Hiposem

Główne informacje

  • Nazwa własna:
  • Hiposem tabletka
  • Forma farmaceutyczna:
  • tabletka
  • Używać do:
  • Ludzie
  • Typ medycyny:
  • alopatycznych narkotyków

Dokumenty

Lokalizacja

  • Dostępne w:
  • Hiposem tabletka
    Polska
  • Język:
  • polski

Informacje terapeutyczne

  • Podsumowanie produktu:
  • 30 tabl., 5909990614783, OTC; 60 tabl., 5909991036010, OTC; 90 tabl., 5909991036027, OTC

Inne informacje

Status

  • Źródło:
  • Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych
  • Numer pozwolenia:
  • 10360
  • Ostatnia aktualizacja:
  • 17-03-2018

Ulotkę dla pacjenta: substancji czynnych, wskazania, dawkowanie, interakcje, działania niepożądane, ciąża, laktacja

INFORMACJE ZAMIESZCZANE NA OPAKOWANIACH BEZPOŚREDNICH

POJEMNIK DO TABLETEK - ETYKIETA (zewnętrz

na część etykieto-ulotki)

1.

NAZWA PRODUKTU LECZNICZEGO

HIPOSEM 340 mg, tabletka

Hippocastani semen

2.

ZAWARTOŚĆ SUBSTANCJI CZYNNEJ

Skład:

nasienie kasztanowca - 340 mg

3.

WYKAZ SUBSTANCJI POMOCNICZYCH

4.

POSTAĆ FARMACEUTYCZNA I ZAWARTOŚĆ OPAKOWANIA

30 tabletek

Kod EAN UCC:

5909990614783

5.

SPOSÓB I DROGA PODANIA

Należy zapoznać się z treścią ulotki.

Podanie doustne.

6.

OSTRZEŻENIE DOTYCZĄCE PRZECHOWYWANIA PRODUKTU LECZNICZEGO

W MIEJSCU NIEWIDOCZNYM I NIEDOSTĘPNYM DLA DZIECI

7.

INNE OSTRZEŻENIA SPECJALNE, JEŚLI KONIECZNE

8.

TERMIN WAŻNOŚCI

Termin ważn.:

9.

WARUNKI PRZECHOWYWANIA

Przechowywać w zamkniętym opakowaniu, w temperaturze nie wyższej niż 25

10.

SPECJALNE ŚRODKI OSTROŻNOŚCI DOTYCZĄCE USUWANIA NIEZUŻYTEGO

PRODUKTU LECZNICZEGO LUB POCHODZĄCYCH Z NIEGO ODPADÓW, JEŚLI

WŁAŚCIWE

11.

NAZWA I ADRES PODMIOTU ODPOWIEDZIALNEGO

12.

NUMER POZWOLENIA NA DOPUSZCZENIE DO OBROTU

Pozwolenie nr:

10360

13.

NUMER SERII

Nr serii:

14.

OGÓLNA KATEGORIA DOSTĘPNOŚCI

Lek wydawany bez przepisu lekarza - OTC.

15.

INSTRUKCJA UŻYCIA - ULOTKA DLA PACJENTA (wewnętrzna część etykieto-

ulotki)

ULOTKA DLA PACJENTA

HIPOSEM

Hippocastani semen

340 mg, tabletka

30 tabletek

Wskazania:

Lek stosuje się tradycyjnie w objawach przewlekłej niewydolności żylnej oraz żylakowatości.

Przeciwwskazania:

Nie należy stosować w niewydolności nerek lub wątroby oraz w przypadku nadwrażliwości na

którykolwiek ze składników leku.

Ostrzeżenia i środki ostrożności:

Jeżeli objawy nie ustąpią po 3-4 tygodniach, ulegną nasileniu, lub

wystąpi zapalenie skóry,

zakrzepowe zapalenie żył lub stwardnienie podskórne, silny ból, owrzodzenie, nagły obrzęk

jednej lub obu kończyn dolnych, niewydolność serca lub nerek należy skonsultować się z

lekarzem.

Lek nie jest przeznaczony do stosowania u dzieci i młodzieży.

Interakcje:

Brak danych.

Ostrzeżenia specjalne:

Ciąża i karmienie piersią:

Nie należy stosować w okresie ciąży i karmienia piersią.

Prowadzenie pojazdów i obsługiwanie maszyn:

Brak danych.

Dawkowanie, sposób stosowania i droga podania:

Droga podania:

doustna.

Dawkowanie:

Dorośli: 2 tabletki 3 razy na dobę.

Przedawkowanie:

W przypadku przedawkowania leku należy skontaktować się z lekarzem.

Postępowanie w przypadku pominięcia dawki leku:

Nie należy stosować dawki podwójnej w celu uzupełnienia pominiętej dawki.

W celu uzyskania wyjaśnień, co do stosowania leku należy poradzić się lekarza lub farmaceuty.

Działania niepożądane:

W pojedynczych przypadkach nasienie kasztanowca może powodować podrażnienia błony śluzowej

żołądka i jelit oraz reakcje alergiczne.

Zgłaszanie działań niepożądanych

Jeśli wystąpią jakiekolwiek objawy niepożądane, w tym wszelkie objawy niepożądane niewymienione

ulotce,

należy

powiedzieć

lekarzowi

farmaceucie,

pielęgniarce.

