Marketing Authorization For The Medicinal Product For Usoumano "triamlo"

Original Language Title: Autorizzazione all'immissione in commercio del medicinale per usoumano «Triamlo»

Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-03-19&atto.codiceRedazionale=15A01967&elenco30giorni=false&atto.tipoProvvedimento=DECRETO

Retrieved determines V & A n. 328/2015 of 20 February 2015
Description of the medicine and no attribution. AIC
And 'authorized the placing on the market of: TRIAMLO, in the form and packaging: "2.5 mg + 5 mg hard capsules" 28 capsules in blister PA / AL / PVC / AL, "2.5 mg + 5 mg hard capsules "30 capsules in blister PA / AL / PVC / AL," 2.5 mg + 5 mg hard capsules "32 capsules in blister PA / AL / PVC / AL," 2.5 mg + 5 mg capsules rigid "56 capsules in blister PA / AL / PVC / AL," 2.5 mg + 5 mg hard capsules "60 capsules in blister PA / AL / PVC / AL," 2.5 mg + 5 mg hard capsules "90 capsules blister PA / AL / PVC / AL, "2.5 mg + 5 mg hard capsules" 91 capsules in blister PA / AL / PVC / AL, "2.5 mg + 5 mg hard capsules" 96 capsules in blister PA / AL / PVC / AL, "2.5 mg + 5 mg hard capsules" 98 capsules in blister PA / AL / PVC / AL, "2.5 mg + 5 mg hard capsules" 100 capsules in blister PA / Al / PVC / AL, "5 mg + 5 mg hard capsules" 28 capsules in blister PA / AL / PVC / AL, "5 mg + 5 mg hard capsules" 30 capsules in blister PA / AL / PVC / AL, "5 mg + 5 mg hard capsules "32 capsules in blister PA / AL / PVC / AL," 5 mg + 5 mg hard capsules "56 capsules in blister PA / AL / PVC / AL," + 5mg 5mg hard capsules "60 capsules in PA / blister / PVC / AL, "5 mg + 5 mg hard capsules" 90 capsules in blister PA / AL / PVC / AL, "5 mg + 5 mg hard capsules" 91 capsules in blister PA / AL / PVC / AL, "5 mg + 5 mg hard capsules "96 capsules in blister PA / AL / PVC / AL," 5 mg + 5 mg hard capsules "98 capsules in blister PA / AL / PVC / AL," 5 mg + 5 mg hard capsules "100 capsules blister PA / AL / PVC / AL, "5mg + 10mg hard capsules" 28 capsules in blister PA / AL / PVC / AL, "5 mg + 10 mg hard capsules" 30 capsules in blister PA / AL / PVC / AL " 5mg + 10mg hard capsules "32 capsules in blister PA / AL / PVC / AL," 5 mg + 10 mg hard capsules "56 capsules in blister PA / AL / PVC / AL," 5mg + 10mg hard capsules "60 capsules in blister PA / AL / PVC / AL, "5 mg + 10 mg hard capsules" 90 capsules in blister PA / AL / PVC / AL, "5 mg + 10 mg hard capsules" 91 capsules in blister PA / AL / PVC / AL "5 mg + 10 mg hard capsules" 96 capsules in blister PA / AL / PVC / AL, "5 mg + 10mg hard capsules" 98 capsules in blister PA / AL / PVC / AL, "5 mg + 10 mg hard capsules" 100 capsules in blister PA / Al / PVC / Al, "10 mg + 5 mg hard capsules" 28 capsules in blister PA / Al / PVC / Al, "10 mg + 5 mg hard capsules" 30 capsules in blister PA / AL / PVC / AL, "10mg + 5mg hard capsules" 32 capsules in blister PA / Al / PVC / Al, "10 mg + 5mg hard capsules" 56 capsules in blister PA / Al / PVC / Al, "10 mg + 5 mg hard capsules "60 capsules in blister PA / Al / PVC / Al," 10 mg + 5 mg hard capsules "90 capsules in blister PA / AL / PVC / AL," 10mg + 5mg hard capsules "91 capsules in blister PA / AL / PVC / AL, "10 mg + 5 mg hard capsules" 96 capsules in blister PA / Al / PVC / Al, "10 mg + 5 mg hard capsules" 98 capsules in blister PA / Al / PVC / Al, "10 mg + 5 mg capsules "100 capsules in blister PA / Al / PVC / Al," 10 mg + 10 mg hard capsules "28 capsules in blister PA / Al / PVC / Al," 10 mg + 10 mg hard capsules "30 capsules in blister PA / AL / PVC / AL, "10mg + 10mg hard capsules" 32 capsules in blister PA / Al / PVC / Al, "10 mg + 10 mg hard capsules" 56 capsules in blister PA / Al / PVC / Al, "10 mg + 10 mg hard capsules "60 capsules in blister PA / Al / PVC / Al," 10 mg + 10mg hard capsules "90 capsules in blister PA / Al / PVC / Al," 10 mg + 10 mg hard capsules "91 capsules blister PA / Al / PVC / Al, "10 mg + 10 mg hard capsules" 96 capsules in blister PA / Al / PVC / Al, "10 mg + 10 mg hard capsules" 98 capsules in blister PA / Al / PVC / AL, "10 mg + 10 mg hard capsules" 100 capsules in blister PA / AL / PVC / AL, under the conditions and compliance with the following specifications:
MAH: Zentiva Italy Srl, Viale Bodio, 37 / B, ch. 20158 - Milan, Italy, tax code 11388870153.
Package: "2.5 mg + 5 mg hard capsules" 28 capsules in blister PA / AL / PVC / AL - AIC n. 043405012 (base 10) 19DMQN (in base 32).
Package: "2.5 mg + 5 mg hard capsules" 30 capsules in blister PA / AL / PVC / AL - AIC n. 043405024 (base 10) 19DMR0 (in base 32).
Package: "2.5 mg + 5 mg hard capsules" 32 capsules in blister PA / AL / PVC / AL - AIC n. 043405036 (base 10) 19DMRD (in base 32).
Package: "2.5 mg + 5 mg hard capsules" 56 capsules in blister PA / AL / PVC / AL - AIC n. 043405048 (base 10) 19DMRS (in base 32).
Package: "2.5 mg + 5 mg hard capsules" 60 capsules in blister PA / AL / PVC / AL - AIC n. 043405051 (base 10) 19DMRV (in base 32).
Package: "2.5 mg + 5 mg hard capsules" 90 capsules in blister PA / AL / PVC / AL - AIC n. 043405063 (base 10) 19DMS7 (in base 32).
