Circular · Safety Notice AIFD · Güvenlik Duyuruları 12.01.2020

12.01.2021 Tarihli ve E.24931227-000 Asetilsalisilik Asit İçeren Tekli veya Kombine İlaçlar Hakkında

AIFD Portal Source TR · Download Original (PDF) EN · Download Translation (PDF)
TR EN ZH RU DE AR FR JA
EN: This is the official English version published by the authority (TİTCK), imported from the AIFD Legislation Portal archive. The binding text is the official Turkish version.

12.01.2021 Tarihli ve E.24931227-000 Asetilsalisilik Asit İçeren Tekli veya Kombine İlaçlar Hakkında, ENG

RESTRICTED

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

Number : 62820468-000-E.24931227-000- Subject : Medicines containing acetylsalicylic acid alone or in combination NORMAL

12.01.2021 DOSSIER Ref: Our decision for Associations, dated 16.01.2020, with No. E. 12525.

The section on “2-Products containing only Acetylsalicylic Acid (75 mg, 80 mg, 81 mg, 100 mg, 150 mg, 300 mg)” in our association announcement regarding products containing acetylsalicylic acid alone or in combination has been amended in line with the decision adopted by the “Clinical Evaluation Commission of Medicinal Products for Human Use” within our Agency, and the updated association decision is presented below.
It has been decided to annul the following association decisions upon their re-evaluation by the “Clinical Evaluation Commission of Medicinal Products for Human Use”: • Association announcement dated 19.07.2007 on “Preparations Containing Combination of Acetylsalicylic Acid and Ascorbic Acid”, • Association announcement dated 20.04.2009, on “Acetylsalicylic Acid Preparations”, • Association announcement dated 06.02.2012, with No. 0012552 and job tacking No. 549646, on “Preparations Containing Acetylsalicylic Acid”, • Association announcement dated 07.08.2014, with No. 95839 and job tacking No. 1391881, on “Preparations Containing Acetylsalicylic Acid”, • Association announcement dated 30.09.2014, with No. 117489 and job tacking No. 1445084 on “Preparations Containing Acetylsalicylic Acid”. • Furthermore, it is suitable for all preparations containing acetylsalicylic acid alone or in combination to be prescription medicines. 1-General Provisions: a- The upper limits on what may be contained in the indications specific to the active substance content of each medicinal product have been designated below. Registration applicants may declare one, some or all of these indications relating to the product referred in the circular in the indications section of the product; however, they should not add a new indication other than these. b- In case of statements indicating the “age limit for children/adults” in the indications of the products, it is mandatory for registration applicants to remove the statements on age from this section, add the following note instead of these and indicate in the relevant section what is required by this note. “See section 4.4. Special warnings and precautions for use for children and adolescents of the product.”

Note: Registration applicants may declare the upper age limit where desired provided that they do not go below the age limit indicated for children in their declarations on critical age groups. 2- The indications should be as follows for products containing only Acetylsalicylic acid (75 mg, 80 mg, 81 mg, 100 mg, 150 mg, 300 mg):

SUMMARY OF PRODUCT CHARACTERISTICS It may be used,

  • As part of standard treatment in unstable angina pectoris,
  • As part of standard treatment in acute myocardial infarction,
  • In reinfarction prophylaxis,
  • Following the operations and other interventions related with arterial blood vessels [Percutaneous transluminal coronary angioplasty (PTCA), coronary artery bypass grafting (CABG)],
  • In the prevention of transient ischemic attacks and cerebral infarction in risky patient groups,
  • In Kawasaki disease; ○ For reducing inflammation in the febrile period, ○ As a prophylactic in the prevention of thrombocyte aggregation in coronary aneurysm.

PACKAGE LEAFLET

  • As part of standard treatment in chest pain occurring at rest/not associated with movement (unstable angina pectoris),
  • As part of standard treatment in sudden heart attack (acute myocardial infarction),
  • In the protection against recurrence of heart attack (reinfarction),
  • In the prevention of vascular occlusion and clots following cardiovascular surgeries,
  • In the prevention of temporary paralyses and strokes in risky patient groups,
  • In vasculitis frequently developing in young children under the age of five and characterized with fever, skin rash, strawberry tongue, red and cracked lips, redness in the palms of the hands and the soles of the feet (Kawasaki disease),
    ○ For reducing inflammation in the febrile period ○ In the prevention of blood clotting in of abnormal expansion (aneurism) in the walls of blood vessels feeding the heart.