Działania

niepożądane można zgłaszać bezpośrednio do Departamentu Monitorowania Niepożądanych Działań

Produkt

Leczniczych

Urzędu

Rejestracji

Produktów

Leczniczych,

Wyrobów

Medycznych

Produktów

Biobójczych:

Jerozolimskie

181C,

02-222

Warszawa,

tel.:

49-21-301,

fax: 22 49-21-309, e-mail: ndl@urpl.gov.pl.

Działania niepożądane można zgłaszać również podmiotowi odpowiedzialnemu. Dzięki zgłaszaniu

działań

niepożądanych

można

będzie

zgromadzić

więcej

informacji

temat

bezpieczeństwa

stosowania leku.

Przechowywanie leku:

Przechowywać

zamkniętym

opakowaniu,

temperaturze

wyższej

niż

miejscu

niewidocznym i niedostępnym dla dzieci.

Nie należy stosować leku po upływie terminu ważności zamieszczonego na opakowaniu.

Skład leku:

Hippocastani semen

- 340 mg

Substancje pomocnicze: karboksymetyloskrobia sodowa (typ C), skrobia ziemniaczana, krzemionka

koloidalna bezwodna.

Jedna tabletka zawiera nie mniej niż 10 mg escyny.

Podmiot odpowiedzialny:

Laboratorium Farmaceutyczne

Labofarm

Sp. z o.o. Sp. k.

ul. Lubichowska 176 b

83-200 Starogard Gdański

tel. 58 561 20 08

e-mail: poczta@labofarm.com.pl

Wytwórca:

IWLF

Labofarm

mgr farm. Tadeusz Pawełek

ul. Lubichowska 176 b

83-200 Starogard Gdański

celu

uzyskania

bardziej

szczegółowych

informacji

należy

zwrócić

się

podmiotu

odpowiedzialnego.

Data zatwierdzenia tekstu ulotki:

16.

INFORMACJA PODANA SYSTEMEM BRAILLE’A

Hiposem

17.

NIEPOWTARZALNY IDENTYFIKATOR – KOD 2D

Nie dotyczy.

18.

NIEPOWTARZALNY IDENTYFIKATOR – DANE CZYTELNE DLA CZŁOWIEKA

Nie dotyczy.

INFORMACJE ZAMIESZCZANE NA OPAKOWANIACH BEZPOŚREDNICH

POJEMNIK DO TABLETEK - ETYKIETA (zewnętrz

na część etykieto-ulotki)

1.

NAZWA PRODUKTU LECZNICZEGO

HIPOSEM 340 mg, tabletka

Hippocastani semen

2.

ZAWARTOŚĆ SUBSTANCJI CZYNNEJ

Skład:

nasienie kasztanowca - 340 mg

3.

WYKAZ SUBSTANCJI POMOCNICZYCH

4.

POSTAĆ FARMACEUTYCZNA I ZAWARTOŚĆ OPAKOWANIA

60 tabletek

Kod EAN UCC:

5909991036010

90 tabletek

Kod EAN UCC:

5909991036027

5.

SPOSÓB I DROGA PODANIA

Należy zapoznać się z treścią ulotki.

Droga podania:

doustna.

Dawkowanie:

Dorośli:

2 tabletki 3 razy na dobę.

Wskazania

do

stosowania:

tradycyjnie

objawach

przewlekłej

niewydolności

żylnej,

żylakowatości.

6.

OSTRZEŻENIE DOTYCZĄCE PRZECHOWYWANIA PRODUKTU LECZNICZEGO

W MIEJSCU NIEWIDOCZNYM I NIEDOSTĘPNYM DLA DZIECI

7.

INNE OSTRZEŻENIA SPECJALNE, JEŚLI KONIECZNE

8.

TERMIN WAŻNOŚCI

Termin ważn.:

9.

WARUNKI PRZECHOWYWANIA

Przechowywać

zamkniętym

opakowaniu,

temperaturze

wyższej

niż

miejscu

niewidocznym i niedostępnym dla dzieci.

10.

SPECJALNE ŚRODKI OSTROŻNOŚCI DOTYCZĄCE USUWANIA NIEZUŻYTEGO

PRODUKTU LECZNICZEGO LUB POCHODZĄCYCH Z NIEGO ODPADÓW, JEŚLI

WŁAŚCIWE

11.

NAZWA I ADRES PODMIOTU ODPOWIEDZIALNEGO

Labofarm

Sp. z o.o. Sp. k.

ul. Lubichowska 176 b

83-200 Starogard Gd.

12.

NUMER POZWOLENIA NA DOPUSZCZENIE DO OBROTU

Pozwolenie nr:

10360

13.

NUMER SERII

Nr serii:

14.

OGÓLNA KATEGORIA DOSTĘPNOŚCI

Lek wydawany bez przepisu lekarza - OTC.

15.

INSTRUKCJA UŻYCIA- ULOTKA DLA PACJENTA (wewnętrzna część etykieto-

ulotki)

ULOTKA DLA PACJENTA

HIPOSEM

Hippocastani semen

340 mg, tabletka

60 tabletek

90 tabletek

Wskazania:

Lek stosuje się tradycyjnie w objawach przewlekłej niewydolności żylnej oraz żylakowatości.

Przeciwwskazania:

Nie należy stosować w niewydolności nerek lub wątroby oraz w przypadku nadwrażliwości na

którykolwiek ze składników leku.