Package: "2.5 mg + 5 mg hard capsules" 91 capsules in blister PA / AL / PVC / AL - AIC n. 043405075 (base 10) 19DMSM (in base 32).
Package: "2.5 mg + 5 mg hard capsules" 96 capsules in blister PA / AL / PVC / AL - AIC n. 043405087 (base 10) 19DMSZ (in base 32).

Package: "2.5 mg + 5mg hard capsules" 98 capsules in blister PA / AL / PVC / AL - AIC n. 043405099 (base 10) 19DMTC (in base 32).
Package: "2.5 mg + 5 mg hard capsules" 100 capsules in blister PA / AL / PVC / AL - AIC n. 043405101 (base 10) 19DMTF (in base 32).
Pharmaceutical form: capsules.
Validity 'entire product: 2 years from date of manufacture.
Special precautions for storage: Store below 30 ° C.
Store in the original package to protect from light.
Composition: Each capsule contains:
Active ingredient: 2.5 mg of ramipril and amlodipine besylate equivalent to 5 mg amlodipine.
Excipients: Capsule contents: microcrystalline cellulose, anhydrous dibasic calcium phosphate, pregelatinised maize starch, sodium starch glycolate (type A), sodium stearyl fumarate; capsule shell: red iron oxide (E172), titanium dioxide (E171), gelatin.
Manufacturer of active ingredient:
Dr. Reddy's Laboratories Limited, Plot No. 116, Sri Venkateswara Co-Operative Industrial Estate, IDA bolarum, Jinnaram Mandal, 502325 Medak District, Andhra Pradesh, India (amlodipine besylate);
Dr. Reddy's Laboratories Limited, Plot No. 110 & 111, Sri Venkateswara Co-Operative Industrial Estate, bolarum village, Jinnaram Mandal, 502325 Medak district, Andhra Pradesh, India (amlodipine besylate);
Huhai Zhejiang Pharmaceutical Co. Ltd., Xunquiao, 317-024 Linhai City, Zhejiang Province China (ramipril).
Manufacturer of finished product:
Zaklad Farmaceutyczny Adamed Pharma SA, Szkolna 33 str., 95-054 Ksawerow, Poland (production, primary and secondary packaging, control and batch release);
Pabianickie Zaklady Farmaceutyczne Polfa SA, Marszalka Jozefa Pilsudskiego 5 str., 95-200 Pabianice, Poland (control and batch release);
Adamed Sp. Z oo, Pienkow 149.05 to 152 Czosnow, Poland (batch release);
DHL Supply Chain (Italy) Spa - Viale delle Industrie, 2-20090 Settala (MI) Italy (secondary packaging).
Package: "+ 5mg 5mg hard capsules" 28 capsules in blister PA / AL / PVC / AL - AIC n. 043405113 (base 10) 19DMTT (in base 32).
Package: "5 mg + 5 mg hard capsules" 30 capsules in blister PA / AL / PVC / AL - AIC n. 043405125 (base 10) 19DMU5 (in base 32).
Package: "5 mg + 5 mg hard capsules" 32 capsules in blister PA / AL / PVC / AL - AIC n. 043405137 (base 10) 19DMUK (in base 32).
Package: "+ 5mg 5mg hard capsules" 56 capsules in blister PA / AL / PVC / AL - AIC n. 043405149 (base 10) 19DMUX (in base 32).
Package: "5 mg + 5 mg hard capsules" 60 capsules in blister PA / AL / PVC / AL - AIC n. 043405152 (base 10) 19DMV0 (in base 32).
Package: "5 mg + 5 mg hard capsules" 90 capsules in blister PA / AL / PVC / AL - AIC n. 043405164 (base 10) 19DMVD (in base 32).
Package: "5 mg + 5 mg hard capsules" 91 capsules in blister PA / AL / PVC / AL - AIC n. 043405176 (base 10) 19DMVS (in base 32).
Package: "5 mg + 5 mg hard capsules" 96 capsules in blister PA / AL / PVC / AL - AIC n. 043405188 (base 10) 19DMW4 (in base 32).
Package: "5 mg + 5 mg hard capsules" 98 capsules in blister PA / AL / PVC / AL - AIC n. 043405190 (base 10) 19DMW6 (in base 32).
Package: "5 mg + 5 mg hard capsules" 100 capsules in blister PA / AL / PVC / AL - AIC n. 043405202 (base 10) 19DMWL (in base 32).
Pharmaceutical form: capsules.
Validity 'product: 30 months from date of manufacture.
Special precautions for storage: Store at temperatures below 30 ° C.
Store in the original package to protect from light.
Composition: Each capsule contains:
Active ingredient: 5 mg of ramipril and amlodipine besylate equivalent to 5 mg of amlodipine;
Excipients: Capsule contents: microcrystalline cellulose, anhydrous dibasic calcium phosphate, Pregelatinised maize starch, sodium starch glycolate (type A), sodium stearyl fumarate; capsule shell: red iron oxide (E172), titanium dioxide (E171), gelatin
Manufacturer of active ingredient:
Dr. Reddy's Laboratories Limited, Plot No. 116, Sri Venkateswara Co-Operative Industrial Estate, IDA bolarum, Jinnaram Mandal, 502325 Medak District, Andhra Pradesh, India (amlodipine besylate);
Dr. Reddy's Laboratories Limited, Plot No. 110 & 111, Sri Venkateswara Co-Operative Industrial Estate, bolarum village, Jinnaram Mandal, 502325 Medak district, Andhra Pradesh, India (amlodipine besylate);
Huhai Zhejiang Pharmaceutical Co. Ltd., Xunquiao, 317-024 Linhai City, Zhejiang Province China (ramipril).
Manufacturer of finished product:

Zaklad Farmaceutyczny Adamed Pharma SA, Szkolna 33 str., 95-054 Ksawerow, Poland (production, primary and secondary packaging, control and batch release);
Pabianickie Zaklady Farmaceutyczne Polfa SA, Marszalka Jozefa Pilsudskiego 5 str., 95-200 Pabianice, Poland (control and batch release);
Adamed Sp. Z oo, Pienkow 149.05 to 152 Czosnow, Poland (batch release).
DHL Supply Chain (Italy) Spa - Viale delle Industrie, 2-20090 Settala (MI) Italy (secondary packaging).
Package: "5 mg + 10 mg hard capsules" 28 capsules in blister PA / AL / PVC / AL - AIC n. 043405214 (base 10) 19DMWY (in base 32).
