17.06.2019 Tarihli Demir İçeren Ürünler hk._ENG

RESTRICTED

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

Number : 62820468-000-E.94242 Subject : Products Containing Iron NORMAL

17.06.2019

DOSSIER

The products containing the active substance iron and the announcements to Associations published in relation with these products have been evaluated by the “Clinical Evaluation Commission of Medicinal Products for Human Use” and applications shall be submitted as indicated below:

Revoked Association Announcements Effective Association Announcements Dated 20.04.2007, with No. 22690 Dated 09.09.2015, with No. 112245 Dated 24.06.2010, with No. 46862 Dated 22.09.2017, with No. E. 188954 Dated 16.11.2016, with No. 151061 Dated 26.11.2018, with No. 204551

Pregnancy Category of Preparations Containing Iron: • Pregnancy category of oral iron preparations shall be A, • Depending on the active substance content, the pregnancy category of parenteral iron preparations shall be B or C; thus, the categories of the preparations containing iron and currently available in Turkey shall be as follows: o Iron hydroxy/sucrose – category B o Ferric gluconate – category B o Iron carboxy maltose – category C o Iron isomaltoside – category C o Low molecular weight iron dextran – category C o Iron hydroxy polymaltose – category C, • Different category information in different trimesters seen in some of the current SPCs and PLs in the pregnancy categories of iron preparations shall be revised, “trimester-specific category information shall not be indicated”; abovementioned categories shall be revised to comprise all trimesters, • A standard statement similar to the one provided below shall be used for all medicines right below the section where the pregnancy category is specified in the SPC regardless of the category, the referred text shall be presented in a framed box for medicines in categories C, D and X, o The final decision to be adopted by a physician on whether a medicine will be used by a pregnant patient regardless of her pregnancy category shall be taken by making a detailed benefit-risk assessment based on the week of pregnancy, existing/identified disease of the pregnant patient and other characteristics. o Although the risk categories provide guidance to the healthcare personnel on the potential risks during pregnancy, the assessment of the physician shall be taken as basis.

For parenteral iron preparations: The following statements shall be added to the sections on indications in the Summary of Product Characteristics and the Package Leaflet: • Summary of Product Characteristics – 4.1. Therapeutic Indications It is indicated; o For iron deficiency anemia in case of disruption of iron absorption from the gastrointestinal system, o In iron deficiency anemia developing in patients with active gastrointestinal bleeding, o In iron deficiency anemia developing in patients who underwent total or subtotal gastrectomy, o In subjects with iron deficiency anemia who cannot tolerate oral iron therapy, o In iron deficiency anemia resistant to oral iron therapy, o In case of clinical need for ensuring a rapid iron binding, o In the presence of iron deficiency in patients with chronic kidney disease who receive erythropoietin (EPO) therapy and who are dependent or non-dependent on dialysis. (Name of medicine) should not be recommended in the first trimester. It may be used in the 2 nd and 3 rd

trimester of pregnancy where deemed necessary by the physician.

• Package Leaflet – 1. What is ….. and what it is used for

o If anemia has developed due to disruption in iron absorption from the gastrointestinal system, o If anemia has developed due to iron deficiency because of severe bleeding in the gastro- intestinal system, o If iron deficiency and anemia has developed due to full or partial gastrectomy, o In patients who have anemia due to iron deficiency and cannot tolerate orally administered iron, o In patients who develop anemia due to iron deficiency and in whom orally administered iron does not provide a sufficient impact, o If your physician has decided that your iron stores need to be rapidly replenished and thus iron should be administered,
o In the presence of iron deficiency in patients who receive erythropoietin EPO) therapy (a hormone triggering blood formation), who are or are not dependent on dialysis and have chronic renal failure, (Name of product) should not be recommended in the first trimester of pregnancy. It may be used in the 2 nd and 3 rd trimester of pregnancy where deemed necessary by the physician.

