Карбосорб

Основна информация

  • Търговско наименование:
  • Карбосорб 250 mg таблетки x 20
  • Използвай за:
  • Хората
  • Вид на лекарството:
  • алопатични наркотици

Документи

Локализация

  • Предлага се в:
  • Карбосорб 250 mg таблетки x 20
    България
  • Език:
  • български

Терапевтична информация

  • Каталог на резюме:
  • Carbosorb, 250 mg tablets x 20;

Друга информация

Състояние

  • Източник:
  • Изпълнителна агенция по лекарствата - Bulgarian Drug Agency - Bulgaria
  • Номер на разрешението:
  • 20100813
  • Дата Оторизация:
  • 08-12-2010
  • Последна актуализация:
  • 01-06-2018

11-6-2018

Peekaboo Beans Inc. recalls Peekaboo Beans Dark Heather Charcoal Infant Garments

Peekaboo Beans Inc. recalls Peekaboo Beans Dark Heather Charcoal Infant Garments

The bean logo can become detached, posing a potential choking hazard.

Health Canada

30-5-2018

12 applications for allocation of special funds related to medicinal cannabis

12 applications for allocation of special funds related to medicinal cannabis

The application deadline for the second allocation of special funds for accumulation of scientific knowledge in regard to the medicinal cannabis pilot programme has now expired. The Danish Medicines Agency received 12 applications.

Danish Medicines Agency

17-5-2018

Intent to submit a marketing authorisation application for a veterinary medicinal product using the decentralised procedure with France as a Reference Member State (RMS).

Intent to submit a marketing authorisation application for a veterinary medicinal product using the decentralised procedure with France as a Reference Member State (RMS).

An applicant intending to submit a marketing authorisation application for a veterinary medicinal product using the decentralised procedure with France acting as RMS has to inform the Anses-ANMV at least 2 months in advance.

France - Agence Nationale du Médicament Vétérinaire

8-5-2018

New Tariff for fees collected by the Icelandic
Medicines Agency

New Tariff for fees collected by the Icelandic Medicines Agency

Tariff No 404/2018 for marketing authorisations, annual fees and other licence fees for medicinal products and other related products, collected by the Icelandic Medicines Agency, was published in the Official Journal on 25th of april 2018 and came into force on the 7th of May 2018.TARIFF No 545/2017 for inspections and registration regarding medical devices remains the same. 

IMA - Icelandic Medicines Agency

30-4-2018

Z-classification revoked for S-classified medicinal
products from May 1st 2018

Z-classification revoked for S-classified medicinal products from May 1st 2018

The Icelandic Medicines Agency has revoked the Z-classified status of medicinal products, which are exclusively used in hospitals and healthcare institution and will continue to be S-classified as announced on the IMA website earlier this month. Medicines which are exclusively used in hospitals and healthcare institutions will as of May 1st only be S-classified.

IMA - Icelandic Medicines Agency

12-4-2018

Z-classification revoked for S-classified medicinal products, which are foreseen to maintain their S-classified status

Z-classification revoked for S-classified medicinal products, which are foreseen to maintain their S-classified status

The Agency intends to revoke Z-classification of those S-classified medicinal products, which are foreseen to maintain their S-classified status. In case a marketing authorisation holder has any comments on the Agency´s planned action, such comments must be submitted before 16 April 2018.

IMA - Icelandic Medicines Agency

12-4-2018

What is medicinal cannabis?

What is medicinal cannabis?

The Danish Medicines Agency has produced a short infographic film illustrating the different types of medicinal cannabis.

Danish Medicines Agency

21-3-2018

Infographic on the medicinal cannabis pilot programme

Infographic on the medicinal cannabis pilot programme

The Danish Medicines Agency has produced a short infographic film about the medicinal cannabis pilot programme. The film gives a brief introduction to the programme and is intended for sharing on social media.

Danish Medicines Agency

20-3-2018

New funds for accumulation of knowledge about medicinal cannabis

New funds for accumulation of knowledge about medicinal cannabis

The parties negotiating the special funds have earmarked a further DKK 5 million to increase knowledge about the use and effect of medicinal cannabis. You can apply for the funds now.

Danish Medicines Agency

18-1-2018

Updating of summaries of product characteristics due to changed ATC codes for 2018

Updating of summaries of product characteristics due to changed ATC codes for 2018

Marketing authorisation holders of medicinal products authorised under the national procedure, the decentralised procedure as well as the mutual recognition procedure should be aware that some ATC codes have been changed for 2018.

