Authorisation For The Medicinal Product For Usoumano «Ramantal».

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

Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-03-04&atto.codiceRedazionale=15A01512&elenco30giorni=false&atto.tipoProvvedimento=DECRETO

Retrieved February 16, 2015 V&A # 281/2015 of description determines medicine and assigning AIC.
It is authorised for placing on the market of the medicinal product: RAMANTAL in form and packaging: «2.5 mg + 5 mg hard capsules» 28 capsules in PA/AL/PVC-AL, «5 mg + 5 mg hard capsules» 28 capsules in PA/AL/PVC-AL, «10 mg + 5 mg hard capsules» 28 capsules in PA/AL/PVC-AL, «5 mg + 10 mg capsule» 28 capsules in PA/AL/PVC-AL, «10 mg + 10 mg capsule» 28 capsules in PA/AL/PVC-AL under the conditions and with the specifications mentioned below: Mah: Errekappa Euroterapici S.p.A. Via Ciro Menotti, 1/A, 20129-Milan, Italy, tax code 09674060158.
Package: «2.5 mg + 5 mg hard capsules» 28 capsules in PA/AL/PVC-AL-AIC # 043313016 (10) 199TVS (based on 32).
Dosage form: capsules.
Complete appliance validity: 2 years from date of manufacture special precautions for storage: do not store above 30° c. Store in the original package to protect from light.
Composition: Each capsule contains: active ingredient: ramipril 2.5 mg and AMLODIPINE BESYLATE 6.934 mg (corresponding to amlodipine 5 mg);
Other ingredients: capsule filling: microcrystalline cellulose (grade: 200), calcium hydrogen phosphate anhydrous, pregelatinised starch, pregelatinized starch low in moisture, sodium starch glycolate (type A), sodium Stearyl fumarate.
The capsule shell: red iron oxide (E 172), titanium dioxide (E 171), jelly.
The active substance manufacturer: Dr. Reddy's Laboratories Limited, Plot No. 116, Sri Venkateswara Co-Operative Industrial Estate I.D.A. Bolarum, Jinnaram Mandal, Medak District, Andhra Pradesh India-502 325 (AMLODIPINE BESYLATE);
Dr. Reddy's Laboratories Limited, Plot No. 110 111, Sri Venkateswara & Co-Operative Industrial Estate, Jinnaram Mandal, India-502 325 Bolarum Village, Medak District, Andhra Pradesh (AMLODIPINE BESYLATE);
Zhejiang Huhai Pharmaceutical Co. Ltd., 317-024 Xunqiao, Linhai city, Zhejiang Province China (ramipril) manufacturer of the finished product: Zakład Farmaceutyczny Adamed Pharma s.a., Szkolna Street 33, 95-054 Ksawerow, Poland (production, primary and secondary packaging, control and batch release);
Phardis S.r.l., Via Milano n. 2, 24040 Calvenzano (BG) (outer packaging for the mere application of optical label);
Pabianickie Zakłady Farmaceutyczne Polfa S.A., Marszałka Jozefa 95-200 5, Pabianice, Poland Piłsudskiego Street (control and batch release);
Adamed Sp. z o.o., Pieńkow 149, 05-152 Czosnow, Poland (batch release).
Package: «5 mg + 5 mg hard capsules» 28 capsules in PA/AL/PVC-AL-AIC # 043313028 (10) 199TW4 (based on 32) dosage form: capsules validity complete appliance: 2 years from date of manufacture special precautions for storage: do not store above 30° c. Store in the original package to protect from light.
Composition: Each capsule contains: active ingredient: ramipril 5 mg and AMLODIPINE BESYLATE 6.934 mg (corresponding to amlodipine 5 mg);
Other ingredients: capsule filling: microcrystalline cellulose (grade: 200), calcium hydrogen phosphate anhydrous, pregelatinised starch, pregelatinized starch low in moisture, sodium starch glycolate (type A), sodium Stearyl fumarate.