Package: "5 mg + 10 mg hard capsules" 30 capsules in blister PA / AL / PVC / AL - AIC n. 043405226 (base 10) 19DMXB (in base 32).
Package: "5 mg + 10 mg hard capsules" 32 capsules in blister PA / AL / PVC / AL - AIC n. 043405238 (base 10) 19DMXQ (in base 32).
Package: "5 mg + 10 mg hard capsules" 56 capsules in blister PA / AL / PVC / AL - AIC n. 043405240 (base 10) 19DMXS (in base 32).
Package: "5 mg + 10 mg hard capsules" 60 capsules in blister PA / AL / PVC / AL - AIC n. 043405253 (base 10) 19DMY5 (in base 32).
Package: "5 mg + 10 mg hard capsules" 90 capsules in blister PA / AL / PVC / AL - AIC n. 043405265 (base 10) 19DMYK (in base 32).
Package: "5 mg + 10 mg hard capsules" 91 capsules in blister PA / AL / PVC / AL - AIC n. 043405277 (base 10) 19DMYX (in base 32).
Package: "5 mg + 10 mg hard capsules" 96 capsules in blister PA / AL / PVC / AL - AIC n. 043405289 (base 10) 19DMZ9 (in base 32).
Package: "5 mg + 10 mg hard capsules" 98 capsules in blister PA / AL / PVC / AL - AIC n. 043405291 (base 10) 19DMZC (in base 32).
Package: "5 mg + 10 mg hard capsules" 100 capsules in blister PA / AL / PVC / AL - AIC n. 043405303 (base 10) 19DMZR (in base 32).
Pharmaceutical form: capsules.
Validity 'product: 30 months from date of manufacture.
Special precautions for storage: Store at temperatures below 30 ° C.
Store in the original package to protect from light.
Composition: Each capsule contains:
Active ingredient: 5 mg of ramipril and amlodipine besylate equivalent to 10 mg of amlodipine;
Excipients: capsule contents: microcrystalline cellulose, anhydrous dibasic calcium phosphate, pregelatinised maize starch, sodium starch glycolate (type A), sodium stearyl fumarate; capsule shell: red iron oxide (E172), titanium dioxide (E171), gelatin
Manufacturer of active ingredient:
Dr. Reddy's Laboratories Limited, Plot No. 116, Sri Venkateswara Co-Operative Industrial Estate, IDA bolarum, Jinnaram Mandal, 502325 Medak District, Andhra Pradesh, India (amlodipine besylate);
Dr. Reddy's Laboratories Limited, Plot No. 110 & 111, Sri Venkateswara Co-Operative Industrial Estate, bolarum village, Jinnaram Mandal, 502325 Medak district, Andhra Pradesh, India (amlodipine besylate);
Huhai Zhejiang Pharmaceutical Co. Ltd., Xunquiao, 317-024 Linhai City, Zhejiang Province China (ramipril).
Manufacturer of finished product:
Zaklad Farmaceutyczny Adamed Pharma SA, Szkolna 33 str., 95-054 Ksawerow, Poland (production, primary and secondary packaging, control and batch release);
Pabianickie Zaklady Farmaceutyczne Polfa SA, Marszalka Jozefa Pilsudskiego 5 str., 95-200 Pabianice, Poland (control and batch release);
Adamed Sp. Z oo, Pienkow 149.05 to 152 Czosnow, Poland (batch release).
DHL Supply Chain (Italy) Spa - Viale delle Industrie, 2-20090 Settala (MI) Italy (secondary packaging).
Package: "10 mg + 5 mg hard capsules" 28 capsules in blister PA / AL / PVC / AL - AIC n. 043405315 (base 10) 19DN03 (in base 32).
Package: "10 mg + 5 mg hard capsules" 30 capsules in blister PA / AL / PVC / AL - AIC n. 043405327 (base 10) 19DN0H (in base 32).
Package: "10 mg + 5 mg hard capsules" 32 capsules in blister PA / AL / PVC / AL - AIC n. 043405339 (base 10) 19DN0V (in base 32).
Package: "10 mg + 5 mg hard capsules" 56 capsules in blister PA / AL / PVC / AL - AIC n. 043405341 (base 10) 19DN0X (in base 32).
Package: "10 mg hard capsules + 5 m g" 60 capsules in blister PA / AL / PVC / AL - AIC n. 043405354 (base 10) 19DN1B (in base 32).
Package: "10 mg + 5 mg hard capsules" 90 capsules in blister PA / AL / PVC / AL - AIC n. 043405366 (base 10) 19DN1Q (in base 32).
Package: "10 mg + 5 mg hard capsules" 91 capsules in blister PA / AL / PVC / AL - AIC n. 043405378 (base 10) 19DN22 (in base 32).
Package: "10 mg + 5 mg hard capsules" 96 capsules in blister PA / AL / PVC / AL - AIC n. 043405380 (base 10) 19DN24 (in base 32).

Package: "10 mg + 5 mg hard capsules" 98 capsules in blister PA / AL / PVC / AL - AIC n. 043405392 (base 10) 19DN2J (in base 32).
Package: "10 mg + 5 mg hard capsules" 100 capsules in blister PA / AL / PVC / AL - AIC n. 043405404 (base 10) 19DN2W (in base 32).
Pharmaceutical form: capsules.
Validity 'product: 30 months from date of manufacture.
Special precautions for storage: Store at temperatures below 30 ° C.
Store in the original package to protect from light.
Composition: Each capsule contains:
Active ingredient: 10 mg of ramipril and amlodipine besylate equivalent to 5 mg of amlodipine;
Excipients: capsule contents: microcrystalline cellulose, anhydrous dibasic calcium phosphate, pregelatinised maize starch, sodium starch glycolate (type A), sodium stearyl fumarate; capsule shell: red iron oxide (E172), titanium dioxide (E171), gelatin
Manufacturer of active ingredient:
Dr. Reddy's Laboratories Limited, Plot No. 116, Sri Venkateswara Co-Operative Industrial Estate, IDA bolarum, Jinnaram Mandal, 502325 Medak District, Andhra Pradesh, India (amlodipine besylate);
Dr. Reddy's Laboratories Limited, Plot No. 110 & 111, Sri Venkateswara Co-Operative Industrial Estate, bolarum village, Jinnaram Mandal, 502325 Medak district, Andhra Pradesh, India (amlodipine besylate);
Huhai Zhejiang Pharmaceutical Co. Ltd., Xunquiao, 317-024 Linhai City, Zhejiang Province China (ramipril).