Danish Medicines Agency

9-1-2018

DKMA Update December 2017

DKMA Update December 2017

In this issue of DKMA Update, you can read about the new medicinal cannabis pilot programme, about how to read the summary of product characteristics, and about two new studies on the use of contraceptive pills and adverse reactions.

Danish Medicines Agency

18-12-2017

News on dose dispensing of medicinal products

News on dose dispensing of medicinal products

The Danish executive order on dose dispensing of medicinal products has been updated. Based on the update, the storage period is among other thing extended from 4 to 6 weeks for medicinal products approved for dose dispensing.

Danish Medicines Agency

28-11-2017

The Icelandic Medicines
Agency starts publishing educational materials on its medicinal product
information website

The Icelandic Medicines Agency starts publishing educational materials on its medicinal product information website

Following a successful pilot project, the Icelandic Medicines Agency has decided to start publishing aRMM educational materials on its website: www.serlyfjaskra.is.

IMA - Icelandic Medicines Agency

14-11-2017

The European Commission has published three recommendations for the clinical trials regulation

The European Commission has published three recommendations for the clinical trials regulation

In cooperation with the clinical trials expert group, the European Commission is updating and issuing new recommendations as a result of the regulation on clinical trials on medicinal products for human use.

Danish Medicines Agency

10-11-2017

New format requirements for marketing authorisation applications from 1 January 2018

New format requirements for marketing authorisation applications from 1 January 2018

The NeeS submission format will be discontinued for applications submitted under the mutual recognition procedure (MRP). This change is related to medicinal products for human use. Parallel import and parallel distribution are not affected by this change.

Danish Medicines Agency

10-10-2017

DKMA Update October 2017

DKMA Update October 2017

In this issue of DKMA Update, you can read about the decision to change the dispensing status of a number of opioids, about the new guidelines on medicinal cannabis for doctors, and about the executive order on the import of cannabis products.

Danish Medicines Agency

5-10-2017

Collection of scientific experience for medicinal cannabis pilot programme

Collection of scientific experience for medicinal cannabis pilot programme

One or more research projects should be carried out for the purpose of gathering scientific experience on medicinal cannabis. The projects will form part of the medicinal cannabis pilot programme.

Danish Medicines Agency

11-9-2017

DKMA Update

DKMA Update

Our newsletter Danish Pharmacovigilance Update changes name to DKMA Update and will from now on contain information about medicinal products in general, patient safety and life science.

Danish Medicines Agency

14-7-2017

Adverse reaction reports received from the Danish Patient Compensation Association

Adverse reaction reports received from the Danish Patient Compensation Association

The marketing authorisation holder of a medicinal product shall not submit reports to the Danish Medicines Agency about any adverse reactions appearing from decisions about compensation for medicinal injuries, which the company has received from the Danish Patient Compensation Association.

Danish Medicines Agency

6-7-2017

The European Commission's decision concerning veterinary medicinal products containing zinc oxide

The European Commission's decision concerning veterinary medicinal products containing zinc oxide

On 26 June 2017, the European Commission adopted a decision to withdraw all marketing authorisations for veterinary medicinal products containing zinc oxide administered orally to food producing species. The medicinal products affected by the decision appear from Annex I to the decision.

Danish Medicines Agency

3-7-2017

New fees for medicinal products, pharmaceutical companies and clinical trials from 1 July 2017

New fees for medicinal products, pharmaceutical companies and clinical trials from 1 July 2017

On 1 July 2017, a new executive order on fees payable for medicinal products, pharmaceutical companies and clinical trials became effective. The new fees involve changes in a number of areas.

Danish Medicines Agency

3-7-2017

Adverse event reports for centrally authorised veterinary medicinal products should not be sent to the DKMA

Adverse event reports for centrally authorised veterinary medicinal products should not be sent to the DKMA

The Danish Medicines Agency no longer requests the direct transfer of serious and unexpected third-country adverse event reports for centrally authorised veterinary medicinal products.

Danish Medicines Agency

13-6-2017

Tramadol: It is important that we are informed of side effects

Tramadol: It is important that we are informed of side effects

Doctors should contact the Danish Medicines Agency if clinical experience shows that the side-effect profile of a medicinal product is not consistent with the summary of product characteristics.

