan
08/09/2008 Lamictal lamotrigine
05/08/2008 Singulair Montelukast
28/09/2007 Xefo lornoxicam
20/12/2006 Agopton lansoprazole
06/09/2006 Neurontin gabapentin
05/09/2006 Prozac fluoxetine
14/07/2006 Stamaril live attenuated yellow fever virus
16/05/2006 Prograf tacrolimus
09/08/2005 Calcium Sandoz calcium carbonate
18/08/2004 Lopid gemfibrozil
09/08/2004 Zestril lisinopril
09/06/2004 Zocord simvastatin
13/05/2004 Pravachol pravastatin
21/01/2004 Calcichew D3 calcium 500 mg / cholecalciferol 10 µg
21/01/2004 Calcichew D3 mite calcium 500 mg / cholecalciferol 10 µg
21/01/2004 Calcitugg calcium carbonate
23/12/2003 Coversyl perindopril
01/12/2003 Renitec enalapril
01/12/2003 Roaccutane isotretinoin
14/08/2003 Lederfoline calcium folinate
12/11/2002 Leponex clozapine
17/10/2002 Motilium domperidone
19/09/2002 Ecazide captopril/hydrochlorothiazide
16/09/2002 Hypnovel midazolam
25/07/2002 Floxyfral fluvoxamine

Article 11
06/02/2001 Glucophage metformin hydrochloride
28/08/2000 Engerix B hepatitis B vacine

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