3- The indications should be as follows for Acetylsalicylic acid 500 mg: “- In mild-moderate pains,

  • Fever, See section 4.4. Special warnings and precautions for use for children and adolescents.)”

4-The indications for Acetylsalicylic acid + Ascorbic acid (Vitamin C) or citric acid should be as follows (The upper limits for the active substance amount should be 500 mg for ASA + 250 mg for Vitamin C, respectively): “It is indicated in pain and fever associated with cold and flu in adolescents aged 16 and above and adults.” 5- The indications for Acetylsalicylic acid + Pseudoephedrine should be as follows (The upper limits for the active substance amount should be 500 mg for ASA + 30 mg for Pseudoephedrine, respectively. All precautions relating to pseudoephedrine should be arranged in line with the Association announcement dated 15.03.2018, with No. E.50239 on “Medicines containing pseudoephedrine salts”:

“It is indicated in case of nasal congestion where fever is accompanied by pain and cold and flu accompanied with mild body pain in adolescents aged 16 and above and adults”.

SUMMARY OF PRODUCT CHARACTERISTICS The following statement should be included into the section 4.4. Special warnings and precautions for use: “It should be used with caution in patients aged above 60, with hypertension, hyperthyroidism, diabetes mellitus, cardiovascular disease, ischemic heart disease, glaucoma, kidney failure or prostate hypertrophy (hyperplasia). It should not be used for longer than five days.”

PACKAGE LEAFLET The statement mentioned in the section “USE … CAREFULLY in the following conditions” should be arranged as follows: “It should be used with caution in patients aged above 60, with hypertension, hyperthyroidism, diabetes, cardiovascular disease, ischemic heart disease (disease which develops due to malnutrition of heart muscle), glaucoma (elevation in intraocular pressure), kidney failure or prostate enlargement. It should not be used for longer than five days.” 6-The indications for Acetylsalicylic acid + Caffeine should be as follows: (The upper limits for the active substance amount should be 500 mg for ASA + 65 mg for Caffeine, respectively) “It is indicated for mild and moderate acute pain and febrile conditions in adolescents aged 16 and above and adults.” 7- The indications for Acetylsalicylic acid + Paracetamol + Caffeine should be as follows: [The total upper limit of both active substances in the combination of ASA + Paracetamol should not surpass 500 mg (their individual amount should not be less than 200 mg) + the upper limit of Caffeine should be 65 mg. In combination preparations containing paracetamol, the daily dose of paracetamol should not surpass 2 grams in those taking alcohol and 4 grams in those not taking alcohol.]

SUMMARY OF PRODUCT CHARACTERISTICS “It is indicated in mild and moderate pains such as headache, dental pain, acute migraine attacks, neuralgia, musculoskeletal system pains, and dysmenorrhea and conditions accompanied with pain such as cold in adolescents aged 16 and above and adults. See section “4.4. Special warnings and precautions for use” of the product for children and adolescents.

PACKAGE LEAFLET “It is indicated in mild and moderate pains such as headache, dental pain, acute migraine attacks, neuralgia, musculoskeletal system pains and dysmenorrhea and conditions accompanied with pain such as cold in adolescents aged 16 and above and adults. See section “4.4. Special warnings and precautions for use” of the product for children and adolescents. 8- Only one of the following statements specific to the product should be written in addition to “It should not be used without the physician’s recommendation in children” in the part on children in the section 4.4. Special warnings and precautions for use in the SPC of the products:

  • In combination products containing ASA: “Its use is not recommended under the age of 16 unless there is a specific indication.”
  • In products containing only ASA: “Its use is not recommended under the age of 16 unless there is a specific indication (such as Kawasaki disease).” 9-All statements related to indications, posology, warnings-precautions within the scope of this announcement shall be adequately reflected in the Package Leaflet as well.
    The SPC/PL applications related to the products in which abovementioned amendments are made should be submitted to the Pharmacological Evaluation Unit within 1 month as of the date of publication of this announcement decision for review, the applications related to the products with ongoing registration process should be submitted to the Registration Unit and this announcement should be taken into account for products for which a registration application will be made. I hereby submit for your information and kindly request for relevant action so that the referred applications are not submitted to the Clinical Evaluation Unit. Assoc. Prof. Dr. Tolga TOLUNAY 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 : 62820468-000-E.12525 Subject : Medicines containing acetylsalicylic acid alone or in combination NORMAL