Manufacturer of finished product:
Zaklad Farmaceutyczny Adamed Pharma SA, Szkolna 33 str., 95-054 Ksawerow, Poland (production, primary and secondary packaging, control and batch release);
Pabianickie Zaklady Farmaceutyczne Polfa SA, Marszalka Jozefa Pilsudskiego 5 str., 95-200 Pabianice, Poland (control and batch release);
Adamed Sp. Z oo, Pienkow 149.05 to 152 Czosnow, Poland (batch release);
DHL Supply Chain (Italy) Spa - Viale delle Industrie, 2-20090 Settala (MI) Italy (secondary packaging).
Package: "10 mg + 10 mg hard capsules" 28 capsules in blister PA / AL / PVC / AL - AIC n. 043405416 (base 10) 19DN38 (in base 32).
Package: "10 mg + 10 mg hard capsules" 30 capsules in blister PA / AL / PVC / AL - AIC n. 043405428 (base 10) 19DN3N (in base 32).
Package: "10 mg + 10 mg hard capsules" 32 capsules in blister PA / AL / PVC / AL - AIC n. 043405430 (base 10) 19DN3Q (in base 32).
Package: "10 mg + 10 mg hard capsules" 56 capsules in blister PA / AL / PVC / AL - AIC n. 043405442 (base 10) 19DN42 (in base 32).
Package: "10 mg + 10 mg hard capsules" 60 capsules in blister PA / AL / PVC / AL - AIC n. 043405455 (base 10) 19DN4H (in base 32).
Package: "10 mg + 10 mg hard capsules" 90 capsules in blister PA / AL / PVC / AL - AIC n. 043405467 (base 10) 19DN4V (in base 32).
Package: "10 mg + 10 mg hard capsules" 91 capsules in blister PA / AL / PVC / AL - AIC n. 043405479 (base 10) 19DN57 (in base 32).
Package: "10 mg + 10 mg hard capsules" 96 capsules in blister PA / AL / PVC / AL - AIC n. 043405481 (base 10) 19DN59 (in base 32).
Package: "10 mg + 10 mg hard capsules" 98 capsules in blister PA / AL / PVC / AL - AIC n. 043405493 (base 10) 19DN5P (in base 32).
Package: "10 mg + 10 mg hard capsules" 100 capsules in blister PA / AL / PVC / AL - AIC n. 043405505 (base 10) 19DN61 (in base 32).
Pharmaceutical form: capsules.
Validity 'product: 30 months from date of manufacture.
Special precautions for storage: Store at temperatures below 30 ° C.
Store in the original package to protect from light.
Composition: Each capsule contains:
Active ingredient: 10 mg of ramipril and amlodipine besylate equivalent to 10 mg of amlodipine;
Excipients: Capsule contents: microcrystalline cellulose, anhydrous dibasic calcium phosphate, Pregelatinised maize starch, sodium starch glycolate (type A), sodium stearyl
Capsule shell (10 mg / 10 mg): Yellow iron oxide ( E172), black iron oxide (E172), red iron oxide (E172), titanium dioxide (E171), gelatin.
Manufacturer of active ingredient:
Dr. Reddy's Laboratories Limited, Plot No. 116, Sri Venkateswara Co-Operative Industrial Estate, IDA bolarum, Jinnaram Mandal, 502325 Medak District, Andhra Pradesh, India (amlodipine besylate);
Dr. Reddy's Laboratories Limited, Plot No. 110 & 111, Sri Venkateswara Co-Operative Industrial Estate, bolarum village, Jinnaram Mandal, 502325 Medak district, Andhra Pradesh, India (amlodipine besylate);
Huhai Zhejiang Pharmaceutical Co. Ltd., Xunquiao, 317-024 Linhai City, Zhejiang Province China (ramipril).
Manufacturer of finished product:

Zaklad Farmaceutyczny Adamed Pharma SA, Szkolna 33 str., 95-054 Ksawerow, Poland (production, primary and secondary packaging, control and batch release);
Pabianickie Zaklady Farmaceutyczne Polfa SA, Marszalka Jozefa Pilsudskiego 5 str., 95-200 Pabianice, Poland (control and batch release);
Adamed Sp. Z oo, Pienkow 149.05 to 152 Czosnow, Poland (batch release);
DHL Supply Chain (Italy) Spa - Viale delle Industrie, 2-20090 Settala (MI) Italy (secondary packaging).
Therapeutic indications:
Treatment of hypertension in adults.
Triamlo and 'indicated as replacement therapy in patients with blood pressure adequately controlled with ramipril and amlodipine given concurrently at the same dose of the combination.
Classification for the purposes of reimbursement '
Package: "2.5 mg + 5 mg hard capsules" 28 capsules in blister PA / AL / PVC / AL - AIC n. 043405012.
redeemability 'Class: Relevant section of the class in art. 8, paragraph 10, letter c) of the Law of 24 December 1993, n. 537, as amended, dedicated to drugs not yet assessed for the purposes of reimbursement ', called Class C (nn).
Package: "2.5 mg + 5 mg hard capsules" 30 capsules in blister PA / AL / PVC / AL - AIC n. 043405024.
redeemability 'Class: Relevant section of the class in art. 8, paragraph 10, letter c) of the Law of 24 December 1993, n. 537, as amended, dedicated to drugs not yet assessed for the purposes of reimbursement ', called Class C (nn).
Package: "2.5 mg + 5 mg hard capsules" 32 capsules in blister PA / AL / PVC / AL - AIC n. 043405036.
redeemability 'Class: Relevant section of the class in art. 8, paragraph 10, letter c) of the Law of 24 December 1993, n. 537, as amended, dedicated to drugs not yet assessed for the purposes of reimbursement ', called Class C (nn).
Package: "2.5 mg + 5 mg hard capsules" 56 capsules in blister PA / AL / PVC / AL - AIC n. 043405048.
redeemability 'Class: Relevant section of the class in art. 8, paragraph 10, letter c) of the Law of 24 December 1993, n. 537, as amended, dedicated to drugs not yet assessed for the purposes of reimbursement ', called Class C (nn).
Package: "2.5 mg + 5 mg hard capsules" 60 capsules in blister PA / AL / PVC / AL - AIC n. 043405051.
redeemability 'Class: Relevant section of the class in art. 8, paragraph 10, letter c) of the Law of 24 December 1993, n. 537, as amended, dedicated to drugs not yet assessed for the purposes of reimbursement ', called Class C (nn).
Package: "2.5 mg + 5 mg hard capsules" 90 capsules in blister PA / AL / PVC / AL - AIC n. 043405063.
redeemability 'Class: Relevant section of the class in art. 8, paragraph 10, letter c) of the Act of 24 December 1993, n. 537, as amended, dedicated to drugs not yet assessed for the purposes of reimbursement ', called Class C (nn).