Ostrzeżenia i środki ostrożności:

Jeżeli objawy nie ustąpią po 3-4 tygodniach, ulegną nasileniu, lub

wystąpi zapalenie skóry,

zakrzepowe zapalenie żył lub stwardnienie podskórne, silny ból, owrzodzenie, nagły obrzęk

jednej lub obu kończyn dolnych, niewydolność serca lub nerek należy skonsultować się z

lekarzem.

Lek nie jest przeznaczony do stosowania u dzieci i młodzieży.

Interakcje:

Brak danych.

Ostrzeżenia specjalne:

Ciąża i karmienie piersią:

Nie należy stosować w okresie ciąży i karmienia piersią.

Prowadzenie pojazdów i obsługiwanie maszyn:

Brak danych.

Dawkowanie, sposób stosowania i droga podania:

Droga podania:

doustna.

Dawkowanie:

Dorośli: 2 tabletki 3 razy na dobę.

Przedawkowanie:

W przypadku przedawkowania leku należy skontaktować się z lekarzem.

Postępowanie w przypadku pominięcia dawki leku:

Nie należy stosować dawki podwójnej w celu uzupełnienia pominiętej dawki.

W celu uzyskania wyjaśnień, co do stosowania leku należy poradzić się lekarza lub farmaceuty.

Działania niepożądane:

W pojedynczych przypadkach nasienie kasztanowca może powodować podrażnienia błony śluzowej

żołądka i jelit oraz reakcje alergiczne.

Zgłaszanie działań niepożądanych

Jeśli wy

stąpią jakiekolwiek objawy niepożądane, w tym wszelkie objawy niepożądane niewymienione

ulotce,

należy

powiedzieć

lekarzowi

farmaceucie,

pielęgniarce.

Działania

niepożądane można zgłaszać bezpośrednio do Departamentu Monitorowania Niepożądanych Działań

Produktów

Leczniczych

Urzędu

Rejestracji

Produktów

Leczniczych,

Wyrobów

Medycznych

Produktów

Biobójczych:

Jerozolimskie

181C,

02-222

Warszawa,

tel.:

49-21-301,

fax: 22 49-21-309, e-mail: ndl@urpl.gov.pl.

Działania niepożądane można zgłaszać również podmiotowi odpowiedzialnemu. Dzięki zgłaszaniu

działań

niepożądanych

można

będzie

zgromadzić

więcej

informacji

temat

bezpieczeństwa

stosowania leku.

Przechowywanie leku:

Przechowywać

zamkniętym

opakowaniu,

temperaturze

wyższej

niż

miejscu

niewidocznym i niedostępnym dla dzieci.

Nie należy stosować leku po upływie terminu ważności zamieszczonego na

opakowaniu.

Skład leku:

Hippocastani semen

- 340 mg

Substancje pomocnicze: karboksymetyloskrobia sodowa (typ C), skrobia ziemniaczana, krzemionka

koloidalna bezwodna.

Jedna tabletka zawiera nie mniej niż 10 mg escyny.

Podmiot odpowiedzialny:

Laboratorium Farmaceutyczne

Labofarm

Sp. z o.o. Sp. k.

ul. Lubichowska 176 b

83-200 Starogard Gdański

tel. 58 561 20 08

e-mail: poczta@labofarm.com.pl

Wytwórca:

IWLF

Labofarm

mgr farm. Tadeusz Pawełek

ul. Lubichowska 176 b

83-200 Starogard Gdański

celu

uzyskania

bardziej

szczegółowych

informacji

należy

zwrócić

się

podmiotu

odpowiedzialnego.

Data zatwierdzenia tekstu ulotki:

16.

INFORMACJA PODANA SYSTEMEM BRAILLE’A

Hiposem

17.

NIEPOWTARZALNY IDENTYFIKATOR – KOD 2D

Nie dotyczy.

18.

NIEPOWTARZALNY IDENTYFIKATOR – DANE CZYTELNE DLA CZŁOWIEKA

Nie dotyczy.

16-1-2019

Reimbursement of medicinal cannabis of the pilot programme effective as of 1 January 2019

Reimbursement of medicinal cannabis of the pilot programme effective as of 1 January 2019

On 1 January 2019, a special reimbursement scheme for medicinal cannabis in the four-year pilot programme entered into force. Reimbursement is retroactive for purchases made in 2018.

Danish Medicines Agency

21-11-2018

Risk for animal and human health related to the presence of dioxins and dioxin-like PCBs in feed and food

Risk for animal and human health related to the presence of dioxins and dioxin-like PCBs in feed and food

Published on: Tue, 20 Nov 2018 The European Commission asked EFSA for a scientific opinion on the risks for animal and human health related to the presence of dioxins (PCDD/Fs) and DL‐PCBs in feed and food. The data from experimental animal and epidemiological studies were reviewed and it was decided to base the human risk assessment on effects observed in humans and to use animal data as supportive evidence. The critical effect was on semen quality, following pre‐ and postnatal exposure. The critical s...

Europe - EFSA - European Food Safety Authority Publications

7-11-2018

Reactie op berichtgeving over nota Waarborgfonds

Reactie op berichtgeving over nota Waarborgfonds

Op dinsdag 30 oktober heeft minister Bruno Bruins een feitenrelaas rondom het faillissement van de MC Groep naar de Tweede Kamer gestuurd.

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

3-4-2018

Three new reimbursement guidelines

Three new reimbursement guidelines

The Danish Medicines Agency has issued three new guidelines on reimbursement (in Danish only). This regards Guideline on application for general reimbursement and general conditional reimbursement, Guideline on periodic reassessment of the reimbursement status of medicines and Guideline on the making of health economic analyses of medicines.

