17.07.2019 Tarihli ve e.111657 sayılı Oksimetazolin ve Ksilometazolin İçeren Preparatlar_ENG

MINISTRY OF HEALTH OF THE REPUBLIC OF TURKEY Medicines and Medical Devices Agency of Turkey

Number : 62820468-000-E.111657 Subject : Preparations Containing Oxymetazoline and Xylometazoline NORMAL

17.07.2019

DOSSIER

The preparations containing Oxymetazoline and Xylometazoline have been evaluated by the “Clinical Evaluation Commission on Medicinal Products for Human Use”.

In accordance with the decision adopted;

• The association decision dated 10.04.2018, with No. 24533, on “Cold and Cough Medicines”, the decision dated 07.07.2008, with No. 43710, on “Preparations Containing Phenylephrine, Ephedrine, Pseudoephedrine, Oxymetazoline and Xylometazoline”, the decision dated 16.03.2010, with No. 20514 on “Preparations Containing Oxymetazoline and Xylometazoline” and the decision dated 23.07.2013, with No. 80969, on “Medicines Used in Cold and Cough Treatment” have been annulled.

• Generally, the amount of active substance in nasal topical decongestant products should not surpass 0.025% for oxymetazoline and 0.05% for xylometazoline in pediatric use.

• It is necessary to review and standardize the indication, posology and warnings/precautions sections on the pediatric use of oxymetazoline (0.025%) in accordance with statements suitable for the following pediatric age groups. a) It is contraindicated for children below the age of 2 years. b) It should not be used in children aged between 2-6 years (age interval of 2 years and above to 6 years). c) The statement reading “It may be used provided that a benefit/risk assessment is made by the physician” should be included to the warnings/precautions section of the product’s SPC/PL for children aged between 6-12 years (age interval of 6 years and above to 12 years).

• It is necessary to review and standardize the indication, posology and warnings/precautions sections on the use of 0.05% form of oxymetazoline in accordance with statements suitable for the following age groups.

• a) It is contraindicated for children below the age of 6 years.

• b) It should not be used in children aged between 6-12 years (age interval of 6 years and above to 12 years). c) The statement reading “It may be used in adequate age groups in children provided that a benefit/risk assessment is made by the physician” in the warnings/precautions section of the product’s SPC/PL in children aged between 6-12 years (age interval of 6 years and above to 12 years).

• It is necessary to review and standardize the indication, posology and warnings/precautions sections on the pediatric use of xylometazoline (0.05%) in accordance with statements suitable for the following pediatric age groups. a) It is contraindicated for children below the age of 2 years.

• b) It should not be used in children aged between 2-6 years (age interval of 2 years and above to 6 years). c) The statement reading “It may be used provided that a benefit/risk assessment is made by the physician” in the warnings/precautions section of the product’s SPC/PL in children aged between 6-12 years (age interval of 6 years and above to 12 years).

• It is necessary to review and standardize the indication, posology and warnings/precautions sections on the use of 0.1% form of xylometazoline in accordance with statements suitable for the following age groups.

• a) It is contraindicated for children below the age of 6 years.

• b) It should not be used in children aged between 6-12 years (age interval of 6 years and above to 12 years). c) The statement reading “It may be used in adequate age groups in children provided that a benefit/risk assessment is made by the physician” should be added to the warnings/precautions section of the product’s SPC/PL.

• All nasal topical decongestant products containing the active substances Oxymetazoline and Xylometazoline, including the products with an active substance amount lower than those specified above are contraindicated for children below the age of 2 years.

I hereby would like to inform you and kindly request that any views, proposals and remarks regarding the decision adopted should be submitted to the Clinical Evaluation Unit until 16.08.2019 and that no application is made to the Pharmacological Evaluation Unit regarding products containing topical corticosteroid within the referred period.

Spec. Pharm. Hacer COŞKUN ÇETİNTAŞ on behalf of the President of the Agency
Head of Department

Distribution: Association of Research-Based Pharmaceutical Companies Pharmaceutical Manufacturers Association of Turkey Turkish Pharmaceutical Industry Association Association of Innovator Pharmaceutical Companies Self-Care Products Association

RESTRICTED

Effective as of 2023

MINISTRY OF HEALTH OF THE REPUBLIC OF TURKEY Medicines and Medical Devices Agency of Turkey

Number : 77893119-000-E.188534 Subject : Products with the active substance Aripiprazole

NORMAL 30.10.2018

DOSSIER

The literature annexed to the objections received from companies regarding the association announcement entitled “Products with the active substance Aripiprazole”, dated 28.02.2018, with No. E.39828, has been evaluated by the “Clinical Evaluation Commission on Medicinal Products for Human Use” and it has been decided to annul the referred association decision.

It is necessary to amend the indications section of the medicinal products for human use containing the active substance “Aripiprazole” as follows: “It is indicated as an add-on therapy for enhancing antidepressant therapy in major depression patients who are resistant to antidepressant therapy.”

I hereby submit for your information and kindly request that the SPC/PL applications for the products in which abovementioned changes are made are submitted to the Pharmacological Evaluation Unit until 12.11.2018 for review.

         Dr. Hakkı GÜRSÖZ 

President of the Agency

Distribution: Association of Research-Based Pharmaceutical Companies Pharmaceutical Manufacturers Association of Turkey Turkish Pharmaceutical Industry Association Association of Innovator Pharmaceutical Companies Self-Care Products Association