Danish Medicines Agency

21-3-2017

New recommendation for phasing out zinc oxide for young pigs

New recommendation for phasing out zinc oxide for young pigs

The European Medicines Agency's Committee for Medicinal Products for Veterinary Use (CVMP) has confirmed a previous decision to phase out zinc oxide. Consequently, the CVMP has once more recommended to the European Commission that medicinal products containing zinc oxide for the prevention of diarrhoea in young pigs should be withdrawn from the market.

Danish Medicines Agency

20-1-2017

Updating of summaries of product characteristics due to changed ATC codes for 2017

Updating of summaries of product characteristics due to changed ATC codes for 2017

Marketing authorisation holders of medicinal products authorised under the national procedure, the decentralised procedure as well as the mutual recognition procedure should be aware that some ATC codes have been changed for 2017.

Danish Medicines Agency

5-1-2017

Re-examination of the CVMP's decision to phase out zinc oxide for young pigs

Re-examination of the CVMP's decision to phase out zinc oxide for young pigs

The European Medicines Agency's Committee for Medicinal Products for Veterinary Use (CVMP) will re-examine the decision to phase out medicinal products containing zinc oxide for the prevention of diarrhoea in young pigs.

Danish Medicines Agency

3-1-2017

Suspension of Europharma DK ApS’ authorisation to manufacture and distribute parallel imported medicinal products

Suspension of Europharma DK ApS’ authorisation to manufacture and distribute parallel imported medicinal products

Today, 3 January 2017, the Danish Medicines Agency suspended Europharma DK ApS’ authorisation number 30308 issued on 23 March 2015 for the manufacturing and import of medicinal products and intermediate products (GMP authorisation).

Danish Medicines Agency

19-12-2016

Zinc oxide for young pigs to be phased out

Zinc oxide for young pigs to be phased out

The European Medicines Agency's Committee for Medicinal Products for Veterinary Use (CVMP) has recommended to the European Commission that medicinal products containing zinc oxide for the prevention of diarrhoea in young pigs should be withdrawn from the market.

Danish Medicines Agency

12-12-2016

Phasing-out of the NeeS format for applications for marketing authorisations of medicinal products

Phasing-out of the NeeS format for applications for marketing authorisations of medicinal products

Due to an increasing number of requests, we would like to point out the phasing-out plan for NeeS and the transition to eCTD/VNeeS as outlined in the eSubmission Roadmap. The format requirements apply to applications for marketing authorisations for medicinal products as well as maintenance of these (variations, renewals etc.). The changes do not apply to parallel import and parallel distribution.

Danish Medicines Agency

28-10-2016

Available time slots for DCP applications with Denmark as reference member state

Available time slots for DCP applications with Denmark as reference member state

Companies wishing to apply for a marketing authorisation for a medicinal product can request a specified submission date (time slot). Time slots are available.

Danish Medicines Agency

5-9-2016

Improved access to patient data in clinical trials for monitors and GCP inspectors

Improved access to patient data in clinical trials for monitors and GCP inspectors

The Danish Medicines Agency's inspectors have direct access to health information in patient records in all clinical trials on medicinal products notified from 1 July 2016.

Danish Medicines Agency

20-7-2016

Marketing authorisation for medicine for cows suspended in the EU/EEA

Marketing authorisation for medicine for cows suspended in the EU/EEA

On 14 July 2016, the Committee for Medicinal Products for Veterinary Use (CVMP) recommended that the marketing authorisation for the centrally authorised medicinal product Velactis (cabergoline) be suspended temporarily. Velactis is used to reduce milk production in dairy cows at the time of drying off. The recommendation follows reports of serious adverse events after treatment with Velactis.

Danish Medicines Agency

27-6-2016

New rules governing medicine packages

New rules governing medicine packages

The Danish Medicines Agency has amended the guideline on variations to marketing authorisations and the executive order on product numbers for medicinal products.

Danish Medicines Agency

25-5-2016

New Danish act on clinical trials

New Danish act on clinical trials

The Danish Parliament has adopted a new act on clinical trials of medicinal products, which means that new research ethics committees will be established. However, the act does not come into force until 2018.

Danish Medicines Agency

4-2-2016

Updated list of biological medicinal products

Updated list of biological medicinal products

The Danish Medicines Agency has added five new medicinal products to the list of biological and biosimilar medicinal products.