Danish Medicines Agency

4-1-2016

The Danish Medicines Agency has a new website

The Danish Medicines Agency has a new website

Today, the Danish Medicines Agency launched its new website – laegemiddelstyrelsen.dk/en – where you can read about and subscribe to news about licensing and supervision of medicines, side effects, reimbursement, pharmacies and medical devices.

Danish Medicines Agency

16-1-2014

Reimbursement of medicines bought in another EU/EEA country

Reimbursement of medicines bought in another EU/EEA country

From 1 January 2014, you can obtain reimbursement of prescription-only medicines bought in another EU/EEA country under the general reimbursement rules of the Danish Health Act. You have to be covered by the national health insurance in Denmark and have a health insurance card (the yellow card) and the medicine must be reimbursable in Denmark.

Danish Medicines Agency

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

6-3-2012

Comments received on the reassessment of reimbursement status of antidiabetic medicines (ATC group A10)

Comments received on the reassessment of reimbursement status of antidiabetic medicines (ATC group A10)

The Danish National Board of Health has received a number of comments from stakeholders about the Reimbursement Committee's discussion of the reimbursement status of antidiabetic medicines (ATC group A10).

Danish Medicines Agency

22-2-2012

Decision on general conditional reimbursement for alendronate-containing medicines

Decision on general conditional reimbursement for alendronate-containing medicines

In cooperation with the Reimbursement Committee, we have decided to grant alendronate-containing medicines general conditional reimbursement from 5 March 2012. Reimbursement is conditional as it is reserved for patients with low-energy hip fractures. For any other patients who are treated with alendronate, the doctor must apply for single reimbursement, and the guiding criteria for single reimbursement remain unchanged for these patients. Alendronate is used for the treatment of osteoporosis (brittle bon...

Danish Medicines Agency

22-2-2012

Changed criteria for single reimbursement for osteoporosis medicines other than alendronate

Changed criteria for single reimbursement for osteoporosis medicines other than alendronate

As of 5 March 2012, it will only be possible to obtain a single reimbursement grant for the other medicines used in osteoporosis treatment for patients that cannot use alendronate. The criteria for single reimbursement are changed because of the large price gaps between the different medicines, where the reimbursement price of alendronate is by far the lowest.

Danish Medicines Agency

2-2-2012

Applications for general reimbursement in 2011

Applications for general reimbursement in 2011

In 2011, we reviewed 21 applications for general reimbursement for 20 different medicinal products. 15 of the applications ended with the granting of general reimbursement or general conditional reimbursement, and the remaining six applications were refused.

Danish Medicines Agency

25-1-2012

Review concluded regarding general reimbursement for Xarelto®

Review concluded regarding general reimbursement for Xarelto®

The Danish Medicines Agency has completed its review of an application for general reimbursement for two new strengths of Xarelto®. The product maintains general reimbursement.

Danish Medicines Agency

20-1-2012

Review concluded regarding general reimbursement for Zomig Nasal®

Review concluded regarding general reimbursement for Zomig Nasal®

The Danish Medicines Agency has completed its review of an application for general reimbursement for Zomig Nasal®. The product has been granted general reimbursement.

Danish Medicines Agency

17-1-2012

Decision on general reimbursement for Yellox®

Decision on general reimbursement for Yellox®

The Danish Medicines Agency has completed its review of an application for general reimbursement for Yellox®. The product has been granted general reimbursement.

Danish Medicines Agency

16-1-2012

Review concluded regarding general reimbursement for Multaq®

Review concluded regarding general reimbursement for Multaq®

The Danish Medicines Agency has completed its review of an application for general reimbursement for Multaq®. The product is neither eligible for general nor general conditional reimbursement.

Danish Medicines Agency

13-1-2012

Reassessment of reimbursement status of antidiabetic medicines (ATC group A10)

Reassessment of reimbursement status of antidiabetic medicines (ATC group A10)

On 22 December 2009, the Danish Medicines Agency announced that we would begin our reassessment of the reimbursement status of a number of groups of medicines, including antidiabetics (ATC group A10). Within a few months, the Reimbursement Committee will begin to discuss the reimbursement status of antidiabetics.

Danish Medicines Agency

5-1-2012

Consultation on the Reimbursement Committee's recommendation concerning the reimbursement status of strong painkillers (opioids)

Consultation on the Reimbursement Committee's recommendation concerning the reimbursement status of strong painkillers (opioids)

At the Danish Medicines Agency's request, the Reimbursement Committee has reassessed the reimbursement status of medicines in ATC group N02A, opioids, as well as certain medicines in ATC groups N07BC and R05DA.

Danish Medicines Agency

4-11-2011

Comments received on the reassessment of reimbursement status of strong analgesics (opioids)

Comments received on the reassessment of reimbursement status of strong analgesics (opioids)

The Danish Medicines Agency has received a number of comments for the Reimbursement Committee's discussion of reimbursement status of strong analgesics (opioids). These comments were presented to the Reimbursement Committee at its meeting on 27 September 2011. The Reimbursement Committee is currently processing a recommendation.