16.01.2020 DOSSIER Ref: Our decision for Associations, dated 04.04.2019, with No. E. 56366.

The section on “2-Products containing only Acetylsalicylic Acid (75 mg, 80 mg, 81 mg, 100 mg, 150 mg, 300 mg)” in our association announcement regarding products containing acetylsalicylic acid alone or in combination” has been amended in line with the decision adopted by the “Clinical Evaluation Commission of Medicinal Products for Human Use” within our Agency and the updated association decision is provided below.
It has been decided to annul the following association decisions upon their re-evaluation by the “Clinical Evaluation Commission of Medicinal Products for Human Use”: • Association announcement dated 19.07.2007 on “Preparations Containing Combination of Acetylsalicylic Acid and Ascorbic Acid”, • Association announcement dated 20.04.2009, on “Acetylsalicylic Acid Preparations”, • Association announcement dated 06.02.2012, with No. 0012552 and job tacking No. 549646, on “Preparations Containing Acetylsalicylic Acid”, • Association announcement dated 07.08.2014, with No. 95839 and job tacking No. 1391881, on “Preparations Containing Acetylsalicylic Acid”, • Association announcement dated 30.09.2014, with No. 117489 and job tacking No. 1445084 on “Preparations Containing Acetylsalicylic Acid”. • Furthermore, it is suitable for all preparations containing acetylsalicylic acid alone or in combination to be prescription medicines. 1-General Provisions: a- The upper limits on what may be contained in the indications specific to the active substance content of each medicinal product have been designated below. Registration applicants may declare one, some or all of these indications relating to the product referred in the circular in the indications section of the product; however, they should not add a new indication other than these. b- In case of statements indicating the “age limit for children/adults” in the indications of the products, it is mandatory for registration applicants to remove the statements on age from this section, add the following note instead of these and indicate in the relevant section what is required by this note. Note: Registration applicants may declare the upper age limit where desired provided that they do not go below the age limit indicated for children in their declarations on critical age groups.

2- The indications should be as follows for products containing only Acetylsalicylic acid (75 mg, 80 mg, 81 mg, 100 mg, 150 mg, 300 mg):

SUMMARY OF PRODUCT CHARACTERISTICS It may be used,

  • As part of standard treatment in unstable angina pectoris,
  • As part of standard treatment in acute myocardial infarction,
  • In reinfarction prophylaxis,
  • Following the operations and other interventions related to arterial blood vessels [Percutaneous transluminal coronary angioplasty (PTCA), coronary artery bypass grafting (CABG)],
  • In the prevention of transient ischemic attacks and cerebral infarction in risky patient groups,
  • In Kawasaki disease; ○ For reducing inflammation in the febrile period, ○ As a prophylactic in the prevention of thrombocyte aggregation in coronary aneurysm.
  • For the purpose of preventing cardiovascular events to all persons who fulfill the following conditions in people with no atherosclerotic cardiovascular disease: ○ Patients aged between 40-70 years, ○ With a 10-year cardiovascular event risk of more than 10% (SCORE risk calculation, etc.), ○ With a low bleeding potential.

PACKAGE LEAFLET

  • As part of standard treatment in chest pain occurring at rest/not associated with movement (Unstable angina pectoris),
  • As part of standard treatment in sudden heart attack (Acute myocardial infarction),
  • In the protection against recurrence of heart attack (reinfarction),
  • In the prevention of vascular occlusion and clots following cardiovascular surgeries,
  • In the prevention of temporary paralyses and strokes in risky patient groups,
  • In vasculitis frequently developing in young children under the age of five and characterized with fever, skin rash, strawberry tongue, red and cracked lips, redness in the palms of the hands and the soles of the feet (Kawasaki disease),
    ○ For reducing inflammation in the febrile period ○ In the prevention of blood clotting in of abnormal expansion (aneurism) in the walls of blood vessels feeding the heart.
  • It may be used for the purpose of preventing cardiovascular events to all persons who fulfill all of the following conditions in people with no atherosclerotic cardiovascular disease: ○ Patients aged between 40-70 years, ○ With a 10-year cardiovascular event risk of more than 10% (SCORE risk calculation, etc.),

○ With a low bleeding potential.