Package: "2.5 mg + 5 mg hard capsules" 91 capsules in blister PA / AL / PVC / AL - AIC n. 043405075.
redeemability 'Class: Relevant section of the class in art. 8, paragraph 10, letter c) of the Law of 24 December 1993, n. 537, as amended, dedicated to drugs not yet assessed for the purposes of reimbursement ', called Class C (nn).
Package: "2.5 mg + 5 mg hard capsules" 96 capsules in blister PA / AL / PVC / AL -AIC n. 043405087.
redeemability 'Class: Relevant section of the class in art. 8, paragraph 10, letter c) of the Law of 24 December 1993, n. 537, as amended, dedicated to drugs not yet assessed for the purposes of reimbursement ', called Class C (nn).
Package: "2.5 mg + 5 mg hard capsules" 98 capsules in blister PA / AL / PVC / AL - AIC n. 043405099.
redeemability 'Class: Relevant section of the class in art. 8, paragraph 10, letter c) of the Law of 24 December 1993, n. 537, as amended, dedicated to drugs not yet assessed for the purposes of reimbursement ', called Class C (nn).
Package: "2.5 mg + 5 mg hard capsules" 100 capsules in blister PA / AL / PVC / AL - AIC n. 043405101.
redeemability 'Class: Relevant section of the class in art. 8, paragraph 10, letter c) of the Law of 24 December 1993, n. 537, as amended, dedicated to drugs not yet assessed for the purposes of reimbursement ', called Class C (nn).
Package: "5 mg + 5 mg hard capsules" 28 capsules in blister PA / AL / PVC / AL - AIC n. 043405113.
redeemability 'Class: Relevant section of the class in art. 8, paragraph 10, letter c) of the Law of 24 December 1993, n. 537, as amended, dedicated to drugs not yet assessed for the purposes of reimbursement ', called Class C (nn).

Package: "5 mg + 5 mg hard capsules" 30 capsules in blister PA / AL / PVC / AL - AIC n. 043405125.
redeemability 'Class: Relevant section of the class in art. 8, paragraph 10, letter c) of the Law of 24 December 1993, n. 537, as amended, dedicated to drugs not yet assessed for the purposes of reimbursement ', called Class C (nn).
Package: "5 mg + 5 mg hard capsules" 32 capsules in blister PA / AL / PVC / AL - AIC n. 043405137.
redeemability 'Class: Relevant section of the class in art. 8, paragraph 10, letter c) of the Law of 24 December 1993, n. 537, as amended, dedicated to drugs not yet assessed for the purposes of reimbursement ', called Class C (nn).
Package: "+ 5mg 5mg hard capsules" 56 capsules in blister PA / AL / PVC / AL - AIC n. 043405149.
redeemability 'Class: Relevant section of the class in art. 8, paragraph 10, letter c) of the Law of 24 December 1993, n. 537, as amended, dedicated to drugs not yet assessed for the purposes of reimbursement ', called Class C (nn).
Package: "5 mg + 5 mg hard capsules" 60 capsules in blister PA / AL / PVC / AL - AIC n. 043405152.
redeemability 'Class: Relevant section of the class in art. 8, paragraph 10, letter c) of the Law of 24 December 1993, n. 537, as amended, dedicated to drugs not yet assessed for the purposes of reimbursement ', called Class C (nn).
Package: "5 mg + 5 mg hard capsules" 90 capsules in blister PA / AL / PVC / AL - AIC n. 043405164.
redeemability 'Class: Relevant section of the class in art. 8, paragraph 10, letter c) of the Law of 24 December 1993, n. 537, as amended, dedicated to drugs not yet assessed for the purposes of reimbursement ', called Class C (nn).
Package: "5 mg + 5 mg hard capsules" 91 capsules in blister PA / AL / PVC / AL - AIC n. 043405176.
redeemability 'Class: Relevant section of the class in art. 8, paragraph 10, letter c) of the Law of 24 December 1993, n. 537, as amended, dedicated to drugs not yet assessed for the purposes of reimbursement ', called Class C (nn).
Package: "5 mg + 5 mg hard capsules" 96 capsules in blister PA / AL / PVC / AL - AIC n. 043405188.
redeemability 'Class: Relevant section of the class in art. 8, paragraph 10, letter c) of the Law of 24 December 1993, n. 537, as amended, dedicated to drugs not yet assessed for the purposes of reimbursement ', called Class C (nn).
Package: "5 mg + 5 mg hard capsules" 98 capsules in blister PA / AL / PVC / AL - AIC n. 043405190.
redeemability 'Class: Relevant section of the class in art. 8, paragraph 10, letter c) of the Law of 24 December 1993, n. 537, as amended, dedicated to drugs not yet assessed for the purposes of reimbursement ', called Class C (nn).
Package: "5 mg + 5 mg hard capsules" 100 capsules in blister PA / AL / PVC / AL - AIC n. 043405202.
redeemability 'Class: Relevant section of the class in art. 8, paragraph 10, letter c) of the Law of 24 December 1993, n. 537, as amended, dedicated to drugs not yet assessed for the purposes of reimbursement ', called Class C (nn).
Package: "5 mg + 10 mg hard capsules" 28 capsules in blister PA / AL / PVC / AL - AIC n. 043405214.
redeemability 'Class: Relevant section of the class in art. 8, paragraph 10, letter c) of the Law of 24 December 1993, n. 537, as amended, dedicated to drugs not yet assessed for the purposes of reimbursement ', called Class C (nn).
Package: "5 mg + 10 mg hard capsules" 30 capsules in blister PA / AL / PVC / AL - AIC n. 043405226.
redeemability 'Class: Relevant section of the class in art. 8, paragraph 10, letter c) of the Law of 24 December 1993, n. 537, as amended, dedicated to drugs not yet assessed for the purposes of reimbursement ', called Class C (nn).
Package: "5 mg + 10 mg hard capsules" 32 capsules in blister PA / AL / PVC / AL - AIC n. 043405238.
redeemability 'Class: Relevant section of the class in art. 8, paragraph 10, letter c) of the Law of 24 December 1993, n. 537, as amended, dedicated to drugs not yet assessed for the purposes of reimbursement ', called Class C (nn).
Package: "5 mg + 10 mg hard capsules" 56 capsules in blister PA / AL / PVC / AL - AIC n. 043405240.
redeemability 'Class: Relevant section of the class in art. 8, paragraph 10, letter c) of the Law of 24 December 1993, n. 537, as amended, dedicated to drugs not yet assessed for the purposes of reimbursement ', called Class C (nn).