Danish Medicines Agency

7-10-2011

Changed reimbursement for medicines for depression and anxiety as of 5 March 2012

Changed reimbursement for medicines for depression and anxiety as of 5 March 2012

With effect from 5 March 2012, the reimbursement is changed for certain medicinal products for treatment of depression and anxiety (antidepressants and anxiolytics). Based on the Reimbursement Committee's recommendation, the Danish Medicines Agency has decided that in future the general rule is that treatment with inexpensive medicines (e.g. sertraline and citalopram) must be attempted before reimbursement can be granted for more expensive medicines (e.g. escitalopram, duloxetine, pregabalin and agomelat...

Danish Medicines Agency

4-10-2011

The reimbursement for glucosamine is removed on 28 November 2011

The reimbursement for glucosamine is removed on 28 November 2011

The Reimbursement Committee and the Danish Medicines Agency have reassessed the reimbursement status of glucosamine-containing medicines. We have decided to remove the reimbursement for these over-the-counter medicines on 28 November 2011. Glucosamine is used for the alleviation of painful osteoarthritis.

Danish Medicines Agency

20-9-2011

Consultation responses on the Reimbursement Committee’s recommendation concerning the reimbursement status of glucosamine-containing medicines

Consultation responses on the Reimbursement Committee’s recommendation concerning the reimbursement status of glucosamine-containing medicines

The Reimbursement Committee’s recommendation on the future reimbursement status of glucosamine-containing medicines was open for consultation until 8 August 2011. The Danish Medicines Agency received 4 consultation responses.

Danish Medicines Agency

20-9-2011

Consultation responses on the Reimbursement Committee’s recommendation concerning the reimbursement status of medicines for treatment of depression and anxiety (ACT group N06A, etc.)

Consultation responses on the Reimbursement Committee’s recommendation concerning the reimbursement status of medicines for treatment of depression and anxiety (ACT group N06A, etc.)

The Reimbursement Committee’s recommendation on the future reimbursement status of medicines in ATC group N06A, antidepressants, as well as certain medicines in ATC groups N03A, N05A and N05B was open for consultation until 15 August 2011. The Danish Medicines Agency received 9 consultation responses.

Danish Medicines Agency

26-8-2011

Reassessment of reimbursement status of strong analgesics (opioids) – methadone and codeine

Reassessment of reimbursement status of strong analgesics (opioids) – methadone and codeine

On 15 August 2011, the Danish Medicines Agency announced that we would begin reassessing the reimbursement status of medicines in ATC group N02A, opioids. The Reimbursement Committee opened its preliminary discussions at its meeting on 23 August 2011 and recommended to include the opioids methadone (N07BC02) and codeine (R05DA04), also used in pain management, in the reassessment of reimbursement status of medicinal products in ATC group N02A.

Danish Medicines Agency

15-8-2011

Reassessment of reimbursement status of strong analgesics (opioids)

Reassessment of reimbursement status of strong analgesics (opioids)

On 22 December 2009, the Danish Medicines Agency announced that it would begin reassessing the reimbursement status of medicines in ATC group N (nervous system) starting with the ATC subgroup N06A (antidepressants) and then N02A (opioids). The Reimbursement Committee is having the initial discussions of the opioids at its meeting on 23 August 2011.

Danish Medicines Agency

5-7-2011

Consultation on the Reimbursement Committee’s recommendation concerning the reimbursement status of medicines in ATC group C01 (cardiac therapy)

Consultation on the Reimbursement Committee’s recommendation concerning the reimbursement status of medicines in ATC group C01 (cardiac therapy)

At the request of the Danish Medicines Agency, the Reimbursement Committee has reassessed the reimbursement status of medicines in ATC group C01 – cardiac therapy. These medicines are used for the treatment of cardiac arrhythmia (e.g. atrial fibrillation) and heart cramps (angina pectoris).

Danish Medicines Agency

28-6-2011

Decision on future reimbursement status of medicines in ATC group C05 (vasoprotectives)

Decision on future reimbursement status of medicines in ATC group C05 (vasoprotectives)

On 27 June 2011, the Danish Medicines Agency decided on the future reimbursement status of medicines in ATC group C05 (vasoprotectives). These medicines will still not be eligible for general reimbursement.

Danish Medicines Agency

27-5-2011

Consultation on the Reimbursement Committee's recommendation for glucosamine

Consultation on the Reimbursement Committee's recommendation for glucosamine

The Reimbursement Committee has reassessed the reimbursement status of glucosamine-containing medicines. Glucosamine-containing medicines are used for the alleviation of painful osteoarthritis. The Reimbursement Committee recommends removing general conditional reimbursement for these medicines.

Danish Medicines Agency

6-5-2011

Consultation on the Reimbursement Committee’s recommendation concerning the reimbursement status of medicines for treatment of depression and anxiety (medicines in ACT group N06A, etc.)

Consultation on the Reimbursement Committee’s recommendation concerning the reimbursement status of medicines for treatment of depression and anxiety (medicines in ACT group N06A, etc.)

At the Danish Medicines Agency’s request, the Reimbursement Committee has reassessed the reimbursement status of medicines in ATC group N06A, antidepressants, as well as certain medicines in ATC groups N03A, N05A and N05B.

Danish Medicines Agency

3-3-2011

The Danish Medicines Agency begins ad hoc reassessment of reimbursement status of glucosamine (M01AX05)

The Danish Medicines Agency begins ad hoc reassessment of reimbursement status of glucosamine (M01AX05)

Clinical studies have called into question the efficacy of glucosamine for the alleviation of painful osteoarthritis. This has contributed to the Danish Medicines Agency’s decision to initiate ad hoc reassessment of glucosamine-containing medicines, which today have general conditional reimbursement when prescribed for the alleviation of symptoms of mild to moderate osteoarthritis and when prescribed to old-age pensioners.