3- The indications should be as follows for Acetylsalicylic acid 500 mg: “- In mild-moderate pains,

  • Fever, See section 4.4. Special warnings and precautions for use for children and adolescents.” 4-The indications for Acetylsalicylic acid + Ascorbic acid (Vitamin C) or citric acid should be as follows: (The upper limits for the active substance amount should be 500 mg for ASA + 250 mg for Vitamin C, respectively.) “It is indicated in pain and fever associated with cold and flu in adolescents aged 16 and above and adults.” 5- The indications for Acetylsalicylic acid + Pseudoephedrine should be as follows (The upper limits for the active substance amount should be 500 mg for ASA + 30 mg for Pseudoephedrine, respectively. All precautions relating to pseudoephedrine should be arranged in line with the Association announcement dated 15.03.2018, with No. E.50239 on “Medicines containing pseudoephedrine salts”:

“It is indicated in case of nasal congestion where fever is accompanied by pain and cold and flu accompanied with mild body pain in adolescents aged 16 and above and adults”.

SUMMARY OF PRODUCT CHARACTERISTICS The following statement should be included into the section 4.4. Special warnings and precautions for use: “It should be used with caution in patients aged above 60, with hypertension, hyperthyroidism, diabetes mellitus, cardiovascular disease, ischemic heart disease, glaucoma, kidney failure or prostate hypertrophy (hyperplasia). It should not be used for longer than five days.”

PACKAGE LEAFLET The statement mentioned in the section “USE … CAREFULLY in the following conditions” should be arranged as follows: “It should be used with caution in patients aged above 60, with hypertension, hyperthyroidism, diabetes, cardiovascular disease, ischemic heart disease (disease which develops due to malnutrition of heart muscle), glaucoma (elevation in intraocular pressure), kidney failure or prostate enlargement. It should not be used for longer than five days.” 6-The indications for Acetylsalicylic acid + Caffeine should be as follows: (The upper limits for the active substance amount should be 500 mg for ASA + 65 mg for Caffeine, respectively) “It is indicated for mild and moderate acute pain and febrile conditions in adolescents aged 16 and above and adults.” 7- The indications for Acetylsalicylic acid + Paracetamol + Caffeine should be as follows: [The total upper limit of both active substances in the combination of ASA + Paracetamol should not surpass 500 mg (their individual amount should not be less than 200 mg) + the upper limit of Caffeine should be 65

mg. In combination preparations containing paracetamol, the daily dose of paracetamol should not surpass 2 grams in those taking alcohol and 4 grams in those not taking alcohol.]

SUMMARY OF PRODUCT CHARACTERISTICS “It is indicated in mild and moderate pains such as headache, dental pain, acute migraine attacks, neuralgia, musculoskeletal system pains and dysmenorrhea and conditions accompanied with pain such as cold in adolescents aged 16 and above and adults. See section “4.4. Special warnings and precautions for use” of the product for children and adolescents.

PACKAGE LEAFLET “It is indicated in mild and moderate pains such as headache, dental pain, acute migraine attacks, neuralgia, musculoskeletal system pains and dysmenorrhea and conditions accompanied with pain such as cold in adolescents aged 16 and above and adults. See section “4.4. Special warnings and precautions for use” of the product for children and adolescents. 8- Only one of the following statements specific to the product should be written in addition to “It should not be used without the physician’s recommendation in children” in the part on children in the section 4.4. Special warnings and precautions for use in the SPC of the products:

  • In combination products containing ASA: “Its use is not recommended under the age of 16 unless there is a specific indication.”
  • In products containing only ASA: “Its use is not recommended under the age of 16 unless there is a specific indication (such as Kawasaki disease).” 9-All statements related to indications, posology, warnings-precautions within the scope of this announcement shall be adequately reflected in the Package Leaflet as well.
    I hereby submit for your information and kindly request that the SPC/PL applications in which abovementioned amendments are made are sent to the Pharmacological Evaluation Unit until 31.01.2020 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

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

Outgoing Document Service Outgoing Document No: 117489 Outgoing Document Date: 30.09.2014 Security Code: 868882 Job Tracking No: 1445084

