ASBIMA

Základní informace

  • Název přípravku:
  • ASBIMA Potahovaná tableta 5MG/160MG
  • Dávkování:
  • 5MG/160MG
  • Léková forma:
  • Potahovaná tableta
  • Podání:
  • Perorální podání
  • Jednotky v balení:
  • 98 Blistr
  • Druh předpisu:
  • na lékařský předpis
  • Použij pro:
  • Lidé
  • Léčitelství typu:
  • alopatický drog

Dokumenty

Lokalizace

  • K dispozici v:
  • ASBIMA Potahovaná tableta 5MG/160MG
    Česká republika
  • Jazyk:
  • čeština

Terapeutická informace

  • Terapeutické oblasti:
  • VALSARTAN A AMLODIPIN
  • Přehled produktů:
  • ASBIMA

Další informace

Stav

  • Zdroj:
  • SUKL - Státní ústav pro kontrolu léčiv
  • Stav Autorizace:
  • R - registrovaný léčivý přípravek.
  • Registrační číslo:
  • 58/ 163/16-C
  • Poslední aktualizace:
  • 19-09-2017

13-9-2018

FDA provides update on its ongoing investigation into valsartan products; and reports on the finding of an additional impurity identified in one firm’s already recalled products

FDA provides update on its ongoing investigation into valsartan products; and reports on the finding of an additional impurity identified in one firm’s already recalled products

FDA update on the ongoing investigation into valsartan impurities, recalls and current findings.

FDA - U.S. Food and Drug Administration

13-9-2018

Contaminated valsartan has so far not caused an increased incidence of cancer cases in Denmark

Contaminated valsartan has so far not caused an increased incidence of cancer cases in Denmark

A Danish registry study has examined if the cancer incidence rate is higher among people treated with the blood pressure lowering medicine Valsartan, which due to the risk of contamination was recalled from the market in July 2018. The study concludes that no increased cancer incidence can be seen at present.

Danish Medicines Agency

13-9-2018

Health Canada advises of a second impurity linked to recalled valsartan drugs

Health Canada advises of a second impurity linked to recalled valsartan drugs

OTTAWA - Health Canada is advising Canadians that a second impurity, called N-nitrosodiethylamine (NDEA) has been found in valsartan manufactured by Zhejiang Huahai Pharmaceuticals in China.

Health Canada

10-9-2018

Health Canada updates Canadians on estimates of health risks for recalled valsartan drugs containing NDMA

Health Canada updates Canadians on estimates of health risks for recalled valsartan drugs containing NDMA

OTTAWA –Health Canada is sharing the results of its review of potential long-term health effects involving valsartan drugs that were found to contain the impurity N-nitrosodimethylamine (NDMA). Health Canada scientists have assessed the available data to determine the potential increased risk of developing cancer, to help put the risk into context for Canadians.

Health Canada

22-8-2018

UPDATED: Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Valsartan/Amlodipine/HCTZ, Valsartan/Amlodipine and Valsartan Tablets

UPDATED: Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Valsartan/Amlodipine/HCTZ, Valsartan/Amlodipine and Valsartan Tablets

Torrent Pharmaceuticals Limited is voluntarily recalling ALL LOTS within expiry of Valsartan/Amlodipine/HCTZ, Valsartan/Amlodipine and Valsartan tablets to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Zhejiang Huahai Pharmaceuticals. The impurity detected in the API is N-nitrosodimethylamine (NDMA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industr...

FDA - U.S. Food and Drug Administration

18-8-2018

Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Valsartan / Amlodipine / HCTZ Tablets

Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Valsartan / Amlodipine / HCTZ Tablets

Torrent Pharmaceuticals Limited is voluntarily recalling 14 lots of Valsartan/Amlodipine/HCTZ tablets to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Zhejiang Huahai Pharmaceuticals. The impurity detected in the API is N-nitrosodimethylamine (NDMA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probabl...

FDA - U.S. Food and Drug Administration

9-8-2018

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Valsartan Tablets, USP, 40mg, 80mg, 160mg and 320mg Due to The Detection of Trace Amounts of N-Nitrosodimethylamine (NDMA) Impurity, Found in an Active Pharmaceutical Ingredient (API)

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Valsartan Tablets, USP, 40mg, 80mg, 160mg and 320mg Due to The Detection of Trace Amounts of N-Nitrosodimethylamine (NDMA) Impurity, Found in an Active Pharmaceutical Ingredient (API)

As a precautionary measure, Camber Pharmaceuticals, Inc. is voluntarily recalling all unexpired lots of Valsartan Tablets, USP, 40mg, 80mg, 160mg and 320mg to the hospital, retail and consumer level. This recall of multiple batches of Valsartan Tablets was prompted due to the detection of trace amounts of N-Nitrosodimethylamine (NDMA), a possible process impurity or contaminant in an active pharmaceutical ingredient, manufactured by Hetero Labs Limited, Unit – I (API manufacturer).