Package: "5 mg + 10 mg hard capsules" 60 capsules in blister PA / AL / PVC / AL - AIC n. 043,405,253.

Redeemability 'Class: Relevant section of the class in art. 8, paragraph 10, letter c) of the Law of 24 December 1993, n. 537, as amended, dedicated to drugs not yet assessed for the purposes of reimbursement ', called Class C (nn).
Package: "5 mg + 10 mg hard capsules" 90 capsules in blister PA / AL / PVC / AL - AIC n. 043405265.
redeemability 'Class: Relevant section of the class in art. 8, paragraph 10, letter c) of the Law of 24 December 1993, n. 537, as amended, dedicated to drugs not yet assessed for the purposes of reimbursement ', called Class C (nn).
Package: "5 mg + 10 mg hard capsules" 91 capsules in blister PA / AL / PVC / AL - AIC n. 043405277.
redeemability 'Class: Relevant section of the class in art. 8, paragraph 10, letter c) of the Law of 24 December 1993, n. 537, as amended, dedicated to drugs not yet assessed for the purposes of reimbursement ', called Class C (nn).
Package: "5 mg + 10 mg hard capsules" 96 capsules in blister PA / AL / PVC / AL - AIC n. 043405289.
redeemability 'Class: Relevant section of the class in art. 8, paragraph 10, letter c) of the Law of 24 December 1993, n. 537, as amended, dedicated to drugs not yet assessed for the purposes of reimbursement ', called Class C (nn).
Package: "5 mg + 10 mg hard capsules" 98 capsules in blister PA / AL / PVC / AL - AIC n. 043405291.
redeemability 'Class: Relevant section of the class in art. 8, paragraph 10, letter c) of the Law of 24 December 1993, n. 537, as amended, dedicated to drugs not yet assessed for the purposes of reimbursement ', called Class C (nn).
Package: "5 mg + 10 mg hard capsules" 100 capsules in blister PA / AL / PVC / AL - AIC n. 043405303.
redeemability 'Class: Relevant section of the class in art. 8, paragraph 10, letter c) of the Law of 24 December 1993, n. 537, as amended, dedicated to drugs not yet assessed for the purposes of reimbursement ', called Class C (nn).
Package: "10 mg + 5 mg hard capsules" 28 capsules in blister PA / AL / PVC / AL - AIC n. 043405315.
redeemability 'Class: Relevant section of the class in art. 8, paragraph 10, letter c) of the Law of 24 December 1993, n. 537, as amended, dedicated to drugs not yet assessed for the purposes of reimbursement ', called Class C (nn).
Package: "10 mg + 5 mg hard capsules" 30 capsules in blister PA / AL / PVC / AL - AIC n. 043405327.
redeemability 'Class: Relevant section of the class in art. 8, paragraph 10, letter c) of the Law of 24 December 1993, n. 537, as amended, dedicated to drugs not yet assessed for the purposes of reimbursement ', called Class C (nn).
Package: "10 mg + 5 mg hard capsules" 32 capsules in blister PA / AL / PVC / AL - AIC n. 043405339.
redeemability 'Class: Relevant section of the class in art. 8, paragraph 10, letter c) of the Law of 24 December 1993, n. 537, as amended, dedicated to drugs not yet assessed for the purposes of reimbursement ', called Class C (nn).
Package: "10 mg + 5 mg hard capsules" 56 capsules in blister PA / AL / PVC / AL - AIC n. 043405341.
redeemability 'Class: Relevant section of the class in art. 8, paragraph 10, letter c) of the Law of 24 December 1993, n. 537, as amended, dedicated to drugs not yet assessed for the purposes of reimbursement ', called Class C (nn).
Package: "10 mg hard capsules + 5 m g" 60 capsules in blister PA / AL / PVC / AL - AIC n. 043405354.
redeemability 'Class: Relevant section of the class in art. 8, paragraph 10, letter c) of the Law of 24 December 1993, n. 537, as amended, dedicated to drugs not yet assessed for the purposes of reimbursement ', called Class C (nn).
Package: "10 mg + 5 mg hard capsules" 90 capsules in blister PA / AL / PVC / AL - AIC n. 043405366.
redeemability 'Class: Relevant section of the class in art. 8, paragraph 10, letter c) of the Law of 24 December 1993, n. 537, as amended, dedicated to drugs not yet assessed for the purposes of reimbursement ', called Class C (nn).
Package: "10 mg + 5 mg hard capsules" 91 capsules in blister PA / AL / PVC / AL - AIC n. 043405378.
redeemability 'Class: Relevant section of the class in art. 8, paragraph 10, letter c) of the Law of 24 December 1993, n. 537, as amended, dedicated to drugs not yet assessed for the purposes of reimbursement ', called Class C (nn).
Package: "10 mg + 5 mg hard capsules" 96 capsules in blister PA / AL / PVC / AL - AIC n. 043,405,380.

Redeemability 'Class: Relevant section of the class in art. 8, paragraph 10, letter c) of the Law of 24 December 1993, n. 537, as amended, dedicated to drugs not yet assessed for the purposes of reimbursement ', called Class C (nn).
Package: "10 mg + 5 mg hard capsules" 98 capsules in blister PA / AL / PVC / AL - AIC n. 043405392.
redeemability 'Class: Relevant section of the class in art. 8, paragraph 10, letter c) of the Law of 24 December 1993, n. 537, as amended, dedicated to drugs not yet assessed for the purposes of reimbursement ', called Class C (nn).
Package: "10 mg + 5 mg hard capsules" 100 capsules in blister PA / AL / PVC / AL - AIC n. 043405404.
redeemability 'Class: Relevant section of the class in art. 8, paragraph 10, letter c) of the Law of 24 December 1993, n. 537, as amended, dedicated to drugs not yet assessed for the purposes of reimbursement ', called Class C (nn).
Package: "10 mg + 10 mg hard capsules" 28 capsules in blister PA / AL / PVC / AL - AIC n. 043405416.
redeemability 'Class: Relevant section of the class in art. 8, paragraph 10, letter c) of the Law of 24 December 1993, n. 537, as amended, dedicated to drugs not yet assessed for the purposes of reimbursement ', called Class C (nn).
Package: "10 mg + 10 mg hard capsules" 30 capsules in blister PA / AL / PVC / AL - AIC n. 043405428.
redeemability 'Class: Relevant section of the class in art. 8, paragraph 10, letter c) of the Law of 24 December 1993, n. 537, as amended, dedicated to drugs not yet assessed for the purposes of reimbursement ', called Class C (nn).