Danish Medicines Agency

11-1-2011

Reassessment of reimbursement status of medicines for treatment of depression and anxiety disorders

Reassessment of reimbursement status of medicines for treatment of depression and anxiety disorders

On 22 December 2009, the Danish Medicines Agency announced that it would begin reassessing the reimbursement status of medicines in ATC group N

Danish Medicines Agency

14-6-2010

Changes in reimbursements for anti-ulcer medicines

Changes in reimbursements for anti-ulcer medicines

The Reimbursement Committee and the Danish Medicines Agency have reviewed medicinal products for the treatment of heartburns, sour eructations and ulcers ('acid-related disorders') in order to assess whether they meet the criteria for public reimbursement.

Danish Medicines Agency

14-6-2010

Change of the reimbursement for certain cardiovascular products as of 15 November 2010

Change of the reimbursement for certain cardiovascular products as of 15 November 2010

The Reimbursement Committee and the Danish Medicines Agency have reviewed some of the medicinal products used for the treatment of cardiovascular disease (antihypertensives) in order to assess whether they meet the criteria for public reimbursement. The medicinal products concerned are the so-called angiotensin II antagonists and renin inhibitors.

Danish Medicines Agency

3-6-2010

Consultation responses on the Reimbursement Committee’s recommendation concerning the reimbursement status of medicinal products in ATC groups C09C, C09D and C09X (angiotensin II antagonists and renin inhibitors)

Consultation responses on the Reimbursement Committee’s recommendation concerning the reimbursement status of medicinal products in ATC groups C09C, C09D and C09X (angiotensin II antagonists and renin inhibitors)

The Reimbursement Committee’s recommendation concerning the future reimbursement status of medicinal products in ATC groups C09C, C09D and C09X (angiotensin II antagonists and renin inhibitors) was open for consultation until 7 May 2010.

Danish Medicines Agency

21-4-2010

Decision on future reimbursement status of losartan-containing medicines (C09CA01 and C09DA01) - angiotensin II antagonists

Decision on future reimbursement status of losartan-containing medicines (C09CA01 and C09DA01) - angiotensin II antagonists

On 16 April 2010, the Danish Medicines Agency decided on the future reimbursement status of some of the losartan-containing medicines in ATC groups C09C and C09D, making these products eligible for general reimbursement as of 19 April 2010.

Danish Medicines Agency

9-4-2010

Consultation responses on the Reimbursement Committee’s recommendation concerning the reimbursement status of medicinal products in ATC group A02 (drugs for acid related disorders)

Consultation responses on the Reimbursement Committee’s recommendation concerning the reimbursement status of medicinal products in ATC group A02 (drugs for acid related disorders)

The Reimbursement Committee’s recommendation concerning the future reimbursement status of medicinal products in ATC group A02 (drugs for acid related disorders) was open for consultation until 15 March 2010.

Danish Medicines Agency

31-3-2010

Consultation on the Reimbursement Committee's recommendation concerning the reimbursement status of medicinal products in ATC groups C09C, C09D and C09X (angiotensin II antagonists and renin inhibitors)

Consultation on the Reimbursement Committee's recommendation concerning the reimbursement status of medicinal products in ATC groups C09C, C09D and C09X (angiotensin II antagonists and renin inhibitors)

At the Danish Medicines Agency's request, the Reimbursement Committee has reassessed the reimbursement status of medicinal products in ATC groups C09C, C09D and C09X (angiotensin II antagonists and renin inhibitors).

Danish Medicines Agency

24-3-2010

The Danish Medicines Agency begins ad hoc reassessment of reimbursement status of medicines in ATC groups C09C, C09D and C09X

The Danish Medicines Agency begins ad hoc reassessment of reimbursement status of medicines in ATC groups C09C, C09D and C09X

On 8 March 2010, a number of pharmaceutical companies put generic copies of the angiotensin II antagonist losartan on the market at prices comparable to those of the cheapest ACE inhibitors.

Danish Medicines Agency

19-2-2010

Reassessment of the reimbursement status of ATC group A – alimentary tract and metabolism

Reassessment of the reimbursement status of ATC group A – alimentary tract and metabolism

The Danish Medicines Agency will begin its reassessment of ATC group A, alimentary tract and metabolism, which includes.

Danish Medicines Agency

7-1-2010

The Danish Medicines Agency initiates the reassessment of reimbursement status of medicines in ATC group N

The Danish Medicines Agency initiates the reassessment of reimbursement status of medicines in ATC group N

The Danish Medicines Agency initiates its reassessment of the reimbursement status of medicines in ATC group N (Nervous system). It will take place concurrently with the reassessment process for the remaining subgroups in ATC groups A and J.

Danish Medicines Agency

17-12-2009

Consultation on the Reimbursement Committee's recommendation concerning the reimbursement status of medicinal products in ATC group A02 (drugs for acid related disorders)

Consultation on the Reimbursement Committee's recommendation concerning the reimbursement status of medicinal products in ATC group A02 (drugs for acid related disorders)

At the request of the Danish Medicines Agency, the Reimbursement Committee has reassessed the reimbursement status of medicinal products in ATC group A02 (drugs for acid related disorders).