NB: The following indication shall also be applicable for parenteral iron preparations containing the active substance Ferric carboxymaltose, presenting sufficient scientific evidence in addition to abovementioned indications. Where the following indication is requested for other parenteral iron preparations, this will be taken into account provided that evidence specific to the active substance is provided for the referred indication:

Summary of Product Characteristics – 4.1. Therapeutic Indications o In case of iron deficiency (ferritin < 100 µg/L) and iron deficiency anemia in patients classified as Class II or higher heart failure according to the American New York Heart Association (NYHA) classification.

Package Leaflet – 1. What is …. and what it is used for o It shall be used in case of iron deficiency or anemia developing due to iron deficiency in patients with a heart failure of Class II and above.

The following statements shall be added to the sections on posology in the Summary of Product Characteristics and Package Leaflet: • The use of parenteral iron preparations is not recommended for children aged below 14 years due to lack of clinical experience. • Oral iron should be discontinued during the administration.

I hereby submit for your information and kindly request that in case of any views, proposals and additions regarding the decision adopted, these should be submitted to the Clinical Evaluation Unit until 25.07.2019, and that no application is made to the Clinical Evaluation Unit except for any views, proposals and additions regarding “Parenteral preparations containing iron” within the referred process and that no application is submitted to the Pharmacological Evaluation Unit regarding the referred active substance.

                        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

Revoked

MINISTRY OF HEALTH OF THE REPUBLIC OF TURKEY Pharmaceutical General Directorate

Number : B.10.0.IEG.0.10.000.02 Subject :

APRIL 20, 2007

ANKARA

22690

DOSSIER In line with the decision adopted for the preparations in oral solution form (vial), containing an Iron III hydroxide polymaltose complex, by the “Advisory Commission on the Registration of Medicinal Products for Human Use” within our Ministry,
The “Indications” section in the package inserts relating to the preparations containing the referred active substance shall be amended as “It shall be used in the treatment of all latent and manifest iron deficiency, starting with iron deficiency anemia” and in case of information on use in children younger than 12 years, such information shall be removed from the “Mode of Administration and Dose” section. I hereby submit for your information and kindly request for the notification of the members of your Association on the requirement to submit three package insert samples prepared as described above until 01.05.2007.

Dr. Mahmut TOKAÇ On behalf of the Minister General Director

Distribution: Association of Research-Based Pharmaceutical Companies Pharmaceutical Manufacturers Association of Turkey Turkish Pharmaceutical Industry Association

Revoked

MINISTRY OF HEALTH OF THE REPUBLIC OF TURKEY Pharmaceutical General Directorate

Number : B.10.0.IEG.0.10.000.03 Subject : Iron preparations

June 24, 2010

46862

DOSSIER In line with the decision adopted for Iron preparations by the “Advisory Commission on the Registration of Medicinal Products for Human Use” within our Ministry,
It has been deemed suitable to amend/revise the pregnancy category of the referred preparations as A. Furthermore, the statement reading, “Inadvertent administration/ingestion of products containing iron by children younger than 6 years may lead to fatal poisoning. Therefore, keep these medicines away from children’s reach. In case of overdose, contact immediately your physician or poison consultant.” should be added to the section on “Special warnings and precautions for use” in suitable sentences for healthcare personnel and to the section on “In case of overdose with X” in the PL. I hereby submit for your information and kindly request that the relevant member companies of your Association are duly informed on the need to conduct the referred arrangements/amendments in the SPC/PL applications or previously submitted SPC/PL applications.

Dr. Saim KERMAN on behalf of the Minister General Director

Distribution: Association of Research-Based Pharmaceutical Companies Pharmaceutical Manufacturers Association of Turkey Turkish Pharmaceutical Industry Association

Revoked

RESTRICTED

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

No. : 77893119-000-1511061 Subject: Parenteral Iron-Containing Preparations
NORMAL

16.11.2016

DOSSIER

In line with the decision regarding parenteral iron-containing products, adopted by the “Clinical Evaluation Commission on Medicinal Products for Human Use” of our Agency, the indications of parenteral products containing iron shall be arranged as indicated below.