Number : 77893119 Subject : Preparations Containing Acetylsalicylic Acid

DOSSIER

The decision announced to associations with the letter dated 07.09.2014, with No. 95839 by our Agency regarding the preparations containing acetylsalicylic acid has been updated as follows in line with the evaluation made by the “Advisory Commission for the Registration of Medicinal Products for Human Use”. As per the referred decision;

  • The preparations containing 300 mg and less acetylsalicylic acid will be regarded as non-prescription medicines,
  • The preparations containing more than 300 mg of acetylsalicylic acid will be regarded as prescription medicines,
  • The preparations with indication for pediatric population use will be regarded as prescription medicines,
  • The preparations with indication for cardiovascular use will be regarded as prescription medicines,
  • In preparations containing one or multiple active substances in combination together with acetylsalicylic acid, the evaluation will be made on a product basis (considering the active substance(s) used in the combination, formulation, pharmaceutical form, etc.) depending on whether they are prescription/non-prescription. I hereby submit for your information and kindly request for relevant action so that the necessary information is provided to the member companies of your Association regarding abovementioned matters in the applications made/to be made to us for registration, SPC/PL and packaging, and that companies that are registration holder of “Preparations Containing Acetylsalicylic Acid” submit their application to the relevant units with the SPC-PL and packaging samples which fulfill abovementioned requirements until 14.11.2014. Dr. Hakkı GÜRSÖZ Deputy President of the Agency Distribution for the adoption of relevant action: Association of Research-Based Pharmaceutical Companies Pharmaceutical Manufacturers Association of Turkey Turkish Pharmaceutical Industry Association Association of Innovator Pharmaceutical Companies Self-Care Products Association MINISTRY OF HEALTH OF THE REPUBLIC OF TURKEY

Medicines and Medical Devices Agency of Turkey REVOKED

Outgoing Document Service Outgoing Document No: 95839 Outgoing Document Date: 07.08.2014 Security Code: 976829 Job Tracking No: 1391881

Number : 77893119 Subject : Preparations Containing Acetylsalicylic Acid

DOSSIER

In line with the decision adopted by the “Advisory Commission on the Registration of Medicinal Products for Human Use” of our Agency regarding the preparations acetylsalicylic acid, it has been decided suitable to regard as follows the preparations containing acetylsalicylic acid alone or in combination with other active substances: the preparations containing a dose of 300 mg and less will be regarded as nonprescription while the preparations containing a dose of 300 mg and higher will be regarded as prescription medicines.
I hereby submit for your information and kindly request for relevant action so that the necessary information is provided to the member companies of your Association regarding abovementioned matters in the applications made/to be made to us for registration, SPC/PL and packaging, and that companies that are registration holders of “Preparations Containing Acetylsalicylic Acid” submit their application to the relevant unit along with the SPC-PL and packaging samples which fulfill abovementioned requirements until 30.09.2014. Dr. Saim KERMAN President of the Agency Distribution for the adoption of relevant action: Association of Research-Based Pharmaceutical Companies Pharmaceutical Manufacturers Association of Turkey Turkish Pharmaceutical Industry Association Association of Innovator Pharmaceutical Companies Self-Care Products Association

MINISTRY OF HEALTH OF THE REPUBLIC OF TURKEY General Directorate of Medicines and Pharmacy REVOKED

Ministry of Health of the Republic of Turkey General Directorate of Medicines and Pharmacy Outgoing Document Service of the Documents
and Correspondences Department Date: 06.02.2012 Document No: 0012552 007007549646 Job Tracking No: 549646 Document Annex:

Number : B.10.0.IEG.0.10.00.03 Subject : Preparations containing acetylsalicylic acid