Danish Medicines Agency

26-1-2016

Updated memo on medicinal use of Cannabis

Updated memo on medicinal use of Cannabis

The Danish Medicines Agency has updated the memo on medicinal use of Cannabis, and the third edition of the memo is now available.

Danish Medicines Agency

13-1-2016

Access to results in EudraCT from 13 January

Access to results in EudraCT from 13 January

When a clinical trial of medicinal products has ended, the trial results must be entered in the EudraCT database. The system has been unavailable for a period of time during which data could not be entered in the EudraCT database. The EMA now re-opens the database and results can be entered in EudraCT again.

Danish Medicines Agency

7-1-2016

Updating of summaries of product characteristics due to changed ATC codes for 2016

Updating of summaries of product characteristics due to changed ATC codes for 2016

Marketing authorisation holders of medicinal products authorised under the national procedure, the decentralised procedure as well as the mutual recognition procedure should be aware that some ATC codes have been changed for 2016.

Danish Medicines Agency

14-12-2015

New application forms mandatory from 1 January

New application forms mandatory from 1 January

From 1 January 2016, it will be mandatory to use the eAF to apply for marketing authorisations, renewals and variations. This applies to both human and veterinary medicinal products, and it applies to all procedure types.

Danish Medicines Agency

13-7-2015

New format requirements for applications for authorisation of medicinal products

New format requirements for applications for authorisation of medicinal products

On 1 July 2015, the rules governing applications for marketing authorisations for medicinal products were amended in three areas as a result of new requirements from the European Medicines Agency (EMA).

Danish Medicines Agency

31-3-2015

New guidelines on good distribution practice for APIs

New guidelines on good distribution practice for APIs

The European Commission has published new guidelines on good distribution practice (GDP) for active substances (API) for medicinal products for human use.

Danish Medicines Agency

11-2-2015

Send Danish package leaflet when applying for changes to product information

Send Danish package leaflet when applying for changes to product information

When applying for changes to the product information, marketing authorisation holders must always send a Danish version of the package leaflet to the Danish Health and Medicines Authority, whether the medicinal product is marketed in Denmark or not (unless the medicinal product is subject to section 11 about omission of the package leaflet, cf. Executive order no. 869 of 21 July 2011, as amended, on the labelling etc. of medicinal products).

Danish Medicines Agency

30-1-2015

Digitisation of procedure for issuing export certificates for medicinal products

Digitisation of procedure for issuing export certificates for medicinal products

We are simplifying the procedure for issuing export certificates for medicinal products. Previously, an export certificate was sent back and forth between the company and us by ordinary post. We are now simplifying and digitising the process.

Danish Medicines Agency

16-1-2015

Updating of summaries of product characteristics due to changed ATC codes for 2015

Updating of summaries of product characteristics due to changed ATC codes for 2015

Marketing authorisation holders of medicinal products authorised under the National Procedure, the Decentralised Procedure, as well as the Mutual Recognition Procedure, should be aware that some ATC codes have been changed in 2015.

Danish Medicines Agency

14-11-2014

Available time slots in Q1 2015 for DCP applications with Denmark as reference member state

Available time slots in Q1 2015 for DCP applications with Denmark as reference member state

Companies wishing to apply for a marketing authorisation for a medicinal product can request a specified submission date (time slot). Time slots are available in the first quarter of 2015.

Danish Medicines Agency

19-6-2018

 CHMP ORGAM minutes for the meeting on 22 May 2018

CHMP ORGAM minutes for the meeting on 22 May 2018

Committee for medicinal products for human use (CHMP) ORGAM minutes of the meeting on 22 May 2018

Europe - EMA - European Medicines Agency

18-6-2018

Agenda:  Agenda - COMP agenda of the 19-21 June 2018 meeting

Agenda: Agenda - COMP agenda of the 19-21 June 2018 meeting

Committee for Orphan Medicinal Products (COMP) draft agenda for the meeting on 19-21 June 2018

Europe - EMA - European Medicines Agency

15-6-2018

 Minutes of the CHMP meeting 23-26 April 2018

Minutes of the CHMP meeting 23-26 April 2018

Committee for medicinal products for human use (CHMP) minutes of the meeting on 23-26 April 2018