FDA - U.S. Food and Drug Administration

19-7-2018

Doporučení SÚKL k řešení situace výpadku léčivých přípravků s obsahem léčivé látky valsartan (Aktualizace 19. 7. 2018)

Doporučení SÚKL k řešení situace výpadku léčivých přípravků s obsahem léčivé látky valsartan (Aktualizace 19. 7. 2018)

Státní ústav pro kontrolu léčiv (dále jen „Ústav“) informoval na svých webových stránkách dne 3. 7. 2018, že některé léčivé přípravky s obsahem léčivé látky valsartan jsou předmětem stahování až z úrovně zdravotnických zařízení z důvodu podezření na závadu v jakosti – možnou přítomnost nedeklarované nečistoty v léčivé látce.

Český Republich - SUKL - State Institute for Drug Control

19-7-2018

Valsartan-Containing Products: Update Health Professional and Consumer on Recent Recalled Products

Valsartan-Containing Products: Update Health Professional and Consumer on Recent Recalled Products

The investigation into valsartan-containing products is ongoing and there are currently three voluntary recalls related to the NDMA impurity detected in the valsartan

FDA - U.S. Food and Drug Administration

17-7-2018

Teva Pharmaceuticals USA Issues Voluntary Nationwide Recall of Valsartan and Valsartan Hydrochlorothiazide Tablets

Teva Pharmaceuticals USA Issues Voluntary Nationwide Recall of Valsartan and Valsartan Hydrochlorothiazide Tablets

Teva Pharmaceuticals USA today confirmed a voluntary recall to the consumer / user level of 29 lots of single and 51 lots of combination valsartan medicines distributed under the Actavis label in the U.S. due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Zhejiang Huahai Pharmaceutical. The impurity detected in the API is N- nitrosodimethylamine (NDMA), which is a substance that occurs naturally in certain foods, drinking wat...

FDA - U.S. Food and Drug Administration

16-7-2018

Major Pharmaceuticals Issues Voluntary Nationwide Recall of Valsartan Due to The Potential Presence of a Probable Carcinogen (NDMA)

Major Pharmaceuticals Issues Voluntary Nationwide Recall of Valsartan Due to The Potential Presence of a Probable Carcinogen (NDMA)

As a precautionary measure, the distribution firm, Major Pharmaceuticals, is issuing a nationwide voluntary recall of all lots within expiry of Valsartan which were supplied by Teva Pharmaceuticals and labeled as Major Pharmaceuticals.

FDA - U.S. Food and Drug Administration

13-7-2018

Prinston Pharmaceutical Inc Issues Voluntary Nationwide Recall of Valsartan and Valsartan HCTZ Tablets Due to Detection of a Trace Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA) in The Products

Prinston Pharmaceutical Inc Issues Voluntary Nationwide Recall of Valsartan and Valsartan HCTZ Tablets Due to Detection of a Trace Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA) in The Products

Prinston Pharmaceutical Inc. dba Solco Healthcare LLC. is recalling all lots of Valsartan Tablets, 40 mg, 80mg, 160mg, and 320mg; and Valsartan-Hydrochlorothiazide Tablets, 80mg/12.5mg, 160mg/12.5mg, 160mg/25mg, 320mg/12.5mg, and 320mg/25mg to the retail level. This product recall is due to the detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA), made by the manufacturer – Zhejiang Huahai Pharmaceutical Co. Ltd. -- that is used in the manufacture of the subject product ...

FDA - U.S. Food and Drug Administration

13-7-2018

FDA announces voluntary recall of several medicines containing valsartan following detection of an impurity

FDA announces voluntary recall of several medicines containing valsartan following detection of an impurity

FDA is alerting the public about a voluntary recall of several drug products containing valsartan, used to treat high blood pressure and heart failure

FDA - U.S. Food and Drug Administration

13-7-2018

Verze 2: Doporučení SÚKL k řešení situace výpadku léčivých přípravků s obsahem léčivé látky valsartan (aktualizace 13. 7. 2018)

Verze 2: Doporučení SÚKL k řešení situace výpadku léčivých přípravků s obsahem léčivé látky valsartan (aktualizace 13. 7. 2018)

V případě některých léčivých přípravků s obsahem léčivé látky valsartan, které jsou předmětem stahování, doporučuje Státní ústav pro kontrolu léčiv následující postup:

Český Republich - SUKL - State Institute for Drug Control

11-7-2018

SÚKL informuje o stahování některých léčivých přípravků s valsartanem

SÚKL informuje o stahování některých léčivých přípravků s valsartanem

SÚKL zveřejnil informaci o stahování některých léčivých přípravků s léčivou látkou valsartan z úrovně zdravotnických zařízení, lékáren a distributorů.