DOSSIER

In line with the decision adopted by the “Advisory Commission on the Registration of Medicinal Products for Human Use” of our Ministry regarding the preparations containing the active substance Acetylsalicylic acid (ASA) (alone or in combination), it has been regarded suitable to arrange/amend as follows the indications section of the preparations containing the referred active substance. ASA (at doses lower than 500 mg) + Paracetamol + Caffeine
It is indicated for mild and moderate acute pain and febrile conditions in adolescents aged above 16 years and adults. ASA (at doses lower than 500 mg) + Ascorbic acid (Vitamin C) or Citric acid It is indicated for mild and moderate acute pain and febrile conditions in adolescents aged above 16 years and adults. ASA (500 mg)
It is indicated for mild and moderate acute pain and febrile conditions in adolescents aged above 16 years and adults. It is indicated for the treatment of inflammatory rheumatoid diseases. ASA (500 mg) + Caffeine It is indicated for mild and moderate acute pain and febrile conditions in adults. ASA + Pseudoephedrine
It is indicated for mild and moderate acute pain and febrile conditions accompanied with nasal congestion in adolescents aged above 16 years and adults. ASA (100 mg) It is indicated for mild and moderate acute pain and febrile conditions. It is indicated for the treatment of inflammatory rheumatoid diseases. It is indicated as an anti-thrombotic for non-stable angina pectoris and the prevention of coronary thrombosis in (hypertensive, hyperlipidemic, diabetic) patients under risk, in the prophylaxis of myocardial re-infarction, in the prevention of postoperative thrombosis and embolism in cardiovascular surgery and particularly in aortocoronary bypass and arteriovenous shunts, and in the prophylaxis of transient ischemic attacks and strokes.

Furthermore, the statement reading, “Do not use in children without the advice of a physician” should be added to the Warnings/Precautions section.
ASA (300 mg) It is indicated for mild and moderate acute pain and febrile conditions. It is indicated for the treatment of inflammatory rheumatoid diseases. It is indicated as an anti-thrombotic in the inflammation of superficial veins, in non-stable angina pectoris and in the prevention of coronary thrombosis in (hypertensive, hyperlipidemic, diabetic) patients under risk, in the prevention of coronary thrombosis, in the prophylaxis of myocardial re-infarction, in the prevention of postoperative thrombosis and embolism in cardiovascular surgery and particularly in aortocoronary bypass and arteriovenous shunts, and in the prophylaxis of transient ischemic attacks and strokes. Furthermore, the statement reading, “Do not use in children without the advice of a physician” should be added to the Warnings/Precautions section.
I kindly request that relevant information is provided to the member companies of your Association regarding abovementioned matters in the SPC/PL applications made/to be made to us.
Dr. Saim KERMAN 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

MINISTRY OF HEALTH OF THE REPUBLIC OF TURKEY General Directorate of Medicines and Pharmacy REVOKED

Number : B.10.0.IEG.0.10.000.02-P Subject : Acetylsalicylic Acid Preparations

DOSSIER In line with the decision adopted for the preparations containing “Acetylsalicylic Acid 0.5 g” by the Advisory Commission for the Registration of Medicinal Products for Human Use” of our Ministry. It is regarded suitable to arrange the indications of the referred preparations as, “It is used for the symptomatic treatment of mild to moderate pain and fever.” Furthermore, it is regarded suitable to include the statement reading, “It should not be used in children without the advice of a physician” in the “Warnings/Precautions” section of the package insert or the relevant sections of the SPC/Package Leaflet. Samples of the package inserts, Summary of Product Characteristics / Package Leaflet, prepared in line with this decision, should be submitted to us until 08.05.2009 for review.
I hereby submit for your information and kindly request for the adoption of relevant action so that the member companies of your Association informed thereof. Dr. Mahmut TOKAÇ on behalf of the Minister General Manager

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

MINISTRY OF HEALTH OF THE REPUBLIC OF TURKEY General Directorate of Medicines and Pharmacy REVOKED

Number : B.10.0.IEG.0.10.000.02-P Subject : Preparations Containing Acetylsalicylic Acid and Ascorbic Acid Combination

DOSSIER In line with the decision adopted regarding the preparations in effervescent tablet form containing Acetylsalicylic Acid and ascorbic acid combination by the “Advisory Commission for the Registration of Medicinal Products for Human Use” of our Ministry; Only the “Analgesic and antipyretic” indications should be included in the “Indications” section of the package inserts of the preparations in effervescent tablet form containing less than 500 mg of acetylsalicylic acid and ascorbic acid. I hereby submit for your information and kindly request for the adoption of relevant action so that the member companies of your Association are informed about the need to send us three package insert samples prepared in this direction until 01.09.2007 for review. Dr. Mahmut TOKAÇ on behalf of the Minister General Manager

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

July 19, 2007