Danish Medicines Agency

1-12-2009

Decision on future reimbursement status of medicinal products in ATC groups A04 and A03FA

Decision on future reimbursement status of medicinal products in ATC groups A04 and A03FA

On 25 November 2009, the Danish Medicines Agency made a decision on the future reimbursement status of medicinal products in ATC group A04 (antiemetics and antinauseants) and medical products in ATC group A03FA (propulsives)

Danish Medicines Agency

5-10-2009

Decision on future reimbursement status for medicinal products in ATC group C04 (peripheral vasodilators)

Decision on future reimbursement status for medicinal products in ATC group C04 (peripheral vasodilators)

On 21 September 2009, the Danish Medicines Agency decided on the future reimbursement status of medicinal products in ATC group (peripheral vasodilators).

Danish Medicines Agency

2-10-2009

Consultation on the Reimbursement Committee’s recommendation concerning the reimbursement status of medicinal products in ATC group C05 (Vasoprotectives)

Consultation on the Reimbursement Committee’s recommendation concerning the reimbursement status of medicinal products in ATC group C05 (Vasoprotectives)

At the Danish Medicines Agency's request, the Reimbursement Committee has reassessed the reimbursement status of medicinal products authorised for marketing in Denmark in ATC group C05 (Vasoprotectives).

Danish Medicines Agency

8-9-2009

Decision on future reimbursement status of medicinal products in ATC group A06 (laxatives) and A02AA04 (magnesium compounds)

Decision on future reimbursement status of medicinal products in ATC group A06 (laxatives) and A02AA04 (magnesium compounds)

On 3 september 2009, the Danish Medicines Agency decided on the future reimbursement status of medicinal products in ATC group A06 (laxatives) and A02AA04 (magnesium compounds).

Danish Medicines Agency

4-8-2009

Decision on the future reimbursement status of medicinal products in ATC group A08 (antiobesity preparations, excl. diet products)

Decision on the future reimbursement status of medicinal products in ATC group A08 (antiobesity preparations, excl. diet products)

On 3 July 2009, the Danish Medicines Agency made a decision on the future reimbursement status of medicinal products in ATC group A08 (antiobesity preparations excl. diet products).

Danish Medicines Agency

30-6-2009

Consultation on the Reimbursement Committee’s recommendation concerning the reimbursement status of medicinal products in ATC group C04 (Peripheral vasodilators)

Consultation on the Reimbursement Committee’s recommendation concerning the reimbursement status of medicinal products in ATC group C04 (Peripheral vasodilators)

At the Danish Medicines Agency's request, the Reimbursement Committee has reassessed the reimbursement status of medicinal products authorised for marketing in Denmark in ATC group C04 (Peripheral vasodilators)

Danish Medicines Agency

30-6-2009

Consultation on the Reimbursement Committee’s recommendation concerning the reimbursement status of medicinal products in ATC groups A04 (antiemetics and antinauseants) and A03FA (propulsives)

Consultation on the Reimbursement Committee’s recommendation concerning the reimbursement status of medicinal products in ATC groups A04 (antiemetics and antinauseants) and A03FA (propulsives)

At the Danish Medicines Agency’s request, the Reimbursement Committee has reassessed the reimbursement status of medicinal products authorised for marketing in Denmark in ATC groups A04 (antiemetics and antinauseants) and A03FA (propulsives).

Danish Medicines Agency

9-6-2009

Changes in reimbursement for cardiovascular medicine as of 13 July 2009

Changes in reimbursement for cardiovascular medicine as of 13 July 2009

The Reimbursement Committee and the Danish Medicines Agency have reviewed medicinal products for the treatment of cardiovascular disease (‘antihypertensives’) in order to assess whether they meet the

Danish Medicines Agency

4-6-2009

Reimbursement status of medicinal products in ATC groups A06 and A02AA04, laxatives: Consultation responses to the Reimbursement Committee's recommendation

Reimbursement status of medicinal products in ATC groups A06 and A02AA04, laxatives: Consultation responses to the Reimbursement Committee's recommendation

The Reimbursement Committee's recommendation on the future reimbursement status of laxatives (ATC groups A06 and A02AA04) has been open for consultation until 27 May 2009.

Danish Medicines Agency

4-6-2009

Reimbursement status of medicinal products in ATC group A08, antiobesity preparations, excl. diet products: Consultation responses to the Reimbursement Committee's recommendation

Reimbursement status of medicinal products in ATC group A08, antiobesity preparations, excl. diet products: Consultation responses to the Reimbursement Committee's recommendation

The Reimbursement Committee's recommendation on the future reimbursement status of antiobesity preparations, excl. diet products (ATC group A08) has been open for consultation until 25 May 2009.

Danish Medicines Agency

4-5-2009

Consultation on the reimbursement status of medicinal products in ATC group A06 (laxatives) and A02AA04 (magnesium hydroxide)

Consultation on the reimbursement status of medicinal products in ATC group A06 (laxatives) and A02AA04 (magnesium hydroxide)

At the Danish Medicines Agency's request, the Reimbursement Committee has reassessed the reimbursement status of medicinal products authorised for marketing in Denmark in ATC group A06 (laxatives) and A02AA04 (magnesium hydroxide)

Danish Medicines Agency

30-4-2009

Consultation on the Reimbursement Committee’s recommendation concerning the reimbursement status of medicinal products in ATC group A08 (antiobesity preparations, excl. diet products)

Consultation on the Reimbursement Committee’s recommendation concerning the reimbursement status of medicinal products in ATC group A08 (antiobesity preparations, excl. diet products)

At the Danish Medicines Agency's request, the Reimbursement Committee has reassessed the reimbursement status of medicinal products authorised for marketing in Denmark in ATC group A08 (antiobesity preparations, excl. diet products).

