MirZnaet.ru

Лучшее из переведенного

Decision of refusal to amendments to documents contained in Registration Dossier for registered medicinal product for medical use просмотров: 1976

MINISTRY OF HEALTH


AND SOCIAL DEVELOPMENT


OF THE RUSSIAN FEDERATION


(Minzdravsocrazvitia Rossii) 


 


Rakhmanovskiy pereulok, 3/25,


127994, Moscow, Official Municipal Post-4.


Tel.: +7 495 628-44-53;


Fax: 7 495 628-50-58


 


Date: May 15, 2012


 


Ref No: 31-3-417701


 


In reply response to your letter No___ of___


           


Recipient: OOO (Limited liability Company) "UCB Pharma", Moscow, 105082, Perevedenovsky pereulok, 13, bidg. 21.


 


 Decision of refusal to amendments to documents contained in Registration Dossier for registered medicinal product for medical use


 


 Ministry of Health and Social Development of the Russian Federation, on the basis of the documents and data, in accordance with Article 30 of the Federal Law No.61-FZ “On the circulation of drugs” dated April 12, 2010, has made a decision to refuse to amend the documents contained in the registration dossier for a registered drug for medical use


 


Xyzal


(Trade name of medicinal drug)


 


levocetirizine


(International nonproprietary or chemical name of medicinal drug)


 


5 mg/ml oral drops, solution


(Dosage form, dosage)


 


UCB Farchim S.A., Italy, Via Praglia, 15, 1-10044, Pianezza, Italy


(Manufacturer’s name and place of manufacturing of the drug)


 


UCB Farchim S.A., Switzerland


Chemin de Croix Blanche 10, CH – 1630, Bulle, Switzerland


(Name and address of the entity/ marketing authorization holder)


 


LCE-001308/08 from August 29, 2008


(Number of marketing authorization, registration date)


 


LCE -001308/08-290808


(Normative documents)


 


The reason for refusal to amendments to documents contained in the Registration Dossier for registered medicinal product for medical use is a conclusion of an expert committee on the results of examination of relationship of expected benefit with possible risks of use of medicinal product for medical use.


Based on clinical data changes are written in the sections of the Package Leaflet: "Side Effects" (write in additional side effects are written in), "Indications for use" (extension of indications - urticaria, use in children aged 6 months). In addition, "Pregnancy” is removed from the section "Contraindications". In the section "Use in pregnancy and lactation" it is formerly stated that "… levocetirizine should not be used during pregnancy" while in the represented edition - "... you must be careful by prescription ...".


 In the section "Interaction with other drugs" interaction between cetirizine and ritanovir is added. In the section "Dosage and administration" the dosing regimen in children 6 to 12 months is added, treatment regimen by hay fever and chronic conditions is removed. In the company files there is no argumentation for the change of this information. Expert evaluation of the results of several clinical studies of the drug was conducted. The studies were conducted with the purpose of evaluation of safety of levocetirizine in children aged 6 months up to 6 years suffering from seasonal and/or perennial allergic rhinitis and chronic idiopathic urticaria. Results of studies have shown that Xyzal® was well tolerated; the incidence of adverse events was similar to that of placebo.


By the pharmacokinetics study it was found out that administration of levocetirizine in a dose of 1.25 mg once a day for children from 6 months up to 11 months and 1.25 mg 2 times a day at age from 1 year to 5 years obtains drug concentration in plasma similar to that of adults. Effectiveness and safety are confirmed, one will be able to judge about absence of change in the relationship of expected benefit with possible risks of use taking into account the changes made after taking into account notes on the Package Leaflet’s project. As a result of examination it is necessary:


 


1.      Edit indications in the section "Indications” according to the results of clinical studies and information from the site of FDA.


 


2.      In the section "Dosage and administration" section to edit dosing regimen depending on age according to the results of clinical studies and information from FDA site; treatment regimen by hay fever and chronic conditions is removed.


 


3.      In the section "Contraindications" to justify the removal of contraindication "pregnancy" in the text.


 


4.      In the section "Pregnancy and lactation" to entitle the section "Application by pregnancy and during breast-feeding" and place it after the section "Precautions". In the company files there is no argumentation for alteration of the information available. Previously, "... levocetirizine should not be        prescribed by pregnancy", now -" ... you must be careful by prescription of ...".


 


5.      To issue section «Precautions" in a separate field labeled "Precautions", place it after the section "Contraindications" and insert there information from the "Precautions": chronic kidney insufficiency (correction of dosage regimen is necessary), elderly age (may decrease glomerular filtration rate).


 


6.      In the section "Side Effects" to correct "... heartbeat ..." and change it for ... palpitations.


 


7.      To place section "Overdose" after the section "Side Effects”.


 


8.      In the section "Interaction with other drugs" to correct "with antipyrine" and change it ... with phenazone (antipyrine).


 


9.      To entitle the section "Caution", place it after the section "Interaction with other drugs" and move information from the section "Precautions".


 


Taking the information written above into account, to make changes into documents contained in the Registration Dossier for the registered medicinal product Xyzal® 5 mg/ml oral drops, solution, manufactured by the company UCB Farchim SA, Switzerland, is not possible.


 


 


Director of the Department of state regulation of circulation of medicines:       


 


M. R. Sakayev (signed)


 


State seal of the Ministry of Health and Social Development of the Russian Federation


 


 

- 0 +    дата: 4 апреля 2014

   Загружено переводчиком: Агафонычев Владимир Александрович Биржа переводов 01
   Язык оригинала: русский    Источник: MINISTRY OF HEALTH AND SOCIAL DEVELOPMENT OF THE RUSSIAN FEDERATION (Minzdravsocrazvitia Rossii)