M2 EQUITYBITES-April 28, 2016-Arch Biopartners receives positive opinion recommending AB569 as orphan medicinal product
M2 PHARMA-April 28, 2016-Arch Biopartners receives positive opinion recommending AB569 as orphan medicinal product
Each medicinal product
that is present in the Slovenian market must have valid marketing authorization and should have set a price.
The court acknowledges that the Italian law in question constitutes a restriction on freedom of establishment because, unlike a pharmacist operating a pharmacy, a pharmacist operating a para-pharmacy cannot sell this type of medicinal product
and is "excluded from the economic benefits accruing from the market for prescription-only medicinal products
A generic medicinal product
is described in Directive 2001/83/EC (as amended by Directive 2004/27/EC) as
In each scenario below, would you consider the combination product a medical device, medicinal product
or equally both?
Only a few months ago BioPartners received marketing authorization for the European Union for Valtropin, a further biosimilar medicinal product
The exact ruling of the ECJ is: "In the case where an application for a marketing authorisation for a medicinal product
is submitted with reference to a medicinal product
that has already been authorised, the medicinal product
which is the subject of the application is imported from a Member State in which it has obtained a marketing authorisation, the assessment of safety and efficacy carried out for the medicinal product
which is already authorised can be used in the application for a marketing authorisation for the second medicinal product
without any risk to public health .
Contract award notice: Invitation to tender for the finished medicinal product
with the active substance duloxetine.
However, RDL 8/2010 will not be applicable to generic medicinal products
and medicines affected by the reference price system for medicinal products
(article 10 Paragraph 1 RDL 8/2010), unless, in this latter case, the medicinal product
forms part of an inactive compound (article 8 Paragraph 3 RDL 8/2010).
M2 PHARMA-October 15, 2010-Allos Therapeutics gets EU Orphan Medicinal Product
designation for pralatrexate in Hodgkin lymphoma(C)2010 M2 COMMUNICATIONS
has announced that the Commission of the European Communities has designated Surfaxin(r) as an Orphan Medicinal Product