The capsule shell: red iron oxide (E 172), titanium dioxide (E 171), jelly.
The active substance manufacturer: Dr. Reddy's Laboratories Limited, Plot No. 116, Sri Venkateswara Co-Operative Industrial Estate I.D.A. Bolarum, Jinnaram Mandal, Medak District, Andhra Pradesh India-502 325 (AMLODIPINE BESYLATE);
Dr. Reddy's Laboratories Limited, Plot No. 110 111, Sri Venkateswara & Co-Operative Industrial Estate, Jinnaram Mandal, India-502 325 Bolarum Village, Medak District, Andhra Pradesh (AMLODIPINE BESYLATE);
Zhejiang Huhai Pharmaceutical Co. Ltd., 317-024 Xunqiao, Linhai city, Zhejiang Province China (ramipril) manufacturer of the finished product: Zakład Farmaceutyczny Adamed Pharma s.a., Szkolna Street 33, 95-054 Ksawerow, Poland (production, primary and secondary packaging, control and batch release);
Phardis S.r.l., Via Milano n. 2, 24040 Calvenzano (BG) (outer packaging for the mere application of optical label);
Pabianickie Zakłady Farmaceutyczne Polfa S.A., Marszałka Jozefa 95-200 5, Pabianice, Poland Piłsudskiego Street (control and batch release);
Adamed Sp. z o.o., Pieńkow 149, 05-152 Czosnow, Poland (batch release).
Package: «10 mg + 5 mg hard capsules» 28 capsules in PA/AL/PVC-AL-AIC # 043313030 (10) 199TW6 (based on 32).
Dosage form: capsules.
Complete appliance validity: 2 years from date of manufacture.
Special precautions for storage: do not store above 30° c. Store in the original package to protect from light.
Composition: Each capsule contains: active ingredient: ramipril 10 mg and AMLODIPINE BESYLATE 6.934 mg (corresponding to amlodipine 5 mg);
Other ingredients: capsule filling: microcrystalline cellulose (grade: 200), calcium hydrogen phosphate anhydrous, pregelatinised starch, pregelatinized starch low in moisture, sodium starch glycolate (type A), sodium Stearyl fumarate.
The capsule shell: red iron oxide (E 172), titanium dioxide (E 171), jelly.
The active substance manufacturer: Dr. Reddy's Laboratories Limited, Plot No. 116, Sri Venkateswara Co-Operative Industrial Estate I.D.A. Bolarum, Jinnaram Mandal, Medak District, Andhra Pradesh India-502 325 (AMLODIPINE BESYLATE);
Dr. Reddy's Laboratories Limited, Plot No. 110 111, Sri Venkateswara & Co-Operative Industrial Estate, Jinnaram Mandal, India-502 325 Bolarum Village, Medak District, Andhra Pradesh (AMLODIPINE BESYLATE);
Zhejiang Huhai Pharmaceutical Co. Ltd., 317-024 Xunqiao, Linhai city, Zhejiang Province China (ramipril) manufacturer of the finished product: Zakład Farmaceutyczny Adamed Pharma s.a., Szkolna Street 33, 95-054 Ksawerow, Poland (production, primary and secondary packaging, control and batch release);
Phardis S.r.l., Via Milano n. 2, 24040 Calvenzano (BG) (outer packaging for the mere application of optical label);
Pabianickie Zakłady Farmaceutyczne Polfa S.A., Marszałka Jozefa 95-200 5, Pabianice, Poland Piłsudskiego Street (control and batch release);

Adamed Sp. z o.o., Pieńkow 149, 05-152 Czosnow, Poland (batch release).
Packaging: 5 mg + 10 mg ' on colored rigid» 28 capsules in PA/AL/PVC-AL-AIC # 043313042 (10) 199TWL (based on 32) dosage form: capsules validity complete appliance: 2 years from date of manufacture special precautions for storage: do not store above 30° c. Store in the original package to protect from light.
