The Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) endorsed the Pharmacovigilance Risk Assessment Committee (PRAC) recommendation to revoke the marketing authorisations of fusafungine-containing medicines.
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Fusafungine is a medicinal product with bacteriostatic and anti-inflammatory properties indicated in the treatment of upper respiratory tract infections (rhinopharyngitis, sinusitis, rhino-sinusitis, rhinitis, tonsillitis and laryngitis).
The first marketing authorization was granted in 1963 and fusafungine is marketed in 31 countries worldwide under the following trade names: Bioparox, Fusaloyos, Locabiosol and Locabiotal.
The PRAC considered that, taking into account the mild and self-limiting nature of upper airway diseases (such as blocked nose, cold), the benefits of fusafungine did not outweigh the risk of rare but serious allergic reactions.
In accordance with the CMDh’s position, Les Laboratoires Servier will proceed with the withdrawal of Bioparox, Fusaloyos, Locabiosol and Locabiotal. The withdrawal will be implemented in all concerned countries.
Les Laboratoires Servier will extend this withdrawal measure to Locabiotal distributed in France, which does not contain fusafungine but peppermint oil.
Les Laboratoires Servier, an pharmaceutical group, will send detailed information to healthcare professionals specifying the decision of health European authorities and the practical implications for the management of their patients.
Servier has decided to move some of its production operations from France and Ireland to Turkey. The company will produce around 21 million medicine packages in the next 18 months.
The company plans to increase its annual production capacity through Abdi İbrahim and İlko İlac in Turkey to 32 million packages by 2018, said company management at a press meeting on April 1.
“The production operations of 21 million packages of medicines will be moved to Turkey partly until the end of 2016. The operations will be moved to Turkey in the next 18 months. This figure is equal to some 97 percent of our current sales in Turkey now,” said Servier Turkey chief Philippe Mea.
“In addition to this, we plan to produce an additional five million packages of medicines in our product group, which is to be licensed. By 2018, we will reach a total of 32 million packages of annual production capacity. We can increase this figure if we make exports to the neighboring region,” he noted.
Servier Turkey plans to reach over 200 million Turkish Liras of revenue over this year, said Mea. The company had a number of local contractors producing around 6.23 million medicine pacakges annually until now.
Servier sells cardiology, psychiatry, diabetes and oncology medicines in Turkey.
With Servier transferring its production to Turkey through Turkey’s Abdi İbrahim and İlko İlac, Mea said that İlko İlac will make 11 million liras of investments.
“Turkey’s health system is quite appealing. There are some grounds of challenge in the pricing strategy for us, but we need to balance these two elements,” he said. ■