Package: "10 mg + 10 mg hard capsules" 32 capsules in blister PA / AL / PVC / AL - AIC n. 043405430.
redeemability 'Class: Relevant section of the class in art. 8, paragraph 10, letter c) of the Law of 24 December 1993, n. 537, as amended, dedicated to drugs not yet assessed for the purposes of reimbursement ', called Class C (nn).
Package: "10 mg + 10 mg hard capsules" 56 capsules in blister PA / AL / PVC / AL - AIC n. 043405442.
redeemability 'Class: Relevant section of the class in art. 8, paragraph 10, letter c) of the Law of 24 December 1993, n. 537, as amended, dedicated to drugs not yet assessed for the purposes of reimbursement ', called Class C (nn).
Package: "10 mg + 10 mg hard capsules" 60 capsules in blister PA / AL / PVC / AL - AIC n. 043405455.
redeemability 'Class: Relevant section of the class in art. 8, paragraph 10, letter c) of the Law of 24 December 1993, n. 537, as amended, dedicated to drugs not yet assessed for the purposes of reimbursement ', called Class C (nn).
Package: "10 mg + 10 mg hard capsules" 90 capsules in blister PA / AL / PVC / AL - AIC n. 043405467.
redeemability 'Class: Relevant section of the class in art. 8, paragraph 10, letter c) of the Law of 24 December 1993, n. 537, as amended, dedicated to drugs not yet assessed for the purposes of reimbursement ', called Class C (nn).
Package: "10 mg + 10 mg hard capsules" 91 capsules in blister PA / AL / PVC / AL - AIC n. 043405479.
redeemability 'Class: Relevant section of the class in art. 8, paragraph 10, letter c) of the Law of 24 December 1993, n. 537, as amended, dedicated to drugs not yet assessed for the purposes of reimbursement ', called Class C (nn).
Package: "10 mg + 10 mg hard capsules" 96 capsules in blister PA / AL / PVC / AL - AIC n. 043405481.
redeemability 'Class: Relevant section of the class in art. 8, paragraph 10, letter c) of the Law of 24 December 1993, n. 537, as amended, dedicated to drugs not yet assessed for the purposes of reimbursement ', called Class C (nn).
Package: "10 mg + 10 mg hard capsules" 98 capsules in blister PA / AL / PVC / AL - AIC n. 043405493.
redeemability 'Class: Relevant section of the class in art. 8, paragraph 10, letter c) of the Law of 24 December 1993, n. 537, as amended, dedicated to drugs not yet assessed for the purposes of reimbursement ', called Class C (nn).
Package: "10 mg + 10 mg hard capsules" 100 capsules in blister PA / AL / PVC / AL - AIC n. 043405505.
redeemability 'Class: Relevant section of the class in art. 8, paragraph 10, letter c) of the Law of 24 December 1993, n. 537, as amended, dedicated to drugs not yet assessed for the purposes of reimbursement ', called Class C (nn).
Classification for the purpose of providing
Package: "2.5 mg + 5 mg hard capsules" 28 capsules in blister PA / AL / PVC / AL - AIC n. 043405012 - RR: Medicinal product subject to medical prescription.

Package: "2.5 mg + 5 mg hard capsules" 30 capsules in blister PA / AL / PVC / AL - AIC n. 043405024 - RR: Medicinal product subject to medical prescription.
Package: "2.5 mg + 5 mg hard capsules" 32 capsules in blister PA / AL / PVC / AL - AIC n. 043405036 - RR: Medicinal product subject to medical prescription.
Package: "2.5 mg + 5 mg hard capsules" 56 capsules in blister PA / AL / PVC / AL - AIC n. 043405048 - RR: Medicinal product subject to medical prescription.
Package: "2.5 mg + 5 mg hard capsules" 60 capsules in blister PA / AL / PVC / AL - AIC n. 043405051 - RR: Medicinal product subject to medical prescription.
Package: "2.5 mg + 5 mg hard capsules" 90 capsules in blister PA / AL / PVC / AL - AIC n. 043405063 - RR: Medicinal product subject to medical prescription.
Package: "2.5 mg + 5 mg hard capsules" 91 capsules in blister PA / AL / PVC / AL - AIC n. 043405075 - RR: Medicinal product subject to medical prescription.
Package: "2.5 mg + 5 mg hard capsules" 96 capsules in blister PA / AL / PVC / AL - AIC n. 043405087 - RR: Medicinal product subject to medical prescription.
Package: "2.5 mg + 5 mg hard capsules" 98 capsules in blister PA / AL / PVC / AL - AIC n. 043405099 - RR: Medicinal product subject to medical prescription.
Package: "2.5 mg + 5 mg hard capsules" 100 capsules in blister PA / AL / PVC / AL - AIC n. 043405101 - RR: Medicinal product subject to medical prescription.
Package: "5 mg + 5 mg hard capsules" 28 capsules in blister PA / AL / PVC / AL - AIC n. 043405113 - RR: Medicinal product subject to medical prescription.
Package: "5 mg + 5 mg hard capsules" 30 capsules in blister PA / AL / PVC / AL - AIC n. 043405125 - RR: Medicinal product subject to medical prescription.
Package: "5 mg + 5 mg hard capsules" 32 capsules in blister PA / AL / PVC / AL - AIC n. 043405137 - RR: Medicinal product subject to medical prescription.
Package: "5 mg + 5 mg hard capsules" 56 capsules in blister PA / AL / PVC / AL - AIC n. 043405149 - RR: Medicinal product subject to medical prescription.
Package: "5 mg + 5 mg hard capsules" 60 capsules in blister PA / AL / PVC / AL - AIC n. 043405152 - RR: Medicinal product subject to medical prescription.
Package: "5 mg + 5 mg hard capsules" 90 capsules in blister PA / AL / PVC / AL - AIC n. 043405164 - RR: Medicinal product subject to medical prescription.
Package: "5 mg + 5 mg hard capsules" 91 capsules in blister PA / AL / PVC / AL - AIC n. 043405176 - RR: Medicinal product subject to medical prescription.
Package: "5 mg + 5 mg hard capsules" 96 capsules in blister PA / AL / PVC / AL - AIC n. 043405188 - RR: Medicinal product subject to medical prescription.
Package: "5 mg + 5 mg hard capsules" 98 capsules in blister PA / AL / PVC / AL - AIC n. 043405190 - RR: Medicinal product subject to medical prescription.