Europe - EMA - European Medicines Agency

13-6-2018

Agenda:  Agenda and registration form - eXtended EudraVigilance medicinal product dictionary face-to-face training course, London, November 2018

Agenda: Agenda and registration form - eXtended EudraVigilance medicinal product dictionary face-to-face training course, London, November 2018

The training focuses on explaining the guidance and specifically the mandatory data elements necessary for the electronic submission of information on medicinal products, applying the format of the eXtended EudraVigilance Product Report Message (XEVPRM) and the use of the XEVMPD data entry tool (EVWEB). It includes exercises in the XEVPRM data entry tool (EVWEB) for the electronic submission and maintenance of different types of medicinal products.

Europe - EMA - European Medicines Agency

13-6-2018

Agenda:  Agenda and registration form - eXtended EudraVigilance medicinal product dictionary face-to-face training course, London, September 2018

Agenda: Agenda and registration form - eXtended EudraVigilance medicinal product dictionary face-to-face training course, London, September 2018

The training focuses on explaining the guidance and specifically the mandatory data elements necessary for the electronic submission of information on medicinal products, applying the format of the eXtended EudraVigilance Product Report Message (XEVPRM) and the use of the XEVMPD data entry tool (EVWEB). It includes exercises in the XEVPRM data entry tool (EVWEB) for the electronic submission and maintenance of different types of medicinal products.

Europe - EMA - European Medicines Agency

13-6-2018

Scientific guideline:  Concept paper on preparation of a revised guideline on the evaluation of medicinal products indicated for treatment of bacterial infections, draft: consultation open

Scientific guideline: Concept paper on preparation of a revised guideline on the evaluation of medicinal products indicated for treatment of bacterial infections, draft: consultation open

This concept paper proposes the development of a single guideline on the clinical evaluation of medicinal products indicated for treatment of bacterial infections. The development of this single guideline is intended to merge, revise and add to the guidance that is currently included in two separate documents as follows: guideline on the evaluation of medicinal products indicated for treatment of bacterial infections (CPMP/EWP/558/95 Rev. 2), adopted in 2011 and in force since 2012 and the addendum ...

Europe - EMA - European Medicines Agency

1-6-2018

Valproate

Valproate

Valproate (Active substance: medicinal products containing substances related to valproate (sodium valproate, valproic acid, valproate semisodium, valpromide, valproate magnesium)) - Community Referrals - Art 31 - Commission Decision (2018)3623 of Fri, 01 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/A-31/1454

Europe -DG Health and Food Safety

1-6-2018

News and press releases:  Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 28-31 May 2018

News and press releases: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 28-31 May 2018

Nine medicines recommended for approval, including two orphans

Europe - EMA - European Medicines Agency

29-5-2018

Medicinal cannabis products: Patient information

Medicinal cannabis products: Patient information

Medicinal cannabis: Patient information

Therapeutic Goods Administration - Australia

28-5-2018

News and press releases:  Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 23–25 May 2018

News and press releases: Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 23–25 May 2018

New vaccine to reduce the incidence of intramammary infections in cows/heifers recommended for approval

Europe - EMA - European Medicines Agency

23-5-2018

Scientific guideline:  Draft guideline on the responsibilities of the sponsor with regard to handling and shipping of investigational medicinal products for human use in accordance with good clinical practice and good manufacturing practice, draft: consul

Scientific guideline: Draft guideline on the responsibilities of the sponsor with regard to handling and shipping of investigational medicinal products for human use in accordance with good clinical practice and good manufacturing practice, draft: consul

The guideline lays down the principles for the two-step release and shipping of the investigational medicinal products by the qualified person and the sponsor. The guideline also describes the areas of interface between the manufacturer and the sponsor and the required contractual agreements.

Europe - EMA - European Medicines Agency

30-4-2018

Regulatory and procedural guideline:  Draft guideline on the summary of product characteristics (SPC) for veterinary medicinal products containing antimicrobial substances, draft: consultation open

Regulatory and procedural guideline: Draft guideline on the summary of product characteristics (SPC) for veterinary medicinal products containing antimicrobial substances, draft: consultation open

The guideline, which was developed to encourage optimal use and to minimise selection of antimicrobial resistance (AMR), was revised in order to improve consistency of the summary of product characteristics (SPCs) for antimicrobial products in the EU Member States.

Europe - EMA - European Medicines Agency