Danish Medicines Agency

2-2-2009

Consultation responses on the future reimbursement status of 5 combination products in ATC groups C07, C08 and C09

Consultation responses on the future reimbursement status of 5 combination products in ATC groups C07, C08 and C09

The Danish Medicines Agency's assessment of the future reimbursement status of 5 combination products in ATC groups C07, C08 and C09 for the treatment of cardiovascular diseases has been submitted for consultation with 11 December 2008 as the consultation deadline.

Danish Medicines Agency

19-12-2008

Consultation responses on the future reimbursement status of dihydropyridine calcium antagonists (C08CA)

Consultation responses on the future reimbursement status of dihydropyridine calcium antagonists (C08CA)

The Danish Medicines Agency's assessment of the future reimbursement status of the dihydropyridine calcium antagonists (C08CA) were submitted for consultation with 11 November 2008 as the consultation deadline.

Danish Medicines Agency

27-11-2008

Reassessment of reimbursement status for 5 combination products in ATC groups C07, C08 and C09

Reassessment of reimbursement status for 5 combination products in ATC groups C07, C08 and C09

The Danish Medicines Agency has assessed the question of the future reimbursement status for five combination products in ATC groups C07, C08 and C09 on the basis of updated information about prices and consumption of these medicinal products.

Danish Medicines Agency

21-11-2008

Consultation responses on the future reimbursement status of medicinal products for cardiovascular diseases

Consultation responses on the future reimbursement status of medicinal products for cardiovascular diseases

The Reimbursement Committee’s additional recommendation concerning the future reimbursement status of medicinal products for cardiovascular diseases in ATC groups C02, C03, C07, C08 and C09 (antihypertensives) was submitted for consultation with 19 September 2008 as the consultation deadline

Danish Medicines Agency

29-10-2008

Reassessment of reimbursement status for medicinal products in ATC group C08CA

Reassessment of reimbursement status for medicinal products in ATC group C08CA

The Danish Medicines Agency has assessed the question of the future reimbursement status for medicinal products in ATC group C08CA (dihydropyridine calcium channel blockers) which are used for the treatment of cardiovascular diseases.

Danish Medicines Agency

8-9-2008

Reassessment of reimbursement status of medicinal products for cardiovascular diseases – additional recommendation from the Reimbursement Committee

Reassessment of reimbursement status of medicinal products for cardiovascular diseases – additional recommendation from the Reimbursement Committee

The Danish Medicines Agency has asked the Reimbursement Committee to reassess the reimbursement status of medicinal products authorised for marketing in Denmark in the ATC groups C02 (antihypertensives), C03 (diuretics), C07 (beta blocking agents), C08 (calcium channel blockers) and C09 (ACE inhibitors, angiotensin II antagonists and renin inhibitors).

Danish Medicines Agency

7-7-2008

Consultation responses to the recommendation about the reimbursement status for medicinal products for the treatment cardiovascular diseases

Consultation responses to the recommendation about the reimbursement status for medicinal products for the treatment cardiovascular diseases

The Reimbursement Committee's recommendation about the future reimbursement status of medicinal products for the treatment of cardiovascular diseases in ATC groups C02, C03, C07, C08 and C09 (antihypertensive drugs) was submitted for consultation on 5 May 2008.

Danish Medicines Agency

14-2-2008

Reassessment of reimbursement status for medicinal products for the treatment of cardiovascular diseases

Reassessment of reimbursement status for medicinal products for the treatment of cardiovascular diseases

Following a request from the Danish Medicines Agency, the Reimbursement Committee has reassessed the reimbursement status for medicinal products authorised for marketing in Denmark in ATC groups C02 (antihypertensives), C03 (diuretics), C07 (beta blocking agents), C08 (calcium channel blockers) and C09 (ACE inhibitors, angiotensin II antagonists and renin inhibitors).

Danish Medicines Agency

23-5-2007

Reassessment of the reimbursement status of blood pressure products resumed in the Reimbursement Committee

Reassessment of the reimbursement status of blood pressure products resumed in the Reimbursement Committee

At its meeting on 12 December 2006, the Reimbursement Committee resumed the reassessment of the reimbursement status of blood pressure products.

Danish Medicines Agency

29-3-2007

New reimbursement status of lipid lowering medicinal products enters into force on 23 April 2007

New reimbursement status of lipid lowering medicinal products enters into force on 23 April 2007

As of 23 April 2007, the reimbursement status of lipid lowering medicinal products will be changed. The decision includes all lipid lowering medicinal products with marketing authorisations in Denmark on 15 March 2007.

Danish Medicines Agency

15-2-2007

Reassessment of reimbursement status of medicinal products in ATC-groups A01, A04, C04, C05 and C10

Reassessment of reimbursement status of medicinal products in ATC-groups A01, A04, C04, C05 and C10

In connection with the reassessment of the reimbursement status of medicinal products, the Reimbursement Committee discussed the reimbursement status of certain ATC groups at its meeting on 16 January 2007.

Danish Medicines Agency

18-12-2006

Reassessment of reimbursement status for medicinal products for hypertension

Reassessment of reimbursement status for medicinal products for hypertension

In March 2006, the Danish Medicines Agency contacted a number of scientific societies to clarify certain aspects of the treatment of hypertension in Denmark.

Danish Medicines Agency

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