Composition: Each capsule contains: active ingredient: ramipril 5 mg and AMLODIPINE BESYLATE 13.868 mg (corresponding to amlodipine 10 mg);
Other ingredients: capsule filling: microcrystalline cellulose (grade: 200), calcium hydrogen phosphate anhydrous, pregelatinised starch, pregelatinized starch low in moisture, sodium starch glycolate (type A), sodium Stearyl fumarate.
The capsule shell: red iron oxide (E 172), titanium dioxide (E 171), jelly.
The active substance manufacturer: Dr. Reddy's Laboratories Limited, Plot No. 116, Sri Venkateswara Co-Operative Industrial Estate I.D.A. Bolarum, Jinnaram Mandal, Medak District, Andhra Pradesh India-502 325 (AMLODIPINE BESYLATE);
Dr. Reddy's Laboratories Limited, Plot No. 110 111, Sri Venkateswara & Co-Operative Industrial Estate, Jinnaram Mandal, India-502 325 Bolarum Village, Medak District, Andhra Pradesh (AMLODIPINE BESYLATE);
Zhejiang Huhai Pharmaceutical Co. Ltd., 317-024 Xunqiao, Linhai city, Zhejiang Province China (ramipril) manufacturer of the finished product: Zakład Farmaceutyczny Adamed Pharma s.a., Szkolna Street 33, 95-054 Ksawerow, Poland (production, primary and secondary packaging, control and batch release);
Phardis S.r.l., Via Milano n. 2, 24040 Calvenzano (BG) (outer packaging for the mere application of optical label);
Pabianickie Zakłady Farmaceutyczne Polfa S.A., Marszałka Jozefa 95-200 5, Pabianice, Poland Piłsudskiego Street (control and batch release);
Adamed Sp. z o.o., Pieńkow 149, 05-152 Czosnow, Poland (batch release).
Packaging: 10 mg + 10 mg capsule «» 28 capsules in PA/AL/PVC-AL-AIC # 043313055 (10) 199TWZ (based on 32) dosage form: capsules validity complete appliance: 2 years from date of manufacture special precautions for storage: do not store above 30° c. Store in the original package to protect from light.
Composition: Each capsule contains: active ingredient: ramipril 10 mg and AMLODIPINE BESYLATE 13.868 mg (corresponding to amlodipine 10 mg);
Other ingredients: capsule filling: microcrystalline cellulose (grade: 200), calcium hydrogen phosphate anhydrous, pregelatinised starch, pregelatinized starch low in moisture, sodium starch glycolate (type A), sodium Stearyl fumarate.
The capsule shell: yellow iron oxide (E 172), black iron oxide (E 172), red iron oxide (E 172), titanium dioxide (E 171), jelly.
The active substance manufacturer: Dr. Reddy's Laboratories Limited, Plot No. 116, Sri Venkateswara Co-Operative Industrial Estate I.D.A. Bolarum, Jinnaram Mandal, Medak District, Andhra Pradesh India-502 325 (AMLODIPINE BESYLATE);
Dr. Reddy's Laboratories Limited, Plot No. 110 111, Sri Venkateswara & Co-Operative Industrial Estate, Jinnaram Mandal, India-502 325 Bolarum Village, Medak District, Andhra Pradesh (AMLODIPINE BESYLATE);
Zhejiang Huhai Pharmaceutical Co. Ltd., 317-024 Xunqiao, Linhai city, Zhejiang Province China (ramipril) manufacturer of the finished product: Zakład Farmaceutyczny Adamed Pharma s.a., Szkolna Street 33, 95-054 Ksawerow, Poland (production, primary and secondary packaging, control and batch release);
Phardis S.r.l., Via Milano n. 2, 24040 Calvenzano (BG) (outer packaging for the mere application of optical label);
Pabianickie Zakłady Farmaceutyczne Polfa S.A., Marszałka Jozefa 95-200 5, Pabianice, Poland Piłsudskiego Street (control and batch release);
Adamed Sp. z o.o., Pieńkow 149, 05-152 Czosnow, Poland (batch release).