• In iron-deficiency anemia cases developing in case of disruption of iron absorption from the gastrointestinal system, • In iron-deficiency anemia cases developing in patients with active gastrointestinal bleeding, • In iron-deficiency anemia cases developing in patients with total or subtotal gastrectomy,
• In iron deficiency cases that do not tolerate oral iron therapy, • In iron deficiency anemia cases resistant to oral iron therapy, • In cases where there is a clinical need for rapid iron provision, • In patients using erythropoietin EPO) where hemodialysis treatment is administered due to chronic renal failure, treatment shall be initiated until Hgb is <10 g/dL and it will be used until Hgb reaches >11.5 g/dL or ferritin reaches >500 mg/dL.

I hereby inform you and kindly request for the conduct of relevant action for the provision of relevant information to the member companies of your Association regarding abovementioned points in their registration or SmPC/PL applications submitted/to be submitted to our Agency and for ensuring that the companies holding a registration for “Parenteral iron-containing products” apply to the “Clinical Evaluation Unit” until 30.12.2016 with relevant SPCs/PL samples, demonstrating that the requirements relating to the topic indicated above are fulfilled.

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

Revoked RESTRICTED

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

Number : 77893119-000-E.204551 Subject : Parenteral iron-containing products

NORMAL 26.11.2018

DOSSIER

Ref: Our announcement to associations, dated 16.11.2016, with No. 151061.

Our announcement to associations regarding “parenteral preparations containing iron” has been updated as follows in line with the decision adopted by the “Clinical Evaluation Commission of Medicinal Products for Human Use” of our Agency.

Summary of Product Characteristics – 4.1. Therapeutic Indications It is indicated; • For iron deficiency anemia in case of disruption of iron absorption from the gastrointestinal system, • In iron deficiency anemia developing in patients with active gastrointestinal bleeding, • In iron deficiency anemia developing in patients who underwent total or subtotal gastrectomy, • In subjects with iron deficiency anemia who cannot tolerate oral iron therapy, • In iron deficiency anemia resistant to oral iron therapy, • In case of clinical need for ensuring a rapid iron binding, • In the presence of iron deficiency in patients with chronic kidney disease who receive erythropoietin (EPO) therapy and who are dependent or non-dependent on dialysis, • In case of iron deficiency (ferritin < 100 µg/L) and iron deficiency anemia in patients classified as Class II or higher heart failure according to the American New York Heart Association (NYHA) classification
Package Leaflet – 1. What ….. is and what it is used for It is used; • If anemia has developed due to disruption of iron absorption from the gastro-intestinal system, • If anemia has developed due to iron deficiency caused by severe bleeding in the gastro- intestinal system, • If iron deficiency and anemia have developed due to total or subtotal gastrectomy, • In patients with anemia due to iron deficiency unable to tolerate oral iron, • In patients with anemia due to iron deficiency in whom orally taken iron does not provide a sufficient effect,

• If your physician decides that you need to forthwith replenish your body iron store and that, therefore, iron needs to be administered, • In the presence of iron deficiency in patients with chronic kidney deficiency, receiving erythropoietin (EPO) (a hormone stimulating blood formation) therapy, who are dependent or non-dependent on dialysis (blood cleaning procedure), • In patients with class II or higher heart failure with iron deficiency or with anemia arising due to iron deficiency. I hereby submit for your information and kindly request that any views, proposals and additions on the decision adopted are sent to the Clinical Evaluation Unit until 06.12.2018, that no application is submitted to the Clinical Evaluation Unit regarding “Parenteral iron-containing products” within the referred process except for relevant views, proposals and additions, and that no application is submitted to the Pharmacological Evaluation Unit regarding the referred active substance.

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