Český Republich - SUKL - State Institute for Drug Control

9-7-2018

Several drugs containing valsartan being recalled due to contamination with a potential carcinogen

Several drugs containing valsartan being recalled due to contamination with a potential carcinogen

Several drugs containing the ingredient valsartan are being recalled by their manufacturers. An impurity, N-nitrosodimethylamine (NDMA), was found in the valsartan used in these products. The valsartan was supplied by Zhejiang Huahai Pharmaceuticals. NDMA is a potential human carcinogen, which means that it could cause cancer with long-term exposure. Five companies have affected products, which are being recalled (identified in table below).

Health Canada

5-7-2018

Recall of valsartan blood pressure medicine

Recall of valsartan blood pressure medicine

Impurities that could potentially be harmful to health have been found in variants of medicines containing the active substance valsartan. The medicine is used to treat hypertension and heart failure. Patients treated with these medicines are therefore advised to contact their doctor as soon as possible to be switched to another type of medicine.

Danish Medicines Agency

4-7-2018

Verze 1: Doporučení SÚKL k řešení situace výpadku léčivých přípravků s obsahem léčivé látky valsartan

Verze 1: Doporučení SÚKL k řešení situace výpadku léčivých přípravků s obsahem léčivé látky valsartan

V případě některých léčivých přípravků s obsahem léčivé látky valsartan, které jsou předmětem stahování, doporučuje Státní ústav pro kontrolu léčiv následující postup:

Český Republich - SUKL - State Institute for Drug Control

4-7-2018

Doporučení Státního ústavu pro kontrolu léčiv k řešení situace výpadku léčivých přípravků s obsahem léčivé látky valsartan

Doporučení Státního ústavu pro kontrolu léčiv k řešení situace výpadku léčivých přípravků s obsahem léčivé látky valsartan

V případě některých léčivých přípravků s obsahem léčivé látky valsartan, které jsou předmětem stahování, doporučuje Státní ústav pro kontrolu léčiv následující postup:

Český Republich - SUKL - State Institute for Drug Control

8-3-2012

Review concluded regarding general reimbursement for Valsartan/Hydrochlorothiazide "Actavis"

Review concluded regarding general reimbursement for Valsartan/Hydrochlorothiazide "Actavis"

We have completed our review of an application for general reimbursement for Valsartan/Hydrochlorothiazide "Actavis". The product is neither eligible for general nor general conditional reimbursement.

Danish Medicines Agency

27-6-2018

Copalia HCT (Novartis Europharm Limited)

Copalia HCT (Novartis Europharm Limited)

Copalia HCT (Active substance: amlodipine besylate / valsartan / hydrochlorothiazide) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)4082 of Wed, 27 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1159/T/67

Europe -DG Health and Food Safety

27-6-2018

Exforge (Novartis Europharm Limited)

Exforge (Novartis Europharm Limited)

Exforge (Active substance: amlodipine / valsartan) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)4085 of Wed, 27 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/716/T/96

Europe -DG Health and Food Safety

27-6-2018

Dafiro HCT (Novartis Europharm Limited)

Dafiro HCT (Novartis Europharm Limited)

Dafiro HCT (Active substance: amlodipine besylate / valsartan / hydrochlorothiazide) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)4084 of Wed, 27 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1160/T/68

Europe -DG Health and Food Safety

11-6-2018

Exforge HCT (Novartis Europharm Limited)

Exforge HCT (Novartis Europharm Limited)

Exforge HCT (Active substance: amlodipine besylate / valsartan / hydrochlorothiazide) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3752 of Mon, 11 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1068/T/66

Europe -DG Health and Food Safety

11-6-2018

Dafiro (Novartis Europharm Limited)

Dafiro (Novartis Europharm Limited)

Dafiro (Active substance: amlodipine / valsartan) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3753 of Mon, 11 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/776/T/99

Europe -DG Health and Food Safety

6-6-2018

Copalia (Novartis Europharm Limited)

Copalia (Novartis Europharm Limited)

Copalia (Active substance: amlodipine / valsartan) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3695 of Wed, 06 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/774/T/97

Europe -DG Health and Food Safety

4-6-2018

Twynsta (Boehringer Ingelheim International GmbH)

Twynsta (Boehringer Ingelheim International GmbH)

Twynsta (Active substance: telmisartan / amlodipine) - Centralised - Yearly update - Commission Decision (2018)3625 of Mon, 04 Jun 2018

Europe -DG Health and Food Safety