Package: "5 mg + 5 mg hard capsules" 100 capsules in blister PA / AL / PVC / AL - AIC n. 043405202 - RR: Medicinal product subject to medical prescription.
Package: "5 mg + 10 mg hard capsules" 28 capsules in blister PA / AL / PVC / AL - AIC n. 043405214 - RR: Medicinal product subject to medical prescription.
Package: "5 mg + 10 mg hard capsules" 30 capsules in blister PA / AL / PVC / AL - AIC n. 043405226 - RR: Medicinal product subject to medical prescription.
Package: "5 mg + 10 mg hard capsules" 32 capsules in blister PA / AL / PVC / AL - AIC n. 043405238 - RR: Medicinal product subject to medical prescription.
Package: "5 mg + 10 mg hard capsules" 56 capsules in blister PA / AL / PVC / AL - AIC n. 043405240 - RR: Medicinal product subject to medical prescription.
Package: "5 mg + 10 mg hard capsules" 60 capsules in blister PA / AL / PVC / AL - AIC n. 043405253 - RR: Medicinal product subject to medical prescription.
Package: "5 mg + 10 mg hard capsules" 90 capsules in blister PA / AL / PVC / AL - AIC n. 043405265 - RR: Medicinal product subject to medical prescription.
Package: "5 mg + 10 mg hard capsules" 91 capsules in blister PA / AL / PVC / AL - AIC n. 043405277 - RR: Medicinal product subject to medical prescription.
Package: "5 mg + 10 mg hard capsules" 96 capsules in blister PA / AL / PVC / AL - AIC n. 043405289 - RR: Medicinal product subject to medical prescription.
Package: "5 mg + 10 mg hard capsules" 98 capsules in blister PA / AL / PVC / AL - AIC n. 043405291 - RR: Medicinal product subject to medical prescription.
Package: "5 mg + 10 mg hard capsules" 100 capsules in blister PA / AL / PVC / AL - AIC n. 043405303 - RR: Medicinal product subject to medical prescription.
Package: "10 mg + 5 mg hard capsules" 28 capsules in blister PA / AL / PVC / AL - AIC n. 043405315 - RR: Medicinal product subject to medical prescription.
Package: "10 mg + 5 mg hard capsules" 30 capsules in blister PA / AL / PVC / AL - AIC n. 043405327 - RR: Medicinal product subject to medical prescription.

Package: "10 mg + 5 mg hard capsules" 32 capsules in blister PA / AL / PVC / AL - AIC n. 043405339 - RR: Medicinal product subject to medical prescription.
Package: "10 mg + 5 mg hard capsules" 56 capsules in blister PA / AL / PVC / AL - AIC n. 043405341 - RR: Medicinal product subject to medical prescription.
Package: "10 mg + 5 mg hard capsules" 60 capsules in blister PA / AL / PVC / AL - AIC n. 043405354 - RR: Medicinal product subject to medical prescription.
Package: "10 mg + 5 mg hard capsules" 90 capsules in blister PA / AL / PVC / AL - AIC n. 043405366 - RR: Medicinal product subject to medical prescription.
Package: "10 mg + 5 mg hard capsules" 91 capsules in blister PA / AL / PVC / AL - AIC n. 043405378 - RR: Medicinal product subject to medical prescription.
Package: "10 mg + 5 mg hard capsules" 96 capsules in blister PA / AL / PVC / AL - AIC n. 043405380 - RR: Medicinal product subject to medical prescription.
Package: "10 mg + 5 mg hard capsules" 98 capsules in blister PA / AL / PVC / AL - AIC n. 043405392 - RR: Medicinal product subject to medical prescription.
Package: "10 mg + 5 mg hard capsules" 100 capsules in blister PA / AL / PVC / AL - AIC n. 043405404 - RR: Medicinal product subject to medical prescription.
Package: "10 mg + 10 mg hard capsules" 28 capsules in blister PA / AL / PVC / AL - AIC n. 043405416 - RR: Medicinal product subject to medical prescription.
Package: "10 mg + 10 mg hard capsules" 30 capsules in blister PA / AL / PVC / AL - AIC n. 043405428 - RR: Medicinal product subject to medical prescription.
Package: "10 mg + 10 mg hard capsules" 32 capsules in blister PA / AL / PVC / AL - AIC n. 043405430 - RR: Medicinal product subject to medical prescription.
Package: "10 mg + 10 mg hard capsules" 56 capsules in blister PA / AL / PVC / AL - AIC n. 043405442 - RR: Medicinal product subject to medical prescription.
Package: "10 mg + 10 mg hard capsules" 60 capsules in blister PA / AL / PVC / AL - AIC n. 043405455 - RR: Medicinal product subject to medical prescription.
Package: "10 mg + 10 mg hard capsules" 90 capsules in blister PA / AL / PVC / AL - AIC n. 043405467 - RR: Medicinal product subject to medical prescription.
Package: "10 mg + 10 mg hard capsules" 91 capsules in blister PA / AL / PVC / AL - AIC n. 043405479 - RR: Medicinal product subject to medical prescription.
Package: "10 mg + 10 mg hard capsules" 96 capsules in blister PA / AL / PVC / AL - AIC n. 043405481 - RR: Medicinal product subject to medical prescription.
Package: "10 mg + 10 mg hard capsules" 98 capsules in blister PA / AL / PVC / AL - AIC n. 043405493 - RR: Medicinal product subject to medical prescription.
Package: "10 mg + 10 mg hard capsules" 100 capsules in blister PA / AL / PVC / AL - AIC n. 043405505 - RR: Medicinal product subject to medical prescription.

The printed the medicine packaging must be placed on the market with labels and leaflets in accordance with the text attached to the determination, referred to in this extract.
E 'approved the summary of product characteristics attached to the assessment, referred to in this extract.
As required by Art. 80 paragraphs 1 and 3 of the Legislative Decree 24 April 2006, n. 219, as amended leaflet and labels must be written in Italian and, for medicinal products marketed in the province of Bolzano, also in German. The MAH that it intends to use complementary use of foreign languages, must give prior notice to AIFA and keep the certified translation of the texts in German and / or other foreign language speaking. In case of non-compliance with labeling provisions and the leaflet to the sanctions provided for in Article. 82 of this decree.
periodic safety update reports - PSUR
The holder of the marketing authorization must provide periodic safety update reports for this product in accordance with the requirements defined in the list of reference dates for the European Union ( EURD list) provided for in Article 107 quater, para. 7) of Directive 2010/84 / EC and published on the web portal European Medicines Agency.
Effective date of the determination from the day following that of its publication, to extract, in the Official Gazette of the Italian Republic.