Medical indications: treatment of hypertension.
RAMANTAL it is used as replacement therapy in patients with blood pressure adequately controlled with amlodipine and ramipril administered simultaneously at the same dose.
Classification for the purposes of new listings ' box: 2.5 mg + 5 mg capsule "» 28 capsules in PA/AL/PVC-AL-AIC # 043313016 new listings ' class: section of the class referred to in art. 8, paragraph 10) (c) of the Act December 24, 1993, no. 537 as amended, dedicated to drugs not yet evaluated for the purposes of new listings, called class C (nn).
Package: «5 mg + 5 mg hard capsules» 28 capsules in PA/AL/PVC-AL-AIC # 043313028.
New listings ' class: section of the class referred to in art. 8, paragraph 10) (c) of the Act December 24, 1993, no. 537 as amended, dedicated to drugs not yet evaluated for the purposes of new listings, called class C (nn).
Package: «10 mg + 5 mg hard capsules» 28 capsules in PA/AL/PVC-AL-AIC # 043313030 new listings ' class: section of the class referred to in art. 8, paragraph 10) (c) of the Act December 24, 1993, no. 537 as amended, dedicated to drugs not yet evaluated for the purposes of new listings, called class C (nn).
Package: «5 mg + 10 mg capsule» 28 capsules in PA/AL/PVC-AL-AIC # 043313042.
New listings ' class: section of the class referred to in art. 8, paragraph 10) (c) of the Act December 24, 1993, no. 537 as amended, dedicated to drugs not yet evaluated for the purposes of new listings, called class C (nn).
Packaging: 10 mg + 10 mg capsule «» 28 capsules in PA/AL/PVC-AL-AIC # 043313055.
New listings ' class: section of the class referred to in art. 8, paragraph 10) (c) of the Act December 24, 1993, no. 537 as amended, dedicated to drugs not yet evaluated for the purposes of new listings, called class C (nn).
Classification for the purposes of delivery set: «2.5 mg + 5 mg hard capsules» 28 capsules in PA/AL/PVC-AL-A.I.C. # 043313016 RR: medicinal product subject to medical prescription.
Package: «5 mg + 5 mg hard capsules» 28 capsules in PA/AL/PVC-AL-A.I.C. # 043313028 RR: medicinal product subject to medical prescription.

Package: «10 mg + 5 mg hard capsules» 28 capsules in PA/AL/PVC-AL-A.I.C. # 043313030 RR: medicinal product subject to medical prescription.
Package: «5 mg + 10 mg capsule» 28 capsules in PA/AL/PVC-AL-A.I.C. # 043313042 RR: medicinal product subject to medical prescription.
Packaging: 10 mg + 10 mg capsule «» 28 capsules in PA/AL/PVC-AL-A.I.C. # 043313055 RR: medicinal product subject to medical prescription.
Packaging of printed material should be marketed with labels and package leaflets comply with the attached text to the determination, under this extract.
It approved the summary of the product characteristics attached to the assessment, referred to in this excerpt.
In accordance with art. 80 paragraphs 1 and 3 of the Legislative Decree of April 24, 2006, # 219 s and the package leaflet and labels must be written in Italian and, limited to medicinal products marketed in the province of Bolzano, in German. The mAh avails itself of the complementary use of foreign languages, must give prior notice to the AIFA and keep available the certified translation of German texts and/or in another foreign language. In case of non-compliance with the provisions on the labelling and package leaflet shall apply sanctions under art. 82 of the aforementioned legislative decree.
Periodic safety update reports PSUR-The marketing authorisation holder shall provide periodic safety update reports for this product in accordance with the requirements set out in the list of dates of reference (EURD list) referred to in article 107-quater, para. 2010/84/EC Directive 7) and published on the web portal of the European Medicines Agency.
Date of determination: from the day following that of its publication, to decompress, in Gazzetta Ufficiale della Repubblica italiana.